Apparatuses and methods for manufacturing a protective garment

Abstract

An improved protective garment, and systems and methods of manufacturing are disclosed, wherein a method of manufacturing the protective garment, includes: providing a cuff material; providing a sleeve of a protective garment; and bonding the cuff material to the sleeve at a predetermined first bonding zone of the sleeve, wherein the bonding includes: applying an adhesive on the predetermined first bonding zone of the sleeve; positioning the cuff material over the sleeve such that a predetermined second bonding zone of the cuff material is aligned with the predetermined first bonding zone of the sleeve; and applying heat to the first and second bonding zones, thereby forming a seal between the elastic cuff material and the sleeve at the first and second bonding zones.

Description

J1404-00110APPARATUSES AND METHODS FOR MANUFACTURING A PROTECTIVE GARMENTCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of and priority to U.S. Provisional Application No.63 / 805,392, filed on May 14, 2025 and U.S. Provisional Appl. No. 63 / 765,170, filed on February 28, 2025. The entire disclosures of the above applications are incorporated herein by reference.FIELD OF THE PRESENT DISCLOSURE

[0002] The present disclosure is directed to apparatuses and methods for manufacturing a protective garment. The garment may include a fluid management system for an interface between a sleeve of a protective gown and one or more protective gloves to prevent fluids, such as perspiration from the skin of the user that can collect at the sleeve / glove interface, from breaching the sleeve / glove interface, thereby preventing fluids from the wearer (e.g., perspiration or blood) from exiting the sleeve / glove interface and contaminating an external environment (e.g., a sterile surgical operating room, a biohazard room, a laboratory, a clean room of a manufacturing process, etc.) Conversely, the fluid management system disclosed herein can also prevent external fluids from contacting the skin of the wearer of the protective gown and one or more protective gloves.BACKGROUND

[0003] The following disclosure is described in the context of exemplary medical or surgical environments. However, those of ordinary skill in the art will recognize that the embodiments and aspects of the present disclosure can be applied and practiced in any environment or setting in which it is desired to eliminate or reduce contamination between a wearer of a protective gown and an external environment. For example, as would be readily understood by a person of ordinary skill in the art (POSITA), the protective gown disclosed herein can be advantageously utilized in many different settings in which cross-contamination between a wearer of the protective gown and an external environment is desired to be eliminated or reduced. Some exemplary environments include a biohazard room, a sterile laboratory setting, a clean room of a manufacturing process, as well as in food, chemical, and hazardous material handling environments, etc.J1404-00110

[0004] In the context of an exemplary surgical setting, as the literature describes, there is a “weak link” in the barrier between the user and their external environment with personal protective equipment (PPE) used in a surgical setting at the interface between the sleeve of a protective gown and the cuff of the protective glove. Without an adequate barrier, the passage of fluids, such as perspiration, from the user’s skin to the outside sterile environment may occur, contaminating the environment. In addition, fluids such as blood or other bodily fluids may pass through the interface from the outside environment and make contact with the user’s skin.

[0005] Collection of perspiration between the sleeve of protective gown and the cuff of a protective glove, in a surgical setting, results in discomfort for the surgeon and increases the risk of breaking sterile technique. Perspiration from the gloved hand / wrist follows the knitted cuff at the distal end of the sleeve of a surgical gown and results in the collection or pooling of moisture between the impervious (waterproof) surgical gownandthe cuff of the surgical glove, which is also waterproof.

[0006] With pooled moisture (perspiration) between the surgical gown and the cuff of the surgical glove, one cannot change the position of the glove without a break in sterile technique. Therefore, the user’ s hand and arm can become very uncomfortable in order to avoid breaking the sterile environment.

[0007] Fluid leakage from the outside environment to the skin of the user at the glove / gown interface is also a significant problem for surgical and perioperative professionals because direct contact with blood or body fluids can be life threatening, especially when caring for patients with infectious diseases, such as Hepatitis C, HIV, and viral hemorrhagic fevers such as Ebola. Also, contamination of hands and wrists can lead to colonization with drug-resistant bacteria or other germs that could be harmful to patients.

[0008] When the glove rolls down or slips on the sleeve, the risk of exposure to blood or body fluids increases. When gloves are pulled up over the wide and baggy cuff and sleeve of the gown, this also creates an exposure risk. An effect called “channeling” can occur when body fluids seep between the inner surface of gloves and the outer surface of the sleeve toward wrists and hands. Glove “roll-down” or slippage can result from a low frictional interface between the interior side of the glove and the surgical gown sleeve. Prior art techniques of using a cuff on a sleeve to prevent leakage of fluids that accumulate inside a glove do not provide a liquid impervious seam between the cuff material and gown sleeve material, resulting in an unacceptable amount of leakage failures. Thus, there is a need for an improved glove / gown interface in the surgical setting.J1404-00110

[0009] As mentioned above, there are other non-surgical applications where similar problems may arise. These include, but are not limited to, laboratories, clean rooms, and emergency rooms, as well as in food, chemical, and hazardous material handling environments, which would also benefit from an improved glove / gown interface as disclosed herein.

[0010] Additionally, current methods of manufacturing protective gowns have some automated processes like cutting the gown material, but still has many manual assembly operations such as making the sleeve seam, sewing on the knit cuff, and welding ties, Velcro and neck reinforcement materials. Furthermore, current methods of making protective gowns use limited types of materials and designs, in particular, where the cuff and sleeve areas of the gown interact with the protective gloves. Thus, current protective gown designs do not provide a glove-gown interface that is impervious to liquids.SUMMARY

[0011] The benefits and advantages of the present disclosure over existing systems will be readily apparent from the Summary and Detailed Description to follow. One skilled in the art will appreciate that the present teachings can be practiced with embodiments other than those summarized or disclosed below.

[0012] In view of the above deficiencies of prior art protective gown designs and manufacturing methods described above, the inventors of the present application have made improvements to the current gown designs, materials and methods of making a protective gown with a sealing cuff (aka, Tuff Cuff™) that eliminates or greatly reduces leakage of fluids at the glove-gown interface.

[0013] In one aspect, the various embodiments of the present disclosure include a fluid management system for the interface between a sleeve of a protective gown and a protective glove. The fluid management system includes a sleeve member having a first end, a second end, an interior surface, and an exterior surface. The first end of the sleeve member is proximate a distal end of the sleeve of the protective gown and the second end of the sleeve member extends inside of the distal end of the sleeve of the protective gown. A portion of the exterior surface of the sleeve member proximate the second end is in contact with a portion of an interior surface of the sleeve of the gown. There is a cuff member having a first end, a second end, an interior surface, an exterior surface. The interior surface of the cuff member faces and is moveable with respect to portions of the exterior surface of one or both of the sleeve member and the sleeve of the protective gown to enable the insertion of a cuff ring ofJ1404-00110the protective glove between the interior surface of the cuff member and the exterior surface of one of the sleeve member or the sleeve of the protective gown.

[0014] In other aspects of the present disclosure, one or more of the following features may be included. The cuff member may include a retention member to secure the cuff ring of the protective glove in place between the interior surface of the cuff member and the exterior surface of one of the sleeve member and the sleeve of the protective gown. The interior surface of the sleeve member may comprise a moisture wi eking material and the exterior surface of the sleeve member may comprise an impervious material. The interior surface and the exterior surface of the sleeve of the protective gown each may comprise an impervious material. The interior surface of the cuff member may face and be moveable with respect to the exterior surface of both of the sleeve member and the sleeve of the protective gown. The first end of the cuff member may be affixed to the first end of the sleeve member and may be foldable onto the portions of the exterior surfaces of both of the sleeve member and the sleeve of the protective gown. The sleeve member may extend beyond and outside of the distal end of the sleeve of the protective gown. The cuff ring of the protective glove may be sandwiched between retention member of cuff member and the exterior surface of the sleeve of the protective gown. Proximate to where the first end of the cuff member is affixed to the first end of the sleeve member there may be included a dead space between the interior surface of the cuff member and the exterior surface of the sleeve member to trap leaked fluid.

[0015] In yet other aspects of the present disclosure, one or more of the following features may be included. The cuff member may be formed by the distal end of the sleeve of the protective gown and the distal end of the sleeve of the gown may be folded onto only the exterior surface of the sleeve of the gown proximate the first end of the sleeve member. The cuff ring of the protective glove may be sandwiched between retention member on the distal end of the sleeve of the protective gown and the exterior surface of the sleeve of the protective gown. Proximate where the distal end of the sleeve of the gown is folded onto only the exterior surface of the sleeve of the gown there may be included a dead space between the exterior surface of the cuff member and the exterior surface of the sleeve member to trap leaked fluid. The cuff member may be formed by the distal end of the sleeve of the protective gown and the sleeve member may extend beyond and outside of a distal end of the sleeve of the protective gown. The cuff ring of the protective glove may be sandwiched between the distal end of the sleeve of the protective gown and the exterior surface sleeve member. The cuff ring of the protective glove may abut the retention member and the retention member may be spaced a distance from the distal end of the sleeve of the protective gown and laminated between theJ1404-00110interior surface of the sleeve of the protective gown and the exterior surface of the sleeve member. The sleeve member and the cuff member may be tubular in shape.

[0016] In some embodiments, a method of manufacturing the protective garment, includes: providing a cuff material; providing a sleeve of a protective garment; and bonding the cuff material to the sleeve at a predetermined first bonding zone of the sleeve, wherein the bonding includes: applying an adhesive on the predetermined first bonding zone of the sleeve; positioning the cuff material over the sleeve such that a predetermined second bonding zone of the cuff material is aligned with the predetermined first bonding zone of the sleeve; and applying heat to the first and second bonding zones, thereby forming a liquid impermeable seal between the elastic cuff material and the sleeve at the first and second bonding zones, wherein the second bonding zone is located so as to provide a foldable portion of the cuff material located proximally from the second bonding zone when in an unfolded state, and wherein the foldable portion is configured to fold over and cover the second bonding zone in a folded state. In some embodiments, the cuff material comprises an elastic cuff material configured to be stretched by 10% to 40% when applied onto the garment sleeve.

[0017] In accordance with some embodiments, a system for manufacturing a protective garment, includes: a mandrel assembly configured to receive a sleeve of the protective garment thereon; a multi-prong assembly configured to hold a tubular elastic cuff member in an expanded state; a cuff clamping assembly configured to clamp the tubular elastic cuff member, when in an expanded state, onto the sleeve and the mandrel assembly; and a heating assembly configured to apply heat to a predetermined first bonding zone of the tubular elastic cuff member and a predetermined second bonding zone of the sleeve, thereby heating an adhesive disposed between the first and second bonding zones to create a liquid impermeable seal between the tubular elastic cuff member and the sleeve at the first and second bonding zones.

[0018] In further embodiments, a protective garment, includes: a sleeve; a cuff member attached and sealed to an outer surface of the sleeve, the cuff member including: a first bonding zone attached and sealed to a second bonding zone of the sleeve; a foldable cuff portion extending proximally outwardly from the first bonding zone in an unfolded position and configured to fold over and cover the first bonding zone in a folded position; and a liquid impermeable interface between the first and second bonding zones. It has been found that leakage at the cuff / sleeve interface (a.k.a., seam) can be eliminated or at least significantly reduced by implementing the teachings of the present disclosure, as describedin further detail herein.J1404-00110

[0019] These and other features of the present disclosure will be apparent from the following detailed description and the accompanying figures.BRIEF DESCRIPTION OF THE FIGURES

[0020] FIG. 1 A is a perspective view of an embodiment of a sleeve member, in accordance with some embodiments of the present disclosure.

[0021] FIG. IB is an alternate perspective view of the sleeve member shown in FIG. 1 A.

[0022] FIG. 2A is a perspective view of another embodiment of a sleeve member, in accordance with some embodiments of the present disclosure.

[0023] FIG. 2B is a side elevational view of the sleeve member shown in Fig. 2A.

[0024] FIG. 2C is a cross sectional view of the sleeve member shown in Fig. 2B taken along lines A- A.

[0025] FIG. 2D is an enlarged view of area B of the sleeve member shown in Fig. 2C.

[0026] FIG. 3 is a cross-sectional view of a fluid management system, in accordance with some embodiments of the present disclosure.

[0027] FIG. 4 is a cross-sectional view of another embodiment of the fluid management system, in accordance with some embodiments of the present disclosure.

[0028] FIG. 5 is a cross-sectional view of yet another embodiment of the fluid management system, in accordance with some embodiments of the present disclosure.

[0029] FIG. 6 is a cross-sectional view of yet another embodiment of the fluid management system without the protective glove depicted, in accordance with some embodiments of the present disclosure.

[0030] FIG. 7 illustrates a surgical gown sleeve having a rubber cuff welded to a distal end of the sleeve, in accordance with some embodiments of the present disclosure.

[0031] FIG. 8 is a cross-sectional view of a gown having an integrated fluid management system in accordance with some embodiments of the present disclosure.J1404-00110

[0032] FIG. 9A is a cross-sectional view of a sleeve of the gown of FIG. 8 in accordance with some embodiments of the present disclosure.

[0033] FIG. 9B is a cross-sectional detail view of the sleeve of FIG. 9A with inner and outer gloves shown in accordance with some embodiments of the present disclosure.

[0034] FIG. 9C is a cross-sectional detail view of the sleeve of FIG. 9A without inner and outer gloves shown in accordance with some embodiments of the present disclosure.

[0035] FIG. 10A is a cross-sectional view of a glove retention feature of a gown having an integrated fluid management system according to an aspect of the present disclosure.

[0036] FIG. 10B is a cross-sectional view of the glove retention feature of FIG. 10A deployed to retain gloves in accordance with some embodiments of the present disclosure.

[0037] FIG. 11 illustrates a flowchart of a method of manufacturing a protective garment having sleeves with a cuff member attached and sealed to an outer surface of each sleeve in accordance with some embodiments of the present disclosure.

[0038] FIG. 12 illustrates a perspective view of a cuff member, in accordance with some embodiments of the present disclosure.

[0039] FIG. 13 illustrates a perspective view of a system of manufacturing a fluid management system, in accordance with some embodiments of the present disclosure.

[0040] FIGS. 14A-14D illustrate various views of a multi-prong fork assembly of the system shown in FIG. 13, in accordance with some embodiments of the present disclosure.

[0041] FIGS. 15A and 15B illustrate top views of the system shown in FIG. 13 with and without a protective garment sleeve placed on a mandrel assembly, respectively, in accordance with some embodiments of the present disclosure.

[0042] FIGS. 16A and 16B illustrate various views of a cuff clamping assembly of the system shown in FIG. 13, in accordance with some embodiments of the present disclosure.

[0043] FIGS. 17A and 17B illustrate top and front views of the reheating assembly and mandrel assembly with a sleeve disposed thereon, in accordance with some embodiments of the present disclosure.J1404-00110

[0044] FIGS . 18 A- 18C illustrates three different embodiments a protective garment sleeve having a cuff member attached and sealed to an outer surface of the sleeve, in accordance with various embodiments of the present disclosure.

[0045] FIG. 19A illustrates a perspective view of a protective garment sleeve having a new heat-sealed sleeve seam to remove excess sleeve material, in accordance with some embodiments of the present disclosure.

[0046] FIG. 19B illustrates a perspective view of an apparatus for decreasing at least a portion of a diameter of a gown sleeve, in accordance with some embodiments of the present disclosure.

[0047] FIGS. 20A and 20B illustrates two views of a microfold anvil that may be utilized in the mandrel assembly of the system shown in FIG. 13, in accordance with some embodiments of the present disclosure.

[0048] FIG. 21 is a perspective illustration of a sleeve manufacturing apparatus in accordance with some embodiments of the present disclosure.

[0049] FIG. 22 is a perspective illustration of cuff material positioned on a sleeve in accordance with some embodiments of the present disclosure.

[0050] FIG. 23A is top view of the cuff and sleeve of FIG. 22 including a detailed illustration of a gap between an edge of the sleeve and an edge portion of a pattern of bonding material applied to the cuff material in accordance with some embodiments of the present disclosure.

[0051] FIG. 23B is a top view of the cuff and sleeve of FIG. 23 including a wrist element positioned at a wrist opening of the sleeve in addition to the foldable cuff in accordance with some embodiments of the present disclosure.

[0052] FIG. 24 is a top view of an example cuff or cuff material including a pattern of bonding material in accordance with some embodiments of the present disclosure.

[0053] FIG. 25 is a top view of a portion of a sleeve and a cuff illustrating aspects of the pattern of bonding material in accordance with some embodiments of the present disclosure.J1404-00110

[0054] FIG. 26 is a flow chart showing an example method of producing a sleeve and cuff assembly of a protective garment in accordance with some embodiments of the present disclosure.DETAILED DESCRIPTION

[0055] The disclosure and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments and examples that are described and / or illustrated in the accompanying drawings and detailed in the following description. It should be noted that the features illustrated in the drawings are not necessarily drawn to scale, and features of one embodiment may be employed with other embodiments, as the skilled artisan would recognize, even if not explicitly stated herein. Any dimensions included in the figures or used herein are merely exemplary and not limiting.

