Hemostatic textile manufacture

Abstract

Methods of manufacturing hemostatic textiles include knitting glass-based fibers with secondary fibers to form a textile and scouring the textile in a programmable laundry machine. The scouring sequence may include sequential solutions (e.g., alkaline, detergent, and enzyme) with temperature progression and on / off agitation, followed by rinsing, spin-dry, and drying. In some implementations, the textile is provided as a roll or as a flat-knit sheet with linked unit shapes, and size reduction (e.g., slicing a roll or separating linked shapes) is performed before or after scouring. Controls can synchronize drum speed, temperature, and chemistry transitions to improve cleaning and throughput while limiting textile damage. Variants include use of a containment bag (e.g., mesh or doughnut bag), radiopaque fibers, and parameterized subroutines suited to machine capacity and textile construction.

Description

PCT Patent ApplicationDocket No.: 410640-506001 WOHEMOSTATIC TEXTILE MANUFACTURECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to United States (US) provisional application Serial No. 63 / 727,966, filed 04-December-2024, the entire disclosure of which is incorporated by reference as if fully set forth herein in its entirety.FIELD OF THE INVENTION

[0002] In some embodiments, the present disclosure relates to manufacture of hemostatic textiles that can promote blood clotting and wound healing.BACKGROUND OF THE INVENTION

[0003] Hemostatic textiles have evolved with medicine itself. In antiquity, caregivers wrapped wounds with woven linen or wool bandages and relied on pressure and naturally occurring agents (e.g., plant gums, vinegars, honey) to encourage clotting. Through the industrial era, cotton processing and mechanized weaving standardized gauze, while the rise of antisepsis and sterilization in the late nineteenth and early twentieth centuries made sterile dressings commonplace. Conventional finishing operations — scouring, bleaching, and, in some cases, mercerization — were adopted to remove oils and sizing and to increase absorbency.

[0004] During the twentieth century, manufacturing diversified beyond plain- woven gauze to include knit structures and nonwovens. Developers also explored bioactive and pro-coagulant components — such as oxidized cellulose, gelatin, collagen, chitosan, and mineral fillers like kaolin — applied as coatings or integrated with the textile substrate. In parallel, synthetic and regenerated fibers (e.g., rayon) were combined with inorganic fibers (e.g., glass) to engineer capillarity, surface area, and handling characteristics suitable for wound packing.

[0005] Modem manufacturing of hemostatic textiles typically uses continuous open-width ranges (e.g., beam or jet equipment) for wet processing and finishing, followed by drying and sterilization. However, these approaches can be difficult to scale and control for long, narrow, or delicate knit constructions; blends that include glass filaments; and smaller batch sizes typical of specialized medical products. Challenges include tangling or creasing during wet handling, abrasion damage,Docket No.: 410640-506001 WO nonuniform chemical exposure and temperature profiles, high water and energy loads, and inconsistent shrinkage or loop development that can alter hemostatic performance. In addition, placing size-reduction steps after wet processing may re-introduce contamination risks. Accordingly, there remains a need for manufacturing approaches that reproducibly produce stretch-enhanced, high-surface-area hemostatic knits while maintaining textile integrity, enabling flexible batch processing, and supporting reliable downstream sterilization and packaging.BRIEF SUMMARY OF THE INVENTION

[0006] The following presents a simplified summary of the innovation in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the invention. It is intended to neither identify key or critical elements of the invention nor delineate the scope of the invention. Its sole purpose is to present some concepts of the invention in a simplified form as a prelude to the more detailed description that is presented later.

[0007] In a broad embodiment, a problem is that hemostatic dressings have traditionally been composed of cotton or cellulose-based gauze substrates, often augmented with pro-coagulant agents such as chitosan, oxidized regenerated cellulose, or kaolin. In many such systems, loose-woven or nonwoven structures are employed to provide a balance of absorbency and conformability, while surface treatments or coatings impart active clot-promoting functionality. Commercial products in this category have demonstrated effective blood absorption and clot initiation but rely primarily on natural cellulose fibers and external chemical additives.

[0008] Alternative approaches have utilized synthetic and semi-synthetic fibers to achieve enhanced control over textile architecture and fluid management. Herein, rayon, including rayon derived from bamboo viscose, has been knitted or woven into fabrics to improve softness, drapability, and moisture wicking, with some variants subjected to surface functionalization for antimicrobial or hemostatic effects. Glass fiber substrates have seen application in filtration and thermal insulation, and in a limited number of experimental dressings have been combined with thrombotic agents to leverage the high surface area and rigidity of glass filaments for rapid blood uptake.

[0009] To optimize the performance of textile-based wound dressings, various scouring and finishing protocols have been applied herein to remove residualDocket No.: 410640-506001 WO spinning oils, sizing agents, and impurities. Textile scouring can employ a single elevated temperature bath with strong alkali to cleanse the fabric, while more advanced methods have introduced multi-step or multi-temperature sequences to enhance fiber wettability and absorbency. Such processes have been demonstrated on cotton, viscose, and blended fabrics to improve fluid handling, but have not been specifically tailored to the unique demands of hemostatic bandages.

[0010] Herein are explored data, cotton and cellulose gauzes treated with clotpromoting additives, rayon knit textiles — including bamboo-origin viscose — glass fiber substrates combined with pro-coagulants, and both single- and multi-temperature scouring methods to enhance absorbency, with a comprehensive solution that combines the features described in this disclosure.

[0011] In some embodiments, a method of manufacturing a hemostatic textile is disclosed, the method comprising: (a) knitting glass fibers with secondary fibers to form a textile; (b) scouring the textile in a laundry machine through sequential solutions comprising an alkaline solution, a detergent-containing solution, and an enzyme-containing solution; (c) rinsing and spin-drying the textile; and (d) drying the textile.

[0012] According to some aspects, the method can be wherein the enzyme comprises alpha-amylase.

[0013] In some embodiments, the method can be wherein agitation comprises on / off rotation cycles at <50 rpm during liquid scouring.

[0014] According to some aspects, the method can be further comprising cutting a roll into multiple textile units after drying.

[0015] In some embodiments, the method can be wherein the textile is preshaped and linked portions separated after scouring.

[0016] According to some aspects, the method can be wherein the textile is contained in a mesh or doughnut bag during scouring.

[0017] In some embodiments, the method can be wherein the secondary fibers comprise rayon and optionally radiopaque fibers.

[0018] According to some aspects, the method(s) can be wherein temperature increases across the sequential solutions.

[0019] In some embodiments, the technology provides a method for manufacturing a hemostatic textile by knitting glass and secondary fibers with programmable sequential laundry scouring.Docket No.: 410640-506001 WO

[0020] Various hemostatic dressings have been produced by impregnating or coating preformed textile substrates with procoagulant agents. In many old processes, nonwoven gauze or woven fabrics are first knitted or woven from fibers such as cotton, rayon, or synthetic polymers, and then subjected to post-production coating steps. Common techniques include dip-coating, spray application, or pad-dry- cure methods to deposit agents such as kaolin, chitosan, or zeolite onto the textile surface. While these methods achieve local hemostatic activity, they generally rely on multi-step chemical bath applications and lack integration of the functional agents into the textile structure during the knitting or weaving stage.

[0021] Standard industrial practices for scouring and finishing technical textiles — particularly those containing glass or mineral fibers — typically employ continuous or batchwise washers operating at relatively high drum speeds. Alkaline solutions, detergents, and enzymes are often applied in separate treatment stages, each at its own optimized temperature and agitation profile. Drum rotation speeds in these machines frequently exceed 200 rpm, and cycle sequences are fixed by machine programming rather than tailored to the fiber composition or intended end use. This segmented approach can lead to uneven removal of processing oils and sizing agents, as well as inconsistent textile properties.

[0022] Some manufacturers have explored programmable laundry machines to streamline multi-stage treatments, introducing fixed sequences of alkaline, detergent, and enzymatic baths. However, these efforts have typically maintained continuous drum rotation at high speeds and have not leveraged on / off cycling or precise rpm control to moderate mechanical stress on fragile fibers such as glass. Temperature settings are usually held constant within each bath, without progressive adjustment across sequential solutions to optimize scouring and fiber integrity.

[0023] Efforts to integrate fiber selection and washing parameters with hemostatic functionality have remained largely unexplored. Approaches combining customized fiber blends with post-knitting chemical treatments still treat knitting and finishing as distinct operations, and old spin-drying and drying steps are applied without coordination of earlier process variables. In summary, the foregoing approaches have relied on separate impregnation and scouring processes, old high-speed wash cycles, and batchwise addition of alkaline, detergent, and enzyme treatments without coordinated control of drum rotation speed, solution sequence, and temperatureDocket No.: 410640-506001 WO progression. However, none of these approaches have provided a comprehensive solution that combines the features described in this disclosure.

[0024] A method of manufacturing a hemostatic textile includes knitting glass fibers with secondary fibers to form a knit textile; scouring the textile in a programmable laundry machine through sequential solutions comprising an alkaline solution, a detergent-containing solution, and an enzyme-containing solution while applying on / off drum-rotation cycles below 50 rpm and / or below 100 rpm and a controlled temperature progression across the sequential solutions; rinsing and spindrying the textile; and drying the textile to yield a hemostatic textile. The resulting textile exhibits enhanced blood-clotting performance due to the optimized fiber conditioning achieved through the sequential scouring and controlled mechanical and thermal treatment.

[0025] As such, keeping in mind possible combination embodiments and the above discussion, as an additional brief summary or to provide discussion points for a brief summary, some example features of the technology disclosed herein can be briefly summarized by the following list of features, any of which can be intercombined or discussed optionally with any other feature, Figure, Drawing, detail, embodiment, aspect, or example disclosed herein:

[0026] Feature 1 : A method of manufacturing a hemostatic textile, the method comprising: (a) knitting glass fibers with secondary fibers to form a knit textile; (b) scouring the textile in a programmable laundry machine through sequential solutions comprising an alkaline solution, a detergent-containing solution, and an enzymecontaining solution while applying drum-rotation cycles including on / off agitation at a drum speed below 50 rpm and a controlled temperature progression across the sequential solutions; (c) rinsing and spin-drying the textile; and (d) drying the textile to yield a hemostatic textile.

