Barrier oversleeve usable with medical vesture and method of use thereof

Abstract

A barrier oversleeve usable with a protective vesture, the barrier oversleeve having a tubular cuff section comprising a cuff material and having a cuff section first end and a cuff section second end, and a tubular cushion section having a cushion material, the cushion section has a cushion section first end at the cuff section second end and a cushion section second end, the cushion material further includes a convergent material and / or a malleable material, and the cushion material has a first thickness and is capable of exhibiting a thickness variation of at least about 40% upon compression. Systems with barrier oversleeves, methods of manufacture, and methods of use are also disclosed.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Patent Application No. 18 / 330,066, filed on June 6, 2023, and U.S. Provisional Application No. 63 / 350,281, filed on June 8, 2022, the contents of which are incorporated herein in their entirety. Technical Field

[0003] The present disclosure relates to barrier sleeves that may be used with medical gowns and medical gloves. Background Art

[0004] In a medical setting, the interface between the glove and gown is one of the most troublesome areas found by medical professionals as fluids often penetrate the interface between the glove and gown.

[0005] There are several known causes of fluid penetration (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), which are often additive. First, oversized gowns are often used in hospitals and other medical settings to limit the number of gown sizes required (and thus reduce inventory costs). However, excess material at the sleeve of the gown may cause the glove hem to roll down, forming a notch at the glove / gown interface. Additionally, the glove has a tendency to slide due to the low friction interface between the inner surface of the glove and the outer surface of the gown. Additionally, excess material at the sleeve portion of a conventional medical gown may fold over to form longitudinal channels in the sleeve of the gown between the inner surface of the glove and the outer surface of the gown. These channels may allow fluid to pass between the external environment and the wearer.

[0006] Another potential cause of fluid penetration is the size of surgical gloves, which are typically sized for the hand but are often too large in the forearm and wrist area. When the glove does not fit snugly around the wrist and forearm of the user, fluid may leak from under the glove bead and downward through the wrist area. Additionally, excess glove material at the forearm portion and / or glove bead increases the risk of the glove rolling down and sliding, thereby exposing the gown cuff to fluid. There are also situations where the surgical glove fits the hand but the glove bead is too tight on the forearm. In this case, the glove bead may roll down, exposing the cuff which is not a barrier to fluids.

[0007] Previous attempts to address the problem of fluid penetration 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 rolling or sliding, without adequately addressing issues such as longitudinal channels in the sleeve material of the gown. In another example, it has been proposed to add cuffs to the sleeves of existing medical gowns so that the cuffs can be folded over the hem of the glove. However, this alternative requires additional steps in the donning and doffing process of the medical gown and gloves, which may be prohibitive for medical professionals who have been trained in conventional donning and doffing procedures that do not include such additional steps of adding cuffs and removing cuffs.

[0008]

[0006] Therefore, 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

[0009] The present disclosure relates to a barrier sleeve for use with a protective gown, the barrier sleeve comprising a tubular cuff section containing cuff material and having a cuff section first end and a cuff section second end, the tubular liner section containing a gathered liner material, wherein the liner section has a liner section first end and a liner section second end located at the cuff section second end, and wherein the gathered liner material has a first thickness and is configured to exhibit a thickness change of at least about 40% when compressed.

[0010] Also disclosed is a system comprising: a protective gown having a main 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, wherein the barrier sleeve comprises a tubular cuff section having a cuff section first end attached to the inner surface of the first sleeve portion or the second sleeve portion, and wherein the cuff section comprises a cuff material comprising at least two layers of nonwoven material with one or more elastic strands therebetween.

[0011] Also disclosed is a method of manufacturing a barrier sleeve having a padding section, the method comprising providing a padding section having a gathered padding material, wherein the gathered padding material is formed by providing one or more elastic strands in an elongated position, attaching the one or more elastic strands in the elongated position to one or more layers of nonwoven material, and allowing the one or more elastic strands to retract so that the one or more layers of nonwoven material attached thereto are gathered.

[0012] The present disclosure also relates to a medical glove that can be used with the protective gown as described herein. Also included are methods of making and using the barrier sleeve, medical gown, and / or system as described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 A schematic diagram of an exemplary barrier cuff according to aspects of the present disclosure is shown.

[0014] Figure 2 Exemplary medical or protective gowns are shown in accordance with aspects of the present disclosure.

[0015] Figure 3 Exemplary gloves according to aspects of the present disclosure are shown.

[0016] Figure 4 A picture showing a barrier cuff in accordance with aspects of the present disclosure is shown.

[0017] Figure 5 A schematic diagram of an exemplary system according to aspects of the present disclosure is shown.

[0018] Fig. 6A One aspect of an exemplary method of making a system as described herein is shown.

[0019] Figure 6B One aspect of an exemplary method of making a system as described herein is shown.

[0020] Figure 6C One aspect of an exemplary method of making a system as described herein is shown.

[0021] Fig.6D One aspect of an exemplary method of making a system as described herein is shown.

[0022] Fig. 6E One aspect of an exemplary method of making a system as described herein is shown.

[0023] Fig. 6F One aspect of an exemplary method of making a system as described herein is shown.

[0024] Figure 6G One aspect of an exemplary method of making a system as described herein is shown.

[0025] Figure 7 The distances measured in Example IV are shown.

[0026] Fig. 8A Two control cuffs as described in Example IV are shown.

[0027] Figure 8B Two cuffs of the invention as described in Example IV are shown. DETAILED DESCRIPTION

[0028] The specific embodiments described below in conjunction with the accompanying drawings are intended as descriptions of various configurations and are not intended to represent the only configurations in which the concepts described herein can be practiced. For the purpose of providing a thorough understanding of the various concepts, the detailed description includes specific details. However, it is clear to those skilled in the art that these concepts can be practiced without these specific details.

[0029] Throughout the disclosure, the term "substantially" or "approximately" may be used as a modifier of the geometric relationship between elements or the shape of an element or component. Although the term "substantially" or "approximately" is not limited to a specific change and can cover any change that a person of ordinary skill in the art understands to be an acceptable change, some examples are provided below. In one example, the term "substantially" or "approximately" may include a change of less than 10% of the size of an object or component. In another example, the term "substantially" or "approximately" may include a change of less than 5% of an object or component. In another example, the term "substantially" or "approximately" may include a change of less than 3% of an object or component. If the term "substantially" or "approximately" is used to define the angular relationship of one element to another element, a non-limiting example of the term "substantially" or "approximately" may include a change of 5 degrees or less. In another non-limiting example, the term "substantially" or "approximately" may include a change of 3 degrees or less. These examples are not intended to be limiting and may be increased or decreased based on the understanding of acceptable limits by a person skilled in the relevant art.

[0030] As used herein, the word "about" means within ±5%, alternatively within ±4%, alternatively within ±3%, alternatively within ±2%, and alternatively within ±1% of the stated value.

[0031] For purposes of this disclosure, when the systems and devices described herein are mounted in an orientation for use, directional terms are generally expressed relative to a standard reference frame.

[0032] Terms such as "a, an, and the" are not intended to refer to only a single entity, but include general categories that can be illustrated using specific examples. The terms "a, an, and the" can be used interchangeably with the term "at least one." The phrases "at least one of" and "including at least one of" followed by a list refer to any one of the items in the list and any combination of two or more items in the list. Unless otherwise specified, all numerical ranges include their endpoints and non-integer values ​​between the endpoints.

[0033] The terms "first", "second", "third", and "fourth" and other numerical values ​​may be used in the present disclosure. It should be understood that, unless otherwise stated, these terms are used only in a relative sense. In particular, in some aspects, certain components can exist in interchangeable and / or identical multiples (e.g., in pairs). For these components, when describing one or more aspects of the present disclosure, the names of "first", "second", "third", and / or "fourth" may be applied to these components for convenience only.

[0034] In view of the context, an overview of various aspects of the present disclosure and the advantages provided by the present disclosure is provided. This overview and the following specific embodiments are proposed for the purpose of illustration and description. It is not intended to be exhaustive, nor will the present disclosure be limited to the described form. According to the above teachings, many modifications can be made, including combinations of the above-mentioned aspects. Some of these modifications have been discussed, and those skilled in the art will understand other modifications. Various aspects are selected and described in order to best illustrate the principles of the present disclosure and various aspects suitable for the specific purposes envisioned. Of course, the scope of the present disclosure is not limited to the examples or aspects set forth herein, and can be used in any number of applications and equivalent devices by those of ordinary skill in the art. On the contrary, it is hereby intended to limit the scope by the attached claims.

[0035] The present disclosure relates to a barrier sleeve usable with a medical gown, wherein the barrier sleeve is configured to provide reduced fluid transfer between a wearer and an external environment. According to some aspects, the barrier sleeve comprises at least one of a cuff segment, a liner segment, and a funnel-shaped segment, wherein at least a portion of the barrier sleeve is configured to be worn under a sleeve portion of the medical gown. The present disclosure also relates to a medical gown with a barrier sleeve attached and to a system comprising a barrier sleeve as described herein, a medical gown as described herein, and / or a medical glove as described herein that can be used with a medical gown. Also included are methods of making and using a barrier sleeve, a medical gown, and / or a system as described herein.