[0056] Descriptions of well-known components and processing techniques may be omitted to not unnecessarily obscure the embodiments of the disclosure. The examples used herein are intended merely to facilitate an understanding of ways in which the disclosure may be practiced and to further enable those of skill in the art to practice the embodiments of the disclosure. Furthermore, the methods and processes described herein are merely exemplary and do not limit the scope of the disclosure. For example, the order of steps may be changed, steps may be altered, and / or steps may be omitted or added, to the exemplary methods and processes described herein without departing from the scope of the disclosure, as would be understood by persons of ordinary skill in the art. Accordingly, the examples and embodiments herein should not be construed as limiting the scope of the disclosure. Moreover, it should be noted that while an aspect of the present disclosure is described herein in connection with a surgical glove and a surgical gown, the present disclosure is not limited and it may be used in other applications, e.g. food, chemical, hazmat, laboratories, clean rooms, and emergency rooms, and the concepts may be applied to other articles of protective gear.

[0057] The use of wi eking sleeve to decrease accumulation of moisture / fluid between the sleeve of protective gown (e.g. a surgical gown) and the cuff of a protective glove (e.g. a surgical glove) is described below. This aspect of the present disclosure, may be used alone or, in combination with other components, to a form fluid management system for the interface between the sleeve of a protective gown and the cuff of protective glove to prevent both perspiration collecting at the gown / glover interface, as well as to prevent fluids from the outsideJ1404-00110environment penetrating the gown / glove interface and coming into contact with the skin of the person wearing the gown / glove.

[0058] The sleeve 10, according to an aspect of the disclosure, is shown in Figs. 1 A and IB. Sleeve 10 may be tubular in shape and may include a moisture / fluid managem ent material, such as a wicking material. Sleeve 10 may include a forearm opening 12 and a wrist opening 14, and a user’s hand may be inserted into the forearm opening 12 and out through the wrist opening 14 so that the sleeve is worn by the user on their forearm. At each opening, there may be included elastic stitching bands, such as band 13 around the circumference of forearm opening 12 and band 15 around the circumference of wrist opening 14, to ensure a secure fit for sleeve 10 when donned on a user’s forearm. The sleeve may optionally include an opening 17 for a user’s digit (e.g. a thumb) to secure the wrist opening 14 of sleeve 10 in a position about the user’s palm to be well positioned to absorb perspiration.

[0059] The forearm opening 12 is larger-in- size than the wrist opening to accommodate the larger diameter of a user’ s forearm as compared to the user’ s wri st. The size of the openings and the length of the sleeve may be made of various sizes to accommodate various size users or as a “one size fits all.”

[0060] Sleeve 10 may be formed by taking a flat piece of material and rolling it into a tubular shape, which may then be sewn at both ends with an Elastane thread, for example, or affixed using a binder material, heat, ultrasonic welding, or other means known in the art. The flat piece of material maybe formed of multiple layers of material including moisture wicking material on one side of the fabric and an impervious material on the opposite side, for example. When rolled the moisture wicking material may be disposed on the interior surface 18 of tubular sleeve 10 and the impervious material on the exterior surface of the sleeve 10, forming a dual layer sleeve.

[0061] The sleeve 10 may be made as an independent article, which is initially free of the sleeve of the protective gown / garment, or it may be affixed in one or more places to the gown / glove. The sleeve 10 may, alternatively, be formed as an integral part of the sleeve of protective gown / garment. Also, a full sleeve need not be used and instead one or more strips or other structure structures may be used.

[0062] An alternative embodiment of the sleeve according to an aspect of this disclosure is depicted as sleeve 10a in Figs. 2A-2D. Like sleeve 10, sleeve lOamay be tubular in shape andJ1404-00110may include a forearm opening 12a, a wrist opening 14a. A user’s hand may be inserted into the forearm opening 12a and out through the wrist opening 14a so that the sleeve is worn by the user on their forearm. At each opening, there may be included elastic stitching bands, such as band 13a, around the circumference of forearm opening 12a and band 15a, around the circumference of wrist opening 14a, to ensure a secure fit for sleeve 10a when donned on a user’s forearm. The sleeve may optionally include an opening (not shown) for a user’s digit (e.g. a thumb) to secure the wrist opening 14a of sleeve 10a in a position about the user’s palm to be well positioned to absorb perspiration.

[0063] Sleeve 10a may include additional elastic banding / stitching rings 30 and 32 about the circumference of sleeve 10a positioned between forearm opening 12a and wrist opening 14a. These banding rings may be used to form the cuff member described below and used to hold in place a cuff ring of a protective glove. For example, portion 34 of sleeve 10a may be folded over to overlay portion 36 to form a cuff member with the exterior impervious layer of portion 34 facing and in contact with the exterior impervious layer of portion 36. A cuff ring of a protective glove may be inserted into the cuff member formed by portion 34 folded on to portion 36, as is described in Fig. 3, for example.

[0064] A fluid management system according to aspects of the disclosure may be deployed in accordance with multiple embodiments. Three possible examples include but are not limited to:1. The sleeve of the fluid management system can be self-contained and separate from the gown / garment. For example, a sleeve containing the moisture management fiber / material.2. The sleeve of the fluid management system maybe attached to the inner surface of the gown / garment and may be in the form of a strip, band, circumferential sleeve, or some other shape / configuration.3. The sleeve of the fluid management system may be incorporated into the gown / garment as an integral part / component / layer of the gown / garment. For example, a moisture wicking laminate or layer on the inner surface of the gown / garment.

[0065] The sleeve of the fluid management system may use textiles that may be worn on all extremities of the body including, but not limited to between the hand / wrist andJ1404-00110forearm. The sleeve of the fluid management system maybe made of knit, woven, non-woven, ultrasonic bonded, welded or heat-sealed material . The sleeve of the fluid management system may be made of natural or synthetic fibers or blends thereof. Each side of the system may be made with or without coatings or films. For example, a laminated material may be used with one side having its own fluid management system, while the outside may be impervious. In all cases, whether formed of natural or synthetic materials, the textile fluid management system may be composed of highly wi eking material with high moisture pick-up capability.

[0066] The natural or synthetic materials of the sleeve of the sleeve of the fluid management system may include additives, including but not limited to organic material, nanoparticles of various types, chemicals, heavy or light metals, waxes, water based antimicrobials), including but not limited to chitosan.

[0067] The sleeve of the fluid management system may take a multitude of configurations, such as a one-piece tubular sleeve or a single piece flat fabric that, through an attachment process, may be located appropriately on the hand / wrist. Either of these or other configurations can be independent from and / or part of the surgical / protectivegown / garments. The sleeve of the fluid management system may be used in the form of other types of garments or sleeves to be worn / applied / used in connection with various parts of the body and various garments.

[0068] The following are some exemplary features and benefits of the fluid management system according to aspects of the disclosure:• The creation of a moisture management zone that is independent of and / or an integral part of the surgical / protective gown / garment.• The creation of an impervious side independent of the surgical / protective gown.• The creation of an independent pathway for moisture that restricts the movement of moisture from the inside of the surgical / protective sleeve to that of the outer layer surgical protective gown.• The creation of a material reservoirthat collects moisture from the skin in contact with the surgical / protective glove that allows for transportation (vertical wi eking) away from the surgical / protective glove zone.J1404-00110• The creation of a material pathway for moisture to flow from the reservoir to the extremities away from the surgical / protective glove zone where evaporation takes place.• The creation of a mini -environment that decreases the opportunity for infection to migrate away from the moisture management zone closest to the skin.• Utilizes fibers and chemical means to create a mini-environment that effectively enhances moisture management to take place.• To increase the comfort of the user by creating a drier environment within and between the glove and the hand.• The creation of multiple environments within the surgical / protective glove / sleeve / gown / garment to work together as one master system that manages moisture, comfort, temperature, evaporation and infection within the protective gown / garment.• The creation of a new cuff location and fit on the gown sleeve to accept single or double gloves.• The creation of a process (s) both equipment and process parameters to create a reliable and improved cuff-gown seam.• The creation of materials and material properties that provide an improved seam between a cuff member and a gown sleeve.• The creation of materials and material properties for the cuff that forms a reliable and improved interface with the glove (s).• The creation of a method that enables the use of existing gown sleeves by modifying at least a portion of the diameter of a gown sleeve to facilitate forming an improved seam between a cuff member and the gown sleeve material.

[0069] FIGS. 1 A and IB depict two views of one exemplary embodiment, which is in the form of a protective sleeve to be worn on the forearm of a user under the distal end of the sleeve of a protective gown, such as a surgical gown. The protective sleeve may be formed of anyJ1404-00110material suitable for this application, as described above, and it may be positioned proximate the interface between a protective gown and a protective glove to decrease accumulation of moisture between the sleeve of protective gown and the cuff of a protective glove. The ends of the flat material may be connected by sewing / stitching, by gluing, or by any other suitable means of affixing the ends of the material.

[0070] An embodiment of a fluid management system 100 according to an aspect of this disclosure is shown in Fig. 3. This fluid management system provides both a moisture management function as well as a complete barrier between the user and their external environment. Thus, the system prevents fluids (i.e. perspiration) from travelling from the inside gown / glove to the outside environment and it prevents fluids in the outside environment from penetrating the glove / gown interface and reaching the user’s skin.

[0071] As shown in Fig. 3, fluid management system 100 is composed of a lamination of three layers. The firstlayer is the distal end of the impervious surgical gown sleeve 110, which has an exterior surface 112 facing the outside environment and an interior surface 114 facing and in contact with the user. Under the surgical gown sleeve 110, and in contact with at least a portion of interior surface 104 of the surgical gown sleeve 110, is the moisture management / wi eking sleeve member 120, which lies directly on the surface of the wearer’s hand / wrist. Sleeve member 120 maybe comparable to sleeves 10 / 10a described above in Figs.1 and 2, which may be constructed as a dual layer sleeve having an exterior surface 122 formed of an impervious material and an interior surface formed of 124 formed of a moisture wi eking material. When the glove 150 is donned and the user perspires, the wicking layer of layer 124 moves moisture from the inside of the inner glove into the sleeve / arm area under the surgical gown.

[0072] Wicking sleeve member 120 will typically extend a sufficient distance up the gown sleeve 110 to ensure that perspiration will not be transferred out to the exterior of the surgical gown sleeve 110.

[0073] In this embodiment, there may be an impervious member 130, which may be affixed at its first or distal end 132 to the first end 126 of the sleeve member 120. The second end 128 of sleeve member terminates in the interior region of surgical gown sleeve 110. The first or distal end 132 of impervious member 130, which is affixed to a top surface of the first / distal end 126 of the sleeve member 120, extends along and over / facingthe top surface 122 of the sleeve member 120 and a portion of outer surface 112 of the impervious gown sleeve 110. The impervious member 130 forms a cuff member 134, which terminates at its second or proximal end 136. The cuff member 134 overlays and is in contact with the distal end 116 of theJ1404-00110impervious surgical gown sleeve 110. Thus, the distal end 116 of the impervious surgical gown sleeve 110 is sandwiched between the exterior surface 122 of sleeve member layer 120 (on the bottom) and interior surface 137 ofthe impervious member 130 (onthe top), forming the three-layer laminate.

[0074] At the second / proximal end 136 of the impervious member 130 there is affixed a retention member 140 (e.g. rim / b and / strip), which may be similar to an O-ring or some other form of band or strip, and which has a level of stiffness, such that the cuff ring 160 of glove 150 may be affixed to it (i.e. by wrapping around a portion of the retention member 140) and allow the cuff ring on the end of the glove 150 to connect to / engage it to produce a “watertight seal” between the impervious gown sleeve 110 and the inner portion of glove 150. Retention member 140 may have a concave shape complementary to cuff ring 160 so that it may receive and engage cuff ring 160 to secure it in place when interlocked.

[0075] In the event there is leakage at the seal between the cuff ring 160 of glove 150 and cuff member 134 due to movement of the sleeve 110, for example, there is a dead space 180 between the cuff member 134 and the distal end of gown sleeve 110, which will trap leaked fluid.

[0076] In another embodiment of the disclosure, fluid management system 200 is shown in FIG. 4. In this embodiment, the separate impervious layer 130 of Fig. 3 may be removed and, instead, the impervious surgical gown sleeve 210 may be folded back over itself at the first / distal end 212 to form gown sleeve portion 214, which faces and overlays gown sleeve portion 216, together forming cuff member 260.

[0077] At the second / proximal end 218 of the gown sleeve portion 214 there may be affixed a retention member 270, which may be like the retention member 140 at the proximal end of impervious layer 130 in FIG 2. The cuff ring 252 of glove 250 may be inserted into the cuff 260 and affixed in place by the retention member 270 by wrapping the cuff ring 252 around a portion of the retention member 270 to allow the cuff ring 252 on the end of the glove 250 to connect to it to produce a “watertight seal.” The cuff member 260 formed by gown sleeve portion214 and gown sleeve portion 216 of impervious gown sleeve210 are tightly sealed due to the elastic ring around the opening of gown sleeve 210 at end 218 causing the retention member 270 to be forced against the cuff ring 252 in turn sealing it against gown sleeve portion 216.

[0078] In the event there is leakage at the seal between the cuff ring 252 of glove 250 and cuff member 260 due to movement of the sleeve 210, for example, there is a dead space 280 between the cuff member 260 and the distal end of gown sleeve 210, which will trap leakedJ1404-00110fluid. Also shown in this figure is the sleeve member 220, which may be affixed to the bottom surface of the gown sleeve 210 and terminate proximate the location where the cuff 260 is formed by folding the gown sleeve 210 over on itself, or it may extend beyond this point as indicated in phantom at 220a.

[0079] In yet another embodiment, fluid management system 300 is shown in Figs. 5 and 6 to include impervious surgical gown sleeve 310 under which disposed and bonded thereto wicking layer or sleeve 320. Wicking layer or sleeve 320 may extend a portion of the distance up (but not normally the entire length of) the surgical gown sleeve 310. Wicking layer / sleeve 320 will typically extend a sufficient distance up the sleeve to ensure that perspiration will not be transferred out to the exterior of the surgical gown sleeve 10.

[0080] While the surgical gown sleeve 310 includes an impervious material on both the exterior surface 312 and the interior surface 314 thereof, the wicking layer or sleeve 320 may include an impervious material on the exterior surface 322, which will contact the interior surface 314 of the surgical gown sleeve 310 and also the surgical glove 350 when donned, as shown in Fig. 6. The interior surface 324 of wicking layer or sleeve 320 will include a wicking material.

[0081] Proximate the distal ends 316 and 326 of surgical gown sleeve 310 and the wicking layer or sleeve 320, respectively, and interposed between the two, may be affixed a retention member 370 (e.g. rim / band / strip). The composite of the surgical gown sleeve 310, wicking layer or sleeve 320, and the retention member 370 maybe formed by adhering the layers together using an adhesive, sonic or heat welding, sewing, or any other suitable means of adhering the items.

[0082] There is formed cuff member 360 out of the portion of the surgical gown sleeve 310 between the distal end 316 of surgical gown sleeve 310 and the rim / band / strip 370. There is also a cuff portion 380 formed proximate the first of distal end of wicking layer or sleeve 320. It should be noted that cuff member 360 and cuff portion 380 of the wicking layer 320 are not adhered together. The cuff member 360 and cuff portion 380 extend from the edge of retention member 370 to their respective distal ends.

[0083] As shown in Fig. 5, the interior surface of the cuff member 360 of surgical gown sleeve 310 is initially laying directly on the exterior surface of cuff portion 380 of wicking layer or sleeve 20. As can be seen in this view, the cuff portion 360 of the surgical gown sleeve 310 extends a distance X from the rim 370 to its distal end. And, cuff 380 of wicking layer or sleeve 320 extends the distance X and an additional distance Y from the rim 370 (total distance X+Y) to its distal end. In some cases, X maybe different than Y. In one embodiment, X may be equalJ1404-00110to Y and they may both equal approximately three (3) inches. In this example, cuff member 360 would extend three (3) inches from rim 370, while cuff portion 380 would extend six (6) inches from rim 370.

[0084] When the user desires to don the surgical gloves 350, the cuff portion 360 of the surgical gown sleeve 310 is folded onto itself over retention member 370 as shown in Fig. 6. The user then dons the surgical glove 350 such that it covers the exterior of the wicking layer 320 up to the rim 370. Shown in Fig. 6 in phantom is cuff 360’ when it is moved back to its original position over the exterior of surgical glove 350. Thus, fluids from the exterior environment are prevented from penetrating to the user’ s skin and perspiration from the user is prevented from pooling up (as it is wicked away by wicking member / layer 320) and reaching the exterior environment resulting in loss of sterile environment.

[0085] A further embodiment of the present disclosure is depicted in Fig. 7 as fluid management system 400. System 400 is shown to include surgical gown sleeve 410 having a distal end 416. In the opening of gown sleeve 410 at distal end 416 is inserted rubber cuff 490, which may be welded to the interior surface of gown sleeve 410 in the region 492. This embodiment may be utilized with the above-described embodiments of Figs. 3-6. In each of these embodiments the distal ends of the sleeve of the protective gown depicted as 110, 210, and 310, respectively, would be replaced by the rubber cuff 490.Fluid Management Garment

[0086] In some embodiments, the fluid management system may be incorporated into a garment as an integral part / component / layer of the garment. For example, referring now to FIGS. 8 and 9A, a garment 500 having an integrated fluid management system can include a moisture wicking layer 503 generally positioned interior to an inner surface of a sleeve 501 of the garment 500.

