PRIORITY DOCUMENTS

[0001] The present application claims priority from Australian Provisional Patent Application No. 2020904227 titled “METHOD OF MANUFACTURING A SURGICAU GOWN” and filed on 16 November 2020, the content of which is hereby incorporated by reference in its entirety.

TECHNICAL FIELD

[0002] The present disclosure relates to the manufacture of personal protective equipment (PPE) for medical/infection control applications. In a particular form the present disclosure relates to the manufacture of protective gowns.

BACKGROUND

[0003] The COVID-19 pandemic has resulted in an immediate and ongoing need for large quantities of disposable personal protective equipment (PPE) gowns to prevent the spread of infection, particularly for healthcare workers and others interacting with potentially infected and infected patients.

[0004] PPE gowns are designed to prevent contact with the infectious agent, or body fluid that may contain the infectious agent, by creating a barrier between the worker and the infectious material. Whilst these are not required to be sterile, they must provide a fluid barrier over the torso and arms. The gown is typically worn with gloves, masks, and either a face shield, goggles or safety glasses to fully protect the individual. PPE gowns are provided as a single piece garment with a front portion, two long sleeves, an open back (designed to overlap when worn), and ties. The gown is worn by inserting the arms, drawing the front portion over the front of the body (and clothing) and overlapping the two back portions, and then a waist tie is used to secure the gown in place. The sleeves may use elasticised cuffs, or wrist ties may be used to secure the ends of the sleeves around the wrist or hands (typically over gloves).

[0005] Most disposable (single use) PPE gowns are made of non-woven materials or fabrics such as polypropylene (PP), polyester, or polyethylene or similar materials which provide the required fluid repellent/resistant properties to protect the wearer. Depending upon the level of fluid resistance/infection control required they may be provided as a single layer material or be a multi-layered material such as triple layer SMS material which comprises a spunbond (S) polypropylene layer, a meltblown (M) polypropylene layer and another spunbond (S) polypropylene layer to provide increased strength and fluid resistance compared to a single layer of polypropylene. [0006] Manufacture of PPE gowns with full sleeves is currently either a manual or semi-automated process using ultrasonic welding apparatus to bond (weld) together individual pieces. The process involves cutting individual pieces from a roll of suitable non-woven gown material (e.g. PP or SMS) using an appropriate pattern. Automated cutting machines may be used to generate large quantities of individual pieces (e.g. such as a body portion, sleeves and ties). The body portion may be cut as a single portion or as separate front and back portions. These pieces are then manually sewn (bonded/welded) together using an ultrasonic sewing machine.

[0007] An ultrasonic sewing machine is similar to a conventional sewing machine, however the sewing head portion comprising the needle and thread is replaced with an ultrasonic welding head which can be used to bond (weld) or cut non-woven gown materials such as PP, SMS and similar plastics or materials. The ultrasonic welding head comprises a converter, a booster and a horn. A power supply is used to generate high frequency (e.g. 20kHz) electrical signals which are input to the converter (typically a piezoelectric crystal) which converts the input signals into high frequency mechanical vibrations. The booster is then used to fine tune the amplitude of the converter to the required task, and the horn is then used to deliver the mechanical vibrations to the non-woven gown materials (e.g. PP or SMS). An anvil is typically used to support the plastic material against the horn. When the plastic material passes underneath the horn, the mechanical vibrations create frictional heat which can be used to melt and bond (i.e. weld) two or more pieces of non-woven gown materials together. The vibrations/frictional heat may also be used to cut the non-woven gown materials, typically with the assistance of a cutting wheel. The anvil may be patterned to provide a stitching pattern on the material.

[0008] Manufacture of such PPE gowns is thus quite a manual process, and is typically performed in Asia due to the low labour costs. Some attempts have been made to automate this otherwise manual process. As noted above automated cutting machines may be used to generate the individual pieces. In one example an automated cutting and welding machine has been developed to produce aprons (i.e. gowns lacking sleeves). This takes a roll of material and cuts a collar and a waist tie, as well as bonding a pair of pockets onto the front (using another roll of material). However this still requires an operator to finish the garment by attaching the sleeves. This requirement for manual labour slows the rate of production of this high demand item.

[0009] There is thus a need to provide improved methods and apparatus for manufacture of PPE gowns, or to at least provide a useful alternative to existing systems.

SUMMARY

[0010] According to a first aspect, there is provided an apparatus for manufacturing a protective gown formed of a non-woven material comprising: a first ultrasonic welding apparatus comprising an elongated welding head and a power supply, the welding head comprising at least one horn; a first drum anvil located adjacent the at least one horn, wherein a gown pattern is formed on an outer surface of the first drum anvil and the gown pattern comprises a body portion, two shoulder portions, two sleeves each ending in an outer wrist tie and an inner wrist tie, and a pair of waist ties, wherein an upper edge of the body portion forms a neck portion and the upper edge is attached to the shoulder portions, and the shoulder portions connect the sleeves to the body portion, and a pair of waist ties is connected to the body portion; a feed arrangement configured to receive at least two layers of a non-woven material, the two layers comprising an upper layer and a lower layer, wherein the lower layer is formed of a first lower piece and a second lower piece and wherein the feed arrangement feeds the at least two layers between the surface of the first drum anvil and the at least one horn of the first ultrasonic welding apparatus, and in use the non-woven material is ultrasonically welded according to the gown pattern in a single rotation of the first drum anvil such that a pair of continuous outer seams are formed from the neck portion, a respective outer shoulder portion, a respective outer sleeve portion and an outer wrist cuff, and a pair of continuous inner seams are each formed from an inner wrist cuff along an inner side of the respective sleeve, and along a side of the body portion including a waist tie to the respective base of the body portion, and a back opening portion is formed from an inner edge of the first lower piece and an inner edge of the second lower piece.