[0036] According to some aspects, the barrier sleeve includes a cuff section that is configured to be worn on the arm of the wearer, particularly on the wrist and / or hand of the wearer. The cuff section may include a cuff material. In some non-limiting aspects, the cuff material may include a stretchable material. As used herein, "stretchable material" refers to a material with sufficient elasticity so that the structure formed by the material (e.g., the cuff section) remains substantially in contact with the wearer when worn. In some non-limiting examples, the cuff material may include a stretchable material so that the cuff section remains substantially in contact with the wrist and / or hand of the wearer when worn. In particular, the cuff material may have sufficient elasticity so that the cuff section remains in contact with the wrist and / or hand of the wearer under the glove during use, thereby reducing or eliminating fluid transmission between the wearer and the environment outside the cuff section and / or thereby reducing or eliminating the displacement of the cuff section relative to the wearer's arm during use.

[0037] Useful exemplary cuff materials according to 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 knitted fabrics, one or more elastic materials (e.g., spandex or rayon), one or more foams or combinations thereof. Non-limiting examples of nonwoven materials include nonwoven materials that contain polyolefins, such as polyethylene, polypropylene, blends thereof, and copolymers thereof. In some non-limiting examples, nonwoven materials include spunbond materials, meltblown materials, spunbond-meltblown-spunbond (SMS) laminates or combinations thereof. As used herein, "SMS laminates" refer to materials having a first spunbond layer and a second spunbond layer, with a meltblown layer between the first spunbond layer and the second spunbond layer. According to some aspects, the cuff material may include one or more layers of spunbond materials, one or more layers of meltblown materials, and / or one or more layers of SMS laminates as described herein.

[0038] Additionally or alternatively, the cuff material may comprise a laminate of a nonwoven material and an elastomeric film. Non-limiting examples of useful laminates according to the present disclosure include two-layer laminates (e.g., a laminate of a layer of nonwoven material and a layer of elastomeric film) and three-layer laminates (e.g., a laminate in which a layer of nonwoven material is located on both sides of an elastomeric film). In some examples, the elastomeric film may be elongated, and the nonwoven material may be bonded to the elongated film, as will be described herein. Useful non-limiting elastomeric films according to the present disclosure include films described in U.S. Patent No. 9,327,477, the contents of which are expressly incorporated herein in their entirety.

[0039] Additionally or alternatively, the cuff material may comprise a woven material, a knitted material, or a combination thereof. In some non-limiting examples, the cuff material may comprise a circular knitted material. As used herein, the term "circular knitting" refers to a form of weft knitting in which the needles are organized into a circular knitting bed.

[0040] Additionally or alternatively, the cuff material may comprise foam. Non-limiting examples of foam include silicone foam, polyurethane foam, and combinations thereof.

[0041] According to some aspects, the cuff material can include one, two, three, four or more layers of nonwoven materials as described herein, wherein each layer includes the same nonwoven material as other layers or different nonwoven materials. According to some aspects, each layer in the nonwoven material layer can independently include SMS laminate or spunbond material. According to some aspects, each layer of nonwoven material can independently have a weight between about 1gsm and 20gsm, optionally between about 5gsm and 15gsm, optionally between about 8gsm and 16gsm, and optionally about 12gsm. According to some aspects, each layer of the nonwoven material can independently have a weight between about 1 gsm and 20 gsm, optionally between about 10 gsm and 50 gsm, optionally between about 20 gsm and 50 gsm, optionally between about 20 gsm and 25 gsm, optionally between about 25 gsm and 30 gsm, optionally between about 30 gsm and 35 gsm, optionally between about 35 gsm and 40 gsm, optionally between about 40 gsm and 45 gsm, optionally about 22 gsm, optionally about 34 gsm, and optionally about 44 gsm.

[0042] Additionally or alternatively, the cuff material may include one or more elastic strands. As used herein, "strand" may refer to a material composition having fibers or filaments twisted, braided and / or laid in parallel, to form a unit for further twisting and / or braiding into yarn, fine wire, thick rope and / or rope. Exemplary materials for one or more elastic strands include but are not limited to elastic textile fibers, which contain polymers, such as polyurethane and / or poly (polyurethane urea) polymers. According to some aspects, one or more elastic strands may include spandex strands. Commercially available spandex strands include the spandex strands of Lycra, Creora, Roica and Dorlastan by name. According to some aspects, the cuff material may include two or more layers of nonwoven materials, woven materials, knitted materials and / or elastic materials as described herein, with one or more elastic strands being provided between the two or more layers.

[0043] According to some aspects, the cuff material can include one or more elastic strands having a linear quality and / or elongation sufficient to enable the cuff segment to function as described herein. For example, the one or more elastic strands can have a linear quality and / or elongation such that the cuff segment has sufficient elasticity to maintain substantial contact with the wearer's arm, wrist, and / or hand during use, as described herein.

[0044] In some aspects, the cuff material can be sufficiently elastic to maintain the cuff segment in substantial contact with the wearer's hand during donning and use of the glove, and in particular to reduce or eliminate displacement (e.g., proximal displacement) of the cuff segment relative to the wearer's hand during use.

[0045] In some non-limiting examples, one or more elastic strands may have a linear mass 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 elastic strands may have a linear mass of between about 300 dtex and 900 dtex, optionally between about 400 dtex and 800 dtex, optionally between about 500 dtex and 700 dtex, and optionally between about 540 dtex and 680 dtex. In some non-limiting examples, one or more elastic strands may have an elongation between about 100% and 500%, optionally between about 200% and 400%, optionally between about 200% and 350%, and optionally about 300%.

[0046] According to some aspects, the cuff material can include one or more spaced apart elastic strands such that the cuff segment remains in substantial contact with the hand and / or wrist of the wearer during use, as described herein. For example, according to some aspects, the distance between at least the first elastic strand and the second elastic strand can be between about 1 mm and 15 mm, optionally between about 1 mm and 11.5 mm, and optionally between about 2 mm and 7.5 mm. According to some aspects, the cuff material can include 1 to 40 elastic strands, optionally between about 10 and 30, and optionally about 20. According to some aspects, the cuff 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, 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, optionally 20 strands.

[0047] According to some aspects, the cuff material can include one or more elastic strands, wherein at least a portion of the elastic strands extend laterally or substantially laterally relative to the length of a limb (e.g., arm) when the cuff section is worn by a wearer.

[0048] According to some aspects, the cuff material may include one or more elastic strands, which are approximately evenly spaced in the longitudinal direction of the length of the limb when the cuff section is worn by the wearer. Alternatively, the cuff material may include one or more elastic strands, which are unevenly spaced in the longitudinal direction of the length of the limb when the cuff section is worn by the wearer. For example, the space between the strands may be reduced in the distal direction (i.e., in the direction away from the wearer's body). In other words, the strands may be closer together at the first end or distal end of the cuff section than at the second end or proximal end of the cuff section. In this way, the pressure provided by the distal end of the cuff may be reduced. In some aspects, one or more elastic strands may extend parallel to each other or substantially parallel to each other. In some non-limiting examples, one or more parts of the cuff section may not have strands.

[0049] According to some aspects, the cuff material may include a first portion of elastic strands and a second portion of elastic strands, wherein when the cuff section is worn by a wearer, the first portion of elastic strands extend laterally or substantially laterally relative to the length direction of the limb, and the second portion of elastic strands extend longitudinally or substantially longitudinally relative to the length direction of the limb, thereby forming an elastic strand network.

[0050] According to some aspects, the cuff material may include a "gathered" material. As used herein, the term "gathered" refers to a material that has been modified to increase the thickness of the material when compared to the same material that is not gathered. For example, a gathered material may wrinkle or bulge compared to the same material that is not gathered.

[0051] According to some aspects, the gathered material can be formed by a process including one or more gathering steps. In a non-limiting example, one or more gathering steps can include providing one or more elastic strands as described herein in an elongated position, attaching one or more elastic strands to one or more layers of nonwoven material, and allowing one or more elastic strands to retract so that one or more layers of nonwoven material attached thereto gather. Attaching one or more elastic strands to one or more layers of nonwoven material can be performed by a step suitable for gathering as described herein, including but not limited to via an adhesive (such as a hot melt adhesive), ultrasonic bonding, ultrasonic welding, sewing, and combinations thereof.

[0052] Additionally or alternatively, one or more gathering steps may include providing an elastomeric film as described herein in an elongated position, attaching the elastomeric film to one or more layers of nonwoven material, and allowing the elastomeric film to retract so that the one or more layers of nonwoven material attached thereto gather. In this example, the elastomeric film may be elongated in the machine direction, in the cross-machine direction, or in both the machine direction and the cross-machine direction.

[0053] Additionally or alternatively, one or more of the gathering steps may include a dry mechanical compression process, such as that performed by a microcreper system (e.g., In one non-limiting example, one or more gathering steps may include creping one or more layers of nonwoven material as described herein without the use of an elastic material.