[0087] The garment 500, in accordance with various embodiments, can be any garment wherein fluid management is desirable, including, for example, surgical gowns, protective gear / garments for use in other industries and settings such as food preparation and processing, chemical, hazmat, laboratories, cleanrooms, emergency rooms, athletic gear, or combinations thereof. As shown in FIG. 8, the garment 500 can be a surgical gown. Surgical gowns are typically disposable garments having sleeves and can be manufactured from impermeable or fluid-resistant fabrics including nonwoven materials such as polypropylene, polyester, or polyethylene. In order to maintain impermeability, such garments are typically assembled by thermal (e.g., heat welding), chemical (e.g., glues or other adhesives), or mechanical (e.g, adhesive tapes) seaming and not by sewing. Thus, the various components of the garment 500J1404-00110(e.g., sleeves 501 and body 502) shown in FIGS. 8, 9A, and 9B can generally be attached by such seaming techniques, which will hereinafter be referred to as “welds” (e.g., shoulder weld 504 and cuff weld 513). For example, as shown in FIG. 8, the sleeves 501 of the garment 500 can be welded to a shoulder portion of the body 502 of the garment 500.

[0088] The wi eking layer 503 can generally extend through at least a portion of the sleeve 501 of the garment 500. For example, as best shown in FIGS. 8 and 9A, in some embodiments the wicking layer can extend through the entire sleeve 501 of the garment 500, from the wrist all the way to the shoulder and even, in some embodiments, extending distally from the wrist to form a hand portion 505 having a thumb loop 507 and / or a palm draping 509 to further wick moisture form the hand area of the wearer. In other embodiments, the wicking layer 503 may only extend through a portion of the sleeve 501 and terminate at a different location such as, for example, on the wearer’ s forearm, similar to the wicking sleeves illustrated in FIGS. 1 A-1B and 2A-2D.

[0089] Referring again to FIGS. 8 and 9A, the wicking layer 503 can be retained within the garment sleeve 501 by any suitable means capable of maintaining impermeability of the garment 500. For example, the wicking layer may be retained by either lamination or by more intermittent seaming welds as described above with reference to techniques including, for example, thermal e.g., heat welding), chemical (e.g, glues or other adhesives), or mechanical (e.g., adhesive tapes) seaming. For example in some embodiments, the wicking layer 503 can be laminated along its entire surface to the interior of the sleeve 501. In other embodiments, the wicking layer 503 can be welded to the sleeve 501 in one or more locations such as, for exampl e, the wri st, the shoul der, the elbow, the forearm , or combi nations thereof. The wicking material of the wicking layer 503 can generally be any material suitable for transporting or pulling fluid through the fabric and away from the fluid source. Such materials can include, for example, polyester, polypropylene, merino wool, wool, bamboo, micromodal fabrics, nylon, and combinations thereof.

[0090] The hand portion 505 can generally extend distally from the wrist of the sleeve 501. The hand portion can include a thumb loop 507 to provide stability and comfort in the hand area and / or a palm draping 509 to provide moisture management within surgical or other protective gloves by wicking moisture away from the hand area of the wearer. In some embodiments, the thumb loop 507 and palm draping 509 can be formed to provide wicking from the hand while preserving the fit and dexterity afforded by surgical gloves. As best shown in FIG. 9A, the thumb loop 507 can extend downward for insertion of the wearer’ s thumb. The palm draping 509 can preferably extend in a curvilinear manner between the thumb loop 507J1404-00110and the wrist portion of the wicking layer 503 which, in some embodiments, can be sized and shaped to cover the heel of the hand. In contrast, the thumb loop 507, on a side 507a opposite the palm draping 509 can extend directly (substantially straight) backto the wrist in a proximal direction so as to leave the back of the hand free and to minimize volume inside the hand portion of the glove. Such a configuration can thereby provide wicking from the hand without negatively impacting fit, dexterity, or freedom of hand movement of the wearer.

[0091] As best shown in FIG. 9B, the sleeve 501 of the garment 500 can include a cuff member (“flap”) 511 attached thereto. In order to provide secure attachment and preserve impermeability of the garment, the flap 511 can be attached by a seaming cuff weld 513 constructed as described above with reference to techniques including, for example, thermal (e.g., heat welding), chemical (e. ., glues or other adhesives), or mechanical (e.g., adhesive tapes) seaming. The flap 511 can generally be attached at any location along the sleeve 501 suitable for turning the flap 511 down (distally) over the proximal end of a glove 601 (e. , over the o-ring 602 of a surgical glove) to retain the glove in place and to prevent moisture ingress or egress.

[0092] Still referring to FIG. 9B, in many applications both an inner glove 601 and outer glove 603 may be worn. In such embodiments the proximal end and o-ring 602 of the inner glove 601 may be positioned between the flap 511 and the sleeve 501 of the garment 500 to retain the glove in place and to prevent moisture ingress or egress via, for example, channeling. The proximal end of the outer glove(s) 603 may be positioned exterior to the flap 511. In such embodiments it may be preferable to position an o-ring 604 of the outer glove(s) 603 proximal to the seaming weld 513 such that an interaction of the o-ring 604 with the joint between the flap 511 and the weld 513 to further retain the glove 603. FIG. 9C illustrates a cross-sectional view of the sleeve 501 and flap 511 attached to an outer surface of the sleeve 501 by the seam weld 513, as shown in FIG. 9B, but the gloves 601 and 603 are omitted for purposes of clarity.

[0093] In some embodiments, the flap 511 can be constructed from a same material as the sleeve 501 of the garment 500. In some embodiments, the flap 511 can be constructed of a different material such as, for example, a higher-friction material in order to further prevent slipping ofthe gloves 601, 603 relative to the exterior of the sleeve 501. Suitable higher friction materials can include, for example, Thermoplastic Polyurethane (TPU), rubber, or any other suitable impermeable material having a higher coefficient of friction than the material of the sleeve 501.

[0094] In some embodiments, as shown in FIGS. 10A-10B, a filled flap 1001 can be provided to provide greater stiffness and a more compressive fit to better hold the inner gloveJ1404-00110601 and the o-ring602 ofthe inner glove 601 against the sleeve 501. In addition, the filled flap 1001 can also better capture the o-ring 604 of the outer glove(s) 603 when the o-ring 604 of the outer glove(s) 603 is positioned proximal to a j oint between the weld 513 and the filled flap 1001 because the filled flap 1001 results in a larger / thicker protrusion at the joint. In such embodiments the flap 1001 can be filled with any suitable fluidic material including, for example, gases such as air or nitrogen, liquids such as water or saline. Although it will be apparent in view of this disclosure that the filled flap 1001 can be filled to any desired pressure, the flap may, in some embodiments, preferably be filled to a pressure high enough to enhance compression of the inner glove 601 and the o-ring 602 of the inner glove 601 against the sleeve 501 and low enough to permit turning the filled flap 1001 down (distally) over the proximal end of the inner glove 601over the o-ring 602 of the inner glove 601) to retain the inner glove 601 in place and to prevent moisture ingress or egress.

[0095] Still referring to FIGS. 10A and 10B, further retention of the inner glove 601 can be provided by a ridge 1003 extending around a distal portion of the weld 513 in order to provide resistance to distal roll-back or slippage of the o-ring 602 ofthe innerglove 601. This resistance to distal roll-back or slippage works in cooperation with the compression provided by the flap 511 or filled flap 1001 to trap the o-ring 602 ofthe inner glove 601 proximal to the ridge 1003 and prevent removal or partial removal of the inner glove 601 in a manner that would break moisture sealing and thus sterility of the environment. The ridge 1003, in some embodiments, can be constructed of a same material as the sleeve 501 and / or the flap 511 or filled flap 1001. In addition, in some embodiments, the ridge 1003 can be filled similar to the filled flap in order to provide additional height / thickness. It will also be apparent in view of this disclosure that, in some embodiments, such as, for example, where it is preferably for the ridge 1003 to be more rigid than the sleeve 501 or the flap 511 or filled flap 1001, the ridge 1003 can alsobe constructed of other materials such as, for example, rubber, plastic, polymers, surgical stainless steel, combinations thereof, or any other suitable material.

[0096] In some embodiments, the flap 511 orfilledflap 1001 can also include one ormore pull tabs (not shown) in order to facilitate gripping of the flap 511 or filled flap 1001 when turning down (distally) over the inner glove 601 and o-ring 602. In some embodiments, the user can also place a rubber / elasticband or adjustable strap (e.g., an adjustable strap having hook and loop fasteners disposed thereon) to further compress the flap 511 or filled flap 1001 against the inner glove 601 and o-ring 602 to decrease or eliminate fluid / moisture from crossing the glove down interface. In some embodiments, a glue, tape, or adhesive can be applied or attached to the exterior of the sleeve 501, the exterior of the weld 513 and / or an exterior surfaceJ1404-00110of the flap 511 orfilledflap 1001 (“exterior surface” referringto the surface thatis facing away from the user’ s arm when the flap 511 or filled flap 1001 is in the turned down position) so as to further prevent distal roll-back or slippage of the inner glove 601.

[0097] FIG. 11 illustrates a flow chart of a method of making a protective gown having sleeves with a cuff member (aka, Tuff Cuff™) attached to an exterior surface of each sleeve, in accordance with some embodiments. It is understood that the flowchart of FIG. 11 ismerely exemplary and is not intended to limit the scope of the present disclosure. For example, as would be understood by persons of ordinary skill in the art, the order of steps illustrated may be changed, two or more steps may be performed in parallel, some steps may be omitted and / or additional steps may be added without departing from the inventive concepts described in the present disclosure.

[0098] In some embodiments, the cuff member is made from a film, e.g., an elastic film, that is formed into a cylindrical shape. The film is provided as a flat sheet of material having desired material properties, a desired length and a desired width to provide a desired tubular (e.g., cylindrical or conical) shape and size. In some embodiments, the film is an elastic material that will expand and relax around the circumference of the users arm. Such elastic material could be elastic either in a machine direction or a cross direction, or both, when the elastic material is cut from an elastic material roll, in some embodiments, proximal and / or distal ends of the sheet can be folded over and thereafter the overlapping material can be sealed together to improve the strength and tear-resistance of the sheet. Alternatively, the proximal and / or distal ends may be rolled into an O-ring shape, incorporate an O-ring, or include a hot melt bead to form an O-ring, in accordance with various alternative embodiments. The cuff material sheet is then rolled around a lengthwise axis to form the desired tubular shape, and the overlapping lengthwise edges of the sheet are thereafter attached and sealed to one another to retain the desired shape. The above-described seals can be made by heating and / or bonding with adhesive, in accordance with various embodiments. In some embodiments, the tubular cuff is preferably smaller in diameter than the gown sleeve, which allows the elastic property of the film to improve the impermeability of the interface between the cuff member and the exterior surface of the sleeve, as described in further detail below. In some embodiments, the cuff member is made from an elastic material such as an elastomer, such that the un-stretched diameter of the elastic cuff member can be 20 to 30% smaller than the diameter of the gown sleeve at the area of bonding (i.e., bonding zone). In some embodiments, the cuff member length may range from 3 to 5 inches (76 - 127 mm) and is preferably 4 inches (101 mm) long. In some embodiments, the cuff member is bonded to the exterior surface of the gown sleeve,J1404-00110and the bond is leak proof as measured by an ASTM 1670 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood at the interface between the cuff member and the outer surface of the gown sleeve. In some embodiments, the bond is made with a hot melt adhesive that penetrates into the gown material and forms a leak proof bond. One way to achieve this is by reheating a hot melt adhesive applied at the bonding zone and applying pressure and heat after assembly, as described in further detail below.

[0099] At step 1101, a film is unwound from a roll of the film. In some embodiments, the film is made from an elastic material that allows the cuff member made from the film to stretch around the circumference of a wearer’s forearm. The elasticity allows the cuff member and underlying gown sleeve to stretch to allow enough room for the wearer’ s hand to go through the sleeve and thereafter retract around the wearer’s forearm to provide a snug fit between the cuff member / sleeve and the forearm. At step 1102, the unwound film is cut to a desired size and shape to form a cuff member, as described above. In some embodiments, the final shape of the cuff member is cylindrical, hence the initial flat sheet of film unwound from the roll is rectangular, in accordance with some embodiments. In alternative embodiments, the final shape of the cuff member may be conical, hence the initial shape of the flat sheet of film can have straight lines and arcs that will form a cylindrical cone shape when rolled and sealed. Those of ordinary skill in the art will know how to cut the unrolled sheet of film to roll into a desired conic shape, having a desired length (with or without folded edges) and desired circumferences. As used herein, the term “tubular” includes both cylindrical and conical shapes.

[0100] At step 1103, at least one edge (e.g., a distal edge in a folded position of the cuff member) of the cut film is folded over to improve the strength and tear resistance of the cuff member, and further make it easier for a user to grab the foldable portion of the cuff and fold it over. The folded edge also provides a ridge to lock the o-ring of a protective glove to prevent it from moving. In one embodiment, one fold is made, however, multiple folds can be made in alternative embodiments. Alternatively, the edge may be rolled or formed with an O-ring. At step 1104, the folded edge is thermally bonded so the overlapping material is fixed together. Alternatively or additionally, the bond may be made with adhesive. In some embodiments, both opposing edges (distal and proximal) of the film are folded over and sealed to improve the strength and tear resistance of the cuff member. At step 1105, the sheet of film is formed into a cylindrical or conical shape having desired dimensions. In some embodiments, the sheet of film is wound around a mandrel with overlapping material in a longitudinal direction for sealing the longitudinal overlapping edges to each another to createJ1404-00110an overlapping seam. Next, at step 1106, the formed cylindrical (or conical) tube is thermally bonded along the overlapping seam to retain the cylindrical or conical shape of the cuff member. Alternatively or additionally, the bond may be made with an adhesive. In preferred embodiments, the bond leak is proof and is of sufficient strength to prevent delamination.

[0101] FIG. 12 illustrates a perspective view of a cuff member 1200 that is made after performing steps 1101-1106 described above, in accordance with some embodiments. The cuff member 1200 is cylindrical in shape with a desired length 1202 in the longitudinal direction and desired diameter 1204. As further shown in FIG. 12, the cuff member 1200 includes a folded edge 1206 that can be sealed, as described above, and an overlapping seam 1208 created by sealing overlapping longitudinal edges of the film sheet, as described above. After completing steps 1101-1106, the resulting elastic cuff member 1200 is ready to be placed on to an expanding fork assembly, as described in further detail below.

[0102] Referring again to FIG. 11, at step 1107, the cuff member 1200 is placed onto a multi-prong fork assembly. In some embodiments, the cuff member 1200 is made from an elastomer, and the elastic cuff diameter in an un-stretched state is smaller than the gown sleeve diameter. Hence, the cuff member is stretched within its elastic limits to a larger diameter to facilitate assembly over the sleeve. One exemplary way to accomplish this is to place the elastic cuff member onto an expanding a multi -prong fork assembly 1302, as shown in FIG. 13, which will be described in further detail below with reference to FIG. 13.Current protective gowns simply sew an un-stretched knit cuff onto a distal end of the gown sleeve and do not provide a liquid impermeable seam. In contrast, in some embodiments, the cuff member of the present disclosure is attached in a stretched state onto an exterior surface of the gown sleeve at a desired proximal location with respect to the distal end of the gown sleeve (with or without a knit cuff) to provide a liquid impermeable sleeve-glove interface, as described herein. When placed onto the sleeve disposed on the mandrel 1304, the stretched cuff member 1200 applies pressure onto the sleeve and hot-melt adhesive applied at the bonding zone to facilitate creation of a liquid impermeable seal or bond between the cuff member 1200 and the sleeve material, as described in further detail below. In some embodiments, the hot-melt adhesive is pressure activated. Furthermore, by applying the cuff member 1200 onto the sleeve and mandrel in a stretched state, diameter mismatches and wrinkles in the sleeve material and / or cuff material can be eliminated or at least significantly reduced, thereby facilitating formation of a liquid impermeable bond between the cuff member 1200 and the sleeve material. Additionally, by placing the cuff member on the gown sleeve in a stretched state, a snug fit around a user’s forearm area can be provided. AsJ1404-00110described in further detail below, the cuff member 12 is placed onto the expanding fork assembly 1302 in a retracted state, and then the forks are expanded to stretch the cuff member before it is placed onto the gown sleeve that is disposed on a mandrel 1304 of FIG. 13, as described in further detail below.

[0103] Next, at step 1108, a gown sleeve is placed over the mandrel 1304. The sleeve may or may not be attached to the gown body. In accordance with some embodiments, the mandrel 1304 has an anvil for the cuff bonding process (step 1111). Preferably, the anvil is resilientto conform to the varying gown material layers at the sleeve seam. Because current gown manufacturing processes align the sleeve seal manually before seaming there is a high variability in sleeve diameters. In order to make an impervious seam at the interface between the gown sleeve and the cuff member, it is desirable to eliminate or minimize the number and size of wrinkles at the interface surfaces. In some embodiments, excess sleeve material may be removed before bonding to the cuff member, as described in further detail below. In accordance with some embodiments, wrinkles in the gown sleeve at the interface location where the cuff member will be bonded to the sleeve are eliminated or substantially reduced by using a novel mandrel having an anvil that is made from a silicone or urethane rubber, or other suitable material, having a medium durometer of 50A ± 10%. Preferably, the anvil shape and diameter match that of the sleeve at the target interface bonding zone. In some embodiments, the mandrel 1304 may feature vacuum holes to secure and retain the sleeve material close to the mandrel surface, as described in further detail below. In further embodiments, the anvil may further include microfolds to provide an increased anvil circumference, as described in further detail below.