[0027] Feature 2: The method of feature 1 , wherein the enzyme comprises an alpha-amylase.

[0028] Feature 3: The method of feature 1 or 2, wherein the on / off rotation comprises rotation-on for t1 seconds followed by rotation-off for t2 seconds with t2 greater than t1.

[0029] Feature 4: The method of any of features 1 -3, wherein the temperature progression comprises holding a first bath at about 130-140 °F and a subsequent bath at a temperature at least 4 °F higher than the first bath.Docket No.: 410640-506001 WO

[0030] Feature 5: The method of any of features 1-4, further comprising operating the laundry machine during draining at about 50-150 rpm and during spin-drying at about 500-1500 rpm.

[0031] Feature 6: The method of any of features 1-5, wherein the textile is enclosed in a containment bag during scouring, the containment bag comprising a mesh bag or a toroidal doughnut bag.

[0032] Feature 7: The method of any of features 1-6, wherein the secondary fibers comprise rayon and the textile optionally includes radiopaque fibers.

[0033] Feature 8: The method of any of features 1-7, further comprising cutting a roll of the knit textile into multiple textile units prior to scouring to reduce post-scour handling and contamination.

[0034] Feature 9: The method of feature 8, wherein the roll is pre-cut into textile strips having pre-scour lengths in a range from 30 inches to 100 inches, optionally within a range from 36 inches to 80 inches and optionally within a range from 38 inches to 92 inches, the strips being grouped into bundles of about ten strips and secured within mesh bags having a target filled bag weight between 1 .5 lb and 3.0 lb.

[0035] Feature 10: The method of any of features 1-9, wherein the sequential solutions are prepared from non-softened water having a hardness of at least 50 ppm as CaCO3, optionally within a range from 50 ppm to 200 ppm and optionally within a range from 70 ppm to 150 ppm, and wherein an alkaline scouring bath comprises sodium carbonate, a low-foaming non-ionic detergent, and an alpha-amylase enzyme concentrate present at a weight ratio of about 10:1 :1 (sodium carbonate:detergent:enzyme), optionally wherein, for a bath volume between about 15 gallons and about 45 gallons, the alkaline scouring bath comprises sodium carbonate in an amount between about 2.5 oz and about 8.0 oz, the low-foaming nonionic detergent in an amount between about 0.25 oz and about 0.75 oz, and the alpha-amylase enzyme concentrate in an amount between about 0.25 oz and about 0.75 oz, optionally within a narrower range in which, for a bath volume between about 22 gallons and about 38 gallons, the alkaline scouring bath comprises sodium carbonate in an amount between about 4.0 oz and about 6.5 oz, the low-foaming nonionic detergent in an amount between about 0.4 oz and about 0.6 oz, and the alphaamylase enzyme concentrate in an amount between about 0.4 oz and about 0.6 oz, thereby providing a bath pH between 10 and 11 .Docket No.: 410640-506001 WO

[0036] Feature 11 : The method of any of features 1 -10, wherein scouring in the programmable laundry machine comprises: (a) a pre-wash phase in which water fills to a preset level, soda ash is added, and the drum is operated at a speed between about 10 rpm and about 60 rpm, optionally between about 20 rpm and about 35 rpm, in a gentle reverse on / off cycle in which a rotation-on interval is between about 2.5 seconds and about 10 seconds and a rotation-off interval is between about 5 seconds and about 20 seconds, optionally with a rotation-on interval between about 3.75 seconds and about 6.25 seconds and a rotation-off interval between about 7.5 seconds and about 12.5 seconds, for a total pre-wash duration between about 2.5 minutes and about 10 minutes, optionally between about 3.75 minutes and about 6.25 minutes; (b) a soda-ash phase in which water is at a temperature between about 70 °F and about 270 °F, optionally between about 120 °F and about 160 °F and optionally between about 130 °F and about 140 °F, is supplemented with soda ash, and is agitated in the gentle reverse on / off cycle defined in step (a) for a duration between about 0.5 minute and about 2 minutes, optionally between about 0.75 minute and about 1 .25 minutes, without draining; (c) a detergent phase in which water is at a temperature between about 70 °F and about 280 °F, optionally between about 120 °F and about 170 °F and optionally between about 135 °F and about 145 °F, a low- foaming non-ionic washing and wetting agent is added, and the drum is operated in the gentle reverse on / off cycle defined in step (a) for a duration between about 0.5 minute and about 2 minutes, optionally between about 0.75 minute and about 1 .25 minutes, without draining; (d) an enzyme phase in which water is at a temperature between about 70 °F and about 290 °F, optionally between about 120 °F and about 180 °F and optionally between about 135 °F and about 155 °F, an alpha-amylase enzyme is added, and the drum is operated in the gentle reverse on / off cycle defined in step (a) for a duration between about 0.5 minute and about 2 minutes, optionally between about 0.75 minute and about 1 .25 minutes, without draining; and (e) a wash phase in which the bath temperature is increased to a temperature between about 75 °F and about 300 °F, optionally between about 130 °F and about 190 °F and optionally between about 140 °F and about 160 °F, and the drum is operated in the gentle reverse on / off cycle defined in step (a) for a duration between about 5 minutes and about 20 minutes, optionally between about 7.5 minutes and about 12.5 minutes, prior to draining, optionally wherein the alpha-amylase enzyme comprises a Rucolase 180 alpha-amylase formulation.Docket No.: 410640-506001 WO

[0037] Feature 12: The method of any of features 1-11 , wherein rinsing comprises three sequential rinses, each rinse being carried out at a water temperature between about 60 °F and about 240 °F, optionally between about 90 °F and about 150 °F and optionally between about 110 °F and about 130 °F, and wherein each rinse includes drum rotation at a speed between about 10 rpm and about 60 rpm, optionally between about 20 rpm and about 35 rpm, in the gentle reverse on / off cycle defined in feature 11 for a duration between about 1 .5 minutes and about 6 minutes, optionally between about 2.25 minutes and about 3.75 minutes, followed by draining at a speed between about 50 rpm and about 200 rpm, optionally between about 75 rpm and about 125 rpm, for a duration between about 1 minute and about 4 minutes, optionally between about 1 .5 minutes and about 2.5 minutes, and an extract step at a speed between about 500 rpm and about 1900 rpm, optionally between about 700 rpm and about 1200 rpm; and wherein a final extract step is performed at a speed between about 500 rpm and about 1900 rpm, optionally between about 700 rpm and about 1200 rpm, for a duration between about 2.5 minutes and about 10 minutes, optionally between about 3.75 minutes and about 6.25 minutes.

[0038] Feature 13: The method of any of features 1 -12, wherein the scouring solution in the laundry machine provides an alpha-amylase concentration between about 25 ppm and about 200 ppm, optionally between about 50 ppm and about 150 ppm and optionally between about 75 ppm and about 125 ppm, relative to a mass of water, and wherein the sodium carbonate concentration is selected such that the scouring bath has a pH between about 10.0 and about 11 .0, optionally between about 10.3 and about 10.8 and optionally about 10.5.

[0039] Feature 14: The method of any of features 1-13, wherein drying is performed by tumble-drying in a commercial laundry dryer at an air temperature between about 70 °F and about 300 °F, optionally between about 110 °F and about 190 °F and optionally between about 140 °F and about 160 °F, until a fabric moisture content between about 2% and about 8% by weight, optionally between about 3% and about 5% by weight and optionally between about 2% and about 3% by weight, is achieved.

[0040] Feature 15: The method of any of features 1-14, wherein drying is alternatively or additionally performed by feeding a continuous strand of the scoured textile onto a moving belt at an entrance of a hot-air convection oven while using aDocket No.: 410640-506001 WO guide rail and nip roll to fold the strand into stacked layers, the oven being operated at an air temperature between about 60 °F and about 240 °F, optionally between about 90 °F and about 150 °F and optionally between about 100 °F and about 150 °F, and with a belt speed selected to obtain the fabric moisture content defined in feature 14.

[0041] Feature 16: The method of any of features 1-15, wherein drying shrinks the secondary fibers and forms loops of the glass fibers that protrude from at least one surface of the textile and increase exposed glass surface area and textile stretchability.

[0042] Feature 17: The method of any of features 1-16, further comprising sterilizing a packaged textile or a packaged textile bandage by gamma irradiation or ultraviolet irradiation.

[0043] Feature 18: The method of any of features 1 -17, wherein pre-scour textile unit dimensions are selected to account for about 50% area shrinkage such that at least one pre-scour dimension is at least 1 .5 times a target finished dimension.

[0044] Feature 19: The method of any of features 1 -18, wherein the knit textile is produced on a narrow V-bed flat knitting machine in a half-gauge configuration to provide closed long edges, and finished units have a width of about 2-8 inches and a length of at least 24 inches.

[0045] Feature 20: The method of any of features 1 -19, further comprising after scouring neutralizing residual alkali with a citrate buffer rinse.

[0046] Feature 21 : The method of any of features 1 -20, further comprising depositing a calcium-phosphate coating on the glass fibers by radio-frequency plasma and annealing, the plasma being conducted with controlled oxygen partial pressure.

[0047] Feature 22: A scouring composition for cleaning a knit hemostatic textile, the composition consisting essentially of water, 0.5-2 wt% sodium carbonate, 0.2-1 wt% fatty-alcohol-ethoxylate non-ionic surfactant, and 50-150 ppm alpha-amylase enzyme, the solution having a pH between 10 and 11 at 135-150 °F.

[0048] Feature 23: The composition of feature 22, further comprising 0.05-0.2 wt% ethylenediaminetetraacetic acid (EDTA) to sequester divalent metal ions.

[0049] Feature 24: The composition of feature 22 or 23, wherein the water source has a hardness less than 50 ppm as CaCO3.Docket No.: 410640-506001 WO

[0050] Feature 25: The composition of any of features 22-24, configured for use in a front-loading drum operating at about 25-35 rpm with a liquor ratio of about 20:1 to 30:1.