[0054] It should be understood that one or more gathering steps as described herein can impart elasticity to the material. For example, a non-elastic nonwoven material as described herein can be gathered as described herein to provide an elastic material, i.e. a material that can recover its normal shape after being stretched or compressed.

[0055] In some non-limiting examples, one or both ends of the cuff section can be folded and fixed, thus increasing the strength and durability of the corresponding cuff edge. In some examples, at one or both ends of the cuff section, one, two, three, four or more layers of material as described herein can extend a certain distance past the last strand, so that the material layer can be folded on itself (i.e., the cuff section has no strands) and / or folded on all or part of the cuff section with one or more strands. In some non-limiting examples, the certain distance allows the cuff section without strands to be folded on the entire part of the cuff section with one or more strands. That is, the certain distance can be at least about the length of the part of the cuff section with one or more strands in the longitudinal direction of the length of the limb. 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 can have strands and can be folded as described herein. According to some aspects, the folded portion can have a length of between about 1mm and 10mm, optionally about 5mm, in the longitudinal direction of the length of the limb. According to some aspects, securing the folded portion may include providing a permanent attachment. As used herein, the terms "permanently attached" and "permanent attachment" refer to attachments that are not easily broken, for example, attachments via adhesives (such as hot melt adhesives), stitching (including ultrasonic stitching), ultrasonic bonding, thermal bonding, tape, sealing (such as heat sealing), glue, and combinations thereof.

[0056] According to some aspects, the thickness of the cuff material can be selected so as to reduce the inhibition of the wearer's movement by the cuff section at the hand and / or wrist located proximal to the cuff section. As used herein, the thickness of a material can refer to the distance between its first side and its second side, and can be measured using a device such as a caliper. According to some aspects, the cuff material can have a first thickness, which is between about 1 mm and 10 mm, optionally between about 1 mm and 5 mm, optionally about 2.5 mm, and optionally no more than about 2.5 mm.

[0057] According to some aspects, the cuff segment can define a generally tubular shape sufficient to fit on the arm, wrist and / or hand of the wearer, as described herein. As used herein, the term "tubular" can refer to an elongated, closed and hollow shape, and is not necessarily limited to a specific cross-sectional shape. In some examples, the generally tubular shape can have a circular cross-sectional shape. In some examples, the generally tubular shape can have an oval cross-sectional shape. According to some aspects, the generally tubular shape can be formed by attaching two, three, four or more sections of the cuff material as described herein along the length of the tubular shape to provide a tube. According to some aspects, the generally tubular shape can be formed by attaching two sections of the cuff material having approximately the same size along the length of the tubular shape via a permanent attachment as described herein. Additionally or alternatively, the cuff segment can be formed by attaching two, three, four or more tubular sections of the cuff material as described herein along its circumference to provide a cuff segment. In some non-limiting examples, two, three, four, or more tubular sections may be attached along their circumferences via permanent attachments.

[0058] According to some aspects, the cuff segment can have a diameter between about 1 inch and 10 inches, optionally between about 1 inch and 5 inches, optionally between about 2 inches and 4 inches, and optionally about 2.75 inches. As used herein, the term "diameter" can refer to the maximum diameter of a tubular shape (e.g., the diameter about the outer surface of the tubular member). For purposes of this application, 1 inch is equivalent to 2.54 centimeters.

[0059] In some non-limiting examples, the cuff section may have a gathered circumference of between about 1 inch and 20 inches, optionally between about 2 inches and 14 inches, optionally between about 5 inches and 12 inches, and optionally between about 8 inches and 11 inches.

[0060] It should be understood that when a tubular component as described herein comprises an elastic material, the diameter and circumference of the component may change as the elastic material is stretched. As used herein, the measurements provided for the diameter and circumference of a component may refer to the corresponding dimensions of the component when the component is in an unstretched configuration.

[0061] According to some aspects, the cuff segment can have a length relative to the length of the wearer's limb of between about 1 inch and 20 inches, optionally between about 1 inch and 15 inches, optionally between about 1 inch and 10 inches, optionally between about 2.5 inches and 7.5 inches, optionally about 5 inches, and optionally about 3 inches.

[0062] The barrier sleeve according to the present disclosure may further include a padded section. The padded section may 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 before the wearer's elbow.

[0063] According to some aspects, the pad section can define a generally tubular shape sufficient to fit around a wearer's arm (such as around a wearer's forearm), as described herein. The pad section can have a length (e.g., a dimension along the length of a wearer's arm when worn) of between about 1 inch and 20 inches, optionally between about 1 inch and 15 inches, optionally between about 1 inch and 10 inches, optionally between about 2 inches and 7.5 inches, and optionally about 5 inches.

[0064] According to some aspects, the cushion segment can have a diameter between about 1 inch and 10 inches, optionally between about 1 inch and 6 inches, optionally between about 1 inch and 5 inches, and optionally about 3.50 inches.

[0065] According to some aspects, the cushion segments can have a gathered circumference between about 3 inches and 25 inches, optionally between about 5 inches and 20 inches, optionally between about 7 inches and 18 inches, optionally between about 8 inches and 15 inches, and optionally between about 10 inches and 13 inches.

[0066] According to some aspects, the pad section can have a first end and a second end, wherein the first end can be attached to and / or attached to the second end of the cuff section, as described herein. According to some aspects, the "first end" as described herein can be the distal end, i.e., the end of the component farthest from the wearer's body when the component is worn. The "second end" as described herein can be the proximal end, i.e., the end of the component closest to the wearer's body when the component is worn.

[0067] It should be understood that the term "attachment" as used herein encompasses reversible attachment and permanent attachment. As used herein, the term "reversibly attached" refers to an attachment that can be easily disconnected, such as an attachment via a fastener. Examples of fasteners include any fastener known in the art that is configured to reversibly connect two parts of a garment as described herein and is suitable for use in a medical environment. For example, the fastener can be selected from the group consisting of a tie, a snap, a button, a fabric hook and loop fastener, a zipper, a buckle, a hook and eye, a cord, a hitch, a brooch, an eyelet, and / or a combination thereof. The term "permanent attachment" has been described above.

[0068] According to some aspects, the pad section and the cuff section can include discrete materials so that no attachment is necessarily required. For example, the pad section and the cuff section can include one or more layers of material as described herein, wherein the one or more layers of material form at least a portion of the cuff section and at least a portion of the pad section.

[0069] According to some aspects, the pad section may include a pad material. In some non-limiting examples, the pad material may include a stretchable material so that the pad section remains in substantial contact with the wearer's arm during use and, in particular, reduces or eliminates displacement of the pad section relative to the wearer's arm during use.

[0070] Useful exemplary padding materials according to the present disclosure include, but are not limited to, one or more nonwoven materials, one or more woven materials, one or more knitted fabrics, one or more elastic materials, one or more foams, or combinations thereof, as described herein. According to some aspects, the padding material may comprise one or more nonwoven materials and / or one or more elastomeric films, as described herein. According to some aspects, the padding material may comprise one or more layers of spunbond, meltblown, and / or SMS laminates, as described herein.

[0071] According to some aspects, the cushioning material can include one, two, three, four or more layers of elastic material as described herein, wherein each layer includes the same material as the other layers or a different material. Each of the one, two, three, four or more layers of elastic material can be attached to at least one other layer by any of the attachment mechanisms as described herein.

[0072] According to some aspects, the backing material may include one, two, three, four or more layers of spunbond, meltblown and / or SMS laminate, wherein each of the layers is the same material as the other layers or a different material than the other layers. According to some aspects, the backing material may include one, two, three, four or more layers of SMS laminate, wherein each layer may independently have a weight between about 1 gsm and 50 gsm, optionally between about 1 gsm and 40 gsm, optionally between about 10 gsm and 30 gsm, optionally about 20 gsm, and optionally about 25 gsm.

[0073] According to some aspects, the cushioning material can include one or more elastic strands as described herein. According to some aspects, the cushioning material can include two or more layers, as described herein, with the elastic strands provided between the two or more layers. According to some aspects, the elastic strands can be attached to the one or more layers by any process suitable according to the present disclosure, as described herein.

[0074] According to some aspects, the padding material may include one or more elastic strands having a linear quality and / or elongation such that the padding section remains substantially in contact with the wearer's forearm during use, as described herein. In some non-limiting examples, the one or more elastic strands may have a linear quality 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, one or more elastic strands may have a linear mass of between about 300 dtex and 900 dtex, optionally between about 400 dtex and 800 dtex, optionally between about 500 dtex and 700 dtex, and optionally between about 540 dtex and 680 dtex. Additionally or alternatively, one or more elastic strands may have a linear mass of about 1100 dtex or about 1520 dtex. In some non-limiting examples, one or more elastic strands may have an elongation of between about 100% and 500%, optionally between about 200% and 400%, optionally between about 250% and 350%, optionally between about 275% and 350%, and optionally between about 275% and 325%.

[0075] According to some aspects, the padding material can include one or more spaced apart elastic strands such that the padding section remains in substantial contact with the wearer's arm during use, as described herein. For example, according to some aspects, the distance between at least the first elastic strand and the second elastic strand can be between about 0.1 inches and 5 inches, optionally between about 0.1 inches and 2 inches, and optionally about 1 inch. According to some aspects, the distance between at least the first elastic strand and the second elastic strand can be between about 3 mm and 100 mm, optionally between about 5 mm and 50 mm, and optionally about 25 mm.