[0104] At step 1109, a pressure sensitive hot melt is applied to the sleeve at the target bonding zone. In accordance with some embodiments, a midpoint of the bond zone is in a range 1.50 - 3.50 inch (38 - 89 mm) from the knit cuff / sleeve interface, and preferably 2.50 inches (63 mm) from the knit cuff / sleeve interface, as described in further detail below with respect to FIG. 18 A. If the sleeve does not end with a knit cuff it may end with a folded seam or an elastic band at its distal end or edge. In this case, a midpoint of the bond zone is in a range 1.50 - 3.50 inch [38 - 89 mm] from the distal end of the sleeve, and preferably 2.50 inches (63 mm) from the distal end of the sleeve, as described in further detail below with respect to FIG. 18B. If the sleeve ends with a thumb hole, the midpoint of the bond zone is in the range of 4.50 - 6.50 inch (114 - 165 mm) from a distal edge of the thumb hole, and preferably 5.50 inches (140 mm) from the distal edge of the thumb hole, as described in further detail below with respect to FIG. 18C.J1404-00110

[0105] In accordance with some embodiments, a standard industrial hot melt system with a non-contact applicator can be used to apply a hot melt adhesive at the bonding zone of the sleeve. A preferred nozzle type is a bead extruder, however, a spray or slot nozzle can also be used to apply the hot melt adhesive, in accordance with various embodiments. In accordance with some embodiments, the hot melt adhesive is applied with a bead weight of 0.1 to 0.5 grams per sleeve to deliver a leak proof bond. In some embodiments, a uniform bead is applied to a rotating sleeve that is rotated by the mandrel 1304 along the entire circumference of the sleeve / cuff interface and the amount of adhesive used is approximately 0.001 gm per millimeter (mm). Alternatively, the hot melt applicator may rotate around a stationary sleeve, in accordance with alternative embodiments. In some embodiments, a styrenic block co-polymer hot melt adhesive manufactured by Bostik, Inc., Wauwatosa, WI, U.S.A., under the product code HM3070, can be used. In some embodiments, the adhesive will have a softening point of 75 degrees C as measured by Herzog- ASTM E28, and a viscosity of 19,130 centipoise (cPs) (at 110 degrees C), 6140 cPs (at 130 degrees C), 2600 cPs (at 150 degrees C), and 1325 cPs (at 170 degrees C). As discussed in further detail below, after applying the adhesive at a first temperature (e.g., 75 degrees C), the adhesive can be reheated at a second higher temperature (e.g., 120-149 degrees C), which will cause the adhesive to flow into the pores of a woven or nonwoven gown sleeve thereby creating a liquid impermeable seam at the cuff / sleeve interface. Additionally, the adhesive’s inherent elastic properties can maintain a strong, liquid impermeable seam between the cuff member and the sleeve in both stretched and relaxed states.

[0106] At step 1110, the expanded cuff member (expanded at step 1107) is positioned over the sleeve disposed on the mandrel 1304 without touching the hot melt adhesive with the expanding fork assembly 1302 in an expanded state. A bonding zone of the cuff member is positioned and aligned over the bonding zone of the sleeve and, thereafter, a leading edge of the cuff member 1200 is clamped to the sleeve at multiple points with a clamping unit 1306, as described in further detail below with respect to FIG. 13. After the cuff member 1200 is clamped to the sleeve, the fork prongs of the multi-prong fork assembly 1302 (or finger prongs of a gripper) are withdrawn. When the prongs are withdrawn, the elastic cuff member snaps to a tight fit around the sleeve and mandrel. In some embodiments, the hot melt adhesive is pressure activated such that it begins to cure when the elastic cuff member applies pressure onto the hot melt disposed at the bonding zones between the cuff member and the exterior surface of the sleeve.J1404-00110

[0107] Next at step 1111, after the hot melt is applied and the cuff member 1200 is placed onto the sleeve, as described above, the hot melt adhesive is reheated to improve the bond strength and further improve the impermeability of the bond seam between the sleeve and the cuff member 1200. In some embodiments, a reheating assembly 1308 is used to reheat the adhesive to cause the adhesive to flow into the sleeve fabric pores, thereby making the bond seam further impervious to liquids, as described in further detail below with respect to FIG.13. In some embodiments, the hot melt is heated to a temperature that allows it to flow, preferably 275 degrees F (135 degrees C). In accordance with various embodiments, the reheat temperature may range from 250 to 300 degrees F (121 to 149 degrees C) depending upon the adhesive properties. In accordance with some embodiments, it has been found that reheating the adhesive at a temperature range of 120-149 degrees C provides a viscosity that allows enough flow into the garment sleeve pore structures without causing too much flow, thereby allowing the adhesive to remain on the bond interface surfaces between the sleeve and the cuff film material to create a liquid impermeable seal at the interface. Additionally, the amount of adhesive used can play a role in creating a liquid impervious bond between the sleeve and the cuff material. Too little adhesive will not create a suitable bond, while too much adhesive may take too long to cool and set. In some embodiments, 0.8 to 1.2 milligrams (mg) per mm, preferable 1 mg / mm, of adhesive is applied as a uniform bead around the entire circumference of the interface / seal between the cuff material and the sleeve material.

[0108] In some embodiments, the reheat assembly 1308 further applies pressure onto a surface of the cuff member at the bonding zone to aid the flow and penetration of hot melt adhesive into the sleeve fabric pores. In some embodiments, the pressure applied is equal to 5 - 10 pounds per square inch (3,500 - 7,000 kilogram force per square meter (kgf / sqm)). Furthermore, the tool contact time may range from 2 to 15 seconds, e.g., 7 seconds, in accordance with some embodiments. The combination of heat, pressure, and contact time ensures a leak proof bond between the sleeve material and the cuff member film. It is understood that the combination of heat, pressure and contact time values can be adjusted depending on different intended purposes of the protective gown and / or to support high-speed automation, for example. In some embodiments, a contact surface of a heating member of the reheating assembly is curved to match a curvature of the bond zone. In some embodiments, the heating member moves from a retracted position to an extended position, clamping the laminated layers of the cuff member, hot melt and sleeve against a round anvil of sleeve mandrel. In some embodiments, the laminated layers are rotated by the mandrel toJ1404-00110allow the heating elements to reheat the adhesive along the entire circumference (360 degrees) of the cylindrical bonding zone. Several rotation and heating cycles may be performed to achieve the full 360 degree coverage. Although two heating elements 1310 are shown in FIG. 13, in alternative embodiments, there may be one heating element, or three or more heating elements, in accordance with various embodiments.

[0109] In accordance with some embodiments, the reheating process includes the following operations:a) Extend the heating member(s) to contact a contact portion of the circumference of bonding zone of the cuff member;b) Allow the heating member(s) to contact the bonding zone for a predetermined period of time (dwell time) to transfer thermal energy and apply pressure; c) Retract the heating member(s) to provide clearance to rotate the mandrel. d) Rotate the sleeve mandrel to a next contact position that overlaps the contact portion.e) Repeat 1-4 until full 360 degrees of contact coverage is achieved.To reduce manufacturing time, additional heating elements can be utilized to reduce the number of cycles (steps a-d above). In some embodiments, three or four heating elements are utilized to achieve 360-degree contact coverage in two or three cycles.

[0102] Next at step 1112, after the hot melt is cooled, the assembled cuff and sleeve are removed from the mandrel. At step 1113, steps 1101 through 1112 are repeated for the other sleeve of the gown. The finished gown will have one cuff member per each sleeve. Finally, at step 1114, the completed gown is packaged for shipment.

[0103] In accordance with an alternative embodiment, the cuff member 1200 can be attached to the gown sleeve during the gown construction stage before the sleeve is attached or sewn to the body of the gown, which can provide manufacturing efficiencies and advantages. In this embodiment, the cuff material is bonded to the sleeve while it is flat before it is seamed into a cylindrical shape and sewn to the gown body. In accordance with some embodiments, the process includes the following steps:1. The sleeve is cut to size and shape from the gown material.2. The cuff member film is cut to size and shape.3. In some embodiments, the cuff member film is an elastomer, and the elastic cuff member film is stretched a predetermined amount (e.g., 10 to 40%) whenJ1404-00110it is placed on the sleeve material. In some embodiments, the elastic cuff member is stretched in the range of 20 to 30%.4. A hot melt adhesive is applied to a first bond zone on the sleeve. In some embodiments, the hot melt adhesive is a pressure-activated adhesive.5. A second bond zone of the cuff memberis positioned and pressed onto the hot melt and first bond zone of the sleeve. In some embodiments, if the cuff memberis an elastic cuff member in a stretched state, the elastic cuff member is maintained in a desired stretched state (e.g., stretched to be 10% to 40% larger in one or more desired directions) by at least two clamps (not shown) on opposites sides of the stretched flat cuff member while the second bond zone of the cuff member is positioned and pressed onto the hot melt and first bond zone of the sleeve.6. Heat and pressure are applied to the first and second bond zones, re-melting the hot melt adhesive, creating a leak proof bond and seam between the cuff member and an outer surface of the sleeve.7. The bonded sleeve and cuff film are wrapped around a mandrel and overlapping longitudinal edges of the sleeve and cuff film are heat sealed to form the sleeve and cuff longitudinal seams. In some embodiments, the longitudinal seams are formed by an adhesive bond that will not melt, shift or otherwise degrade the seams of the cuff member while making the longitudinal sleeve seam. Alternatively or additionally, in some embodiments, the cuff member is made from a material having a higher melting point than that of the gown sleeve, such that the integrity of the cuff member and cuff member seams will not be degraded when making the longitudinal seam of the gown sleeve.8. If desired, a knit cuff is sewn on at the distal end of each sleeve.9. Left and right sleeves are then sewn to the gown body.

[0104] FIG. 13 illustrates a perspective view of a system 1300 for manufacturing a protective gown having a sleeve with a cuff member bonded thereto, in accordance with some embodiments. The manufacturing system 1300 includes the multi-prong fork assembly 1302, a sleeve mandrel assembly 1304, a cuff clamp assembly 1306 and a reheating assembly 1308. For clarity, a hot melt applicator is not shown, however, its location is above the sleeve mandrel assembly 1304. As further shown in FIG. 13, the multi-prong fork assembly 1302 and the cuff clamp assembly 1306 are movably mounted on a linear track 1310 that is fixed on a platformJ1404-001101312. The mandrel assembly 1304 is attached to a rotary arm assembly 1314 also mounted on the platform 1312. The rotary arm assembly 1314 is configured to rotate the mandrel 1304 around a longitudinal axis of the mandrel assembly 1304, which is parallel to the lineartrack 1310. The reheating assembly 1308 includes two linear actuators 1309 and two heating elements 1316 on opposite sides of the sleeve mandrel assembly 1304. Each linear actuator 1309 is configured to move a respective heating element 1316 toward and away from the mandrel 1304, and is mounted on a respective one of two support arms 1318 that are fixed onto the platform 1312 on opposite sides of the sleeve mandrel assembly 1304. Each of the main assemblies 1302, 1304, 1306 and 1308 are described in further detail below.

[0105] FIG. 14A illustrates a perspective view of the multi-prong fork assembly 1302 of FIG. 13. As shown in FIG. 14A, the multi-prong fork assembly 1302 includes a plurality of fork prongs 1402 (e.g., 8 prongs) that extend outwardly from a corresponding one of a plurality of mounting brackets 1404. Each of the mounting brackets 1404 are movably coupled within a corresponding radial slot 1406 formed in an assembly plate 1408. Each mounting bracket 1404 is configured to slide within its corresponding radial slot 1406 in a radial direction as an actuating member 1410 is pushed or pulled linearly along a linear axis that is perpendicular to front and back walls of the assembly plate 1408, thereby moving the plurality of fork prongs 1402 into expanded and retracted states. As shown, a cuff member 1200 is held by the fork prongs 1402 in an expanded state.

[0106] FIG. 14B illustrates a cross-sectional side view of the multi-prong fork assembly 1302. As shown in FIG. 14B, when the actuating member 1410 is pushed toward the assembly plate 1408, each of the mounting brackets are moved radially outwardly in their respective radial slots 1406 to move the fork prongs 1402 radially outwardly to an expanded state. Conversely, when the actuating member 1410 is pulled away linearly from the assembly plate 1408, the mounting brackets are moved radially inwardly to a retracted state. FIG. 14C and 14D illustrate the multi-prong fork assembly in the expanded state and retracted state, respectively. As shown in FIGS. 14C and 14D, a cuff member 1200 is held by the multiple prongs 1402 in the expanded and retracted states, respectively.

[0107] The cuff member 1200 is placed over and around outer surfaces of the multiple fork prongs 1402 in a retracted state. Thereafter, and before positioning the cuff member 1200 over a gown sleeve 501, the fork assembly 1302 is actuated by the actuating member 1410 into an expanded state to stretch the elastic cuff member from its relaxed diameter (e.g., 2.88 inches, 73 mm) to a stretched diameter (e.g., 4.39 inches, 111 mm). After stretching the cuff member 1200 to an expanded state, the cuff member 1200 can be moved over and around the sleeveJ1404-00110501 disposed on the mandrel 1304 without contacting either the sleeve or the hot melt adhesive disposed on the sleeve at the bonding zone of the sleeve. To ensure proper bonding and the formation of a liquid impermeable seal, it is desirable to avoid contact between the cuff member 1200 and the sleeve 501 and hot melt adhesive until the cuff member 1200 is in the correct bonding position. As described in further detail below, after clamping an edge portion of the cuff member onto the sleeve, the fork prongs stay in their expanded state while they are withdrawn. The cuff clamp assembly 1306 holds the cuff member 1200 in position while the forks 1402 are withdrawn and the elastic cuff member 1200 will snap to the sleeve / mandrel diameter to squeeze the outer surface of the sleeve disposed on the mandrel. In some embodiments, after the elastic cuff member 1200 snaps onto the sleeve / mandrel, the elastic cuff member 1200 is still in a stretched state (e.g., its diameter or circumference is 20% to 30% larger compared to its diameter or circumference in an unstretched state). This allows, the cuff member 1200 to apply pressure onto the sleeve and hot-melt adhesive. In some embodiments, the hot melt adhesive can be a pressure-activated adhesive. Thus, when the elastic cuff member 1200 squeezes the outer surface of the sleeve in the bonding zone 1503 (FIG. 15B) where a hot melt adhesive is applied between the cuff member 1200 and the sleeve material 501, the pressure-activated hot melt adhesive will be activated and begin to cure to provide a bond and seal between the cuff member 1200 and the sleeve 501.

[0108] In some embodiments, the actuating member 1410 may be operated manually. In alternative embodiments, the actuating member 1410 may be controlled automatically by a controller and actuator (not shown) in an automated manufacturing system and method. Furthermore, it is understood that the multi -prong fork assembly 1302 shown in FIGS. 13, 14A and 14B is one exemplary embodiment for performing the operations of expanding the elastic cuff member 1200, placing the cuff member 1200 over the sleeve 501 disposed on the mandrel assembly 1304, as described above. In alternative embodiments, these or similar operations may be performed instead with a robotic arm having a gripper with multiple fingers. Such robotic arm may be controlled by one or more controllers and actuators that control the movements of the robotic arm, gripper and fingers in an automated manufacturing environment that utilizes automation software and protocols. As used herein, a “multi-prong assembly” can refer to the multi-prong fork assembly 1302 and similar assemblies such as a robotic arm with a multi-finger gripper.

[0109] FIGS 15A and 15B illustrate top views of the manufacturing system 1300 before and after a garment sleeve is placed onto the mandrel assembly 1304, respectively. As shown in FIGS. 15A and 15B, before a sleeve 1501 is placed on the mandrel assembly 1304, the cuffJ1404-00110clamp assembly is moved via linear track 1310 away from the mandrel assembly 1304 toward the multi-prong fork assembly 1302 so as not to interfere with the placement of the sleeve 1501 onto the mandrel 1304. After the sleeve 1501 is placed on the mandrel 1304, as shown in FIG.15B, the cuff clamp assembly 1306 may be moved along lineartrack 1310 over and past the mandrel assembly 1304 toward the rotary arm assembly 1314 to be in position for clamping the cuff member 1200 onto the outer surface of the sleeve at a position proximal to the bonding zone 1503 of the sleeve 1501. As shown in FIG. 15 A, in accordance with some embodiments, the mandrel 1304 includes an anvil portion 1502 that is positioned to correspond to the bonding zone 1503 of the sleeve 1501 when itis disposed on the mandrel 1304. In some embodiments, the bonding zone 1503 is located approximately 2.5 inches from the seam of sleeve 1501 and a knit cuff 1504. In accordance with some embodiments, the anvil portion 1502 is made from a silicone or urethane rubber, or other suitable material, having a medium durometer of 50A ± 10%. As discussed in further detail below, the anvil portion 1502 assists with minimizing wrinkles in the sleeve material and creating a liquid impermeable seal during a reheating of the hot melt adhesive.