[0011] In one form, the first drum anvil and the first ultrasonic welding apparatus are further configured to cut the seams and to cut a neck opening in the neck portion, a hand opening between the outer wrist tie and the inner wrist tie in each sleeve, and a waist opening at a lower edge of the body portion to create a gown in a single rotation of the first drum anvil.

[0012] In an alternate form, the apparatus further comprises a second drum anvil and a second ultrasonic welding apparatus and the feed arrangement feeds the at least two layers of non-woven material between the second drum anvil and the second ultrasonic welding apparatus after passing through the first drum anvil and the first ultrasonic welding apparatus wherein a cutting pattern is formed on an outer surface of the second drum anvil and the cutting pattern is configured to cu t a neck opening in the neck portion, a hand opening between the outer wrist tie and the inner wrist tie in each sleeve, and a waist opening at a lower edge of the body portion to create a gown in a single rotation of the second drum anvil to create the protective gown.

[0013] In a further form the cutting pattern also cuts the seams created by the first drum anvil and first ultrasonic welding apparatus. [0014] In one form, each shoulder has a bulbous shape such that in use the shoulder provides freedom of movement to the arm of the user and the lower portion of the sleeves are outwardly tapered.

[0015] In one form, the at least two layers of non-woven material are formed from either a single layer of non-woven material or multiple layers of non-woven material folded over such that a central portion forms the upper layer and a first outer edge of the single layer of non-woven material or the multiple layers of non-woven material forms the inner edge of the first lower piece and a second outer edge of the single layer of non-woven material or the multiple layers of non-woven material forms the inner edge of the second lower piece, wherein each of the multiple layers of non-woven material are overlaid and are of the same width. In a further form, the feeder arrangement further comprises a spindle and a folder arrangement configured to draw the single layer of non-woven material or the multiple layers of nonwoven material off the spindle and to fold the single layer of non-woven material or the multiple layers of non-woven material into the two layers or to draw , or the feeder arrangement further comprises a plurality of spindles and a folder arrangement configured to draw the each of the multiple layers of nonwoven material off a respective spindle such that all layers overlap and to fold the multiple layers of nonwoven material into the two layers.

[0016] In another form, the upper layer is formed of a first piece of non-woven material and the lower layer is formed of a first lower piece and a second lower piece, and the upper layer is sealed to the first lower piece and to the second lower piece by the first anvil drum. In a further form, the feeder arrangement further comprising at least two spindles wherein in use a roll of the first piece is loaded on the first spindle, a roll of the first lower piece is loaded onto a second spindle, and a roll of the second lower piece is either loaded onto the second spindle or onto a third spindle.

[0017] In one form, the inner edge of the first lower piece and the inner edge of the second lower piece are located within the neck opening.

[0018] In one form, the gown is a suit and the waist opening in the gown pattern is replaced with a pair of leg sections each including a boot with a pair of boot ties such that the pair of continuous inner seams join in the leg section to form a single continuous inner seam.

[0019] According to a second aspect, there is provided a method for manufacturing a protective gown comprising: obtaining a first drum anvil wherein a gown pattern is formed on an outer surface of the first drum anvil and the gown pattern comprises a body portion, two shoulder portions, two sleeves each ending in an outer wrist tie and an inner wrist tie, and a pair of waist ties, wherein an upper edge of the body portion forms a neck portion and the upper edge is attached to the shoulder portions, and the shoulder portions connect the sleeves to the body portion, and a pair of waist ties is connected to the body portion; passing a double layer of a non-woven material through a first ultrasonic welding apparatus comprising an elongated welding head and a power supply, the welding head comprising at least one horn, and the first drum anvil wherein the non-woven material is ultrasonically welded according to the gown pattern in a single rotation of the first drum anvil such that a pair of continuous outer seams are formed from the neck portion, a respective outer shoulder portion, a respective outer sleeve portion and an outer wrist cuff, and a pair of continuous inner seams are each formed from an inner wrist cuff along an inner side of the respective sleeve, and along a side of the body portion including a waist tie to the respective base of the body portion, and a back opening portion is formed from an inner edge of the first lower piece and an inner edge of the second lower piece; and cutting the seams and cutting a neck opening in the neck portion, a hand opening between the outer wrist tie and the inner wrist tie in each sleeve, and a waist opening at a lower edge of the body portion to create a gown.

[0020] In one form, the welding and cutting is performed by the first drum anvil and the first ultrasonic welding in a single rotation of the first drum anvil.