[0076] According to some aspects, the padding material may include one or more elastic strands, wherein at least a portion of the elastic strands extend in a direction lateral to the length of the limb when the padding section is worn by the wearer. According to some non-limiting examples, the padding material may include one or more elastic strands, which are approximately evenly spaced apart in a direction lateral to the length of the limb when the padding section is worn by the wearer. According to some aspects, the padding material may include 1 to 10 elastic strands, optionally between about 4 to 7, optionally 5 or 6. According to some aspects, the padding 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.

[0077] According to some aspects, the padding material may include a first portion of elastic strands and a second portion of elastic strands, wherein when the padding section is worn by a wearer, the first portion of elastic strands extend laterally or substantially laterally relative to the length direction of the limb, and the second portion of elastic strands extend longitudinally or substantially longitudinally relative to the length direction of the limb, thereby forming an elastic strand network.

[0078] According to some aspects, the padding material can have a second thickness greater than the thickness of the cuff material. For example, the padding material can have a thickness between about 1 mm and 20 mm, optionally between about 5 mm and 15 mm, and optionally between 7.5 mm and 12 mm. According to some aspects, the padding material can have a second thickness greater than the thickness of the cuff material. For example, the padding material can have a thickness between about 1 mm and 10 mm, and optionally between 1 mm and 5 mm. In some examples, the padding 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. According to some aspects, the padding material is configured to be rolled into an elastic loop that is positioned on the forearm distal to the glove bead and proximal to the wearer's wrist, thereby creating an additional thickness of up to 25 mm.

[0079] According to some aspects, the cushion material can include a gathered material, as described herein.

[0080] According to some aspects, the liner material can be easily compressible. As used herein, the term "easy to compress" refers to a material that is configured to have a first thickness and a second thickness when compressed, wherein the second thickness is different from the first thickness. According to some aspects, compression can refer to the approximate compressive force provided by the bead of the glove when worn by a wearer.

[0081] According to some aspects, the material that is easily compressed can be a material that exhibits a certain thickness change when compressed, that is, as described herein, there is a certain difference between the first thickness and the second thickness. In a non-limiting example, a device such as a caliper can be used to measure the change in thickness. A non-limiting example of a caliper for measuring according to the present disclosure includes an Ames model AQD-2110N gauge using a 1-inch diameter foot. According to some aspects, a caliper to which a first pressure is applied can be used to measure the first thickness of the material, and a caliper to which a second pressure is applied can be used to measure the second thickness of the material. According to some aspects, the first pressure can correspond to the use of a caliper without adding additional weight thereto, and the second pressure can be provided by adding weight to the caliper. In some non-limiting examples, the weight can be between about 0.01 pounds and 1 pound, optionally between about 0.25 pounds and 0.75 pounds, and optionally about 0.5375 pounds. For the purposes of this application, the conversion value of 1 pound is 453.6 grams.

[0082] According to some aspects, the easily compressible material can be a material that exhibits a thickness variation 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% when compressed as described herein. According to some aspects, the easily compressible material can be a material that exhibits a thickness variation of between about 20% and 90%, optionally between about 30% and 80%, and optionally between about 40% and 70% when compressed.

[0083] According to some aspects, the gathered material can exhibit a thickness variation when compressed by one or more glove curls, thereby forming a channel in the gathered material located proximal to the one or more glove curls. For example, when a barrier sleeve having a padding segment as described herein extends from a first end to a second end along a longitudinal direction of the length of a wearer's arm when worn, and when the wearer wears one or more gloves over the barrier sleeve, the gathered material can be configured to compress proximal to the glove curl so as to form one or more channels that are substantially transverse (i.e., laterally) to the length dimension (e.g., along the circumference of the tubular padding segment). According to some aspects, the one or more channels may be sufficient to engage with the one or more glove curls to eliminate or reduce penetration of fluid toward the cuff segment. Additionally or alternatively, the one or more channels may be sufficient to engage with the one or more glove curls to eliminate downward rolling of the one or more glove curls.

[0084] According to some aspects, the barrier sleeve can further include a funnel-shaped section. The funnel-shaped section can be configured to be worn on a wearer's arm, such as around a wearer's forearm. The funnel-shaped section can have a first end and a second end, wherein the first end can be attached to and / or attached to the second end of the pad section, as described herein.

[0085] According to some aspects, the funnel-shaped segment can have a circumference and / or diameter that is larger than the circumference and / or diameter of the cushion segment. The funnel-shaped segment can have an approximately constant circumference and / or diameter. Alternatively, the funnel-shaped segment can have a varying circumference and / or diameter along its length. For example, the funnel-shaped segment can have a circumference and / or diameter at the first end that is approximately equal to the circumference and / or diameter of the second end of the cushion segment. In this example, the circumference and / or diameter of the funnel-shaped segment can increase along the length of the funnel-shaped segment toward the second end to form a funnel shape.

[0086] According to some aspects, the funnel-shaped section may include a funnel material. Useful exemplary funnel materials according to the present disclosure include, but are not limited to, nonwoven materials and elastic materials as described herein. For example, the funnel material may include one or more nonwoven materials as described herein, such as a nonwoven material comprising polyolefins. According to some aspects, the funnel material may include one or more layers of spunbond materials, meltblown materials and / or SMS laminates as described herein. According to some aspects, the funnel material may include one, two, three, four or more layers of materials as described herein, wherein each layer includes the same material or different materials as other layers. Additionally or alternatively, the funnel material may include one or more elastic strands as described herein.

[0087] According to some aspects, the funnel-shaped section can be attachable to and / or attached to the cushion section by any mechanism as described herein. Alternatively, the funnel-shaped section and the cushion section can include discrete materials so that an attachment mechanism is not necessarily required. For example, the funnel-shaped section and the cushion section can include one or more layers of material as described herein, wherein the one or more layers form at least a portion of the funnel-shaped section and at least a portion of the cushion section. In a non-limiting example, the funnel-shaped section and the cushion section can include one or more layers of SMS laminate as described herein. In this example, the cushion section can include one or more elastic strands as described herein to provide a gathered cushion material. The funnel-shaped section can also include elastic strands, or the funnel-shaped section can be free of elastic strands so that the funnel material does not gather.

[0088] According to some aspects, the barrier sleeve as described herein can be used with the corresponding sleeve portion of the gown. According to some aspects, the gown is a protective gown, also known 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 according to the present disclosure include, but are not limited to, surgical gowns, isolation gowns, and non-surgical gowns, including gowns used in the central sterilization department of a hospital (where used reusable surgical instruments are manually cleaned in a sink before entering an automatic cleaning machine) and gowns used in hazardous chemical environments with a higher risk of fluid exposure. Exemplary medical environments include, but are not limited to, hospitals, medical offices, blood banks, shelters, imaging and radiology centers, nursing homes, rehabilitation centers, and emergency care centers. According to some aspects, the gown is an industrial gown. As used herein, the term "industrial gown" refers to a gown used in a potentially dangerous industrial environment (such as an industrial environment where people may be exposed to hazardous chemicals).

[0089] According to some aspects, the medical gowns as described herein meet the required performance standards outlined in ASTM F2407 Standard Specification for Surgical Gowns for Use in Medical Facilities. For medical gowns, including but not limited to performance standards for tensile strength (e.g., ASTM D5034, ASTM D1682), tear resistance (e.g., ASTM D5 587 (woven), ASTM D5733 (nonwoven), ASTM D1424), seam strength (e.g., ASTM D751 (stretch woven or knitted)) and ASTM D1683 / D1683M for woven and nonwoven materials, lint generation (e.g., ISO 9073 Part 10), abrasion resistance ASTM D4966, water vapor permeability (e.g., ASTM F1868 Part B, ASTM D6701 (nonwoven), ASTM D737-75, ASTM E96 / E96M, ASTM F1249), or combinations thereof. Additionally or alternatively, the medical gown may meet the requirements of ANSI / AAMIPB 70, Level 1, Level 2, Level 3, or Level 4. In one non-limiting example, the medical gown may meet the requirements of ANSI / AAMIPB 70 (i.e., ASTM F1670 and ASTM F1671), Level 4. Additionally or alternatively, the medical gown may meet one or more requirements for viral penetration specified by ASTM F1671. It should be understood that all performance requirements cited herein are incorporated by reference in their entirety.

[0090] 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 sleeve portions may include a gown material having a low basis weight that is sufficient to provide acceptable drape, i.e., the ability to conform to a surface shape. As used herein, "acceptable drape" may refer to drape 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 will be described with respect to barrier sleeves. It should be understood that gown materials with lower basis weights and / or higher drape may be more likely to form channels than, for example, gown materials that are harder and / or have poorer drape.