[0110] As further shown in FIGS. 15A and 15B, the reheating assembly 1308 / 1316 is initially in a retracted state such that the heating elements 1316 are positioned away from the bonding zone 1503 before the sleeve 1501 is placed on the mandrel 1304. When the sleeve 1501 is positioned on the mandrel 1304, the cuff clamp assembly 1306 is moved away from the fork assembly 1302 toward the rotary assembly 1314. After clamping of an edge portion of the cuff member 1200 onto the sleeve 1501, and the fork assembly 1302 is pulled away from the mandrel assembly 1304, the heating elements 1316 of the reheating assembly 1308 are moved toward the mandrel 1304 to apply heat and pressure to the laminated layers of the cuff member 1200, hot melt adhesive and sleeve 1501, as described above.[OHl] FIGS. 16A and 16B illustrate side and front views of the cuff clamp assembly 1306 of FIG. 13, in accordance with some embodiments. The cuff clamp assembly 1306 includes a plurality (e.g., eight) cuff clamps 1602 disposed at equal intervals to surround the circumference of the mandrel 1304. Each cuff clamp 1602 includes a clamp arm 1604, a cam slot 1606 disposed at a first end of the clamparm 1604 and a clampingpad 1608 disposed at a second end of the clamp arm 1604, opposite the first end. The clamp assembly 1306 further includes a cam lever 1610 that can be manually or automatically operated in similar fashion to the actuating member 1310 described above. In response to operation of the cam lever 1610, the claim arm 1604 is rotated about a pivot member 1612 to press or release the clamping pad 1608 onto a corresponding portion of the outer surface of the cuff member 1200 disposedJ1404-00110around multiple fork prongs 1402 in an expanded (stretched) state. After the cuff member 1200 is positioned over the gown sleeve with the expanded forks, the cuff clamps 1602 close and lock in place the cuff member onto the sleeve 1501 so the multiple fork prongs 1402 can be retracted while the cuff clamps 1602 hold the cuff member 1200 in place relative to the sleeve 1501 andmandrel 1304. In some embodiments, the cam lever 1610is springloaded with spring 1614 disposed on a cam lever rod 1616 coupled to a rotary plate 1618 that holds each of the plurality of cuff clamps 1602 in place to hold the cuff member 1200 on the sleeve 1501. In some embodiments, in this state, the linkages of cuff clamps 1602 are in-line and in a stable position with opposing forces canceling each other. This type of mechanism is known as a toggle mechanism. Thus, the cuff clamps 1602 can clamp and hold the cuff member onto the sleeve at multiple points along the leading edge of the cuff. This holds the cuff in position as the multiple fork prongs are withdrawn, as described above. In some embodiments, each of the multiple cuff clamps 1602 contacts the cuff member between respective two adjacent fork prongs 1402, stretches the elastic cuff member film onto the sleeve surface, applying pressure against the sleeve. Thereafter, the forks prongs 1402 can be withdrawn, causing unclamped portions of the elastic cuff member to snap to a tight fit around the sleeve and mandrel.

[0112] As shown in FIG. 16B, in accordance with some embodiments, the number of cuff clamps 1602 is equal to the number of fork prongs 1402 of the multi-prong fork assembly 1302, and each cuff clamp 1602 is positioned so that each respective clamping pad 1608 when engaged to hold the cuff member 1200 in place is positioned approximately equidistant between two adjacent fork prongs 1402. In thisway, when the clamping pads 1608 are engaged to hold down the cuff member 1200 in place with respect to the sleeve 1501 and mandrel 1304, the multiple fork prongs 1402 can be retracted and moved away from the mandrel assembly 1304 more easily, without disrupting the position of the cuff member 1200.

[0113] FIGS. 17Aand 17B illustrate top and front views of the reheat assembly 1308 when the heating elements 1316 are engaged to apply heat and pressure to the layers of the cuff member 1200, hot melt adhesive and the sleeve material 1501, in accordance with some embodiments. After the cuff member 1200 is positioned such that a bonding zone of the cuff member 1200 is aligned with the bonding zone 1503 of the sleeve, and the multiple fork prongs 1402 are retracted, as described above, two heating elements 1316 are moved toward the mandrel 1304 on opposite sides of the mandrel 1304 to apply heat and pressure onto layers of the cuff member 1201, hot melt adhesive, and the sleeve 1501 at the bonding zone 1503 corresponding to the position of the anvil 1502. As described above, the linear actuators 1309J1404-00110move their respective heating elements 1316 between their engaged and disengaged positions. In accordance with various embodiments, the linear actuators may be operated either manually or automatically as part of an automated manufacturing system, similarly as described above with respect to the actuating member 1410. After reheating is performed at first portions of the bonding zone, the heating elements 1316 are retracted and the mandrel rotated a next predetermined position (e.g., a predetermined number of degrees) to reheat another portion of bonding zone, until the entire circumference of the bonding zone is reheated and sealed to provide a complete liquid impermeable seal around the full 360 circumference of the bonding zone between the cuff member 1200 and the sleeve material 1501. As discussed above, reheating the hot melt adhesive allows the adhesive to flow into the pores and spaces between the fibers of the sleeve material, thereby creating an improved liquid impervious seal between the cuff member 1200 and the sleeve 501 at the bonding zone 1503.

[0114] As described above novel methods and systems of making a protective garment having a cuff member attached to each of its sleeves are disclosed. It is understood that the above described methods and systems are intended to convey certain features and advantages described in the present disclosure, and not intended to limit the scope of the present disclosure. Various modifications to the methods and systems disclosed herein would be apparent to those of ordinary skill in the art to achieve one or more features and advantages disclosed herein. For example, it has been found that bonding the cuff material to the sleeve in an un-stretched state by reheating an adhesive between the cuff material and the sleeve provides a significantly improved seam or bond between the cuff material and sleeve material that is liquid impermeable or substantially liquid impermeable. It has further been found that by bonding the cuff material to the sleeve in a stretched state and reheating the adhesive between the cuff material and the sleeve provides a further improved seam / bond between the cuff material and sleeve material that is reliably and consistently liquid impermeable. Both of these embodiments provide significant advantages and improvements over conventional protective gowns, and method and systems for making same.

[0115] Figures 18A-18C show three different embodiments of garment sleeve with a cuff member 1800 (e.g., a TUFF CUFF™) attached and sealed to an outer surface of the sleeve 1501. FIG. 18A illustrates a first design in which the cuff member 1800 has an overall longitudinal length of 4.00 inches. A bonding zone 1802 between the cuff member 1800 and the sleeve 1501 is approximately 0.5 inches in width and positioned between 0.5 to 1.0 inches away from a distal edge of the cuff member 1200, to provide a skirt portion 1804 of cuff member 1800 having a width 1805 that is approximately 0.5 to 1.0 inches (e.g., 0.75 inches).J1404-00110As shown in FIG. 18A, a mid-point of the bonding zone 1802 is approximately 2.5 inches from a distal edge of the sleeve 1501 where a knit cuff is sewn or otherwise attached to the sleeve. In accordance with various embodiments, the distance between the mid-point of the bonding zone 1802 and the distal edge of the sleeve 1501 can be in the range of 2.0 to 3.0 inches. In some embodiments, when a protective glove is worn by a user, an o-ring of the protective glove will be positioned over the skirt portion 1804. On the other side of the bonding zone 1802, opposite the skirt portion 1804, is a foldable cuff portion 1806 having a width of 1807 that is approximately 2.5 to 3.0 inches.

[0116] As described above with respect to FIGS. 9B to 10B, when a user wears a protective glove over the knit cuff 1504 and the o-ring of the protective glove is position over the skirt portion 1804, the foldable portion 1806 can be folded over the o-ring of the protective glove to sandwich the o-ring between the skirt portion 1804 and the foldable portion 1806. In some embodiments, the surfaces of skirt portion 1804 and the foldable portion 1806 that contact the o-ring and protective glove can be textured and / or have a material composition to provide a resistance to lateral slippage between the o-ring of the protective glove and the surfaces of the skirt portion 1804 and the foldable portion 1806 that sandwich the o-ring. In accordance with some embodiments, the cuff member 1800 can be made from a liquid impermeable material. Thus, the cuff member 1800 can provide a liquid impermeable barrier to prevent liquids (e.g., perspiration) that may accumulate under the protective glove from escaping from the protective glove and entering and contaminating an external environment (e.g., a surgery area). Additionally, since the seam created at bonding zone 1802 between the cuff member 1800 and the gown sleeve 1501 is liquid impermeable, as described above, no liquids can pass through the seam at the bonding zone in either direction, protecting both the wearer of the protective gown and the external environment from cross-contamination.

[0117] FIG. 18B illustrates another embodiment in which the cuff member 1800 is attached and sealed to an outer surface of the sleeve 1501. The embodiment of FIG. 18B is similar to that of FIG. 18 A, except that the sleeve 1501 does not have a knit cuff 1504. Instead a distal end of the sleeve 1501 can incorporate an elasticband toimprovefitandtear-resistance. The other features and dimensions shown in FIG. 18B are substantially the same as that shown in FIG. 18A and, therefore, their description is not repeated here.

[0118] FIG. 18C illustrates a further embodiment in which the cuff member 1800 is attached and sealed to an outer surface of the sleeve 1501. The embodiment of FIG. 18C is similar to that of FIG. 18A, except that the knit cuff 1504 is replaced with a palm draping portion 1808 having a thumb hole 1810 configured to receive a thumb of a wearer therethrough.J1404-00110In this way, the thumb hole 1810 can maintain the position of the sleeve 1501 in a relatively constant position relative to the wearer’ s hands and wrists. As shown in FIG. 18C, a mid-point of the bonding zone 1802 is approximately 5.5 inches from a distal edge of the thumb hole. In accordance with various embodiments, this distance can be in the range of 4.5 to 6.5 inches. The other features and dimensions shown in FIG. 18C are substantially the same as that shown in FIG. 18A and, therefore, their description is not repeated here.

[0119] In some embodiments, cuff member material is a three-layer laminate of an elastomeric material sandwiched between two polypropylene film layers having the desirable properties of elasticity and liquid impermeability described herein. Using such a three-layer laminate film material, a cuff member can be constructed by performing the steps 1101-1106, as described above with respect to FIG. 11. One example of a suitable three-layer laminate film is available from Berry Global Inc. under the name ElastiproR4008, which is a laminate film that is cast-extruded from a blend of styrenic and elastomeric resins with a thin polyolefin skin. It has weight range of 30-35 grams per square meter and a machine direction (MD) Elongation of 730% and a cross direction (CD) elongation of 800%, a MD tensile at break of 32.4 N / inch and a CD tensile at break of 23.5 N / inch. It has a CD Load @ 100% of 1.7 N, a CD load @ 50 % .9 N (2nd upload), a CD Load @100% 1.5 N 2nd Upload), and a CD load @50% .4 N (2nd upload) with a CD Permanent Set @ 100% 5.5%. It has been found that a cuff material made from such a three-layer laminate can avoid degradation of the cuff member during reheating of the hot-melt adhesive, as described above, or during seaming of the gown sleeve after the cuff member is attached to a flat gown sleeve, as described above.

[0120] In some embodiments, the unsealed end of the foldable portion 1806 can be rolled over and sealed to provide the user with a grip to pull the foldable portion 1806 over the o-ring of the protective glove (Inventive Sample 1). In alternative embodiments, a bead of Vistamax™ 6902, a elastomeric hot melt primarily composed of isotactic propylene repeat units with random ethylene distribution, is used to create an elastic o-ring at the unsealed end of the foldable portion 1806 (Inventive Sample 2). In yet another embodiment, a pre-made o-ring is adhesively bonded to the unsealed end of the foldable portion 1806 (Inventive Sample 3). It has been found that each of the above described sample embodiments, can pass the ASTM 1670 Seam Test and the Vartest Laboratories Dunk Test, which test the strength and liquid impermeability of seams formed in cloth or textile materials. A protective garment sleeve having a cuff member sealed to an outer surface of the sleeve (Tuff Cuff™ sleeve) was tested alongside a conventional sleeve with knit cuff (conventional sleeve). As described above with reference to FIG 18 A, a first protective glove was placed over the users hand and over aJ1404-00110knit cuff such that an o-ring of the protective glove was placed over a skirt portion 1804 of the cuff member 1800. The foldable portion 1806 of cuff member 1800 was then folded over the skirt portion 1804 and o-ring of the first protective glove. A second protective glove was then placed over the first protective glove and the cuff member 1800. For the conventional sleeve, a first protective glove was worn to cover the knit cuff and a distal of the convention sleeve. A second protective glove was then worn over the first protective glove such that the second protective glove completely covered the first protective glove.

[0121] In a first test, the conventional sleeve with two protective gloves was immersed in a red dye solution for five (5) seconds, and the Tuff Cuff™ sleeve with two protective gloves was immersed in the same red dye solution for twenty (20) seconds. Upon removal of the two gloves from the conventional sleeve, it was found that both the knit cuff and hand of the wearer were saturated with red dye solution. In contrast, upon removal of the two gloves from the Tuff Cuff™ sleeve, it was found that both the knit cuff and hand of the wearer were completely dry. In a second test, three (3) cubic centimeters (cc) of the red dye solution were injected through tubes running through the Tuff Cuff™ sleeve into the palm of the hand under the first protective glove worn by the user to emulate an extraordinary amount of perspiration pooling inside the first protective glove. After the first inner protective glove was filled with the red dye solution, the second outer protective glove was removed and it was found that that outer surface of the first protective glove was completely dry. Thus, the Tuff Cuff™ prevented any leakage of liquid from inside the first protective glove to an external environment. These tests demonstrate that the cuff member 1200 of the present disclosure provides a liquid impermeable barrier that prevents liquids (e.g., perspiration) that may build up under a protective glove from escaping past the cuff member 1200, while also preventing any liquids from an external environment from contacting the skin of the wearer under the protective glove. No prior art garments, methods or systems provide such a liquid impermeable barrier between the glove / sleeve interface. As described above, in some embodiments, the material of the cuff member 1200 is made from or includes at least one layer of material that is liquid impermeable. As also described above, in some embodiments, the seal between cuff member 1200 and the outer surface of the sleeve at the bonding zone 1802 is also liquid impermeable. As used herein, the term “liquid impermeable” refers to a material or area that does not allow any liquid to pass therethrough.

[0122] In alternative embodiments, the cuff member may be made from an elastic material that can be pre-molded into the desired dimensions of the cuff member, as described above, utilizing dip molding processes used to make disposable surgical gloves, for example,. InJ1404-00110some embodiments, an unsealed side of such a pre-made cuff member can be rolled to create a ring that provides the user with a grip to pull the cuff over the first glove.

[0123] Current methods of manufacturing protective gowns typically use a manual process to make a seam in the sleeves of the protective gowns. Such manual placement of sleeve seams causes high variation from .1 - .8 inches in diameter at the location of conventional sleeves where the cuff member is desired to be placed. This variation and excess material can causes wrinkles and potential failure points when attempting to make a liquid impermeable seam between the cuff member and the gown sleeve. FIG. 19A illustrates an example of a conventional sleeve that may be altered to reduce excess sleeve material and thereby reduce wrinkles in the material when performing the process steps 1108 to 1111 described above with respect to FIG. 11. Thus, when using current gown sleeves made with the current gown sleeve seaming processes, a novel apparatus and process has been designed to ensure consistent and compatible sleeve diameters that allow the cuff member to be attached and sealed to the sleeve with a liquid impermeable bonding zone between the cuff member and the sleeve, as described above. As shown in FIG. 19A, the diameter of a flat conventional sleeve can be altered by heat sealing the sleeve at a desire location linearly to reduce the overall diameter of the sleeve and provide a desired sleeve shape.

[0124] FIG. 19B illustrates a perspective view of sleeve re-seaming assembly 1900 configured to modify a diameter (or circumference) of at least a portion of a conventional sleeve so that wrinkles in the sleeve material can be eliminated or significantly reduced when bonding the sleeve material to a cuff member, as described above. In accordance with some embodiments, the re-seaming assembly 1900 configured to perform the sleeve resizing includes at least two parts: (l)amandrel 1902 forholdinga sleevethereon during re-seaming; and (2) a heating assembly 1904 having at least one heat seal anvil 1906, a heat seal bar 1907 and at least one linear actuator 1908. The heat seal anvil 1906 is attached to the heat seal bar 1907, which is attached to the linear actuator 1908. The linear actuator 1908 can be controlled manually or automatically to move the heat seal bar 1907 and anvil 1906 to apply pressure and transfer thermal energy at the desired new seam location of a sleeve (not shown).

[0125] As shown in FIG. 19B, in some embodiments, the mandrel 1902 has a flat tapered shape configured to receive a sleeve thereon such that the sleeve will be substantially flat during the re-seaming process, in a similar way a sleeve is slat when ironing the sleeve on an ironing board. The mandrel 1902 is attached to a larger platform 1910 that holds and stabilizes the mandrel 1902 during re-seaming. The mandrel 1902 further includes a notch portion 1912 formedbetween a tapered end portion 1914 and a main body portion of the mandrel 1902. TheJ1404-00110notch portion 1912 is configured to provide a seat for a knit cuff or end portion of a sleeve to rest when the sleeve is placed on the mandrel 1902 while the tapered end portion 1914 can extend into or past the knit cuff or past a distal edge of the sleeve. In some embodiments, it is desired that the mandrel diameter matches the sleeve diameter at the bond zone, as described above. If the sleeve diameter is too small, the sleeve seam may rip or tear when placed on the mandrel. If the sleeve diameter is too large the extra material will fold and wrinkle creating a leak across the bond zone. Preferably, the target sleeve and mandrel diameter mismatch is less than 0.06 inch (1.5 mm).

[0126] As further shown in FIG. 19B, the re-seaming assembly 1900 further includes two clamps 1916 located adjacent to opposite ends of the heat seal anvil 1906, and fixedly attached to the platform 1910. The clamps 1916 hold down portions of the sleeve material onto the platform 1910 as the heat seal anvil 1906 is moved downwardly between the two clamps 1916 to re-seam at least a portion of the sleeve, thereby reducing a diameter (or circumference) of the sleeve at the bond zone of the sleeve. As mentioned above, if the sleeve diameter at the bond zone is greater than a diameter near a bond zone of the cuff member, such sleeve may be salvaged by reducing the size of the sleeve. In some embodiments, the excess material of the sleeve can be removed by adding a new heat seal along the original sleeve seam at an internal surface of the sleeve (i.e., the sleeve is turned inside-out) at a location along and adjacent to the original sleeve seam to achieve the desired diameters and size of the sleeve. FIG. 19A illustrates changing the flattened sleeve circumference at the bond zone from 13.50 inches (342 mm) to 12.50 inches (317 mm), in accordance with one exemplary embodiment.