[0021] In another form, the first drum anvil and the first ultrasonic welding apparatus perform the welding in a single rotation of the first drum anvil, and double layer material is fed to a second drum anvil and a second ultrasonic welding apparatus which performs the cutting wherein a cutting pattern is formed on an outer surface of the second drum anvil such that the gown is created in a single rotation of the first drum anvil and a single rotation of the second drum anvil. In a further form the cutting pattern also cuts the seams created by the first drum anvil and first ultrasonic welding apparatus.

[0022] In one form, each shoulder has a bulbous shape such that in use the shoulder provides freedom of movement to the arm of the user and the lower portion of the sleeves are outwardly tapered.

[0023] In one form, the at least two layers of non-woven material are formed from either a single layer of non-woven material or multiple layers of non-woven material folded over such that a central portion forms the upper layer and a first outer edge of the single layer of non-woven material or the multiple layers of non-woven material forms the inner edge of the first lower piece and a second outer edge of the single layer of non-woven material or the multiple layers of non-woven material forms the inner edge of the second lower piece. In a further form the method further comprises folding the single layer of nonwoven material or the multiple layers of non-woven material into the two layers.

[0024] In one form, the upper layer is formed of a first piece of non-woven material and the lower layer is formed of a first lower piece and a second lower piece, and the upper layer is sealed to the first lower piece and to the second lower piece by the first anvil drum. In a further form the method further comprises drawing the first piece from a first spindle, drawing the first lower piece from a second spindle, and drawing the second lower piece from either the second spindle or a third spindle.

[0025] In one form the inner edge of the first lower piece and the inner edge of the second lower piece are located within the neck opening.

[0026] In one form, the gown is a suit and the waist opening in the gown pattern is replaced with a pair of leg sections each including a boot with a pair of boot ties such that the pair of continuous inner seams join in the leg section to form a single continuous inner seam.

BRIEF DESCRIPTION OF DRAWINGS

[0027] Embodiments of the present disclosure will be discussed with reference to the accompanying drawings wherein:

[0028] Figure 1A is a schematic figure of a single pass gown design according to an embodiment;

[0029] Figure IB is an end view of a double layer of non-woven material for manufacturing the single pass gown design shown in Figure 1A according to an embodiment;

[0030] Figure 2 is a perspective view of a patterned anvil drum and ultrasonic head according to an embodiment;

[0031] Figure 3 is a side view of an apparatus for manufacturing a protective gown according to an embodiment;

[0032] Figure 4 is a side view of an apparatus for pre-assembling multi-layers of fabric in preparation for manufacturing a protective gown according to an embodiment;

[0033] Figure 5A is a schematic figure of a single pass suit design according to an embodiment;

[0034] Figure 5B is a schematic figure of a single pass pants design according to an embodiment; and

[0035] Figure 6 is a flow chart of a method for manufacturing a protective gown.

[0036] In the following description, like reference characters designate like or corresponding parts throughout the figures. DESCRIPTION OF EMBODIMENTS

[0037] Referring now to Figure 1A, there is shown a schematic figure of a pattern Ifor manufacturing a protective gown, such as disposable surgical gown, of non-woven material (ie a material suitable to act as a personal protective equipment (PPE)) in a single ultrasonic welding pass according to an embodiment. The non-woven material may be one or more layers of a non-woven material suitable for use as a PPE gown such as polypropylene (PP), polyester, polyethylene, SMS or other plastics or similar materials which are suitable for ultrasonic welding. For the sake of convenience we will use non-woven material to include all such materials (e.g. non-woven PPE gown materials) including single layer and multilayer (eg SMS) materials, and layers of such materials. In one embodiment the gown pattern 1 is ultrasonically welded and cut in a single pass of a patterned anvil drum 60 over a portion of non-woven material which is either a folded over single layer (to form two layers) or multiple layers of a non-woven material by an ultrasonic welder 70. That is the anvil drum 60 and ultrasonic welder 70 are configured to seal and cut the non-woven material, or just cut certain designated portions. Seals are designated by solid lines, and cut only (i.e. unsealed) portions designated by thick dotted lines. In an alternative embodiment a double drum 60 60' arrangement is used in which the gown pattern 1 is first ultrasonically sealed in a single pass of patterned anvil drum 60 over ultrasonic welder 70 and then cut by a second patterned anvil drum 60' over a second ultrasonic welder 70'. Figure IB is an end view of a double layer of non-woven material for manufacturing the single pass gown design shown in Figure 1A. Figure 2 is a perspective view of the patterned anvil drum 60 and ultrasonic head 72 including an elongated horn 74 according to an embodiment and Figure 3 is a side view of a gown manufacturing apparatus 100 for manufacturing a protective gown according to an embodiment.

[0038] With reference to Figures 1A, IB, 2 and 3, a double layer 13 of non-woven material 10 with a width 12 is passed through the gap 66 between the surface of the drum 62 and an ultrasonic head 72 of an ultrasonic welding machine 70. The ultrasonic welding machine 70 comprises a head 72 comprising a converter, a booster and a horn 74 and power supply 76 used to generate high frequency (e.g. 20kHz) electrical signals to drive (i.e. vibrate) the horn. In this embodiment the horn 74 of the ultrasonic head 72 is an elongated rectangular head. The length of the horn 74 is matched to the length of the drum 62 (and the width of the material 12). As shown in Figure 2, the surface of the drum 62 is patterned with raised surface portions corresponding to seal locations (i.e. the gown pattern) and as the non-woven material 10 passes through the gap 66 the anvil drum rotates to apply the pattern (i.e. raised surface portions) on the drum against the horn 74 to ultrasonically seal and/or cut the non-woven material to form the desired gown shape. Control of sealing or cutting can be controlled by the type of projection and/or use of a segmented horn and power.