[0051] Feature 26: The composition of any of features 22-25, for use in a process wherein sodium carbonate is added at about 135 °F, detergent at about 140 °F, and the alpha-amylase at about 145 °F.

[0052] Feature 27: The composition of any of features 22-26, wherein the detergent, enzyme, and sodium carbonate are present at a weight ratio of about 5:1 :5.

[0053] Feature 28: The composition of any of features 22-27, wherein sodium carbonate, the low-foaming non-ionic detergent, and the alpha-amylase enzyme concentrate are present in a weight ratio of about 10:1 :1 (sodium carbonate:detergent:enzyme), optionally wherein, for a bath volume between about 15 gallons and about 60 gallons, the composition comprises sodium carbonate in an amount between about 2.65 oz and about 10.6 oz, the low-foaming non-ionic detergent in an amount between about 0.25 oz and about 1.0 oz, and the alphaamylase enzyme concentrate in an amount between about 0.25 oz and about 1 .0 oz, optionally within a narrower range in which, for a bath volume between about 22.5 gallons and about 37.5 gallons, the composition comprises sodium carbonate in an amount between about 4.0 oz and about 6.5 oz, the low-foaming non-ionic detergent in an amount between about 0.4 oz and about 0.6 oz, and the alpha-amylase enzyme concentrate in an amount between about 0.4 oz and about 0.6 oz, and wherein the composition is prepared with non-softened water having a hardness within a range from 50 ppm to 200 ppm as CaCO3.

[0054] Feature 29: The composition of any of features 22-28, wherein the composition is used while agitating a knit textile with on / off rotation cycles below 50 rpm during liquid scouring.

[0055] Feature 30: A knit hemostatic textile comprising: (a) a first plurality of glass fibers arranged as pile loops exposed on at least one surface; and (b) a second plurality of rayon fibers interknit with the glass fibers,

[0056] Feature 31 : wherein the textile is stretch-enhanced as a result of scouring and drying and is optionally configured for wound packing.

[0057] Feature 32: The textile of feature 30, further comprising radiopaque fibers.Docket No.: 410640-506001 WO

[0058] Feature 33: The textile of feature 30 or 31 , wherein the textile comprises about 65% glass fibers and about 35% rayon, the rayon comprising bamboo-sourced rayon.

[0059] Feature 34: The textile of any of features 30-32, wherein the knit is produced in a relaxed configuration to promote fluid interaction with pile fibers.

[0060] Feature 35: The textile of any of features 30-33, wherein the knit is formed in a half-gauge configuration to produce enlarged carryover loops.

[0061] Feature 36: The textile of any of features 30-34, wherein opposite long edges have closed stitches and short edges are left raw or are serged.

[0062] Feature 37: The textile of any of features 30-35, wherein loops of the glass fibers protrude as a result of de-sizing of the rayon fibers, thereby increasing exposed glass surface area and textile stretchability.

[0063] Feature 38: A toroidal containment bag for scouring textiles, comprising a flexible body configured to zip into a closed loop and to hold a large-area knit textile wound circumferentially to form a stacked loop of fabric.

[0064] Feature 39: The bag of feature 38, wherein the bag reduces tangles, knots, and creases during scouring.

[0065] Feature 40: The bag of feature 38 or 39, configured for use within a frontloading laundry-machine drum.

[0066] Feature 41 : The bag of any of features 38-40, comprising a mesh construction that reduces abrasive effects of agitation on the textile.

[0067] Feature 42: The bag of any of features 38-40, wherein the bag is loaded by rotating the unzipped bag in a circumferential direction while continuously feeding the knit textile to form the stacked loop before zipping closed.

[0068] Feature 43: The bag of any of features 38-41 , wherein the bag confines a continuously knit textile produced on a narrow V-bed flat knitting machine.

[0069] Feature 44: A method of sterile packaging a hemostatic textile or a hemostatic textile bandage, comprising: (a) sealing the textile or bandage in a moisture-barrier pouch; (b) irradiating the sealed pouch to sterilize the textile or bandage; and (c) including in the pouch a metal-ion-sequestering EDTA component to bind trace metals following sterilization.

[0070] Feature 45: The method of feature 43, wherein irradiating comprises gamma irradiation.Docket No.: 410640-506001 WO

[0071] Feature 46: The method of feature 43, wherein irradiating comprises ultraviolet irradiation.

[0072] Feature 47: The method of any of features 43-45, further comprising controlled cooling after irradiation to mitigate thermal stress.

[0073] Feature 48: The method of any of features 43-46, wherein the pouch is EDTA-lined.

[0074] Feature 49: The method of any of features 43-47, wherein the pouch is sealed after drying of the textile or bandage and the packaged textile or packaged bandage is stored in a moisture-barrier environment after sterilization.

[0075] Feature 50: The method of any of features 1 -19, further comprising controlling process parameters such that, prior to terminal sterilization, a bioburden of the textile is less than or equal to 1000 colony-forming units (CFU) per device, optionally within a range from 1 CFU to 300 CFU per device and optionally within a range from 1 CFU to 100 CFU per device.

[0076] Feature 51 : The method of any of features 1 -19, further comprising controlling process parameters such that a finished, sterilized hemostatic textile has an endotoxin content of not more than 20 endotoxin units (EU) per device when tested by a Limulus Amebocyte Lysate assay, optionally within a range from 0.01 EU to 10 EU per device and optionally within a range from 0.05 EU to 2 EU per device.

[0077] Feature 52: The method of feature 14, wherein the fabric moisture content after drying is less than or equal to 5% by weight, optionally within a range from 0.1 % to 4% by weight and optionally within a range from 0.1% to 3% by weight.

[0078] Feature 53: The textile of any of features 30-36, sealed within a moisturebarrier package and sterilized, wherein the sterilized textile has an endotoxin content of not more than 20 endotoxin units per device, optionally within a range from 0.01 endotoxin units to 10 endotoxin units per device and optionally within a range from 0.05 endotoxin units to 2 endotoxin units per device.

[0079] Feature 54: The textile of feature 52, wherein a moisture content of the sterilized textile at package release is less than or equal to 5% by weight, optionally within a range from 0.1 % to 4% by weight and optionally within a range from 0.1 % to 3% by weight.

[0080] Feature 55: The textile of any of features 30-36, prior to terminal sterilization, having a bioburden of less than or equal to 1000 CFU per device,Docket No.: 410640-506001 WO optionally within a range from 1 CFU to 300 CFU per device and optionally within a range from 1 CFU to 100 CFU per device.

[0081] Other implementations are also described and recited herein. These and other features and advantages will be apparent from a reading of the following detailed description and a review of the associated drawings. It is to be understood that both the foregoing general description and the following detailed description are explanatory only and are not restrictive of aspects as claimed.BRIEF DESCRIPTION OF THE DRAWINGS

[0082] Solely for the purpose of illustration, certain embodiments of the present invention are explained using examples in the drawings described below. It should be understood, however, that the invention is not limited to the precise arrangements, dimensions, and configurations shown. In the drawings:

[0083] FIG. 1 illustrates an example of a bandage manufacture process.

[0084] FIGs. 2A-2B illustrate examples of hemostatic textiles.

[0085] FIG. 3 illustrates cutting of a roll of hemostatic textile.

[0086] FIG. 4 illustrates separation of individual textile units joined by linking threads.

[0087] FIGs. 5A-5C illustrate examples of hemostatic textile scouring using a laundry machine.

[0088] FIG. 6 illustrates an example of hemostatic textile processing in a laundry machine.

[0089] FIG. 7 shows exemplary steps of another (optional) manufacturing method.

[0090] FIG. 8 shows exemplary steps of a three-stage scouring method.

[0091] FIG. 9 shows exemplary steps of a sterilization process.

[0092] FIG. 10 shows exemplary steps of a calcium phosphate deposition method.

[0093] FIG. 11 shows exemplary steps of a manufacturing method with one or more buffer rinses.

[0094] FIG. 12 shows exemplary steps of a scouring method with neutralization.

[0095] FIG. 13 shows exemplary steps of a sterilization method with an EDTA pouch.Docket No.: 410640-506001 WO

[0096] FIG. 14 shows exemplary steps of a plasma deposition with oxygen control.

[0097] FIG. 15 shows a non-limiting example of a program chart. FIG. 16 depicts a schematic side view of an illustrative apparatus for feeding a continuous fabric strand into a drying or curing oven, showing a guide rail, nip roll, and belt arrangement configured to form folded layers of the fabric strand at the oven entrance.

[0098] Like reference numbers and designations in the various drawings indicate like elements. Reference numbers can be interchanged for various embodiments. It is also to be understood that the various exemplary implementations shown in the figures are merely illustrative representations and are not necessarily drawn to scale. All trademarks, images, likenesses, words, and depictions in the drawings and the disclosure are plainly in fair use and are provided solely for the purposes of illustration of the invention in view of an urgent need to treat subjects as further discussed in detail below.DETAILED DESCRIPTION OF THE INVENTION

[0099] The subject innovation is now described in some instances, when necessary, with reference to the drawings. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It may be evident, however, that the present invention may be practiced without these specific details. In other instances, well- known structures, methods, and devices are shown in block diagram form or with illustrations in order to facilitate describing the present invention. It is to be appreciated that certain aspects, modes, embodiments, variations and features of the invention are described below in various levels of detail in order to provide a substantial understanding of the present invention.DEFINITIONS

[0100] For convenience, the meaning of some terms and phrases used in the specification, examples, and appended claims, are provided below. Unless stated otherwise, or implicit from context, the following terms and phrases include the meanings provided below. The definitions are provided to aid in describing particular embodiments, and are not intended to limit the claimed invention, because the scope of the invention is limited only by the claims. In an example, the technology can beDocket No.: 410640-506001 WO used under any circumstances or in a surgery wherein a textile is needed1. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. If there is an apparent discrepancy between the usage of a term in the art and its definition provided herein, the definition provided within the specification shall prevail. In general, typical chemical terminology is found in the International Union of Pure and Applied Chemistry GoldBook2. This disclosure is purposefully presented in commonly understood words, known to a person of skill in the art, but Merriam-Webster’s Online Dictionary is used, when appropriate, for terms not specifically demonstrated herein or not known in the art3.