[0127] In alternative embodiments, loose fitting sleeves with excess material can be processed with tooling improvements. Typically, the anvil surface at the bond zone is flat and smooth, and the shape is cylindrical or conic. If excess sleeve material is present on a flat anvil, wrinkles or folds can occur, which can create channels for leakage. One solutionis to replace a smooth anvil with an anvil 2000 containing a scallop shaped microfold surface topography, as shown in FIGS. 20A and 20B. The anvil 2000 includes a plurality of shallow depressions, otherwise referred to herein as “microfolds,” along the exterior perimeter surface of the anvil 2000. The perimeter of the microfold anvil 2000 is larger than a flat anvil and, therefore, can accommodate excess material of the sleeve more readily without allowing the excess material to cause conventional wrinkles or folds. In some embodiments, a plurality (e.g., 100) of small depressions or microfolds 2002 placed around the circumference of the anvil 2000 will increase the circumference and perimeter area of the anvil 2000 5% to 10%. In some embodiments, the microfold anvil 2000 further includes a plurality of vacuum holes 2004 that are configuredJ1404-00110to be coupled to a vacuum source and supply a vacuum suction to hold the material of the garment sleeve on the anvil 2000. Thus, the microfold anvil can hold and absorb extra sleeve material without forming conventional wrinkles or folds, but instead forms evenly-spaced and uniform microfolds or undulating depressions in the material. In some embodiments, as shown in FIG. 20B, small shallow depressions 2002, preferably 0.02 inches (0.50 mm) deep, will fill with hot melt during the reheating process creating a leak proof seal. In various embodiments, the depressions or microfolds can be in the range of 0.01 to 0.05 inches deep. A shallow depression or microfold is different from a typical fold or wrinkle, since typical folds and wrinkles prevent hot melt from penetrating and sealing. In contrast, it has been found that microfolds or shallow depressions can easily fill with hot melt to provide a liquid impermeable seal.

[0128] In various embodiments of the present disclosure, a sleeve with a cuff can be formed in various methodologies resulting in a garment that can be used to form an impervious seal. The sleeve or sleeve material may be formed in various ways and may have different shapes, or configurations when the cuff or cuff material is attached to the sleeve or sleeve material. Some variations of the impervious garment system may be produced as described below:

[0129] In a first example, a sleeve may formed of sleeve material to have a tubular shape. The sleeve may have a tubular shape by connecting two or more pieces of sleeve material together with longitudinal seams to create the tubular shape. The cuff may be formed of cuff material to have a tubular shape in these examples. One or more pieces of cuff material may be connected together with one or more longitudinal seams to create the tubular cuff. The tubular cuff may then be positioned over the tubular sleeve and bonded thereto to form an impervious seal. The tubular cuff may be connected to the tubular sleeve in a manner previously described, such as positioning the tubular sleeve and / or the tubular cuff over a mandrel, or other fixture in these examples. In this category of examples, the sleeve and the cuff are formed separately into their respective tubular shapes and each tubular cuff is joined to a corresponding tubular sleeve.

[0130] In a second example, the sleeve may be formed of sleeve material to have a tubular shape as described above. Cuff material may then be applied to the tubular sleeve. In these examples, the tubular sleeve may have a flat configuration. The tubular sleeve may be flattened such that two pieces of the sleeve material that make the tubular sleeve are positioned against one another or positioned adjacent one another. The cuff material may then be positioned on the flattened tubular sleeve and bonded thereto. The cuff material may be a single or unitary piece of cuff material. The unitary piece of cuff material maybe wrapped around the flattenedJ1404-00110tubular sleeve such that one longitudinal seam is used to form a cuff. The cuff material may also be two separate pieces of cuff material. A first piece of cuff material may be positioned on one side (e.g., a top side) of the flattened tubular sleeve and a second piece of cuff material may be positioned on a second side (e.g., a bottom side) of the flattened tubular sleeve. The first piece of cuff material and the second piece of cuff material may be connected to each other via two longitudinal seams (i.e., one seam at each edge of the sleeve) to form the tubular cuff. In the foregoing examples, the tubular sleeve may be formed first and then the cuff material may be formed into the tubular cuff when the cuff material is joined to the tubular, flattened sleeve.

[0131] In a third example, sleeve material and cuff material positioned and oriented relative to each other and formed into the tubular sleeve and the tubular cuff in the same process steps. The sleeve material may be positioned in a flat manner as a unitary piece of sleeve material folded over onto itself to create a sleeve. The sleeve material may alternatively be two separate pieces of sleeve material positioned adjacent or on top of one another. The cuff material may be a unitary piece of cuff material that folded over and / or wrapped around the sleeve material. The cuff material may alternatively be two separate pieces of cuff material with each piece of cuff material positioned on opposite sides of the sleeve material. In these examples, the tubular sleeve and the tubular cuff may be formed at the same time and / or in the same manufacturing station or process step. The longitudinal sleeve seam(s) may be created to form the tubular sleeve. The longitudinal cuff seam(s) may also be formed at the same process stage to create the impervious sleeve and cuff system. The sleeve and cuff system may be formed in various iterations as described above. It should also be appreciated that the sleeve and cuff system may be produced with the sleeve or sleeve material attached to gown or separate from the gown.

[0132] During the creation of the sleeve and cuff system in the various alternatives described herein, the cuff and / or the cuff material may be stretched when the cuff or cuff material is joined to the sleeve or sleeve material. In some examples, the cuff or cuff material may be stretched in a range of about 10% to about 40%. In other examples, the cuff or cuff material may be stretched in a range of about 20% to about 30%. In still other examples, the cuff or cuff material may be stretched in a range of about 0% to about 40% stretch. In other examples, the cuff or the cuff material not be stretched or may include minimal stretch.

[0133] In accordance with an embodiment, a cuff material can be attached to a gown sleeve material during the gown construction stage before the cuff and sleeve materials are made into a tubular sleeve or, in some cases, a tubular sleeve and body or portion of the body of the gown, which can provide manufacturing efficiencies and advantages. In such an embodiment, theJ1404-00110cuff material is bonded to the sleeve while it is flat. In accordance with some embodiments, the process may include the following steps:1. The sleeve is cut to size and shape from sleeve material.2. The sleeve material is formed into a sleeve. In some embodiments, an adhesive or other bonding materials or bonding methods are used to seal one or more longitudinal edges of the sleeve material to produce a tubular sealed and impervious sleeve.3. The cuff material is cut to size and shape. In some embodiments, this step may be performed after the cuff material is applied and / or bonded to the sleeve.4. In some embodiments, the cuff material is an elastomer, and the elastic cuff material is stretched a predetermined amount (e.g., 10 to 40%) when it is placed on the sleeve or sleeve material and / or when the hot melt adhesive is applied to the cuff material. In some embodiments, the elastic cuff material is stretched in the range of 20 to 30%.5. A hot melt adhesive is applied to a cuff bond zone on either the cuff material orthe sleeve material . In some embodiments, the hot melt adhesive is a pressure-activated adhesive.6. The cuff bond zone of the cuff material with the hot melt adhesive on either the sleeve material or the cuff material is positioned and pressed onto a sleeve bond zone of the sleeve or sleeve material. In some embodiments, if the cuff material is an elastic cuff material in a stretched state, the elastic cuff material is maintained in a desired stretched state (e.g., stretched to be 10% to 40% larger in one or more desired directions) by at least two clamps on opposites sides of the stretched flat cuff material while the cuff bond zone of the cuff material is positioned and pressed onto the sleeve bond zone of the sleeve or sleeve material.7. Heat and pressure are applied to the cuff and sleeve bond zones, re-melting the hot melt adhesive, creating an impervious bond and seam between the cuff material and an outer surface of the sleeve or sleeve material.8. If desired, a knit cuff is sewn on at the distal end of each sleeve.9. Left and right sleeves may be each made in accordance with the above description and the left and right sleeves (with bonded cuffs) are then connected to the gown body or as the tubular sleeves are formed they also form the gown body or portion of the gown body.J1404-00110

[0134] Referring now to FIG. 21, an example apparatus 2100 may be used to perform one or more steps of producing an impervious sleeve and cuff. The sleeve or sleeve material and the cuff or cuff material may then be used to produce a suitable gown with impervious sleeves at the sleeve / glove interface. In this example, the apparatus 2100 may include a first dispenser 2102 and a second dispenser 2104. The first dispenser 2102 and the second dispenser 2104 may be wheel or reel members that can be used to dispense a length of sleeve material. The sleeve material may be the one of the sleeve materials previously described. The first dispenser 2102 and the second dispenser 2104 may be connected to a suitable motor, such as a servo motor, or other controllable motor that can be used to rotate the first dispenser 2102 and / or the second dispenser 2104 at a desired speed and / or intermittently to dispense predetermined lengths of the sleeve material.

[0135] After the sleeve material is dispensed, the sleeve material may be positioned in a substantially horizontal position. Suitable conveyors, platforms or other equipment may be used to hold and / or support the sleeve material 2112. At a first station, edges 2106 of the sleeve material may be connected together to form a sleeve. As can be appreciated, a first piece of material from the first dispenser 2102 is positioned on top of a second piece of material from the second dispenser 2104. The edges 2106 may be sealed together using a suitable connecting process such as thermal, adhesive, or ultrasonic sealing methods. In other examples, a hot melt adhesive may be used at edges 2106 to create the tubular sleeve. The edges 2106 may be bonded together in the form of a fin seal. Such a seal or bond may be external or internal to the sleeve. In still other examples (not shown), a single piece of sleeve material may be used. The single piece of sleeve material may be folded over onto itself such that one edge of the sleeve material is bonded or sealed to create the sleeve.

[0136] As can be seen, the sleeve may have a trapezoidal shape such that an end of the sleeve thatistobe positioned at or near a user’s wrist is smaller than the opposite end thatmay be connected to the gown. The sealingmay be performed inthis trapezoidal shape along edges 2106 to create the trapezoidal shape. Following the sealing or bonding step, the excess portions 2110 of sleeve material maybe cut from the sleeve to leave the trapezoidal shaped sleeve 2108. The cutting of the excess portions 2110 may be performed using a suitable cutting process such as a die cutting process, laser cutting process, trimming process, water jet cutting process, automatic knife cutting, or the like.

[0137] Referring now to FIGs. 22-24, a cuff material 2202 may be coupled to the sleeve 2108 to create the impervious system described above. The cuff material 2202 may be positioned over a sleeve 2108. In this example, the cuff material 2202 may include a patternJ1404-00110of bonding material, such as a hot melt adhesive described above. The pattern 2206 of bonding material may be applied to the cuff material 2202 prior to the cuff material 2202 being positioned on the sleeve2108. Pressure and / or heat may be applied to the pattern2206 around or on the cuff material 2202 and the sleeve 2108. The cuff material 2202 may be bonded to the sleeve 2108 and the cuff material 2202 may be created around the sleeve 2108 now forming the tubular cuff. In FIG. 22, a first piece of material that forms the cuff is shown. This first piece of material for cuff material 2202 is shown above the sleeve 2108. It should be appreciated that s second similar piece of material may be positioned under the sleeve 2108 such that the sleeve 2108 is positioned between an upper layer and a lower layer of cuff material. The pattern of bonding material may be applied to the upper layer, or to the lower layer of the cuff material or to both the upper layer and the lower layer. The process of applying pressure and / or heat to the cuff material 2202 may result in the melting and bonding of the upper layer of cuff material 2202 to the lower layer of cuff material 2202 forming the tubular cuff. The edge portions 2304 (FIG. 23 A) of the pattern 2206 may create the edges of the final cuff and the lateral portion 2306 (FIG. 23 A) of the pattern 2206 may create an impervious seal to prevent or limit liquids from moving past a sleeve / gown interface of the fluid management system.

[0138] The cuff material 2202 may be stretched when the cuff material 2202 is positioned and bonded to the sleeve 2108. In some examples, the cuff material 2202 may be stretched a predetermined amount such as in a range of about 10% to about 40%. In another example, the cuff material 2202 may be stretched a predetermined amount in a range of about 20% to about 30%. In other examples, other predetermined amounts of stretch may be used. In other examples, cuff material may not be stretched.

[0139] The pattern 2206 of bonding material may be deposited in various configurations. In this example, it was determined that the bonding material be deposited such that the edge portions 2304 of the pattern 2206 have a gap g to the edges 2302 of sleeve 2108. The gap g may have various values. It has been determined, however, that a gap of about 2 mm to about 10 mm is desirable. The gap g is desirable so that the cuff material 2202 maintains its ability to be folded downward toward a wrist of the wearer to create the fluid management system described above. If there is not a sufficient gap g between the edge portions 2304 and the edges 2302 of sleeve 2108, the cuff material 2202 may be bonded to the sleeve 2108 at one or more portions above the lateral portion 2306 (toward a shoulder of the wearer). If the cuff material 2202 is bonded to the sleeve 2108 at or along the edge 2302 above lateral portion 2306, the cuff material 2202 will be unable to be folded downward toward a wrist of the wearer. In someJ1404-00110examples, the pattern 2206 is formed of one type of adhesive or hot melt material. In other examples, the pattern 2206 may be formed of multiple different types of adhesive or hot melt material. For example, the edge portions 2304 and lateral portion 2306 can be formed of different types of adhesive or hot melt material since such portions may have different bonding requirements.

[0140] The pattern 2206 may have an H-shape in that the pattern may include two edge portions 2304 and a lateral portion 2306 that is positioned across the cuff material 2202 to connect the edge portions 2304. The edge portions 2304 may be angled relative to the lateral portion 2306 to align with the trapezoidal shaped sleeve 2108. In other examples, the edge portions 2304 and the lateral portion 2306 may have other relative shapes and orientations so long as the edge portions 2304 create a sealed tubular cuff material 2202 and the lateral portion 2306 spans between the edges of the cuff material 2202 to prevent leakage of fluids.

[0141] In various embodiments, the protective garment 2200 may include different configurations at the wrist opening 2314 of the sleeve 2108. As described above with respect to the embodiments shown in FIGs. 18 A, 18B, and 18C, the protective garment 2200 may include no element or an elastic band at wrist opening 2314. Such an embodiment is shown in FIG. 23 A. As shown in FIG. 23B, the protective garment may include a wrist cuff or a hand draping portion depicted as wrist element 2310. The wrist element2310 maybe positioned at the end of the sleeve 2108 and may be connected to the sleeve 2108 at a bonding zone 2312 positioned at or near the wrist opening 2314.

[0142] Wrist element 2310 may be connected to sleeve 2108 using suitable seaming or connecting methods such as adhesive, sonic or heat welding, sewing, or any other suitable means of adhering the items. In some embodiments, an impermeable seal may be created at the bonding zone 2312 using methods previously described. For example, heat and / or pressure may be applied at the bonding zone 2312 and cause an adhesive to fill gaps and / or spaces between the material of the sleeve 2108 and the wrist element 2310 to create an impermeable seal. In some examples, the material of the sleeve 2108 and / or the wrist element 2310 maybe melted via the heat and / or pressure applied at the bonding zone 2312 to create an impermeable seal. In other examples, the wrist element 2310 maybe connected to sleeve 2108 with a seam or other connection that does not create an impermeable seal.

[0143] In some examples, the wrist element 2310 may be configured as a wrist cuff as previously described with respect to example shown and described in FIG. 18 A. In other examples, the wrist element 2310 may be configured as a hand-draping portion as previously described with respect to the example shown and described in FIG. 18C. Either the wrist cuffJ1404-00110configuration or the hand-draping configuration may be connected to the sleeve 2108 as previously described. Various materials may be used for eitherthe wrist cuff configuration or the hand-draping configuration. The wrist cuff may be comprised or otherwise formed of woven materials, nonwoven materials, films, and / or laminate materials. Woven materials may include various elastic woven materials like a knit material. Nonwoven materials may be formed of elastomeric fibers or may be an elastomeric lam inate made from elastomeric fibers and film or elastomeric film and fibers. In some examples, elastomeric nonwovens can be made with elastic filaments such as Lycra or Spandex sandwiched between two non-elastic fabric layers. In other examples, other materials may be used.

[0144] In some examples, the wrist element 2310 maybe connected to the sleeve 2108 in a tubular configuration. In such examples, various mandrels or other fixtures (as previously described) may be used to connect the wrist element 2310 to the sleeve 2108. In other examples, the wrist element 2310 may be connected to the sleeve 2108 while the sleeve 2108 is in a flat state. The wrist element 2310 may be provided as a single piece of material folded onto itself and then positioned over both sides of the sleeve 2108. The wrist element 2310 may be seamed on the open edge to form the closed wrist element 2310 to wrap around a periphery of the sleeve 2108 at the wrist opening 2314. The wrist element 2310 may also be connected and / or sealed to the sleeve 2108 at the same time as the edge is seamed into a tubular configuration. In other examples, the wrist element 2310 may be seamed and then joined to the sleeve 2108 separately.