[0039] As noted above, the gown pattern 1 is formed on the outer surface 62 of the anvil drum 60 as raised surface portions so that a single complete gown may be cut and sealed in a single pass (single rotation) of the drum 60 over a double layer 13 of non-woven material 10. Each layer of the double layer may be a single layer or sheet of non-woven material (including a multilayer material such as SMS), or may be multiple overlapping (or overlaid) layers of non-woven material which will be all sealed together. As shown in Figure 1A, the gown pattern incorporates a body portion 20 with a back portion 21 formed of the lower layer of double layer 13 of non-woven material 10 and front portion 22 formed in the upper layer of double layer 13 of non-woven material 10) with two waist ties (left tie 24 and right tie 26). The two waist ties can be wrapped around the waist like a belt and tied off to create a close fit around the waist of the wearer. In one embodiment a single long waist tie could be provided which is sufficiently long to fully loop around the waist of the wearer to enable it to be tied to itself. Preferably the length of each tie 24 26 is greater than the width of the body portion For example the single tie could be of similar shape to left and right ties 24 and 26, but joined between ends 24 and 26, and separated from body at opening 25.

[0040] Sleeve portions 30 and 40 are directly connected to the body portion. Hand openings 37 47, neck opening 50 and waist opening 27 designated by thick dotted lines. The waist ties 24, 26 each have an E shaped profile to provide a long length of non-woven material to allow it to be wrapped and tied around the waist of the user. In another embodiment the tie could be a straight section extending below the bottom of the front portion 22. However the use of an L shape in which the lower part of the L extends under the bottom of the body portion 20 provides long length has the advantage of reducing wastage of additional non-woven material compared to using a straight segment. The profile of the ties could also be curved (to curve under the bottom of the body portion 20). The open join regions 23 24 of the waist ties to the body portion 20 may also be sealed. In this embodiment a fold down collar 50 is also provided via cut out 52 and fold line 54. In this pattern 1 , the sleeve portions 30 and 40 are directly connected to the body portion, thus avoiding the need to separately sew the sleeves onto the body. The sleeves 30 and 40 each comprises large shoulder portions 32, 42, straight arm portions 34, 44 and cuffs 36, 46 (delineated by thin dashed lines). The shoulder portions 32, 42 preferably have a large bulbous or oversized shape. This ensures the user of freedom of movement of arms and shoulders whilst wearing the gown. The sides of the sleeves are welded together to form a seal whilst the ends of the cuffs 37 47 are simply cut (i.e. not sealed) to leave an opening through which a hand can pass. Additionally the lower section of the sleeves (e.g. from the elbow to cuffs) are outwardly tapered to accommodate the hands.

[0041] The end of each sleeve/cuff has a pair of wrist ties 38 and 48 which are used to secure the end of the sleeve - either over gloves or against the wrist to allow a glove to be placed over the cuffs 36, 46. A seam or pattern may be made at the edge of the cuffs 36, 46 as shown by the thin dashed line in Figure 1. For the sake of clarity it is noted that such a seam would only be formed in the top layer of the material so as not to seal the sleeve closed. This can be achieved through the use of a segmented horn and reducing the power in the sleeve portion as the drum moves over the horn. As is shown in Figure 1A, a continuous outer seam is formed from the neck, outer shoulder, outer arm and outer wrist cuff. A continuous inner seam is formed from the inner wrist cuff along the inner side of the sleeve, and along the side of the body including the waist tie to the base of the body portion. This is replicated on both sides such that there are four continuous seams. Cut sections for the hand 37 47 separate the two wrist cuffs (and thus the continuous inner seam and continuous outer seam), the cut section for the neck 50 (the neck opening) separates the start of the two continuous outer seams (starting at the neck), and cut section at the waist 27 separates the ends of the two continuous inner seams.

[0042] In this embodiment the drum 60 and associated ultrasonic welder 70 are configured to seal and cut the edge of the seal along the solid lines shown in Figure 1A, and to just cut the hand openings 37 47, neck opening 50 and waist opening 27 designated by thick dotted lines. In another embodiment using the double drum 60 60' arrangement, the first drum 60 is patterned with the sealing pattern, that is omitting hand openings 27 37, neck opening 50 and waist opening 27 designated by thick dotted lines in Figure 1A, and the second drum 60' is patterned with the cutting pattern which is configured to cut along the edge of the seals created by the first drum 60 designated by solid lines and including hand openings 27 37, neck opening 50 and waist opening 27 designated by thick dotted lines in Figure 1A.