[0101] As used in this specification and the appended claims, the singular forms "a," "an" and "the" include plural referents unless the content clearly dictates otherwise. For example, reference to "a cell" includes a combination of two or more cells, and the like.

[0102] As used herein, the term "approximately" or "about" in reference to a value or parameter are generally taken to include numbers that fall within a range of 5%, 10%, 15%, or 20% in either direction (greater than or less than) of the number unless otherwise stated or otherwise evident from the context (except where such number would be less than 0% or exceed 100% of a possible value). As used herein, reference to "approximately" or "about" a value or parameter includes (and describes) embodiments that are directed to that value or parameter. For example, description referring to "about X" includes description of "X".

[0103] As used herein, the term “or” means “and / or.” The term "and / or" as used in a phrase such as "A and / or B" herein is intended to include both A and B; A or B; A (alone); and B (alone). Likewise, the term "and / or" as used in a phrase such as "A, B, and / or C" is intended to encompass each of the following embodiments: A, B, and C; A, B, or C; A or C; A or B; B or C; A and C; A and B; B and C; A (alone); B (alone); and C (alone).

[0104] As used herein, the term "comprising" means that other elements can also be present in addition to the defined elements presented. The use of "comprising" indicates inclusion rather than limitation. The term “including” can be interchanged with “comprising”.Docket No.: 410640-506001 WO

[0105] The term "consisting of" refers to compositions, methods, and respective components thereof as described herein, which are exclusive of any element not recited in that description of the embodiment.

[0106] As used herein the term "consisting essentially of" refers to those elements required for a given embodiment. The term permits the presence of additional elements that do not materially affect the basic and novel or functional characteristic(s) of that embodiment of the invention. The term “consisting essentially of” can also be exemplified by plain language provided in the claims.

[0107] The term "statistically significant" or "significantly" refers to statistical significance and generally means a two-standard deviation (2SD) or greater difference.

[0108] As used herein, the term "subject" refers to a mammal, including but not limited to a dog, cat, horse, cow, pig, sheep, goat, rodent, or primate. Subjects can be house pets (e.g., dogs, cats), agricultural stock animals (e.g., cows, horses, pigs, chickens, etc.), laboratory animals (e.g., mice, rats, rabbits, etc.), but are not so limited. Subjects particularly include human subjects in urgent treatment as described herein. The human subject may be a pediatric, adult, or a geriatric subject. The human subject may be of any sex.

[0109] The term “treating” includes prophylactic and / or therapeutic treatments. The term “prophylactic or therapeutic” treatment is art-recognized and includes administration to the host of one or more of the subject compositions and / or application of one or more therapies or surgeries. If this is done prior to clinical manifestation of the unwanted condition (e.g., disease or other unwanted state of the host animal) then the treatment is prophylactic (i.e., it protects the host against developing the unwanted condition), whereas if it is administered after manifestation of the unwanted condition, the treatment is therapeutic, (i.e., it is intended to diminish, ameliorate, or stabilize the existing unwanted condition or side effects thereof).

[0110] As used herein, the terms “treat,” “treatment,” “treating,” or “amelioration” when used in reference to a disease, disorder, or medical condition, refer to therapeutic treatments for a condition, wherein the object is to reverse, alleviate, ameliorate, inhibit, slow down or stop the progression or seventy of a symptom or condition. The term “treating” includes reducing or alleviating at least one adverse effect or symptom of a condition. Treatment is generally “effective” if one or more symptoms or clinical markers are reduced. Alternatively, treatment is “effective” if theDocket No.: 410640-506001 WO progression of a condition is reduced or halted. That is, “treatment” includes not just the improvement of symptoms or markers, but also a cessation or at least slowing of progress or worsening of symptoms that would be expected in the absence of treatment. Beneficial or desired clinical results include, but are not limited to, alleviation of one or more symptom(s), sign(s), diminishment of extent of the deficit, stabilized ( / .e., not worsening) state of a symptom or condition, delay or slowing of onset of symptoms or indications, and an increased lifespan as compared to that expected in the absence of treatment.

[0111] The terms: “decrease”, “reduced”, “reduction”, or “inhibit” are all used herein to mean a decrease by a statistically significant amount. In some embodiments, “reduce,” “reduction" or “decrease" or “inhibit” typically means a decrease by at least 10% as compared to a reference level (e.g., the absence of a given treatment or agent) and can include, for example, a decrease by at least about 10%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, at least about 98%, at least about 99% , or more. As used herein, “reduction” or “inhibition” does not encompass a complete inhibition or reduction as compared to a reference level. “Complete inhibition” is a 100% inhibition as compared to a reference level. A decrease can be preferably down to a level accepted as within the range of normal for an individual without a given disorder.

[0112] In some embodiments, the decrease in the one or more signs or symptoms is evaluated according to a specialized healthcare provider. In some embodiments, signs are observed or measured by a health care provider. Symptoms can be reported by the subject. In some embodiments, the decrease of signs or symptoms occurs in less than about 120 minutes, 90 minutes, less than about 60 minutes, less than about 30 minutes, less than about 15 minutes, less than about 10 minutes, or less than about 5 minutes, or less than about 3 minutes, or less than about 1 minute. In some embodiments, the decrease of signs or symptoms occurs in less than 1 day, less than 1 week, less than 1 month, or in less than 1 year.

[0113] The terms “increased”, “increase”, “enhance”, or “activate” are all used herein to mean an increase by a statistically significant amount. In some embodiments, the terms “increased”, “increase”, “enhance”, or “activate” can mean anDocket No.: 410640-506001 WO increase of at least 10% as compared to a reference level, for example an increase of at least about 20%, or at least about 30%, or at least about 40%, or at least about 50%, or at least about 60%, or at least about 70%, or at least about 80%, or at least about 90% or up to and including a 100% increase or any increase between 10-100% as compared to a reference level, or at least about a 2-fold, or at least about a 3-fold, or at least about a 4-fold, or at least about a 5-fold or at least about a 10-fold increase, or any increase between 2-fold and 10-fold or greater as compared to a reference level. In the context of a marker or symptom, a “increase” is a statistically significant increase in such level.

[0114] As used herein, an agent or a therapeutic agent provided to a subject and suspected to be or involved in a treatment can be a small molecule less than 1000 MW or a large molecule not less than 1000 MW including biologies, oligonucleotides, peptides, oligosaccharides, and larger molecules. Any of the therapeutic agents disclosed herein can be used as or in combination with small molecules and / or large molecules as discussed herein.

[0115] As discussed above, unless otherwise defined herein, scientific and technical terms used in connection with the present application shall have the meanings that are commonly understood by those of ordinary skill in the art to which this disclosure belongs. It should be understood that this invention is not limited to the particular methodology, protocols, and reagents, etc., described herein and as such can vary. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the present invention, which is defined solely by the claims. Definitions of common terms in immunology and molecular biology can be found in The Merck Manual of Diagnosis and Therapy;4The Encyclopedia of Molecular Cell Biology and Molecular Medicine;5Molecular Biology and Biotechnology: a Comprehensive Desk Reference;6Immunology;7Janeway's Immunobiology;8Lewin's Genes XI;9Molecular Cloning: A Laboratory Manual.;10Basic Methods in Molecular Biology;11Laboratory Methods in Enzymology;12Current Protocols in Molecular Biology (CPMB)13; Current Protocols in Protein Science (CPPS);14and Current Protocols in Immunology (CPI)15.

[0116] In the embodiments discussed and in any of the aspects, the disclosure described herein does not concern a process for cloning human beings, processes for modifying the germ line genetic identity of human beings, uses of human embryos for industrial or commercial purposes or processes for modifying the genetic identity ofDocket No.: 410640-506001 WO animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

[0117] Other terms are defined herein within the description of the various aspects of the invention.HEMOSTATIC TEXTILE MANUFACTURE

[0118] Textiles that include glass fibers are known to display “hemostatic” properties, meaning that such textiles promote blood clotting and wound healing. Hemostatic textiles including glass fibers can promote clotting while also absorbing blood, assisting activation of the hemostatic cascade, and find application in emergency and combat environments, among other environments.

[0119] Bandages formed of hemostatic textiles offer the possibility of significantly reducing traumatic deaths from exsanguination. However, the widespread availability of such bandages is limited by the costs associated with their production. Fiberglassbased hemostatic bandages are typically manufactured in a carefully-controlled process that includes “beam scouring,” which can be a costly and time-consuming textile-cleaning procedure. Beam scouring, besides being expensive and lengthy in its own right, also dictates an order in which other portions of the bandage manufacture process can be conducted. This order can lead to contamination of manufactured bandages.

[0120] Implementations according to this disclosure include manufacture of hemostatic bandages without a beam scouring step. For example, in some implementations, pre-cut textile units or uncut textile are scoured in a laundry machine, such as a commercially-available front-loading laundry machine or toploading laundry machine. The use of a laundry machine for scouring, in combination with the manufacture flow described herein, can provide faster, less expensive, more scalable, and cleaner manufacture of hemostatic textile-based bandages, reducing the risk of contamination.

[0121] According to some aspects, FIG. 1 illustrates an example of a bandage manufacturing process 100. In the process 100, glass fibers are knitted together with secondary fibers, in alternating stitches, to form a hemostatic textile (102). For example, the hemostatic textile can be knit by circular knitting using a circular knitting machine, such as a fifteen inch machine with sixteen needles per inch. In some implementations, the hemostatic textile is flat knit using a flat knitting machine. TheDocket No.: 410640-506001 WO resulting hemostatic textile can be formed, for example, in a relaxed, knit stitch, or purl stitch pattern, or in another suitable pattern type. Examples of knitting parameters are provided in U.S. Patent No. 10,406,255, the entirety of which is incorporated herein by reference. It is important to note that in FIG. 1, in some embodiments, a method can be “cut after scour” and / or then “cut after dry” and there is an “OR / optional” branching (not shown, dashed arrows or bracket labels not shown) so that the three cut points (before scour I after scour I after dry) are alternatives and are not a required sequence.