[0091] Non-limiting examples of useful coverall materials according to the present disclosure include laminates with discontinuous bonding. As used herein, a laminate with "discontinuous bonding" refers to a laminate in which less than 100% of the surface area of ​​the laminate layer is bonded. For example, a laminate with discontinuous bonding can include two or more layers bonded via thermal patterned calendar bonding, patterned hot melt spraying, or a combination thereof. According to some aspects, the laminate can include one or more layers of a monolithic film, a nonwoven material, or a combination thereof.

[0092] In some non-limiting examples, the gown material may have a basis weight between about 25 gsm and 90 gsm, optionally between about 30 gsm and 85 gsm, optionally between about 34 gsm and 75 gsm, including any values ​​therebetween.

[0093] The medical gown according to the present disclosure can be a single-use gown or a multiple-use gown. In some non-limiting examples, the multiple-use gown can include a woven material known in the art that is sufficiently launderable.

[0094] In some aspects, a barrier sleeve may be used with a protective gown, which may be used in any situation where the wearer of the gown is protected from the external environment or contaminants associated therewith and / or the external environment is protected from contaminants that the wearer may introduce into the external environment.

[0095] According to some aspects, at least a portion of the barrier sleeve is configured to be worn by a user beneath a sleeve portion of a medical gown. As used herein, the term "below" refers to a location proximal to the wearer's arm. In one example of the above-described sealing interaction (also referred to as a sealing engagement), an elastic glove bead engages a lateral channel formed in a padding segment via compression (e.g., the elastic glove bead may be retained within the lateral channel or otherwise restrained within the lateral channel), as described herein. The engagement interaction does not require the glove bead to directly contact the padding segment (e.g., the sleeve portion of the medical gown may be sandwiched between the glove bead and the padding segment). The engagement interaction may provide an additional one or more layers of sealing interaction between the glove bead and the channel of the padding segment, thereby eliminating or reducing penetration of fluid toward the cuff segment.

[0096] In one preferred example, the pad section can be worn by the user beneath the sleeve of a gown, and the elastic glove cuff can be retentively retained within one or more channels formed in the pad section as described herein, with a portion of the gown sleeve also retentively retained between the glove cuff and the pad section. Thus, in the above examples, the pad section provides a seal or partial seal between the glove cuff and the gown sleeve, thereby reducing and / or eliminating fluid penetration toward the cuff section. In some examples where fluid may penetrate the glove cuff, the pad 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 the forearm toward the hand of the wearer.

[0097] Additionally or alternatively, the barrier cuff can be configured such that if the fluid penetrates beyond the liner section as described herein, the cuff section can protect the hand from fluid exposure.

[0098] Figure 1 An exemplary sleeve portion 101 of a medical gown as described herein is shown. The sleeve portion 101 can have a first circumference 117 as known in the art. For example, the sleeve portion 101 can have a relatively large first circumference 117, so that the sleeve portion 101 is relatively too large relative 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 circumference measured at 9 inches from the end of the gown sleeve, the first circumference is between about 10 inches and 20 inches, optionally between about 15 inches and 21 inches, and optionally between about 16 inches and 18 inches.

[0099] like Figure 1 As shown, the sleeve portion 101 can have a circumference that varies along its length. For example, the sleeve portion 101 can have a first circumference 117 as described herein, which is approximately located proximal to the funnel-shaped section 105 as described herein. It should be understood that the first circumference 117 can be slightly smaller than the circumference of the funnel-shaped section 105 at the second end 115, so that when the funnel-shaped section 105 and the sleeve portion 101 are attached to each other, the funnel-shaped section 105 does not unacceptably pull at the sleeve portion 101 when worn.

[0100] Additionally or alternatively, the sleeve portion can have a second circumference 118 and / or a third circumference 119 that are different from the first circumference 117. In this example, the second circumference 118 can be located approximately proximal to the pad section 104 as described herein, and the third circumference 119 can be located approximately proximal to the cuff section 103 as described herein. The second circumference 118 can be between about 10 inches and 20 inches, optionally between about 10 inches and 15 inches, and optionally between about 12 inches and 14 inches. The third circumference 119 can be between about 5 inches and 20 inches, optionally between about 10 inches and 15 inches, and optionally between about 11 inches.

[0101] Figure 1 Also shown is an exemplary barrier sleeve 102 having a cuff section 103, a pad section 104, and a funnel section 105 as described herein. Figure 1 As shown, the barrier sleeve 102 can be reversibly or permanently attached to the sleeve portion 101. For example, the funnel-shaped section 105 can have a second end 115 that is directly or indirectly attachable and / or attached to the interior surface of the sleeve portion 101, such as Figure 1 According to some aspects, the sleeve portion 101 may be free of structural attachment features, that is, free of structural features configured to facilitate attachment of the barrier sleeve 102 thereto. The structural attachment features may include, for example, tabs, lugs, and / or other accessory structures that would not be provided on the sleeve portion without the barrier sleeve 102.

[0102] According to some aspects, the second end 115 of the funnel-shaped segment 105 can be attached to the inner surface of the sleeve portion 101 via a permanent attachment as described herein. In some non-limiting examples, the permanent attachment can include a hot melt. In this example, a portion 120 of the funnel-shaped segment 105 can be attached to the inner surface of the sleeve portion 101 by applying a hot melt spray to a portion 120 of the funnel-shaped segment 105 having a certain length in the longitudinal direction. According to some aspects, the length of the portion 120 can be between about 0.1 inches and 1 inch, optionally between about 0.25 inches and 0.75 inches, and optionally about 0.5 inches. Additionally or alternatively, a hot melt spray can be applied to a corresponding portion of the inner surface of the sleeve portion 101, and the two portions can be pressed together to form a permanent attachment. However, it should be understood that the present disclosure is not necessarily limited to this approach. For example, portion 120 of funnel section 105 and a corresponding portion of the interior surface of sleeve portion 101 can be attached via any permanent attachment as described herein, including thermal bonding, ultrasonic bonding, or a combination thereof.

[0103] In one non-limiting example, the portion 120 of the funnel-shaped section 105 can be attached to the interior surface of the sleeve portion 101 by first placing the sleeve portion 101 inside outward on the support so that the interior surface of the sleeve portion 101 is exposed. The funnel-shaped section 105 can then be placed on the sleeve portion 101, and at least the portion 120 of the funnel-shaped section 105 can be folded and / or rolled up. Then, optionally, with the rotation of the support, a hot melt spray is applied to the interior surface of the sleeve portion 101 and / or the folded and / or rolled up portion 120 of the funnel-shaped section 105. Then, the folded and / or rolled up portion 120 of the funnel-shaped section 105 can be unfolded and / or rolled out so that it contacts the interior surface of the sleeve portion 101, and then the portion 120 of the funnel-shaped section 105 and the interior surface of the sleeve portion 101 can be pressed together to provide a permanent attachment.

[0104] In another non-limiting example, portion 120 of funnel section 105 and the interior surface of sleeve portion 101 may be attached via ultrasonic bonding to provide a permanent attachment having the characteristics of a single nonwoven layer.

[0105] like Figure 1 As shown, at least a portion of the barrier sleeve 102 may be non-attachable and / or not attached to the sleeve portion 101. For example, the second end 106 of the liner segment 104 may be disposed at the first end 116 of the funnel-shaped segment 105, wherein the liner segment 104 is not otherwise connected to the sleeve portion 101. Figure 1 As shown, the pad section 104 can have a second circumference and / or a second diameter as described herein, wherein the second circumference or second radius is smaller than the second circumference 118 of the sleeve portion 101. In this manner, the sleeve portion 101 can freely move relative to the pad section 104, and vice versa.

[0106] like Figure 1 As shown, the liner section 104 can have a first end 107 at a second end of the cuff section 103 as described herein. In this example, the cuff section 103 can be attachable and / or attached to the sleeve portion 101. For example, as Figure 1 As shown, the cuff section 103 can be attached and / or attached to the inner edge surface 108 of the sleeve portion 101 by any attachment mechanism as described herein. According to some aspects, the cuff section can be attached and / or attached to the inner edge surface of the sleeve portion to avoid holes in the sleeve portion and / or cuff portion, thereby maintaining the barrier properties of the medical gown.

[0107] It should be understood that the cuff section 103 may be attachable and / or attached to the sleeve portion 101 at any location of the cuff section 103. For example, Figure 1As shown, the cuff section 103 can be attachable and / or attached to the sleeve portion 101 at a first distance 110 from the 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 can be between about 1 inch and 10 inches, optionally between about 1 inch and 5 inches, and optionally about 3 inches.

[0108] like Figure 1 As shown, if the cuff segment 103 is attachable and / or attached to the inner edge surface 108 of the sleeve portion 101 at a first distance 110 from the first end 109 of the cuff segment 103, the cuff segment 103 will include an exposed portion 111 and an unexposed portion 112, as shown. In this example, the exposed portion 111 will have a length equal to the first distance 110, while the unexposed portion 112 will have a length equal to a second distance 113, which corresponds to the distance between the second end 114 of the cuff segment 103 and the attachment point of the cuff segment 103 to the inner edge surface 108 of the sleeve portion 101. In some non-limiting examples, the second distance 113 can be between about 1 inch and 10 inches, optionally between about 1 inch and 5 inches, and optionally about 2 inches.