[0145] As shown in FIG. 23B, the wristelement 2310may be positioned with the open end of the wrist element 2310 oriented away from the wrist opening 2314 of the sleeve 2108. In this configuration, the edge or open end of the wrist element 2310 is located further away from the shoulder of the sleeve 2108 than the wrist opening 2314 of the sleeve 2108. In such a configuration, the seam may be visible. In other examples, the wrist element 2310 may be positioned in a reversed configuration in which the wrist element 2310 is positioned with the opening located between the wrist opening 2314 of the sleeve 2108 and the shoulder of the sleeve 2108. The wrist element 2310 can be connected to the sleeve at the bonding zone 2312 and then the open end of the wrist element 2310 can be folded over the bonding zone 2312 in a direction away from the shoulder of the sleeve 2108 to hide a seam that is formed at the bonding zone 2312. In the folded configuration, the open end of the wrist element 2310 may then be positioned at a location that extends beyond the wrist opening 2314 of the sleeve 2108.

[0146] In some examples, the wrist element 2310 maybe connected to the sleeve 2108 in a common manufacturing station or manufacturing cell in which the cuff material 2202 isJ1404-00110connected to the sleeve 2108. The cuff material 2202 may be provided and wrist element material may be provided and positioned on the sleeve material 2108 at predetermined locations. Pressure and / or heat may be provided to the cuff material 2202 and to the wrist element material to j oin the cuff material 2202 and the wrist element 2310 to the sleeve material 2108. In other examples, the wrist element 2310 may be connected to the sleeve material 2108 independently or separately from the cuff material 2202. The wrist element 2310may be added before the cuff material 2202 is connected to the sleeve material 2108 or may be added after the cuff material 2202 is connected to the sleeve material 2108.

[0147] As shown in FIG. 25, the cuff material 2202 may be positioned on the sleeve 2108 at a position at or near a wrist edge 2502 of the sleeve 2108. The cuff material 2202 may be positioned away (or above in FIG. 25) from the wrist edge or wrist opening 2502 at a distance H2. The distance H2 may allowaknit coll ar or other wrist element, such as wrist element 2310 (FIG. 23B) to be attached to the sleeve 2108. In some examples, the distance H2 may be about 1.5 inches. In other examples, other distances may be used.

[0148] The cuff material 2202 may have an overall height Hl. In some examples, the height Hl is about 4 inches. In other examples, the overall height Hl may be in a range of about 2 inches to about 6 inches. The cuff material 2202 may have a sufficient height to allow the cuff material 2202 to be folded on itself and positioned over a first glove of a wearer. In other examples, the overall height Hl may have other sizes.

[0149] The lateral portion 2306 of the pattern 2206 may be positioned above a wrist edge of the cuff material 2202 by a distance H3. The distance H3 may be various suitable distances. In some examples, the distance H3 is in a range of about 0.5 inches to about 1.5 inches.

[0150] The cuff and sleeve assembly previously described may be prepared using various methods contemplated in the present disclosure. With reference to FIG. 26, one example method 2600 is illustrated. The method 2600 may be used to create a sleeve and cuff assembly that may then be attached or formed into a gown or the method 2600 may be used to create the sleeve, cuff assembly, and a portion of the body or full body of the gown. While the description below may reference the cuff and sleeves shown in FIGs. 21 to 25 and described above, it should be appreciated that the method is not limited to these embodiments.

[0151] The method 2600 may begin at step 2602. At step 2602, the sleeve material is provided. The sleeve material may be provided using a dispensing apparatus or other apparatus. In some examples, the sleeve material is provided via one or more rolls of material that is dispensed automatically.J1404-00110

[0152] At step 2602, the sleeve material may be used to create a sleeve, such as sleeve 2108 previously described. The sleeve material may be provided in two layers that are sealed or coupled to one another along open edges of the sleeve material. In some examples, two independent layers of sleeve material are provided and coupled together to form a sleeve. In other examples, one piece of sleeve material may be folded and then the loose edges of the folded material are sealed, bonded or coupled to one another. As part of step 2604, excess sleeve material may be removed from the formed sleeve by cutting or otherwise separating the excess material from the formed sleeve. As can be appreciated, in variations of method 2600, the sleeve may be created at the same time or in the same processing step as bonding the cuff material to the sleeve (or sleeve material). The sleeve material may be provided as two layers or two pieces of sleeve material and the longitudinal edges may be bonded to each other via longitudinal seams. In such examples, step 2604 (i.e., the creation of the tubular sleeve) may be performed at the same time or simultaneously at step 2614.

[0153] At step 2606, a cuff material is provided. The cuff material may be provided on a roll. The cuff material may be dispensed using a cuff dispenser that may provide a predetermined length of the cuff material.

[0154] At step 2608, the cuff material may be stretched. As previously described, various amounts of stretching may be used. In some examples, the cuff may be stretched in a range of about 0% to about 40%. In other examples, the cuff may be stretched in a range of about 10% to about 40%. In other examples, the cuff material may be stretched in a range of about 20% to about 30%. The cuff material may be stretched using a suitable clamp that may apply a force to an edge of the cuff material. The cuff material may be cut a predetermined length and the edges of the cuff material may gripped by a clamp or other device to apply opposing forces to opposite edges of the cuff.

[0155] At step 2610, a pattern of bonding material may be applied to the cuff material. In some examples, the bonding material is applied while the cuff material is in a stretched state. The bonding material, such as a hot melt adhesive or pressure activated adhesive, may be applied in a H-shaped pattern. The H-shaped pattern may have the configuration and shape as that described above.

[0156] At step 2612, the cuff material with the bonding material may be applied to the sleeve. The cuff may be positioned at or near the wrist edge of the sleeve. In some examples, the cuff may be positioned at a predetermined distance away from the wrist edge of the sleeve. Two layers of cuff material may be applied to the sleeve with one layer of cuff material positioned on opposite sides of the sleeve.J1404-00110

[0157] At step 2614, the cuff is bonded to the sleeve. Heat and / or pressure may be applied to the cuff and to the bonding material on the cuff. This step of the process may connect the cuff to the sleeve and may also create fluid resistant or impervious seals at edges of the cuff and between the cuff and the sleeve.

[0158] At step 2616, excess cuff material may be removed from the cuff to define a final size and configuration of the cuff. Cuff material that extends laterally outward of the edge portions of the bonding pattern may be removed to create a tubular cuff.

[0159] While not shown in FIG. 26, the method may also include bonding a wrist element to the sleeve. The method may include the process and / or step previously described. In one example, wrist element material, such as a knit material, may be applied to the sleeve material at or near a wrist edge or wrist opening of the sleeve. Bonding material, such as a hot melt adhesive or pressure activated adhesive, may be applied to the sleeve and / or to the wrist element material ata predetermined bonding zone. The wrist element material maybe applied to the sleeve and heat and / or pressure may be applied at the wrist element bonding zone to bond the wrist element material to the sleeve. Excess wrist element material may be then be removed in examples in which one or both edges of the wrist element material are seamed together to form the wrist element.

[0160] In other methods contemplated by the present disclosure, a method of producing a protective garment is provided. The method may be used, for example, to produce a protective gown that includes multiple sleeves. Each of the sleeves may include a cuff and / or wrist element as previously described. In some examples, the protective garment or protective gown may be manufactured in an assembly line in which protective garments are produced. In some examples, cuff and / or other wrist elements may be applied to and / or added intermittently to the protective gowns. In other examples, the cuffs and / or wrist elements may be added continuously to each of the sleeves of the protective gowns. In still other examples, the cuffs and / or wrist elements may be added continuously or intermittently to sleeves that then may be subsequently added or connected to body portions of the protective gowns.

[0161] In various methods contemplated by the present disclosure, continuous or intermittent processing or both continuous and intermittent processing steps may be used to produce protective garments with cuffs and / or wrist elements. In continuous processing, the materials used to produce the protective garment typically move continuously or with brief pauses between or at processing steps. For example, sleeve material may be dispensed from a roll and continuously move through one or more rollers as it is positioned over a fixture or mandrel. Similarly, cuff material or wrist element material may be continuously dispensedJ1404-00110from a roll or other container. The material of the protective garment may pause during continuous processing but such pauses are typically short in duration and allow protective garments to be produced at a rapid rate. In various examples, protective gowns may be produced at a rate of 20, 100, 300 or 500 garments per minute in continuous processes. Various processes including cutting, bonding, sealing, heating, pressing, or the like may be performed continuously using rollers or other equipment that allow the continuous movement of materials.

[0162] In intermittent or indexed operations, the material that is used to produce the protective garment, the sleeve, the cuff, or wrist element may be moved into position and then remain in a desired position on a fixture, mandrel, or other processing station for a period of time while operations are performed on the material. Such processing may include cutting, bonding, heating, pressing, clamping, or the like. The time at which the materials or elements of the protective garment remain in a non-moving position may be termed a dwell time of the process step. In the present disclosure, the term “continuous” with respect to processing or manufacturing means that the material used to produce the garment moves without pausing at or between processing steps. While some pauses may occur on the order of 1.5 second or less, the process may still be considered continuous for purposes of the present disclosure. In the present disclosure, the term “intermittent” with respect to processing or manufacturing means that the material used to product the protective garment may stop moving at processing steps. The dwell time of intermittent processes may be, for example, greater than 1.5 seconds. In various intermittent processes, dwell times may be, for example, 2 seconds, 3 seconds, 6 seconds, 12 seconds, or other durations. Intermittent process typically have production rates that are slower than continuous processes. Intermittent processes may produce, for example, 5 protective garments per minute or about 20 protective garments per minute.

[0163] In still other example methods of the present disclosure, the method may not exclusively be performed with continuously or intermittently but may use both continuous processing and intermittent processing. For example, sleeve material or cuff material may be dispensed and cut to length continuously. The cut blanks of sleeve material and / or cuff material may then be positioned and bonded to one another in another intermittent processing step.

[0164] In the description of example methods below, the terms cuff and wrist element may be used for illustration purposes. It should be appreciated that either a cuff or a wrist element, such as these terms are described above, may be connected to a protective garment or may both be connected to a protective garment via the methods described below.

[0165] The method may include a step of positioning a sleeve material in or on a sleeve fixture. The sleeve material may be, for example, positioned over a sleeve fixture that includesJ1404-00110a mandrel to accept a tubular sleeve of sleeve material. The mandrel may be cylindrically shaped or conically shaped and may have a shape similar to the shape of the sleeve. In other examples, the sleeve fixture may be configured as a clamping fixture to secure the sleeve material in a desired position and to limit movement of the sleeve material relative to the clamping fixture. In still other examples, the sleeve fixture may include a combination of clamps and fixtures or mandrels.

[0166] The method may also include a step of expanding a cuff material. The cuff material may be positioned over an end of the sleeve or sleeve material after it is expanded. The cuff material or cuff may be elastic to allow the cuff material to be stretched or in the case of a tubular cuff to be expanded from a first diameter to a second larger diameter. The cuff material in the expanded state may fit over the sleeve material and then, when released, return to an unexpanded state in which the cuff or cuff material contacts the sleeve material. Various fixtures, clamps, or other devices may be used to expand the cuff material. In some examples, a multi-fingered device may be used in which elongated fingers may move apart from one another to expand the cuff or cuff material to the expanded state. Such an expanding fixture may also move or translate to allow the expanded cuff or expanded cuff material to be positioned over an end of the sleeve and then to be released to the unexpanded state at the position at the end of the sleeve.

[0167] The method may also include allowingthe expanded cuff or expanded cuff material to return to an unexpanded state at the end of the sleeve. The fixture or device that expands the cuff or cuff material as previously described may return to an original state. In other examples, the expanded cuff or expanded cuff material may be moved off of a conically shaped device to allow the cuff or cuff material to return to an unexpanded state. In still other examples, other devices, fixtures, clamps, robotic grippers, or the like may be used to return the expanded cuff or expanded cuff material to an unexpanded state.

[0168] When the cuff or cuff material is returned to the unexpanded state, the cuff or cuff material may be positioned at the end of the sleeve at a wrist area of the sleeve at which a wearer’s wrist would be position when wearing the protective garment. The cuff or cuff material may be fixed into a desired position at the end of the sleeve. The method may include a step of bonding the cuff or cuff material to the end of the sleeve material. Various suitable techniques may be used to bond the cuff or cuff material to the end of the sleeve. In some examples, a suitable adhesive, such as a hot-melt or pressure-activated adhesive may be used. The adhesive may be deposited on the sleeve and / or on the cuff or cuff material. In one example, the adhesive may be deposited on the sleeve or sleeve material before the cuff or cuffJ1404-00110material is positioned over the end of the sleeve. In such an example, a nozzle or other suitable dispenser may deposit adhesive at the end of the sleeve in a location at which the cuff is desired to be positioned in the finished protective garment. The sleeve may then be expanded and positioned over the end of the sleeve and over the adhesive. The cuff may then be allowed to return to an unexpanded state over the sleeve and over the adhesive.

[0169] In some examples, heat and / or pressure may be applied to the cuff and the sleeve. The heat and / or pressure may cause the adhesive to bond the cuff or cuff material to the sleeve. In some examples, the bond forms an impermeable or impervious seal between the cuff and the sleeve and serves to retain the cuff to the sleeve at a desired location. In other examples, the bond is not an impermeable seal and serves to retain the cuff to the sleeve at a desired location.

[0170] The method described above may be performed one or both sleeves of a protective gown to provide cuffs at each of the sleeves. In some examples, the protective gown is formed in a common manufacturing system in which the cuffs are fixed to the sleeves. In other examples, the cuffs may be added to a pre-existing gown. In still other examples, the cuffs may be added to sleeves and then the sleeves may be connected to the body portion of a protective gown. In yet, other examples, the protective garment may be a sleeve with a cuff and not be connected to a body portion and be used as a protective sleeve.

[0171] The present disclosure describes various examples and embodiments that may be used to create an impervious fluid management system. It should be appreciated that the above examples and embodiments should not be interpreted as limiting the application of other variations or other methodologies known to one of ordinary skill in the art. For example, the joining of the sleeve material, the joining of the cuff material, and / or the joining of the cuff or cuff material to the sleeve or sleeve material may be accomplished using various adhesives, sealers, bonding methods, hot melts, pressure bonding agents, or other materials such as those described above. To create the impervious seams and joints of the present disclosure, the bonding materials may be used to fill and / or prevent leakage by closing gaps between fibers or pores in the respective joined materials. The impervious seams and joints of the present disclosure may also be created by melting the fibers of the one or both of the respective materials being joined together.

[0172] In other examples, other processes may be used to create the sleeves, cuffs, and / or the sleeve and cuff systems of the present disclosure. For example, 3D textile printing methods may be used to form the sleeve, the cuff, the wrist element, and / or the impervious sleeve and cuff systems of the present disclosure. In one example, a 3D textile printing process may beJ1404-00110used to print a gown or other protective garment that may include a gown body, sleeve or sleeves thereon. The protective garment, gown body, sleeve, or sleeves may be printed on a 3D shaped body fixture. The cuff material may be printed onto the sleeve such that the cuff material penetrates and fills any pores or gaps in the 3D printed gown to create an impervious seam at the cuff material and gown / sleeve interface and forming the impervious cuff. In other examples, a sleeve may be 3D printed and then the cuff material may be printed onto the sleeve. The cuff material may penetrate and fill any pores or gaps in the sleeve material to create an impervious seam at the cuff / sleeve interface and forming the impervious cuff. The sleeve / cuff system may then be joined to the gown or other protective garment. In another example, the body material and / or sleeve material, and cuff material may be 3D printed in layers. The cuff material may be printed onto the sleeve material such that cuff material penetrates and filles any pores or gaps in the 3D printed gown or protective garment to create an impervious seam. The printed material with the body material, sleeve material, and / or cuff material may be folded to the body shape, sleeve shape, and / or the impervious cuff. In other examples, the wrist element such as the knit cuff, or hand-draping extension may be 3D printed onto the sleeve material. In various examples, suitable 3D printing techniques may be used to create the gown, protective garment, sleeve, and / or cuff. Such 3D printing techniques may include gravure printing, screen printing, flexographic printing, or nozzle printing. In other examples, other techniques and / or iterations may be used to utilize the advantages and versatility of 3D textile printing methodologies.

[0173] The foregoing outlines features of several embodiments so that those of ordinary skill in the art may better understand the aspects of the present disclosure. Those skilled in the art should appreciate that they may readily use the present disclosure as a basis for designing or modifying other processes and structures for carrying out the same purposes and / or achieving the same advantages of the embodiments introduced herein. Those skilled in the art should also realize that such equivalent constructions do not depart from the spirit and scope of the present disclosure, and that they may make various changes, substitutions, and alterations herein without departing from the spirit and scope of the present disclosure.

[0174] The present disclosure contemplates the embodiments listed below as other combination and features as described above.

[0175] Embodiment 1: A method of manufacturing a protective garment, comprising: providing a tubular cuff; providing a tubular sleeve of a protective garment; flattening the tubular sleeve such that two layers of the tubular sleeve are positioned adjacent one another; bonding the tubular cuff to the flattened tubular sleeve at a predetermined sleeve bonding zoneJ1404-00110of the tubular sleeve forming a liquid impermeable seal between the tubular cuff and the tubular sleeve wherein a foldable portion of the tubular cuff is located proximally to the sleevebonding zone when in an unfolded state, and wherein the foldable portion is configured to fold over and cover the sleeve bonding zone in a folded state.

[0176] Embodiment 2: The method of embodiment 1, wherein the bonding comprises: applying an adhesive at the predetermined sleeve bonding zone of the sleeve; and applying heat to the predetermined sleeve bonding zone.