[0043] Figure 3 shows a side view of a gown manufacturing apparatus 100 comprising a feeding arrangement 80, a drum anvil 60 and an ultrasonic welder 70. An optional second drum anvil 60' and second ultrasonic welder 70' are also shown. In this embodiment the non-woven material 10 is a continuous double layer sheet of non-woven material with edges 14, 16 and width 12 rolled or wound onto a spindle 11. The non-woven material 10 is a pre -folded double layer 13 with the top or upper layer 22 forming the front of the gown and the bottom or lower layer 21 forming the back of the gown. In this embodiment the feed arrangement 80 comprises a series of rollers which are used to draw the material off the spindle 11 and towards the drum anvil 60 and ultrasonic welder 70. Rollers may be located both before and after drum anvil 60 and ultrasonic welder 70. The roller may be driven by a motor or may be an idle or guide wheel (i.e. freely rotates), in which case the spindle 11 and/or drum anvil may be driven. Control of the motors may be performed using a microcontroller or other computing apparatus.

Alternatively the material 10 may be wound onto spindle 11 as a single unfolded sheet and the feed arrangement further comprises the spindle and any associated motors, sensors for controlling the spindle. Then as the material is rolled off the roller 11 , the feed arrangement may comprises a folding arrangement the two edges 15 and 17 are folded over at fold points 14, 16 to create a double layer material which is then fed to drum 60 and ultrasonic welder 70. The folding arrangement may be formed as a funnel like guide or folding shoulder with one end forming a flat section to receive the flat material followed by a mid-section comprising curved guides and/or rollers to gently fold the material over as it is pulled forward to exit the folding arrangement as folded double layer material.. Other feed arrangements and folding arrangements may also be used. [0044] The lower layer 21 comprises an entry portion 18 defined by left edge 15 and right edge 17 to allow rear entry into the gown. As illustrated in Figure IB, which is an end view of a double layer 13 of non-woven material, gowns of different sizes may be manufactured using the same drum 60. The double layer 12 may be formed from a single wide piece of non-woven material which is folded over to create a double layer of total width w 12. The inner ends 15 17 of the material forming the lower layer 21 create a back opening portion 18 for the gown to allow rear entry into the gown. The back opening portion may be separated by a gap or may be partially overlapped. In another embodiment the double layer is formed from three pieces with the upper layer 22 formed of a single material of width w 12 and the bottom (or lower) layer 21 formed from two materials each aligned at outer edges 14 16. The first lower piece has an outer edge 14 and inner edge 15, and the second lower piece has an outer edge 16 and inner edge 17. The two pieces forming the lower layer may have a summed or total width less than w to create gap 19 (e.g. each may each have a width of less than w Z2) or the two pieces forming the lower layer may have a summed or total width greater than w to create an overlap 19 (e.g. each may each have a width of more than w Z2). Varying the widths of the pieces forming the lower layer 21 allows the creation of gowns of different sizes, by either creating a gap between the inner edge of first lower piece 15 and inner edge 17 of the second lower piece or creating an overlap 19.

[0045] Figure IB shows four different gown sizes - a small gown 13a, a medium gown 13b, a large gown 13c and an extra-large gown 13d. The small gown 13a is formed from a single layer or piece of non-woven material formed into a double layer 13 of non-woven material by folding at left edge 14 and right edge 16 to create an upper layer 22 of width w and first lower piece with inner edge 15 (originally one edge of the unfolded fabric), and a second lower piece with inner edge 17 (originally the other edge of the unfolded fabric). A gap 18 is formed between inner edges 15 and 17 as widths of the first and second lower pieces are less than w Z2. The medium gown 13b is formed from three pieces in which the upper layer 21 is formed of a single top piece with outer edges 14 16 and width w. The bottom layer 21 is formed of a first lower piece with outer edge 14 and inner edge 15 and a second lower piece outer edge 16 and inner edge 17. Again the width of the first lower piece and the second lower piece are less than w Z2 to form a gap 18 which is a smaller gap than the gap for the small gown 13a. The large gown 13c is formed from a single layer or piece of non-woven material formed into a double layer 13 of non-woven material by folding at left edge 14 and right edge 16 to create an upper layer 22 of width w and first lower piece with inner edge 15 (originally one edge of the unfolded fabric), and a second lower piece with inner edge 17 (originally the other edge of the unfolded fabric). An overlap 18 is formed between inner edges 15 and 17 as widths of the first and second lower pieces are both greater than w Z2. The extra-large gown 13d is formed from three pieces in which the upper layer 21 is formed of a single top piece with outer edges 14 16 and width w. The bottom layer 21 is formed of a first lower piece with outer edge 14 and inner edge 15 and a second lower piece outer edge 16 and inner edge 17. Again the width of the first lower piece and the second lower piece are greater than w Z2 to form an overlap 18 which is a large overlap than the overlap for the large gown 13c. In the embodiment shown in Figure 1A, the inner edges

15 and 17 are within the neck region 50 so the opening for rear entry is formed within the neck region 50 (which is cut and not sealed).