[0109] It should be understood that although Figure 1 The exemplary barrier sleeve 102 shown in the figure includes a cuff section 103, a pad section 104, and a funnel section 105 as described herein, but the barrier sleeve of the present disclosure is not necessarily limited to this figure. For example, the 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 pad section 104, or only the funnel section 105. In another example, the barrier sleeve may include only the funnel section 105 and the cuff section 103, wherein the second end 114 of the cuff section is disposed at the first end 116 of the funnel section 105. In another example, the barrier sleeve may include only the pad section 104, which may be attachable and / or attached to the sleeve portion 101 or may not be attachable and / or not attached to the sleeve portion.

[0110] Additionally or alternatively, it should be understood that although Figure 1The exemplary barrier sleeve 102 shown in the figure can be attached to and / or attached to the sleeve portion 101 at the second end 115 of the funnel-shaped section 105 and the cuff section 103, but the present disclosure need not be limited to this way. For example, the barrier sleeve 102 can be attached to and / or attached to the sleeve portion 101 only at the second end 115 of the funnel-shaped section 105 or only at the cuff section 103, as shown in the figure. Additionally or alternatively, the sleeve portion 101 can be attached to and / or attached to the funnel-shaped section at a distance from the second end 115 of the funnel-shaped section 105. Alternatively, the barrier sleeve 102 may not be attached to and / or not attached to the sleeve portion 101 at all, and can be presented as a "stand-alone" medical device. In this case, the wearer can use the funnel-shaped section to aseptically wear and remove the independent device.

[0111] Additionally or alternatively, it should be understood that although Figure 1 The exemplary barrier sleeve 102 shown in FIG. 1 is attachable and / or attached to the sleeve portion 101 over the entire circumference of the sleeve portion 101 and the barrier sleeve 102, but the present disclosure is not necessarily limited in this manner. For example, only a portion of the circumference of the second end 115 of the funnel-shaped segment 105 may be attachable and / or attached to the interior surface of the sleeve portion 101. Additionally or alternatively, only a portion of the circumference of the cuff segment 103 may be attachable and / or attached to the sleeve portion 101.

[0112] Figure 4 Shown as Figure 1 A picture of an exemplary barrier sleeve 402 is shown, which has features similar to Figure 1 Features shown include a cuff section 403 having a first end 409 and a second end 414 , a pad section 404 having a first end 407 and a second end 406 , and a funnel section 405 having a first end 416 and a second end point 415 .

[0113] The barrier sleeve according to the present disclosure is configured to provide reduced fluid transmission between the wearer and the external environment. As used herein, "fluid" refers to any fluid that may be found in a medical environment, including but not limited to body fluids (e.g., blood, sweat, urine), medical fluids (e.g., sterile fluids, intravenous fluids), etc.

[0114] According to some aspects, reduced fluid transfer can be achieved at least in part by reducing or eliminating paths for fluid discharge and / or entry compared to a medical gown used without a barrier sleeve as disclosed herein. For example, when used in conjunction with medical gloves known in the art, a medical gown used without a barrier sleeve of the present disclosure may provide fluid discharge and / or entry at or near the glove / gown interface due to displacement, rolling, and / or folding of the glove during use. The barrier sleeve according to the present disclosure can at least partially reduce or eliminate the presence of such displacement, rolling, and / or folding due to the padding material as described herein. Without wishing to be limited by theory, it is hypothesized that the padding material according to the present disclosure can provide sufficient friction at and around the glove / gown interface to reduce or eliminate displacement, rolling, and / or folding of the glove. Additionally or alternatively, the padding material according to the present disclosure can provide one or more lateral channels at and around the glove / gown interface as described herein sufficient to reduce or eliminate displacement, rolling, and / or folding of the glove. It should be understood that although the present disclosure describes a medical glove, other types of gloves may be used, such as industrial gloves (ie, gloves used in potentially hazardous industrial environments).

[0115] In another example, when used in conjunction with a medical glove known in the art, a medical gown used without a barrier sleeve of the present disclosure can provide longitudinal or substantially longitudinal fluid channels at the glove / gown interface due to the loose bunching of the gown material located proximal to the hem of the glove. A barrier sleeve according to the present disclosure can at least partially reduce or eliminate the presence of such longitudinal fluid channels at the glove / gown interface due to the liner material as described herein. Without wishing to be limited by theory, it is hypothesized that a liner 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 longitudinal fluid channels as described herein. In one example, where the liner material is a readily compressible bunched liner material as described herein, the liner segment can include at least one channel that is lateral or substantially lateral relative to the length or longitudinal direction of the liner segment (e.g., a channel extending along the circumference of the tubular liner segment). When used in conjunction with medical gloves known in the art, the rolled edge of the medical glove can form at least one channel in the gathered liner material when the glove is pulled over the gathered liner material as described herein. In this manner, longitudinal or substantially longitudinal fluid channels formed at the glove / gown interface can be reduced or eliminated.

[0116] In one example, a longitudinal channel or substantially a longitudinal channel formed by a cinched or otherwise tightened oversized gown sleeve is interrupted or otherwise blocked by an elastic glove bead that engages (e.g., is retainably retained therein) a compressible padding section, with a portion of the gown sleeve also being retainably retained between the glove bead and the padding section.

[0117] According to some aspects, barrier sleeves according to the present disclosure do not require any additional donning or doffing steps compared to steps known in the art for donning and doffing medical gowns and medical gloves (alternatively, also referred to herein as conventional donning or doffing steps). That is, barrier sleeves, medical gowns, and / or systems including barrier sleeves, medical gowns can be configured such that donning and / or doffing the barrier sleeves, medical gowns, and / or systems are substantially the same as donning and / or doffing a medical gown without a barrier sleeve. For example, donning a medical gown with a barrier sleeve according to the present disclosure may not require additional folding, tucking, and / or rolling steps that are not required for donning or doffing a similar medical gown that does not include a barrier sleeve as described herein. In some aspects, non-routine donning and / or doffing steps may include, for example, steps not described in the AORN Guidelines for Perioperative Practice: Sterile Technique, published on May 27, 2020, the contents of which are incorporated herein in their entirety.

[0118] According to some aspects, all or a portion of the barrier sleeve, medical gown, and / or medical glove described herein can be sterilized via a sterilization process known in the art. Exemplary sterilization processes include, but are not limited to, ethylene oxide (EO) sterilization, gamma radiation, electron beam (ebeam) radiation, and dry heat or steam heating.

[0119] According to some aspects, all or a portion of a barrier sleeve and / or the interface between the barrier sleeve and the gown, and gowns 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), ASTM D5733 (nonwoven), ASTM D1424), seam strength (e.g., ASTM D751 (stretch woven or knitted)), lint generation (e.g., ISO 9073 Part 10), abrasion resistance (e.g., ASTM D4966), water vapor permeability (e.g., ASTM F1868 Part B, ASTM D6701, ASTM E96 / E96M, ASTM D737-75), or combinations thereof. Additionally or alternatively, all or a portion of a barrier sleeve and / or the interface between a barrier sleeve and a gown, and a gown having a barrier sleeve as described herein, can meet the requirements of Level 1, Level 2, Level 3, or Level 4 of ANSI / AAMIPB 70. Additionally or alternatively, all or a portion of a barrier sleeve and / or the interface between a barrier sleeve and a gown, and a gown having a barrier sleeve as described herein, can meet one or more requirements for viral penetration as specified by ANSI F 1671.

[0120] The present disclosure also relates to a system comprising a barrier sleeve as described herein. According to some aspects, the system may include a medical gown as described herein and a barrier sleeve or portions thereof.

[0121] For example, Figure 2 A medical gown 201 is shown having a main 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, wherein 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 a barrier sleeve as described herein. For example, the system may include a medical gown as described herein, having only a cuff segment as described herein, having only a pad segment as described herein, and / or having only a funnel segment as described herein. In another non-limiting example, the system may include a medical gown and only a portion of a cuff segment, a pad segment, and / or a funnel segment as described herein. For example, Figure 5 Shows the medical gown and Figure 1 101 shown in FIG. 10. In this example, the system may include only the example sleeve portion 501 shown in FIG. Figure 1The exposed portion 511 of the cuff section has a first end 5000 and a second end 5001 attached to the sleeve portion 501 .

[0122] The system according to the present disclosure may further include a medical glove as described herein. As used herein, the term "medical glove" refers to a glove suitable for use in a medical environment as described herein. According to some aspects, the medical glove may contain 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 rubber made of hevea rubber latex and guayule latex, and any other natural rubber known in the art. Non-limiting examples of synthetic rubbers include polyisoprene, polychloroprene, polyurethane, polybutadiene, nitrile, styrene-butadiene rubber, block copolymers of styrene and butadiene, block polymers of styrene and isoprene, mixtures of these elastomers and vinyl, and the like. Other synthetic rubbers that can be used include acrylic diene block copolymers, acrylic rubber, butyl rubber, ethylene propylene diene monomer (EPDM) rubber, chlorosulfonated polyethylene rubber, and fluororubber. Exemplary glove materials useful according to the present disclosure include materials described in U.S. Patent No. 10,647,886, the contents of which are incorporated herein by reference in their entirety.