[0177] Embodiment 3: The method of embodiment 1, further comprising: stretching the tubular cuff to increase a diameter of the tubular cuff; and positioning the stretched tubular cuff around the sleeve such that a cuff bonding zone of the tubular cuff is aligned over and around the predetermined sleeve bonding zone while the tubular cuff is in a stretched state.

[0178] Embodiment 4: The method of embodiments, wherein the tubular cuff remains in a stretched state after the bonding of the tubular cuff to the flattened tubular sleeve.

[0179] Embodiment 5 : The method of embodiment 3, wherein the diameter of the stretched tubular elastic cuff member is 20% to 30% larger compared to a diameter of the tubular elastic cuff member in an un- stretched state.

[0180] Embodiment 6: The method of embodiment 1, further comprising: connecting the tubular sleeve to a protective gown after the bonding of the tubular cuff to the tubular sleeve.

[0181] Embodiment 7: The method of embodiment 1, further comprising: bonding a wrist element to the flattened tubular sleeve at or near a wrist opening, wherein the wrist element comprises one of a elastomeric material cuff and a hand-draping extension.

[0182] Embodiment 8: The method of embodiment 7, wherein an open end of the wrist element is oriented away from the wrist opening of the flattened tubular sleeve.

[0183] Embodiment 9: The method of embodiment 7, wherein an open end of the wrist element is positioned between the wrist opening of the sleeve and a shoulder of the sleeve.

[0184] Embodiment 10: The method of embodiment 7, wherein the bonding the elementto the flattened tubular sleeve creates an impermeable seal.

[0185] Embodiment 11: The method of embodiment 7, wherein the bonding the wrist element to the flattened tubular sleeve creates a permeable seal.

[0186] Embodiment 12: The method of embodiment 7, wherein the wrist element comprises an elastomeric wrist element material selected from one of a woven material, a nonwoven material, a laminate material, and a film material.

[0187] Embodiment 13: A method of manufacturing a protective garment comprising: providing at least one piece of cuff material; providing a tubular sleeve of a protectiveJ1404-00110garment; flattening the tubular sleeve such that two layers of the tubular sleeve are positioned adjacent one another; bonding the at least one piece of cuff material to the flattened tubular sleeve at a predetermined sleeve bonding zone of the tubular sleeve forming a tubular cuff and a liquid impermeable seal between the tubular cuff and the tubular sleeve wherein a foldable portion of the tubular cuff is located proximally to the sleeve bonding zone when in an unfolded state, and wherein the foldable portion is configured to fold over and cover the sleeve bonding zone in a folded state.

[0188] Embodiment 14: The method of embodiment 13, wherein the at least one piece of cuff material comprises a unitary piece of cuff material and the unitary piece of cuff material is wrapped around opposite sides of the flattened tubular sleeve.

[0189] Embodiment 15 : The method of embodiment 14, wherein the tubular cuff is formed by a longitudinal seam created during the step of bonding the at least one piece of cuff material to the flattened tubular sleeve.

[0190] Embodiment 16: The method of embodiment 14, wherein the tubular cuff is formed by a longitudinal seam created at the same time as a lateral seam is created to form the impermeable seal between the tubular cuff and the tubular sleeve.

[0191] Embodiment 17: The method of embodiment 13, wherein the at least one piece of cuff material comprises a first piece of cuff material and a second piece of cuff material, the first piece of cuff material positioned on a first side of the tubular sleeve and the second piece of cuff material positioned on a second side of the tubular sleeve opposite to the first side.

[0192] Embodiment 18. The method of embodiment 17, wherein the tubular cuff is formed by a first longitudinal seam and a second longitudinal seam joining opposite edges of the first piece of cuff material and the second piece of cuff material to each other during the step of bonding the at least one piece of cuff material to the flattened tubular sleeve.

[0193] Embodiment 19: Themethod of embodiment 15, wherein the first longitudinal seam and the second longitudinal seam are created at the same time as a lateral seam is created to form the impermeable seal between the tubular cuff and the tubular sleeve.

[0194] Embodiment 20: The method of embodiment 13, wherein the at least one piece of cuff material is stretched while the at least one piece of cuff material is bonded to the tubular sleeve.

[0195] Embodiment 21: The method of embodiment 13, further comprising: connecting the tubular sleeve to a protective gown after the bonding of the at least one piece of cuff material to the tubular sleeve.J1404-00110

[0196] Embodiment 22: The method of embodiment 13, further comprising: bonding a wrist element to the tubular sleeve at or near a wrist opening, wherein the wrist element comprises one of a cuff and a hand-draping extension.

[0197] Embodiment 23: A method of manufacturing a protective garment comprising: providing at least one piece of cuff material; providing at least one piece of sleeve material; positioning the at least one piece of cuff material on a sleeve bonding zone of the at least one piece of sleeve material in a substantially flattened configuration; bonding the at least one piece of cuff material to the at least one piece of sleeve material at a predetermined sleeve bonding zone of the at least one piece of sleeve material forming a tubular cuff and tubular sleeve with a liquid impermeable seal between the tubular cuff and the tubular sleeve wherein a foldable portion of the tubular cuff is located proximally to the first bonding zone when in an unfolded state, and wherein the foldable portion is configured to fold over and cover the sleeve bonding zone in a folded state.

[0198] Embodiment 24: The method of embodiment 23, wherein the at least one piece of cuff material comprises a unitary piece of cuff material and the unitary piece of cuff material is wrapped around opposite sides of the at least one piece of sleeve material.

[0199] Embodiment 25 : The method of embodiment 24, wherein the tubular cuff is formed by a longitudinal seam created during the step of bonding the at least one piece of cuff material to the at least one piece of sleeve material.

[0200] Embodiment 26: The method of embodiment 24, wherein the tubular cuff is formed by a longitudinal seam created at the same time as a lateral seam is created to form the impermeable seal between the at least one piece of cuff material and the at least one piece of sleeve material.

[0201] Embodiment 27: The method of embodiment 23, wherein the at least one piece of cuff material comprises a first piece of cuff material and a second piece of cuff material, the first piece of cuff material positioned on a first side of the at least one piece of sleeve material and the second piece of cuff material positioned on a second side of the at least one piece of sleeve material opposite to the first side.

[0202] Embodiment 28: The method of embodiment 22, wherein the tubular cuff is formed by a first longitudinal seam and a second longitudinal seam joining opposite edges of the first piece of cuff material and the second piece of cuff material to each other during the step of bonding the at least one piece of cuff material to the at least one piece of sleeve material.

[0203] Emb odi m ent 29 : The m ethod of emb odi m ent 23 , wherei n the fi r st 1 ongi tudi nal seam and the second longitudinal seam are created at the same time as a lateral seam is created toJ1404-00110form the impermeable seal between the at least one piece of cuff material and the at least one piece of sleeve material.

[0204] Embodiment 30: The method of embodiment 24, wherein the at least one piece of sleeve material comprises a unitary piece of sleeve material and the unitary piece of sleeve material is folded onto itself to form two adjacent layers of sleeve material.

[0205] Embodiment 31 : The method of embodiment 30, wherein the at least one piece of cuff material comprises a unitary piece of cuff material and the unitary piece of cuff material is wrapped around opposite sides of the unitary piece of sleeve material.

[0206] Embodiment 32: The method of embodiment 31, wherein the tubular cuff is formed by a first longitudinal seam joining edges of the unitary piece of cuff material and the tubular sleeve is formed by a second longitudinal seam joining edges of the unitary piece of sleeve material.

[0207] Embodiment 33 : The method of embodiment 32, wherein the first longitudinal seam and the second longitudinal seam are separated from each other by a gap.

[0208] Embodiment 34: The method of embodiment 33, wherein the impermeable seal is formed by a lateral seam.

[0209] Embodiment 35: The method of embodiment 34, wherein the first longitudinal seam, the second longitudinal seam, and the lateral seam are formed at the same time during the bonding of the at least one piece of cuff material to the at least one piece of sleeve material.

[0210] Embodiment 36: The method of embodiment of 23, wherein the at least one piece of cuff material comprises a first piece of cuff material and a second piece of cuff material, the first piece of cuff material positioned on a first side of the at least one piece of sleeve material and the second piece of cuff material positioned on a second side of the at least one piece of sleeve material opposite to the first side.

[0211] Embodiment37: The method of embodiment 36, wherein the tubular cuff is formed by a first longitudinal seam and a second longitudinal seam joining opposite edges of the first piece of cuff material and the second piece of cuff material to each other during the step of bonding the at least one piece of cuff material to the at least one piece of sleeve material.

[0212] Embodiment 38: The method of embodiment 37, wherein the at least one piece of sleeve material comprises a first piece of sleeve material and a second piece of sleeve material, the first piece of sleeve material positioned adjacent the second piece of sleeve material.

[0213] Embodiment 39: The method of embodiment 38, wherein the tubular sleeve is formed by a third longitudinal seam and a fourth longitudinal seam joining opposite edges of the first piece of sleeve material and the second piece of sleeve material.J1404-00110

[0214] Embodiment 40: The method of embodiment 39, wherein the first longitudinal seam is separated from the third longitudinal seam by a first gap at a first edge of the tubular sleeve and the second longitudinal seam is separated from the fourth longitudinal seam by a second gap at a second edge of the tubular sleeve opposite to the first edge.

[0215] Embodiment 41 : The method of embodiment 40, wherein the impermeable seal is formed by a lateral seam.

[0216] Embodiment 42: The method of embodiment 41, wherein the first longitudinal seam, the second longitudinal seam, the third longitudinal seam, the fourth longitudinal seam, and the lateral seam are formed at the same time during the bonding of the at least one piece of cuff material to the at least one piece of sleeve material.

[0217] Embodiment 43: The method of embodiment 42, wherein the first piece of cuff material and the second piece of cuff material are each stretched while the first piece of cuff material and the second piece of cuff material are bonded to first piece of sleeve material and to the second piece of sleeve material.

[0218] Embodiment 44: The method of embodiment 24, further comprising: connecting the tubular sleeve to a protective gown after the bonding of the at least one piece of cuff material to the at least one piece of sleeve material.

[0219] Embodiment 45: The method of embodiment 23, further comprising: bonding a wrist element to the flattened tubular sleeve at or near a wrist opening, wherein the wrist element comprises one of a cuff and a hand-draping extension.

[0220] Embodiment 46: A method of manufacturing a protective garment comprising: providing a sleeve; and depositing cuff material onto the sleeve at a sleeve bonding zone using a 3D printing technique; wherein the step of depositing cuff material onto the sleeve creates an impervious bond of between the cuff material and the sleeve at the sleeve bonding zone.

[0221] Embodiment 47: The method of embodiment 46, wherein the sleeve is a tubular sleeve and is positioned on a 3D fixture while the step of depositing the cuff material is performed.

[0222] Embodiment 48: The method of embodiment 46, wherein the 3D printing technique comprises one or more of the following techniques or devices: gravure printing, screen printing, flexographic printing, and a nozzle.

[0223] Embodiment 49: The method of embodiment 46, further comprising: attachingthe sleeve to a protective garment after the cuff material is deposited onto the sleeve.J1404-00110

[0224] Embodiment 50: The method of embodiment 46, further comprising: bonding a wrist element to the sleeve at or near a wrist opening, wherein the wrist element comprises one of a cuff and a hand-draping extension.

[0225] Embodiment 51: A method of manufacturing a protective garment comprising: depositing a sleeve material in one or more layers using a 3D printing technique; depositing a cuff material at a sleeve bonding zone of the sleeve material to form an impervious bond between the cuff material and the sleeve material; and folding the sleeve material with the cuff material to form a folded material assembly with an open edge; closing the open edge of the folded material assembly with a longitudinal seam to form a tubular sleeve and cuff system with an impervious bond therebetween.

[0226] Embodiment 52: The method of embodiment 51, whereinthe 3D printing technique comprises one or more of the following techniques or devices: gravure printing, screen printing, flexographic printing, and a nozzle.

[0227] Embodiment 53: A method of producing a protective garment comprising: positioning a sleeve material in or on a sleeve fixture; expanding an elastic cuff material over an end of the sleeve material; allowing elastic cuff material to return to an unexpanded state at the end of the sleeve material; and bonding the elastic cuff material to the end of the sleeve material.

[0228] Embodiment 54: The method of embodiment 53, wherein the sleeve fixture comprises a mandrel.

[0229] Embodiment 55: The method of embodiment 53, wherein the sleeve material is formed into a tubular shape to form a tubular sleeve before the sleeve material is positioned in or on the sleeve fixture.

[0230] Embodiment 56: The method of embodiment 53, wherein the elastic cuff material is formed into a tubular shape to form a tubular cuff before the elastic cuff material is expanded over the end of the sleeve material.

[0231] Embodiment 57: The method of embodiment 53, wherein the elastic cuff material is expanded over the end of the sleeve material while the sleeve material is positioned in or on the sleeve fixture.

[0232] Embodiment 58: The method of embodiment 53, wherein the sleeve material and the elastic cuff material comprise different materials.

[0233] Embodiment 59: The method of embodiment 53, wherein a bonding material bonds the elastic cuff material to the sleeve material, the bonding material comprising a hot-melt adhesive or a pressure activated adhesive.J1404-00110

[0234] Embodiment 60: The method of embodiment 53, wherein the bonding is performed by applying at least one of heat, pressure, and an adhesive to the sleeve material or the cuff material.

[0235] Embodiment 61: The method of embodiment 53, further comprising applying a bonding material to the end of the sleeve material before the elastic cuff material is expanded over the end of the sleeve material.

[0236] Embodiment 62: The method of embodiment 53, wherein the step of bonding the elastic cuff material to the sleeve material forms an impermeable bond.

[0237] Embodiment 63 : The method of embodiment 53, wherein the sleeve material is part of a protective gown.

[0238] Embodiment 64: The method of embodiment 1, 13, 23, or 46, wherein the method is performed continuously.

[0239] Embodiment 65: The method of embodiment 1, 13, 23, or 46, wherein the method is performed intermittently.

[0240] Embodiment 66: The method of embodiment 1, 13, 23, or 46, wherein some steps are performed continuously and some steps are performed intermittently

Claims

J1404-00110CLAIMSWhat is claimed is:

1. A method of manufacturing a protective garment, comprising:providing a tubular cuff;providing a tubular sleeve of a protective garment;flattening the tubular sleeve such that two layers of the tubular sleeve are positioned adj acent one another;bonding the tubular cuff to the flattened tubular sleeve at a predetermined sleeve bonding zone of the tubular sleeve forming a liquid impermeable seal between the tubular cuff and the tubular sleeve wherein a foldable portion of the tubular cuff is located proximally to the sleeve bonding zone when in an unfolded state, and wherein the foldable portion is configured to fold over and cover the sleeve bonding zone in a folded state.

2. The method of claim 1, wherein the bonding comprises:applying an adhesive at the predetermined sleeve bonding zone of the sleeve; and applying heat to the predetermined sleeve bonding zone.

3. The method of claim 1, further comprising:stretching the tubular cuff to increase a diameter of the tubular cuff; and positioning the stretched tubular cuff around the sleeve such that a cuff bonding zone of the tubular cuff is aligned over and around the predetermined sleeve bonding zone while the tubular cuff is in a stretched state.

4. The method of claim 1, wherein the method is performed continuously.

5. The method of claim 3, wherein the diameter of the stretched tubular elastic cuff member is 20% to 30% larger compared to a diameter of the tubular elastic cuff member in an un-stretched state.

6. Themethodof claim 1, further comprising: connecting the tubular sleeve to a protective gown after the bonding of the tubular cuff to the tubular sleeve.J1404-001107. The method of claim 1, further comprising: bonding a wrist element to the flattened tubular sleeve at or near a wrist opening, wherein the wrist element comprises one of a elastomeric material cuff and a hand-draping extension.

8. The method of claim 7, wherein the bonding the element to the flattened tubular sleeve creates an impermeable seal.

9. The method of claim 7, wherein the bonding the wrist element to the flattened tubular sleeve creates a permeable seal.

10. The method of claim 7, wherein the wrist element comprises an elastomeric wrist element material selected from one of a woven material, a nonwoven material, a laminate material, and a film material.

11. A method of producing a protective garment comprising:positioning a sleeve material in or on a sleeve fixture;expanding an elastic cuff material over an end of the sleeve material;allowing elastic cuff material to return to an unexpanded state at the end of the sleeve material; andbonding the elastic cuff material to the end of the sleeve material.

12. The method of claim 11, wherein the sleeve fixture comprises a mandrel.

13. The method of claim 11, wherein the sleeve material is formed into a tubular shape to form a tubular sleeve before the sleeve material is positioned in or on the sleeve fixture.

14. The method of claim 11, wherein the elastic cuff material is formed into a tubular shape to form a tubular cuff before the elastic cuff material is expanded over the end of the sleeve material.

15. The method of claim 11, wherein the elastic cuff material is expanded over the end of the sleeve material while the sleeve material is positioned in or on the sleeve fixture.J1404-0011016. The method of claim 11, wherein the method is performed continuously.

17. The method of claim 11, wherein a bonding material bonds the elastic cuff material to the sleeve material, the bonding material comprising a hot-melt adhesive or a pressure activated adhesive.

18. The method of claim 11, wherein the bonding is performed by applying at least one of heat, pressure, and an adhesive to the sleeve material or the cuff material.

19. The method of claim 11, further comprising applying a bonding material to the end of the sleeve material before the elastic cuff material is expanded over the end of the sleeve material.

20. The method of claim 11, wherein the sleeve material is part of a protective gown.

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