[0046] In the embodiment shown in Figure 3 in which the upper and lower layers 21 22 are formed of a single folded material rolled onto spindle 11. In an alternative embodiment in which top layer 22 is a single piece and the bottom layer 21 is formed of two pieces, the two lower pieces are rolled onto second lower spindle 11' indicated by dashed line in Figure 3 and the upper piece and lower pieces are fed into roller 80. In another embodiment, for example for large and extra-large gowns with overlaps between the lower pieces, each lower piece may be loaded onto a separate spindle 11 and the three pieces of nonwoven material fed into roller 80. The non-woven material is a non-woven fabric material such as a polypropylene (PP), polyester, or polyethylene fabric which provides fluid repellent/resistant properties. The non-woven material may be a multi-layered material using different materials for each layer such and in one embodiment a separate roller/spindle could be used for each layer of non-woven material and the sealing used to bond the layers. In other embodiments the materials on the layer may be multilayer material such as a triple layer SMS material.

[0047] Figure 4 is a side view of an apparatus for pre-assembling multi-layers of fabric in preparation for manufacturing a protective gown according to an embodiment. In this embodiment three rolls 110 112 114 are each loaded with a sheet of non-woven material 111 113 115. In one embodiment the three layers comprise the upper layer 22, and the first lower piece and the second lower piece for the lower layer 21. These are loaded in to a first set of rollers 120 and then wound onto a spindle 11 to form the input roll of non-woven material used in Figure 3. In another embodiment multiple different non-woven materials may be combined to control the fluid repellent/resistant properties of the gown or to incorporate different coloured material. For example some clinics use different coloured gowns to designate different areas with different levels of risk. Thus by incorporating different coloured materials gowns for each region may be produced using the same design. In one embodiment a folder arrangement 130 is used to fold material. In this embodiment the folder arrangement folds the two edges 15 and 17 over at fold edges 14,

16 to create a double layer material. The folded material may be a single piece (or sheet) of non-woven material, or the folded material may be multiple layers of non-woven material wherein each of the multiple layers of non-woven material are overlaid and are of the same width. The folder arrangement may be formed as a funnel like guide or folding shoulder with one end forming a flat section and the other end folded over, and the mid-section comprising guides and rollers to transition between the two ends and gently fold the material over as it is pulled along. Other folding arrangements including rollers and guides to direct the side portions back over the central portion may be used to form a folded material. In one embodiment the single layer of non-woven material, or the multiple layers of non-woven material, are wound onto a single spindle and the feeder arrangement draws off the material (single layer or multiple layers) which are folded by the folder arrangement. In another embodiment multiple spindles may be used, each of which are wound (or loaded) with a single layer of non-woven material, and the feeder arrangement draws off the multiple layers (each of the same width) and overlaps (or overlays) them to form multiple layers which are then folded by the folder arrangement.

[0048] The drum is driven at a rotation rate to ensure sealing and cutting of edges of the pattern. This may be a constant rotation rate or a variable rotation rate. The maximum rotation rate is related to how much time is required for the head to be in contact with the gown material to seal or cut it, which in turn is dependent on factors such as the amount of power delivered by the ultrasonic welding head, cooling rate of the welding head, thickness of material, specific operation (cutting/sealing), etc. The drum may be operated in a continuous mode in which the drum operates at fixed rotation rate and material is fed through the head at a constant rate. Alternatively the drum may pause between rotations/gowns. This may be to allow the welding head to cool between gowns (i.e. cutting/sealing operations), or to allow other operations to be performed on other sections of the feed material or gown at other stages of the production line e.g. to allow separation and capture of the cut gown and collection/disposal of excess material. Similarly the drum may also pause between partial rotations (i.e. partway through cutting/sealing of a gown) to allow cooling or other production line operations to be performed. Further the drum may rotate at variable speeds based on the region of the gown being cut/sealed (i.e. which part of the pattern is being cut/sealed).

[0049] The dimensions of the drum (width 63 and radius 64) are based on the size of the desired pattern/gown. For example to produce a gown with a width of 80cm by 150cm long requires a drum of width 80cm and radius of at least 24cm (corresponding to a circumference of 150.8cm). Different drums could be configured for different size gowns (e.g. small, medium, and large). The diameter may also be influenced by production line considerations. For example in an embodiment where the drum and feed are operated in a continuous mode with the drum rotating at a constant/fixed rate, then a circumference of 25cm would provide a 7cm gap between gowns. Larger diameters create longer gaps between gowns (increasing wastage) but allow additional time for cooling of the ultrasonic head between rotations/cutting operations. Alternatively as noted above the drum may pause between gowns. In that case the circumference may be selected based on the required space to allow separation and collection of a cut gown from surrounding materials (e.g. to enable efficient packing/collection of cut gowns).

[0050] The drum may be formed of steel and/or metal alloys, including hardened steel. The pattern may be formed on the surface of the drum through chemical etching, laser cutting, CNC machining, 3D printing, etc. The thickness of the pattern extending from the drum surface may be sub-mm up to a few mm in thickness. Different projections can be formed or shaped to create different sealing patterns and to control whether sealing or cutting is performed. [0051] In this embodiment horn 74 of the ultrasonic head 72 is an elongated rectangular horn spanning the width of the drum (corresponding to width 12 of the non-woven material). In some embodiments this elongated horn is formed from multiple adjacent rectangular horns. Each horn may have a separate booster and converter or they may be driven by a common booster and converter. The advantage of multiple horns with separate power supplies is that they can be separately activated to reduce overheating. In another embodiment the horn is a rotary horn which is mounted on an axle comprising the converter and booster.