[0123] Figure 3 An exemplary medical glove useful according to the present disclosure is shown. Figure 3 As shown, the glove 300 may include one or more finger portions 301, a palm portion 302, a cuff portion 303, and a rolled edge 304. It should be understood that the rolled edge 304 may be a portion of the glove 300 located proximal to the cuff portion 303, which has been rolled up as known in the art. However, it should be understood that the medical glove is not particularly limited in this manner, and any means of forming a rolled edge known in the art may be provided.

[0124] According to some aspects, the curling 304 can be configured so that when used with one or more other components of the system as described herein, a reduced fluid transfer is provided between the wearer and the external environment. For example, it has been found that by providing a curling having a certain thickness 305 (e.g., the diameter of the rolled portion), when used in combination with one or more other components of the system as described herein, a reduced fluid transfer can be achieved. In some non-limiting examples, the thickness of the curling can be 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 thickness of the curling can be 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 the system as described herein can include a single pair of gloves or a pair of gloves, wherein each glove independently has the same curling thickness as another glove in the system or a different curling thickness. It should be understood that in the case of two pairs of gloves, two gloves can be worn on each hand. In this example, the hem of each glove can be substantially aligned with the hem of the other glove on the same hand. Alternatively, as is known in the art, the outer glove hem can be placed proximal to the inner glove hem on the wearer's arm (i.e., closer to the body than the inner glove hem). Additionally, in the case where two gloves can be worn on each hand, the hem of each glove can have approximately the same thickness as the hem of the other glove on the same hand. Alternatively, as is known in the art, the outer glove hem can be thicker than the inner glove hem.

[0125] According to some aspects, the curl can be configured to engage and sealingly interact with one or more components of the system (such as with a cushioning segment as described herein) to reduce penetration of fluid toward the cuff segment. For example, when a cushioning segment having a gathered cushioning material as described herein is provided, the glove curl can be configured to press downward into the gathered cushioning material to form one or more channels that are substantially lateral to the length dimension of the cushioning segment (e.g., along the circumference of the tubular cushioning segment) when worn by a user, sufficient to sealingly interact with the cushioning segment as described herein. It should be understood that in the case of a system including more than one pair of gloves, the gloves can be worn in a layered arrangement, wherein the outer glove curl of each glove is substantially proximal to the curl of another glove in the layered arrangement, as is known in the art. The glove curl can be oriented so that it rolls outward or rolls inward toward the skin when worn.

[0126] According to some aspects, the system may include all three of a barrier sleeve, a medical gown, and one or more medical gloves as described herein. In this example, the system may be configured for use in a medical setting known in the art. For example, the system may be configured such that a wearer may wear a medical gown with a barrier sleeve attached, and then wear one or more medical gloves on each hand (including a single glove on each hand and / or two gloves in a double layer arrangement on each hand), such that the medical gloves 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 may be configured such that no additional steps are required compared to the steps known in the art for donning medical gowns and medical gloves. For example, donning a medical gown with a barrier sleeve attached and / or donning medical gloves as described herein may not require additional folding, pleating, and / or rolling steps that are not required for donning or doffing similar medical gowns and / or medical gloves that are not provided as part of the system as described herein.

[0127] According to some aspects, all or a portion of the system can be sterilized by a sterilization process as described herein. It should be understood that the components of the system can be sterilized together and / or one or more of the components of the system can be sterilized separately. In a non-limiting example, a medical gown provided with a padded section as described herein can be sterilized in a transfer package inside a vent bag.

[0128] According to some aspects, all or part of the system can be single use. Alternatively, one or more parts of the system can be used multiple times individually. In a non-limiting example, the system can include a multiple use gown and one or more single use pad sections as described herein.

[0129] Also included are methods of making and using a barrier sleeve, medical gown, and / or system as described herein. In one non-limiting example, the method can include providing a barrier sleeve having a funnel section, a pad section, and a cuff section as described herein, and attaching at least one of the funnel section and the cuff section to an interior surface of a sleeve portion of a medical gown as described herein.

[0130] Figure 6A-6G Non-limiting aspects of an exemplary method of manufacturing a medical gown sleeve having a barrier sleeve as described herein attached thereto are shown. In particular, Fig. 6A A generally trapezoidal shaped member 601 is shown for forming an arm portion of a medical gown as described herein. Fig. 6AAs shown, the method may include attaching a fin portion 602 to a component 601 at a first distance 605 from an end of the component 601. For example, the first distance 605 may be between about 5 inches and 15 inches, optionally between about 6 inches and 12 inches, and optionally between about 8 inches and 9 inches. According to some aspects, the fin portion 602 may be attached to the component 601, for example, via a seal 603 as described herein. Fig. 6A It is shown 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 between about 1 inch and 3 inches, optionally about 1.75 inches.

[0131] Figure 6B-6D It is shown that Fig. 6A The illustrated component 601 is an exemplary step for forming the arm portion of a medical gown. Figure 6B As shown, the method may include folding the component 601 in half along the longitudinal axis 606. Figure 6C As shown, the method may include folding one or both of the unsealed portions 604a, 604b of the flap portion 602. The method may then include joining the free end 607 of the component 601, for example, via a seal 608. Figure 6C As shown, seal 608 can optionally be disposed at a distance 609 from proximal end 610 of component 601. Distance 609 can be between about 0.01 inches and 2 inches, and optionally about 1 inch. Additionally or alternatively, seal 608 can optionally be disposed at a distance 611 from free end 607. Distance 611 can be between about 0.01 inches and 1 inch, and optionally about 0.5 inches.

[0132] like Fig.6D As shown, the method can include joining the ends 612 of the flap portion 602 by any joining mechanism as described herein, such as via a seal and / or sewing via a stitcher. A portion of the ends 612 can then be optionally trimmed.

[0133] like Fig. 6E As shown, the method may include providing a barrier sleeve or a portion thereof 613, such as a funnel-shaped section 614 and a pad section 615 as described herein. The method may include aligning the barrier sleeve or a portion thereof 613 with the wing portion 602, such as Fig. 6F It will be appreciated that if the portion 613 of the barrier sleeve does not include a cuff segment 616, such as described herein, the method may include providing the cuff segment 616 and aligning it with the liner segment 615, such as Fig. 6FThe method may further include coupling the funnel-shaped section 614 to the wing portion 602 and / or coupling the cuff section 616 to the liner section 615 by any coupling mechanism as described herein (such as via a seal and / or sewing with a suture), such as Figure 6G As shown. Figure 6G As shown, before attachment, a portion of the cuff section 616 can be folded to provide a double thickness section. The double thickness section has a length of approximately two inches. In this way, the end portion of the cuff section 616 can be reinforced as described herein. Figure 6G It is also shown 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 as described herein having a barrier sleeve attached to an interior surface thereof.

[0134] Although the various aspects described herein have been described in conjunction with the above exemplary aspects, various alternatives, modifications, variations, improvements, and / or substantial equivalents (whether known or currently unforeseeable) may become apparent to one of ordinary skill in the art. Therefore, the exemplary aspects as set forth above are intended to be illustrative, not restrictive. Various changes may be made without departing from the spirit and scope of the present disclosure. Therefore, the present disclosure is intended to cover all known or later developed alternatives, modifications, variations, improvements, and / or substantial equivalents.

[0135] Therefore, the claims are not intended to be limited to the aspects shown herein, but are to be given the full scope consistent with the language of the claims, wherein, unless otherwise specified, reference to an element in the singular is not intended to mean "one and only one", but rather "one or more". All structural and functional equivalents of the elements throughout the various aspects of the disclosure description that are known or later known to one of ordinary skill in the art are expressly incorporated herein by reference and are intended to be covered by the claims. In addition, nothing disclosed herein is intended to be dedicated to the public, regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be interpreted as a device plus function unless a claim element is explicitly recited using the phrase "device for..."

[0136] In addition, the word "example" is used herein to mean "serving as an example, instance, or illustration". Any aspect described as an "example" in this article is not necessarily to be construed as being preferred or advantageous over other aspects. Unless otherwise specifically stated, 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 multiples of A, multiples of B, or multiples of C. Specifically, 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 only A, only B, only C, A and B, A and C, B and C, or A and B and C, wherein any such combination may include one or more members of A, B, or C. Regardless of whether such disclosure is explicitly recited in the claims, nothing disclosed herein is intended to be dedicated to the public.

[0137] The following non-limiting examples illustrate specific embodiments of the articles and processes described herein. The examples are not meant to be comprehensive and cover the entire scope of the articles and processes.

[0138] Example

[0139] Example I: Preparation of the Glove / Gown Interface

[0140] First, three medical gowns of the present invention having barrier sleeves as described herein were manufactured. Each barrier sleeve in the barrier sleeves was formed by a cuff section, a pad section and a funnel section. The pad section of each barrier sleeve was formed by two layers of nonwoven material with an elastic band of 1100 dtex between the nonwoven material layers. Each elastic band had an elongation of 325%. Other properties of the pad section are shown in Table 1.