[0122] FIGs. 2A-2B illustrate examples of hemostatic textiles. As shown in FIG. 2A, hemostatic textile 200 is knitted in a "relaxed" configuration, in that the stitches are not pulled tight upon knitting, resulting in a textile with widely spaced openings therebetween, and thus less overall material per unit surface area compared to hemostatic textile 210 (shown in FIG. 2B), which is more tightly knit. The "relaxed" or loose configuration of hemostatic textile 200 can permit a higher volume of fluid, such as blood, to interact with the pile fibers of the hemostatic textile 200, leading to an increased hemostatic response when a bandage formed from the hemostatic textile 200 is applied to a wound, and, correspondingly, leading to a reduced time to effective clot formation.

[0123] Glass fibers 202 can include, for example, a fiberglass prepared by molten glass extrusion, having fiber diameters from five nanometers (5 nm) to fifteen micrometers (15 pm). The types of glass that can be used for the fiberglass include but are not limited to alumino-borosilicate glasses with low sodium oxide content, borosilicate glass, lead glass, aluminosilicate, alkali-barium silicate, vitreous silica, chalcogenide glass, phosphate glass, and bioactive glass sold under the trade name BIOGLASS™. Details on the glass fibers and their dimension(s), grade(s), and arrangement are provided in U.S. Patent No. 10,406,255 (which is incorporated herein by reference in its entirety). In some implementations, a different primary fiber is used instead of or in addition to glass fibers.

[0124] The hemostatic textile further includes a secondary fiber 204. Examples of fibers that can be used for the secondary fiber 204 include silk fibers; polyester fibers; nylon fibers; ceramic fibers; polysaccharide fibers, including plant fibers such as raw or regenerated (e.g., chemically processed) cotton, rayon, linen, ramie, jute, sisal, flax, soybean, corn, hemp, or lyocell; animal fibers such as wool; lactide and / or glycolide polymers; lactide / glycolide copolymers; silicate fibers; polyamide fibers;Docket No.: 410640-506001 WO feldspar fibers; zeolite fibers or zeolite-containing fibers; acetate fibers; plant fibers that have been genetically engineered to express mammalian coagulation proteins or mammalian vasoactive factors; plant-sourced rayon fibers such as raw or regenerated (e.g., chemically processed) bamboo fibers or cotton fibers; or any combination thereof. Moreover, in some implementations, hemostatic textiles incorporate radiopaque fibers 206, which can aid in textile removal. Details on examples of the secondary fibers 204, the radiopaque fibers 206, and their preparation are provided in U.S. Patent No. 10,406,255 (which is incorporated herein by reference in its entirety). Moreover, additional details on some implementations of the hemostatic textiles 200, 210 and the bandages manufactured therefrom are provided in U.S. Patent No. 10,058,456, the entirety of which is incorporated herein by reference.

[0125] Hemostatic textiles 200 and 210 can be knit on a circular knitting machine or flat bed knitting machine, e.g., a V-bed flat knitting machine such as a narrow V- bed flat knitting machine. The knitting machine may include one or more pairs of primary fiber 202 and secondary fiber 204 loaded onto carriers that knit the respective fibers, e.g., alternating between one complete stitch of primary fiber 202 followed by one complete stitch of secondary fiber 204. While the knitting machine may be configured with any number of engaged carriers loaded with primary fibers 202 or secondary fibers 204, in some implementations, the knitting machine is configured in a "half-gauge" configuration, meaning that every other needle in the knitting machine engages fibers from respective carriers, resulting in a carryover loop that is substantially larger than that which is formed when all needles are engaged. In some implementations, the textiles 200 and 210 include 65% glass fibers and 35% rayon fibers, such as bamboo-sourced rayon fibers. Further details on examples of textile knitting and construction are provided in U.S. Patent No. 10,406,255, the entirety of which is incorporated herein by reference.

[0126] In some implementations, hemostatic textiles 200 and 210 are knit on a narrow V-bed flat knitting machine. Opposite, long edges of the as-knit textiles from the narrow V-bed flat knitting machine can have closed stitches and can be opposite long sides (e.g., longer than two other opposite sides) of resulting bandages formed by cutting the textiles. As such, raw edges of the bandages (e.g., to be subsequently left raw or serged) can be short edges of the bandages, reducing unraveling probability, manufacturing cost, and / or manufacturing complexity compared to someDocket No.: 410640-506001 WO manufacturing arrangements in which long edges of the bandages correspond to raw edges. Some examples of knitting methods and configurations within the scope of this disclosure are provided in U.S. Provisional Patent Application No. 63 / 674,154, filed on July 22, 2024, the entirety of which is incorporated herein by reference.

[0127] Moreover, it will be understood that other textile compositions and knitting / weaving patterns are within the scope of this disclosure.

[0128] The hemostatic textile 200 and 210, as-knit, includes sufficient textile material for many bandages. For example, an as-knit hemostatic textile may be a roll many yards long, e.g., one hundred yards long, having a shape that does not correspond to a finished bandage.

[0129] For example, roll 300 in FIG. 3 can have a length 310 of about one hundred yards. Accordingly, referring back to FIG. 1, the hemostatic textile can be cut into multiple separated textile units, each textile unit corresponding to (e.g., eventually being packaged as) a respective bandage. A width of the hemostatic textile (e.g., width 312 illustrated in FIG. 3) can be determined by, for example, a size of the knitting machine that produces the textile, and / or by a number of needles on the knitting machine (e.g., a number of needles on a flat bed knitter).

[0130] According to some aspects, as shown in FIG. 3, a roll 300 (not illustrated to scale) can subsequently be cut along lines (e.g., lines 302) into individual textile units (e.g., textile units 304). Each textile unit 304 corresponds to a respective bandage that will be formed from the material of the textile unit 304. For example, the textile unit 304 can have a shape similar to or matching a shape of a bandage manufactured from the textile unit 304. In some implementations, each textile unit 304 has a longest dimension of less than thirty inches or less than twenty inches, e.g., between six inches and thirty inches or between six inches and twenty inches, dimensions which may be incompatible with beam scouring. In some implementations, each textile unit 304 has a longest dimension of less than sixty inches, e.g., between 12 inches and sixty inches. Other dimensions of the textile units 304 are also within the scope of this disclosure. In some implementations, the roll 300 has an overall tubular shape, such that each textile unit 304 has a tubular shape. In some implementations, the roll 300 has an overall tubular shape, and the roll 300 is cut length-wise to unfold the tube and obtain single-ply textile units 304.

[0131] In some implementations, when the roll 300 is manufactured using a narrow V-bed flat knitting machine, the width 312 can correspond to (e.g., match) aDocket No.: 410640-506001 WO knitting width of the machine, and the cuts along lines 302 can define short edges of the textile units 304. The short edges can then be left raw or serged relatively efficiently. In some cases, if the short edges are left raw, the negative effects of potential unraveling of the raw edges may be relatively small, given the shortness of the width 312. In some cases, if the short edges are serged, the additional cost and / or additional manufacturing complexity associated with the serging may be relatively small, given the shortness of the width 312. The as-knit opposite sides of the roll 300, which have closed stitches, can be retained as opposite, long edges of the textile units 304, where a length 314 of the textile units 304, with closed stitches, can be larger than the width 312 of the cut edges of the textile units 304. In some implementations, the width 312 is in a range from two inches to eight inches. In some implementations, the length 314 is at least 24 inches. The foregoing widths and lengths may be as-knit dimensions and / or dimensions after subsequent textile treatment as described herein (e.g., scouring, heating, and / or the like). For example, the foregoing widths and lengths may be dimensions of fully-manufactured bandages.

[0132] In some implementations, as shown in FIG. 4, a flat knit hemostatic textile 400 includes many portions 402 pre-shaped into respective bandage shapes, with the portions 402 attached together by linking threads 404. To form individual textile units, the linking threads 404 can be cut to separate the portions 402 from one another, with each portion 402 becoming an individual textile unit upon separation. The individual textile units formed by separation of the flat knit hemostatic textile 400 can have dimensions and / or shapes as described for the textile units 304 formed by cutting the roll 300.

[0133] As is shown in FIG. 1, cutting of the textiles can be performed at one or more stages in the bandage manufacturing process 100. In some implementations, cutting is performed after knitting and prior to scouring and drying (104). In some implementations, cutting is performed after scouring and prior to drying (107). In some implementations, cutting is performed after scouring and drying (110).

[0134] In some implementations, the knit textile or individual textile units (depending on whether cutting has been performed) are further processed prior to scouring. For example, in some implementations, two portions of the knit textile or each textile unit (e.g., opposite ends or sides) are joined together, such as by sewing and / or melting, to form a two-ply textile unit that results in a two-ply bandage. In some implementations, the knit textile (prior to cutting / separation) has a tubular shape, andDocket No.: 410640-506001 WO the textile units have a tubular shape in the absence of subsequent sewing or other attachment.

[0135] In some implementations, the individual textile units, formed prior to scouring, have dimensions that would be incompatible with old beam scouring technology and tools. In a beam scouring process, a textile is wrapped around a perforated beam. Dye or a scouring solution is pumped out from the beam, passing through the textile and treating / cleaning the textile. However, in some cases, small portions of textile cannot be securely wrapped around the beam. For example, for a typical beam circumference of seventy inches, a textile unit having a longest dimension of approximately twenty inches would likely fall from the beam during scouring. Accordingly, beam scouring may be compatible with processing of long textile rolls or extended lengths of flat knit hemostatic textiles, but beam scouring may not be compatible with processing of already-cut or already-separated textile units with relatively small dimensions. For example, as described in U.S. Patent No. 10,406,255, “[i]n the case of bandage 10', after the finishing process [including scouring] the resulting tubular structure of hemostatic bandage 10' may be divided into specified lengths and widths as desired (emphasis added).” 5:64-67.