[0052] A controller, such as a microcontroller, PLC, or computing apparatus may be used to control the apparatus. This may control the rotation and speed of rotation of the drum and the ultrasonic welder 70 such as the frequency and power of the ultrasonic welder 70, including to different sections of a composite head. The horn may be driven at a frequency in the range of 10kHz to 50KHz, and preferably at around 20kHz. The rated power may be in the range of 1000W to 2400W, although powers outside of the range may also be used. The power and frequency will depend upon the horn dimensions and operational speed (e.g. rotational speed) and choices will be guided by integrity or reliability of seals and cuts formed. In one embodiment a rotation sensor, such as an optical or magnetic sensor (encoder) is used to detect the rotational angle (orientation ) of the drum 60 and control the power to the ultrasonic welder or to different parts of a composite head and may be used to control sealing and cutting. The controller may also be used to control motors used in the feed arrangement to feed the non-woven material, including motors driving the spindle 11 containing the roll of non-woven material and/or the rollers adjacent the drums.

[0053] The use of a dual roller system including a separate welding drum 60 with a welding pattern (and associated ultrasonic welder 70), and a separate cutting drum 60' with a cutting pattern (and associated ultrasonic welder 70' used as a cutting element) has an advantage of preserving production speed (or production rate), whilst simplifying manufacture of the drums (e.g. machining of surface patterns on the drum) as well as system design and control, as the two ultrasonic welders can be separately configured and controlled. A single drum system in which a single drum is used to weld and cut in a single pass requires a more complicated drum head, e.g. with sealing and cutting formations on the surface requiring more sophisticated machining of the pattern (i.e. formations on the surface of the drum), and/or a ultrasonic welding and control system to vary power level across a composite head to control sealing and cutting.

[0054] Figure 6 illustrates a method 600 for manufacturing a protective gown. The method comprises a first step 602 comprising obtaining a first drum anvil wherein a gown pattern is formed on an outer surface of the first drum anvil and the gown pattern comprises a body portion, two shoulder portions, two sleeves each ending in an outer wrist tie and an inner wrist tie, and a pair of waist ties, wherein an upper edge of the body portion forms a neck portion and the upper edge is attached to the shoulder portions, and the shoulder portions connect the sleeves to the body portion, and a pair of waist ties is connected to the body portion.

[0055] At step 604 we pass a double layer of a non-woven material through a first ultrasonic welding apparatus comprising an elongated welding head and a power supply, the welding head comprising at least one horn, and the first drum anvil wherein the non-woven material is ultrasonically welded according to the gown pattern in a single rotation of the first drum anvil such that a pair of continuous outer seams are formed from the neck portion, a respective outer shoulder portion, a respective outer sleeve portion and an outer wrist cuff, and a pair of continuous inner seams are each formed from an inner wrist cuff along an inner side of the respective sleeve, and along a side of the body portion including a waist tie to the respective base of the body portion, and a back opening portion is formed from an inner edge of the first lower piece and an inner edge of the second lower piece

[0056] At step 606 we cut the seams and cut a neck opening in the neck portion, a hand opening between the outer wrist tie and the inner wrist tie in each sleeve, and a waist opening at a lower edge of the body portion to create a gown. The welding and cutting may be performed by the first drum anvil and the first ultrasonic welding in a single rotation of the first drum anvil or the first drum anvil and the first ultrasonic welding apparatus perform the welding in a single rotation of the first drum anvil, and double layer material is fed to a second drum anvil and a second ultrasonic welding apparatus which performs the cutting wherein a cutting pattern is formed on an outer surface of the second drum anvil such that the gown is created in a single rotation of the first drum anvil and a single rotation of the second drum anvil. In a further form the cutting pattern also cuts the seams created by the first drum anvil and first ultrasonic welding apparatus

[0057] Other variations such as suits or pants could also be produced using a single pass drum. Figure 5A is a schematic figure of a single pass suit design 500 according to an embodiment and Figure 5B is a schematic figure of a single pass pants design 510 according to an embodiment. Suit design 500 incorporates straight waist bands 24 26, leg section 520, including boots 504 with boot ties 506 608. The construction of a suit requires a large diameter drum. Similarly pants may be formed with leg section 512, boots 514 and boot ties 516 518. In this embodiment the waist ties 24 26 are formed in the top of the pants 511. In one embodiment the pants could be provided as an overall embodiment incorporating a neck strap 519 attached to the top of the pants. Again this embodiment requires a large diameter drum. In this embodiment the waist bands 24 26 could optionally be omitted.

[0058] The use of a patterned drum configured to ultrasonically seal and cut in a single pass, or a pair of patterned drums to seal then cut a gown, each in a single pass, provides a highly efficient, time and cost effective manufacturing process compared to current manual methods requiring manual ultrasonic welding of arm parts together. This single pass pattern enables production of full PPE gowns at high rates of production compared to current methods. In some embodiments production rates of 10-20 pieces per minute can be obtained.

[0059] Those of skill in the art would understand that information and signals may be represented using any of a variety of technologies and techniques. For example, data, instructions, commands, information, signals, bits, symbols, and chips may be referenced throughout the above description may be represented by voltages, currents, electromagnetic waves, magnetic fields or particles, optical fields or particles, or any combination thereof.