[0141] Table 1: Gasket segment properties

[0142]

[0143] The compressibility of each cushion section was measured using a 1 inch diameter measuring foot using a BCAmes Model AQD-2110N caliper gauge. Thickness measurements were made with and without the addition of a .5375 lb weight. The results of the measurements are shown in Table 2. These measurements were made on a flat cuff of two layers of cushion material. While making the measurement, the measuring foot was slowly lowered onto the flat cuff to prevent the foot from dropping quickly onto the surface.

[0144] Table 2: Compressibility of gasket segments

[0145]

[0146]

[0147] Example II: Spray Testing at the Glove / Gown Interface

[0148] First, four glove / gown interfaces were formed. Each interface included one of a control gown, exemplary inventive gown 1, exemplary inventive gown 2, and exemplary inventive gown 3 as described in Test 1. The control gown was identical to the inventive gown, except that the control gown did not include a barrier cuff as disclosed herein.

[0149] To form the glove / gown interface, the user first dons each gown and then, using conventional donning techniques, dons either a single medical glove or two medical gloves (double gloving) on ​​each hand to form the glove / gown interface where the glove partially overlaps the sleeve of the gown. Each glove has a bead with a thickness of 2 mm, 3 mm, or 4 mm, as shown in Table 3 below. In the case of double gloving, the outer glove bead is located proximal to the inner glove bead, in accordance with the double gloving recommendations.

[0150] Each glove / gown interface is then subjected to a 50 second spray test. Specifically, after the user puts on the gown and gloves as described above, the user then reaches through the opening to the worn arm, with the arm upright and the arm twisted, and the hand moved to simulate surgical motions, wherein the arm is sprayed with the water / synthetic blood mixture for 50 seconds above the glove / gown interface (i.e., the near side of the glove / gown interface). If the user's hands and / or arms remain dry after spraying, the interface is considered to have passed the spray test. Failure results in fluid breaking through the glove / gown interface, thereby causing the fluid to reach the user's hands and / or arms. The results of the test are shown in Table 3 below.

[0151] Table 3: Spray test results

[0152]

[0153]

[0154] Example III: Immersion Testing at the Glove / Gown Interface

[0155] First, four glove / gown interfaces using the comparative gown, exemplary inventive gown 1, exemplary inventive gown 2, and exemplary inventive gown 3 were formed as described in Test II. Specifically, the user donned each gown and then donned either a single medical glove or two medical gloves (double gloving) on ​​each hand using conventional donning techniques to form a glove / gown interface where the glove partially overlapped the sleeve of the gown. Each glove had a bead having a thickness of 2 mm, 3 mm, or 4 mm, as shown in Tables 4A and 4B below.

[0156] Then, an immersion test was performed by immersing the gloved hand and forearm in a five gallon bucket of water until the water reached three inches above the glove / overgarment interface. The amount of time for the water to reach the user's hand was then measured. While immersed, the hand did not move or the arm twist. The results are shown in Tables 4A and 4B below.

[0157] Table 4A: Immersion Test Results

[0158]

[0159] Table 4B: Immersion Test Results

[0160]

[0161] Example IV: Dress Study

[0162] Sixteen participants wore medical gowns with barrier sleeves as described herein (i.e., the inventive sleeves) and / or medical gowns without barrier sleeves (i.e., control sleeves). The sleeves were worn either sequentially (i.e., the medical gown with the inventive sleeve first, then the medical gown with the control sleeve) or simultaneously (i.e., the medical gown with one inventive sleeve and one control sleeve). Each participant then performed normal laboratory and / or clinical activities for a two-hour period using each sleeve with the glove overlapping the sleeve. After the two-hour period, the distance 700 from the glove hem to the first end of the cuff section of the sleeve was measured, as shown in FIG. Figure 7 shown.

[0163] Fig. 8A and Figure 8B The results of the wearing study are shown. In particular, Fig. 8A Shown are pictures of two control cuffs after two hours of wear. Figure 8B Two images of the inventive sleeves after two hours of wear are shown. It was determined that the inventive sleeves showed a 40% increase in mean distance, a statistically significant mean difference. In addition, the inventive sleeves showed a 26% decrease in standard deviation compared to the control sleeves, indicating that the inventive sleeves provided less variation in distance after wear among the participants.

Claims

1. A barrier sleeve capable of being used with a protective gown, the barrier sleeve comprising: a tubular cuff section comprising cuff material and having a cuff section first end and a cuff section second end; as well as a tubular gasket section, the gasket section comprising a gasket material, wherein the pad section has a pad section first end portion and a pad section second end portion located at the cuff section second end portion, wherein the cushion material comprises a gathered material and / or an extensible material, and Wherein the gasket material has a first thickness and is configured to exhibit a thickness change of at least about 40% when compressed.

2. The barrier cuff of claim 1 further comprising a funnel-shaped section having a funnel-shaped section first end located at the pad section second end and a funnel-shaped section second end.

3. The barrier sleeve according to claim 2, wherein: The second end of the funnel-shaped section is connected to the inner surface of the sleeve portion of the protective gown.

4. The barrier sleeve according to claim 3, wherein: The funnel-shaped section second end is thermally bonded to the inner surface.

5. The barrier sleeve of claim 1, wherein: The cuff material has a second thickness that is less than the first thickness.

6. The barrier sleeve of claim 1, wherein: The liner material is configured to form at least one channel extending along the circumference of the liner section under compressive force from a glove curl sufficient to provide a sealing engagement with the glove curl, the glove curl being pulled over the liner material and the sleeve portion of the protective gown.

7. The barrier sleeve of claim 6, wherein: The sealed joint was sufficient to pass a 50 second spray test.

8. The barrier sleeve of claim 1, wherein: The liner material comprises at least two layers of nonwoven material with one or more elastic strands between the at least two layers of nonwoven material.

9. The barrier sleeve of claim 8, wherein: The nonwoven material comprises SMS laminate and / or spunbond material.

10. The barrier sleeve of claim 8, wherein: The one or more elastic strands have a linear mass of at least 600 dtex.

11. The barrier sleeve of claim 1, wherein: The pad section first end is attached to the cuff section second end via adhesive, stitching, 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 system comprising: A protective gown having a main 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, wherein the barrier sleeve comprises: a tubular cuff section comprising a cuff material and having a cuff section first end attached to an inner surface of the first sleeve portion or the second sleeve portion and a cuff section second end; and A tubular liner segment comprising a liner material, wherein the liner segment has a liner segment first end and a liner segment second end located at the cuff segment second end, wherein the liner material includes a gather-type material and / or a stretchable material, and wherein the liner material has a first thickness and is configured to exhibit a thickness change of at least about 40% when compressed.

14. The system of claim 13, further comprising a funnel-shaped section having a funnel-shaped section first end located at the pad section second end and a funnel-shaped section second end attached to an inner surface of the first sleeve portion or the second sleeve portion.

15. The system of claim 14, wherein: The pad section is not attached to an 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 of claim 13, further comprising a glove having a glove bead, wherein: The liner material is configured to form at least one channel extending along the circumference of the liner section under a compressive force when the glove bead is pulled over the liner material and the first sleeve portion or the second sleeve portion, the compressive force being from the glove bead sufficient to provide a sealing engagement with the glove bead.

18. The system of claim 17, wherein: The glove bead has a thickness of at least about 3 mm.

19. The system of claim 13, wherein: The liner material comprises at least two layers of nonwoven material with one or more elastic strands between the at least two layers of nonwoven material.

20. The system of claim 13, wherein: The first sleeve portion and the second sleeve portion are free of structural attachment features.

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

22. A system comprising: A protective gown having a main 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, wherein the barrier sleeve comprises a tubular cuff section having a cuff section first end attached to an inner surface of the first sleeve portion and / or the second sleeve portion, and The cuff section comprises a cuff material, wherein the cuff material comprises at least two layers of nonwoven material, and one or more elastic strands are arranged between the at least two layers of nonwoven material.

23. A method of making a barrier sleeve having a padded section, the method comprising: A pad section having a gathered pad material is provided, wherein the gathered pad material is formed by providing one or more elastic strands in an elongated position, attaching the one or more elastic strands in the elongated position to one or more layers of nonwoven material, and allowing the one or more elastic strands to retract so that the one or more layers of nonwoven material attached thereto gather.

24. A method of wearing a system, the method comprising: Wearing a protective gown having a main 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 comprises: a tubular cuff section comprising a cuff material and having a cuff section first end attached to an inner surface of the first sleeve portion or the second sleeve portion and a cuff section second end; and a tubular cushion section comprising a cushion material, wherein the cushion section has a cushion section first end and a cushion section second end located at the cuff section second end, wherein the cushion material comprises a gather material and / or an extensible material, and wherein the cushion material has a first thickness and is configured to exhibit a thickness change of at least about 40% when compressed; and Wearing the glove with the glove cuff so that the glove cuff overlaps the first sleeve portion or the second sleeve portion with the barrier cuff, wherein the liner material is configured to form at least one channel extending along the circumference of the liner segment under the action of a compressive force, the compressive force being from the glove cuff and sufficient to provide a sealing engagement with the glove cuff.

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