[0136] However, beam scouring large-area hemostatic textiles can present drawbacks. First, because scouring represents the primary cleaning process conducted on the textile prior to its packaging as a ready-to-use bandage, it can be desirable to reduce post-scouring processing of the textile. However, when beam scouring is performed on textiles that have not yet been cut / separated into individual textile units (each corresponding to a bandage), cutting / separation is conducted after scouring, potentially introducing contamination or debris into the bandages. For example, textile shards from the cutting / separation may be retained in the textile and enter wounds when the bandage is used, potentially causing infection. Chemical and / or biological contaminants additionally or alternatively may be introduced. “Touch points” associated with handling and transfer of the textile can also present a contamination risk. Further post-scouring operations, such as sewing, also may introduce contamination. And, besides contamination associated with textile handling and processing, mere exposure of the textile after scouring can lead to elevated levels of contamination, e.g., from ambient contaminants which may contact the textile. When beam scouring is performed on textiles that have not yet been cut / separated into individual textile units, the exposure time after scouring may beDocket No.: 410640-506001 WO high compared to processes described in this disclosure, leading to a correspondingly higher chance of contamination.

[0137] The foregoing notwithstanding, in some cases, scouring of large-area (e.g., not-yet-cut) textiles is advantageous. For example, the potential negative aspects of this process order, described above, may be prevented or ameliorated, for example, by suitable selection of fibers of the textiles, by suitable pre-processing of the textiles and / or components thereof prior to scouring, by appropriate configuration of the scouring and / or drying, and / or by suitable processing after scouring and / or drying to, for example, remove textile shards and / or other contamination. Scouring of large-area textiles, and cutting after the scouring (e.g., in operations 107 and / or 110) is fully within the scope of this disclosure.

[0138] However, even when scouring is performed on large-area textiles, beam scouring may be disadvantageous. For example, available beam scouring tools are expensive and bulky. Scaling bandage-manufacture operations may be difficult when the operations include beam scouring, because of high capital costs of tool acquisition and because of the large manufacturing area used to operate the beam scouring tools. Moreover, beam scouring tools are specialized machinery that may be supply-chain limited, presenting another obstacle for scaling bandage manufacturing. Repair, upkeep, and other support operations for beam scouring tools can be difficult, given the tools’ specialized nature. And, in some cases, beam scouring tools provide low throughput compared to other scouring methods. For example, beam scouring may include manual textile handling to wrap each hemostatic textile roll around the beam, increasing costs and processing time.

[0139] For some implementations according to this disclosure, it has been recognized that textiles, such as large-area knit textiles or individual, small-dimension textile units formed of glass fibers, can be scoured using laundry machines, such as commercially-available laundry machines. The use of a laundry machine for scouring can present advantages compared to the use of beam scouring. For example, the use of a laundry machine allows already-cut, individual textile units to be scoured, shifting the scouring and drying to later in the manufacturing process and, in some implementations, reducing post-scouring contamination. Contamination may be reduced (i) because fewer processing steps are performed after scouring and drying (for example, textile separation into individual textile units can be conducted prior to scouring and drying, as opposed to after) and / or (ii) because the exposure time of theDocket No.: 410640-506001 WO textile after scouring and drying is reduced. Per-bandage contamination can be reduced by about half, compared to some alternative processes in which beam scouring is performed prior to textile cutting. The reduced contamination can result in safer patient outcomes when the bandages are used to promote blood-clotting.

[0140] And, even in cases in which large-area knit textiles are scoured (e.g., compared to small-dimension textile units), in some implementations, the use of a laundry machine compared to beam scouring can provide advantages for cost, throughput, upkeep, and / or other aspects of operation, e.g., as discussed above.

[0141] Further, in some implementations, scouring in a laundry machine can result in more stretchable bandages than beam scouring. When textile(s) (e.g., large- area knit textile or textile units) are scoured in a laundry machine, the textile(s) are able to relax. For example, the textile(s) may be generally free to move and shrink (e.g., freely within the laundry machine or freely within a bag), as opposed to being held taut. In some implementations, this freedom of movement increases the stretchability of resulting bandages.

[0142] Accordingly, referring back to FIG. 1, in the bandage manufacturing process 100, the separated, individual textile units, or large-area knit textiles, are scoured in a laundry machine (106). In the subsequent description, a reference to “textile” should be understood to refer to both cases, except where noted otherwise or suggested otherwise by context. For example, as shown in FIG. 5A, in some implementations the laundry machine is a top-loading laundry machine 500. Separate textile units 502 are provided into a drum 504 of the top-loading laundry machine 500, which is filled with a scouring solution (e.g., scouring chemical(s) mixed with water) to at least partially submerge the textile units 502. This results in a high degree of contact between the scouring solution and fibers of the textile units 502, improving scouring effectiveness, e.g., compared to some beam scouring methods. Rotation of the drum 504 in combination with the scouring action of the scouring solution scours the textile units 502. For example, the scouring solution can break down undesirable starch and paraffin surrounding the glass fibers of the textile units 502. In some implementations, the scouring process “de-sizes” the textile units 502, e.g., causes shrinkage of the secondary fibers to the textile units 502, such that loops of the glass fibers are positioned more exteriorly, increasing the surface area of the glass fibers exposed to the exterior of the textile units 502. In some implementations, de-sizing is instead or additionally caused by the drying process, described in further detail below.Docket No.: 410640-506001 WO

[0143] In some implementations, as shown in FIG. 5B, the laundry machine is a front-loading laundry machine 510. Like the top-loading laundry machine 500, the front-loading laundry machine 510 includes a rotatable drum 514 into which textile units 512 are provided. In some implementations, whether using a top-loading laundry machine, a front-loading laundry machine, or another type of laundry machine, the textile units 512 can be enclosed in a bag 516 (e.g., a mesh bag), and the bag 516 is provided into the laundry machine. The bag 516 may reduce abrasive effects of agitation on the textile units 512, which can maintain the overall structural integrity of the textile units 512 and reduce occurrences of portions of the textile units 512 fracturing off and potentially being introduced into wounds. The drum 514 is at least partially filled with a scouring solution to scour the textile units 512.

[0144] As noted above, in some implementations, scouring in a laundry machine is performed on a large area knit textile, e.g., as opposed to being performed on textile units that correspond to bandages. The large-area knit textile can be scoured in a front-loading laundry machine or in a top-loading laundry machine. The large area knit textile can be provided into the laundry machine without a bag or in a bag. In some implementations, the textile is placed in a “doughnut bag” in the laundry machine. A doughnut bag zips into a complete circle, e.g., having an enclosed toroid shape. An example of a doughnut bag 520 is shown in FIG. 5C. The doughnut bag 520 holds a large area knit textile 522. For example, the knit textile 522 can be a continuously knit textile, such as a long, continuously knit textile knit using a narrow V-bed flat knitting machine. The textile 522 can be wound continuously into the unzipped doughnut bag 520 as the bag 520 is rotated in its circumferential direction 526, to form a stacked loop 524 of the fabric around the circumferential direction 526. The bag 520 can then be zipped to form a “doughnut” of product (the textile 522). For purposes of this disclosure, it has been found that, in some implementations, the use of a doughnut bag greatly reduces tangles, knots, and creases. It will be understood that the use of doughnut bags is not required and that other bag types, and scouring without a bag, are also within the scope of this disclosure.

[0145] In some implementations, drum rotation is dynamic. For example, the drum can rotate at different speeds during different portions of the scouring process, and / or the drum can rotate during some portion(s) of the scouring process and not rotate during other portion(s) of the scouring process. The dynamic drum rotation can occur within each sub-process of the scouring process. For example, the dynamicDocket No.: 410640-506001 WO drum rotation can occur while the textile is at least partially submerged in scouring solution, while the textile is being rinsed (e.g., at least partially submerged in water), and / or while the textile is being spun to promote drying. The use of different rotation speeds at different times (including, in some implementations, periods of non-rotation separated by periods of rotation) can provide various advantages in some implementations. For example, different internal temperatures of the drum may be more or less compatible with different rotation speeds, e.g., generate more or less abrasive damage to the textile at different temperatures. Accordingly, in some implementations, the different rotation speeds are at least partially synchronized with different temperatures (e.g., programmed temperatures) inside the drum, so that the drum rotates at a first speed for a first temperature and a second, different speed for a second, different temperature. As another example, different rotation speeds may provide more effective scouring for different amounts of time the textile has been submerged. For example, an initial faster or slower rotation speed can be used to evenly spread the scouring solution throughout the textile, followed by a slower or faster rotation speed to clean particles from the textile units. Some implementations of the laundry machines have a rotational programming capability that allows a rotation speed schedule to be preconfigured for scouring. In some implementations, the laundry machines have a temperature programming capability that allows a temperature schedule to be preconfigured for scouring, e.g., so as to synchronize with different portions of the scouring process and / or different rotation speeds. Accordingly, damage to the textile can be reduced by adapting the rotation speeds and / or drum temperatures to different states of the scouring process, such as a current liquid in the laundry machine (e.g., a current formulation of the scouring solution based on introduced chemical(s)), an amount of time scouring has been performed, etc.

[0146] Various formulations of the scouring solution can be used in various implementations. In some implementations, the scouring solution includes a detergent, an alpha-amylase mixture, and / or a buffered alkali chemical or sodium carbonate. For example, the detergent can include nonionic surfactants, propan-2-ol, (2-methoxymethylethoxy)propanol, and (R)-p-mentha-l ,8-diene. The alpha-amylase mixture can include suitable enzymes in an inert vehicle solution. Sodium carbonate is widely available and is also known in the textile industry as soda ash. Liquid buffered alkali chemicals are available, for example, including aqueous solutions ofDocket No.: 410640-506001 WO potassium hydroxide, diphosphoric acid, tetrapotassium salt, and / or tetrasodium ethylenediamine tetraacetate.