[0060] The steps of a method or algorithm described in connection with the embodiments disclosed herein may be embodied directly in hardware, in a software module executed by a processor (including a microprocessor), or in a combination of the two. For a hardware implementation, processing may be implemented within one or more application specific integrated circuits (ASICs), digital signal processors (DSPs), digital signal processing devices (DSPDs), programmable logic devices (PLDs), field programmable gate arrays (FPGAs), processors, controllers, micro-controllers, microprocessors, or other electronic units designed to perform the functions described herein, or a combination thereof. Various middleware and computing platforms may be used. In some embodiments the processor module comprises one or more Central Processing Units (CPUs). A CPU may comprise an Input/Output Interface, an Arithmetic and Logic Unit (ALU) and a Control Unit and Program Counter element which is in communication with input and output devices through the Input/Output Interface. The Input/Output Interface may comprise a network interface and/or communications module for communicating with an equivalent communications module in another device using a predefined communications protocol (e.g. Bluetooth, Zigbee, IEEE 802.15, IEEE 802.11, TCP/IP, UDP, etc.). The computing apparatus may comprise a single CPU (core) or multiple CPU’s (multiple core), or multiple processors. Memory is operatively coupled to the processor(s) and may comprise RAM and ROM components, and may be provided within or external to the device or processor module. The memory may be used to store an operating system and additional software modules or instructions. The processor(s) may be configured to load and executed the software modules or instructions stored in the memory.

[0061] Those of skill in the art would further appreciate that the various illustrative logical blocks, modules, circuits, and algorithm steps described in connection with the embodiments disclosed herein may be implemented as electronic hardware, computer software or instructions, middleware, platforms, or combinations of both. To clearly illustrate this interchangeability of hardware and software, various illustrative components, blocks, modules, circuits, and steps have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system. Skilled artisans may implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the present disclosure.

[0062] Software modules, also known as computer programs, computer codes, or instructions, may contain a number a number of source code or object code segments or instructions, and may reside in any computer readable medium such as a RAM memory, flash memory, ROM memory, EPROM memory, registers, hard disk, a removable disk, a CD-ROM, a DVD-ROM, a Blu-ray disc, or any other form of computer readable medium. In some aspects the computer-readable media may comprise non-transitory computer-readable media (e.g., tangible media). In addition, for other aspects computer-readable media may comprise transitory computer- readable media (e.g., a signal). Combinations of the above should also be included within the scope of computer-readable media. In another aspect, the computer readable medium may be integral to the processor. The processor and the computer readable medium may reside in an ASIC or related device. The software codes may be stored in a memory unit and the processor may be configured to execute them. The memory unit may be implemented within the processor or external to the processor, in which case it can be communicatively coupled to the processor via various means as is known in the art.

[0063] Further, it should be appreciated that modules and/or other appropriate means for performing the methods and techniques described herein can be downloaded and/or otherwise obtained by computing device. For example, such a device can be coupled to a server to facilitate the transfer of means for performing the methods described herein. Alternatively, various methods described herein can be provided via storage means (e.g., RAM, ROM, a physical storage medium such as a compact disc (CD) or floppy disk, etc.), such that a computing device can obtain the various methods upon coupling or providing the storage means to the device. Moreover, any other suitable technique for providing the methods and techniques described herein to a device can be utilized.

[0064] The methods disclosed herein comprise one or more steps or actions for achieving the described method. The method steps and/or actions may be interchanged with one another without departing from the scope of the claims. In other words, unless a specific order of steps or actions is specified, the order and/or use of specific steps and/or actions may be modified without departing from the scope of the claims.

[0065] The reference to any prior art in this specification is not, and should not be taken as, an acknowledgement or any form of suggestion that such prior art forms part of the common general knowledge.

[0066] It will be understood that the terms “comprise” and “include” and any of their derivatives (e.g. comprises, comprising, includes, including) as used in this specification, and the claims that follow, is to be taken to be inclusive of features to which the term refers, and is not meant to exclude the presence of any additional features unless otherwise stated or implied.

[0067] In some cases, a single embodiment may, for succinctness and/or to assist in understanding the scope of the disclosure, combine multiple features. It is to be understood that in such a case, these multiple features may be provided separately (in separate embodiments), or in any other suitable combination. Alternatively, where separate features are described in separate embodiments, these separate features may be combined into a single embodiment unless otherwise stated or implied. This also applies to the claims which can be recombined in any combination. That is a claim may be amended to include a feature defined in any other claim. Further a phrase referring to “at least one of’ a list of items refers to any combination of those items, including single members. As an example, “at least one of: a, b, or c” is intended to cover: a, b, c, a-b, a-c, b-c, and a-b-c.

[0068] It will be appreciated by those skilled in the art that the disclosure is not restricted in its use to the particular application or applications described. Neither is the present disclosure restricted in its preferred embodiment with regard to the particular elements and/or features described or depicted herein. It will be appreciated that the disclosure is not limited to the embodiment or embodiments disclosed, but is capable of numerous rearrangements, modifications and substitutions without departing from the scope as set forth and defined by the following claims.