[0147] In an example of a scouring process, the drum of the laundry machine is filled with a bleach solution, such as a solution of between 1000:1 and 1500:1 waterbleach by volume. The drum is heated to an elevated temperature, such as a temperature between 100° Fahrenheit (F) and 150°F, and rotated to clean the interior of the drum. The bleach solution is then drained. In some implementations, the drum is rinsed with water after draining the bleach solution.

[0148] After the bleach cleaning, the textile is introduced into the drum, and the drum is at least partially filled with a suitable scouring solution. For example, the scouring solution can be a mixture of a detergent (for example, a fatty alcohol ethoxylate-based detergent), an alpha-amylase mixture or other suitable enzyme composition, and sodium carbonate in a ratio of about 5:1 :5 by weight, respectively, along with an amount of water (e.g., a weight of water 200-400 times the weight of sodium carbonate). The drum rotates to agitate the textile at an elevated temperature, breaking down starch in the textile and de-sizing the textile.

[0149] In some implementations, different component(s) of the scouring solution are introduced at different times and / or at different temperatures to increase their individual and combined effectiveness as well as to retain the structural integrity of the textile. For example, in some implementations, the temperature of water in the drum is increased gradually, and, as the temperature is increased, other components of the scouring solution are added at predetermined temperatures, such as sodium carbonate at a first temperature (e.g., in a range from 130°F to 140°F, or about 135°F), the detergent at a second, higher temperature (e.g., in a range from 135°F to 145°F, or about 140°F), and the alpha-amylase mixture at a third, higher temperature (e.g., in a range from 140°F to 150°F, or about 145°F). At the third temperature or a higher temperature (e.g., in a range from 145°F to 155°F, or about 150°), agitation is initiated. In some implementations, the textile is introduced into the laundry machine after the scouring solution is complete and at the temperature at which a primary portion of the scouring will be performed. In some implementations, the textile is introduced into the laundry machine prior to a complete scouring solution being present and / or prior to the temperature of the scouring solution reaching its predetermined value for scouring. In some embodiments, many amylases start losing activity near the top of the 150° band; thus there is thermostable alpha-amylaseDocket No.: 410640-506001 WO implemented anywhere herein or a cap at the nominal temperature upper limit at <149 °F (which can be used in any range mentioned herein).

[0150] The scouring time is a time during which the interior of the drum is held at an elevated temperature (such as 150°F) or within a predetermined range of temperatures, and during which, in some implementations, the textile is agitated by rotation of the drum. The scouring time can vary in different implementations. In some implementations, the scouring time is between one minute and thirty minutes or between ten minutes and thirty minutes, e.g., about twenty minutes, but other time durations are also within the scope of this disclosure.

[0151] Besides the advantages of laundry machine-based scouring discussed above, in some implementations, the use of a laundry machine for scouring can result in improved scouring results (e.g., cleaner textiles as a result of cleaning), and / or can allow for more textile to be processed, compared to beam-scouring. In a beam scouring process, the scouring solution is pumped from the beam through multiple layers of fabric, passing through the fabric and carrying away particles. However, as a number of the layers of fabric increases (e.g., as additional portions of textile are affixed to the beam and processed), the scouring effectiveness may decrease, because particles released from inner layers may become trapped on outer layers. Moreover, a high number of layers may induce uneven scouring solution flow. For example, the flow may be channeled through paths of lesser resistance, leaving portions of the textiles uncleaned or less-cleaned. By contrast, because of the agitation provided by the laundry machine, many textile units, or a large amount of large-area textile, can be scoured at once without compromising the effectiveness of the scouring process.

[0152] In addition, in some implementations, compared to beam-scouring processes, scouring in a laundry machine can allow for more flexible rotation speed reconfiguration. A beam in a beam scouring tool may be non-rotating or may be rotatable only at slow speeds, potentially resulting in uneven scouring. Moreover, even when the beam is rotatable, the beam scouring tool may not be capable of quickly switching the rotation between high and low / zero rotation speeds, resulting in sub-optimal matches between rotation speed and temperature or scouring process state. By contrast, the drum of a laundry machine can quickly be accelerated to high speeds or braked from high speeds, allowing a programmed rotation routine to beDocket No.: 410640-506001 WO precisely matched by machine operation and precisely synchronized with temperature or other process parameter(s).

[0153] In some implementations, at the end of the scouring time, the scouring solution is drained from the laundry machine. In some implementations, at the end of the scouring time, additional water is added to the laundry machine to dilute the scouring solution, after which the diluted scouring solution is drained. Following removal of the scouring solution, the textile can be rinsed, e.g., within the laundry machine itself (e.g., by addition and removal of water to / from the laundry machine) or using another tool. In some implementations, the textile is rinsed in water held at an elevated temperature, such as 120°F, for a predetermined time duration, e.g., ten minutes. In some implementations, multiple rinses are performed, e.g., two or three rinses, or more. In some implementations, the textile is spun by rotation of the drum, to promote liquid removal from the textile. For example, during a spin-dry portion of the process, the textile can be spun at between 500 and 3000 rotations per minute in the laundry machine.

[0154] FIG. 6 illustrates examples of operations that can be performed using a laundry machine to process textile, e.g., to process individual textile units or large- area knit textiles. The textile is placed in the laundry machine and at least partially submerged in a first scouring solution (600), e.g., a solution including a first combination of chemical(s), such as sodium carbonate or a buffered alkali chemical. During the fill process, a drum of the laundry machine is spun at a first rotation speed S1 (e.g., in a range from 20 rpm to 50 rpm, or in a range from 20 rpm to 30 rpm) and held at two temperatures T1 and T2, for different periods of time. In some implementations, the drum is held substantially at a single temperature T1 during this period. In some implementations, T1 and / or T2 are in a range from 130°F to 140°F, temperatures that have been found to improve scouring when applied at this point in the scouring process. Rotation speeds in a range from 20 rpm to 50 rpm, or in a range from 20 rpm to 30 rpm, or less than 50 rpm or less than 100 rpm, have been found to provide effective scouring when applied at this point and at subsequent points in the scouring process, for example, providing effective cleaning without causing excessive damage to scoured textiles. In some implementations, agitation can pause for a soak at enzyme temperature, then resume. Thus, for example, agitation can be initiated at a third temperature («145 °F), and rotation pauses at T4 before resuming at S4 / T5.Docket No.: 410640-506001 WO

[0155] In some implementations, during at least a portion of process portion 600, rotation is performed in a repeated on / off cycle, e.g., rotation-on for t1 seconds followed by rotation-off for t2 seconds. In some implementations, t2 is greater than t1 , a relationship that has been found to provide effective scouring. In some implementations, one or both of t1 and t2 is in a range from four seconds to fifteen seconds.

[0156] The scouring solution is changed to a second composition (e.g., by adding chemical(s) to the drum and / or draining solution from the drum) and the drum is rotated at speed S2 followed by speed S3, at a temperature T3 (602). For example, the added chemical(s) can include detergent, in some implementations without draining the chemical(s) of the first composition. In some implementations, T3 is higher than T 1 and / or T2, e.g. , in a range from 135°F to 145°F. In some implementations, T3 is at least 4°F higher or at least 5°F higher than T1 and / or T2, a temperature difference that has been found to result in improved textile scouring. In some implementations, during process portion 602, the drum is rotated substantially at a single speed S2. Moreover, S2 and / or S3 need not be different from S1 , e.g., can be equal to S1 , e.g., in a range from 20 rpm to 50 rpm, or in a range from 20 rpm to 30 rpm, or less than 50 rpm or less than 100 rpm. In some implementations, during process portion 602, the repeated on / off cycle described with respect to process portion 600 is performed.

[0157] The scouring solution is changed to a third composition (604). For example, an enzyme composition, such as an alpha-amylase mixture, can be added, in some implementations without draining the previous composition.

[0158] In some implementations, during process portion 604, rotation is stopped (rotation speed of 0 or substantially 0) while the temperature is held at T4, and, subsequently, the rotational speed is modified to S4 while the temperature is held at T5. In some implementations, a substantially single non-zero rotation speed S4 and / or a substantially single temperature T4 are applied during process portion 604, e.g., without use of non-rotation and / or temperature T5. S4 can be equal to S1 and / or S2 discussed above. In some implementations, T4 is higher than T1 , T2, and / or T3, e.g., at least 4°F higher or at least 5°F higher than T3 and / or T4, which is / are applied during process portion 602. For example, T4 can be in a range from 140°F to 150°F. This temperature difference has been found to result in improved textile scouring. InDocket No.: 410640-506001 WO some implementations, during process portion 604, the repeated on / off cycle described with respect to process portion 600 is performed.

[0159] In some implementations, each of washing portions 600, 602, 604 is performed for about 1-2 minutes. In some embodiments, an extended hold / agitation period is included to reach 1-30 min total.

[0160] After process portion 604, a washing process can be performed (606). In the washing process 606, water can be added, e.g., without draining the previous composition. In some implementations, the temperature is changed to T6. In some implementations, T6 is higher than T4 and / or T5 (e.g., at least 4°F higher or at least 5°F higher than T3 and / or T4), which is / are applied during process portion 604. This temperature difference has been found to result in improved textile scouring. For example, T6 can be in a range from 145°F to 155°F.

[0161] During the washing process 606, rotation speeds of S5 and / or S6 can be used. In some implementations, S5 is substantially the same as prior rotation speeds, e.g., S1 to S4. In some implementations, during the use of rotation speed S5, the repeated on / off cycle described with respect to process portion 600 is performed. In some implementations, after a period of rotation at S5, the scouring solution in the laundry machine is drained, and rotation is performed at S6, a higher speed than S5. For example, S6 can be in a range from 50 rpm to 150 rpm, or about 100 rpm. Because the laundry machine allows for rapid rotation changes, the drum can be transitioned from S5 to S6 rapidly compared to a beam of a beam scouring tool, in some implementations provided improved and / or faster draining. Rotation at S6 can be performed during and / or after draining. In some implementations, rotation at S5 in the scouring solution can be performed for at least ten minutes (e.g., about twenty minutes), and rotation at S6 can be performed for about 1-2 minutes.

[0162] Following washing (606), one or more rinse cycles can be performed (608). From the drained state at the end of the washing process 606, water can be added and the temperature can be modified to T7. In some implementations, T7 is less than T 1 to T6. For example, T7 can be in a range from 115°F to 125°F. In a rinse cycle (608), rotation can be performed at speed S7 in the water, the water can be drained, and during and / or after draining, rotation can be performed at speed S8. In some implementations, S7 matches or substantially S5, and S8 matches or substantially matches S6. In some implementations, each rinse cycle, including rinsing and draining, consumes about five minutes.Docket No.: 410640-506001 WO

[0163] For a subsequent spin-dry or “extract” process (610), from the drained state at the end of the one or more rinse cycles 608, the drum is spun at speed S9 and temperature T8 to at least partially dry the textile. In some implementations, S9 is a high speed, e.g., greater than one or more of S1 to S8. For example, in some implementations, S9 is at least 500 rpm, e.g., in a range from 500 rpm to 1500 rpm, such as about 1000 rpm. In some implementations, T8 is an elevated temperature, such as in a range from 100° to 200°F. In some implementations, heating is not performed during the spin-dry, e.g., in this example, T8 can be room temperature or a temperature resulting from natural cool-down after the one or more rinse cycles 608.

[0164] Throughout the foregoing process, the rotation speeds, temperatures, liquid composition in the drum, and / or other operations of the laundry machine can be synchronized with one another and precisely managed based on the high levels of programmability and rotation speed control provided by the laundry machine, e.g., compared to some beam-scouring tools.

[0165] Referring again to FIG. 1, in some implementations, following scouring, the scoured textile is dried (108). For example, the textile can be tumble-dried in a commercial laundry dryer. In some implementations, the textile is dried at an elevated temperature (e.g., between 100° and 200°F, such as at 150°F) for a predetermined duration of time (e.g., 90 minutes). As noted above, the drying process can cause shrinkage of the secondary fibers of the textile (de-sizing), resulting in the formation and protrusion of loops of the glass fibers, improving hemostatic properties of the bandages. Further, in some implementations, the de-sizing results in higher stretchability of the textile, providing improved wound-packing.

[0166] After cooling down, a large-area knit textile can be cut to form textile units. The textile units, whether resulting from cutting after drying (110) or cut previously (104 and / or 107) are ready for packaging as bandages. For example, the scoured and dried textile units can be folded and shipped to customers in a ready-to-use manner.

[0167] In some implementations, the bandages are packaged in a sterile manner, e.g., as a sterile package. For example, the bandages can be subjected to sterilization, such as gamma or UV irradiation.

[0168] In some cases, when bandages are cut to their final size after scouring and drying, textile area shrinking due to the scouring and drying (and / or altering) may not be specifically accounted for, because the size of resulting bandages may beDocket No.: 410640-506001 WO defined by the cuts made after any shrinking. However, in some implementations according to this disclosure, textile knitting and / or cutting are performed to account for shrinking that will occur due to scouring and drying after separation of textiles into individual textile units. For example, dimensions of a textile unit may shrink by about 50% during scouring and drying. Accordingly, for a given target dimension of a manufactured bandage (e.g., width or length), in some implementations, the textile units are manufactured to have a dimension with a predetermined ratio to the target dimension. For example, to produce a bandage that is x inches long, textile units formed before scouring and / or drying (e.g., by operations 104 and / or 107) can be provided with length 2x, or another factor of x. In some implementations, the factor is at least 1 .5, such that each textile unit has a dimension that is at least 50% larger than a corresponding dimension of the bandage formed from (corresponding to) the textile unit. The textile units can be configured to the desired dimension by cutting appropriate lengths of a roll of the hemostatic textile (e.g., as shown in FIG. 3) or by flat knitting the textile units to have the desired dimension (e.g., as shown in FIG. 4).

[0169] In some implementations, using a textile and / or a method herein, later manufactured bandages are non-adhesive, e.g., so as to not adhere to blood or flesh in a region of blood-clotting. The non-adhesiveness can promote cleanliness, reducing potential contamination (e.g., which may cause infection), and can allow for non-destructive removal of the bandage from the region of blood-clotting.

[0170] In some implementations, the glass fibers 202 are specially processed and / or configured to facilitate scouring in a laundry machine. Compared to beamscouring, in which the textile is held still, textile scoured in a laundry machine may be subject to additional agitation, which may be harsher on the glass fibers 202 (e.g., fiberglass). However, glass fibers may be fragile and damaged by scouring in a laundry machine, absent specific compensatory processing. As such, in some implementations, the glass fibers 202 are configured, and / or are specially processed, to have increased mechanical robustness, thereby permitting the use of laundry machine-based scouring without high levels of fiber damage.

[0171] For example, in some implementations, the glass fibers 202 are texturized. Texturizing can provide the glass fibers 202 with additional protection, so as to withstand scouring in a laundry machine. In some implementations, texturizing is performed after removing a binder included on as-purchased glass fibers 202. InDocket No.: 410640-506001 WO some implementations, the glass fibers 202 are covered by other fibers (e.g., bamboo fibers) in a core-spinning process.

[0172] While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any invention or on the scope of what may be claimed, but rather as descriptions of features that may be specific to particular embodiments of particular inventions. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations and even initially be claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination.

[0173] Particular embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims. For example, the actions described can be performed in a different order and still achieve desirable results. As one example, the processes depicted in the accompanying figures do not necessarily require the particular order shown, or sequential order, to achieve desirable results. In some cases, multitasking and parallel processing may be advantageous.

[0174] While this document may describe many specifics, these should not be construed as limitations on the scope of this disclosure, but rather as descriptions of features specific to particular implementations or classes of implementations. Certain features that are described in this document in the context of separate implementations can also be implemented in combination in a single implementations. Conversely, various features that are described in the context of a single implementations can also be implemented in multiple implementations separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination in some cases can be excised from the combination, and the claimed combination may be directed to a sub-combination or a variation of a sub-combination. Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that suchDocket No.: 410640-506001 WO operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results.

[0175] Only a few examples and implementations are disclosed. Variations, modifications, and enhancements to the described examples and implementations and other implementations can be made based on what is disclosed.

[0176] In a discussion, study or a reading of the details, features, embodiments, aspects, any figure or any part of any figure, and / or examples of the technology disclosed herein, any of the features, embodiments, aspects, and / or examples herein can be optionally inter-combined (or inter-discussed) with the example details listed below, and any portion (or aspect) of any detail below can be inter-combined with any portion of any feature or example disclosed herein:

[0177] Detail 1 : A method of manufacturing a hemostatic textile, the method comprising: knitting glass fibers with secondary fibers to form a knit textile; scouring the textile in a programmable laundry machine through sequential solutions comprising an alkaline solution, a detergent-containing solution, and an enzymecontaining solution while applying on / off drum-rotation cycles below 50-100 rpm and a temperature progression across the sequential solutions; rinsing and spin-drying the textile; and drying the textile to yield a hemostatic textile.

[0178] Detail 2: The method of detail 1 , wherein drum-speed changes are synchronized with at least one of (i) additions of the sequential solutions and (ii) attainment of temperature setpoints for the respective solutions.

[0179] Detail 3: The method of detail 1 , further comprising fully draining the drum between successive ones of the sequential solutions and refilling with a next solution.

[0180] Detail 4: The method of detail 1 , wherein the enzyme-containing solution is introduced by dosing into the detergent-containing solution without an intervening drain step.

[0181] Detail 5: The method of detail 1 , further comprising a cool-down segment between completion of scouring and the rinsing.

[0182] Detail 6: The method of detail 1 , further comprising performing a sanitizing bleach clean and rinse of the empty drum prior to loading the knit textile.

[0183] Detail 7: The method of detail 1 , wherein the programmable laundry machine executes a stored program comprising a scouring sequence variant corresponding to any of the process subroutines depicted in FIGs. 7-14 of the drawings.Docket No.: 410640-506001 WO

[0184] Detail 8: The method of detail 1 , wherein the spin-drying is performed at a highest temperature stage of the program.

[0185] Detail 9: The method of detail 1 , wherein the rinsing is performed at a temperature lower than each of the scouring solutions.

[0186] Detail 10: The method of detail 1 , wherein the drying comprises tumbledrying in a rotary heated drum.

[0187] Detail 11 : The method of detail 1 , further comprising, prior to the spindrying, performing an intermediate drain accompanied by low-speed rotation to expel liquid from the textile.

[0188] Detail 12: The method of detail 1 , wherein the knitting comprises alternating stitches that interleave the glass fibers and the secondary fibers in successive courses.

[0189] Detail 13: The method of detail 1 , further comprising, after the drying, cutting the textile to form multiple separated textile units.

[0190] Detail 14: The method of detail 1 , wherein during draining the drum is operated at successive low speeds to redistribute the textile before spin-drying.

[0191] Detail 15: The method of detail 1 , wherein the temperature across the sequential solutions increases monotonically from an earlier solution to a later solution.

[0192] Detail 16: The method of detail 1 , wherein the enzyme-containing solution is introduced only after a temperature setpoint for the enzyme-containing solution is reached.

[0193] Detail 17: The method of detail 1 , wherein the liquid-agitation speed during scouring is lower than an extraction speed used during the spin-drying.

[0194] Detail 18: The method of detail 1 , wherein the scouring is carried out with the textile freely placed in the drum without a containment bag.

[0195] Detail 19: The method of detail 1 , further comprising pre-cleaning the drum by filling it with a bleach solution of between 1000:1 and 1500:1 water: bleach by volume, heating, rotating, draining, and optionally rinsing prior to introducing the textile."

[0196] Detail 20: The method of detail 1 , wherein the laundry machine is a frontloading laundry machine.

[0197] Detail 21 : The method of detail 1 , wherein the laundry machine is a toploading laundry machine.Docket No.: 410640-506001 WO

[0198] Detail 22: The method of detail 1 , wherein a rotation-speed schedule is preconfigured and synchronized with a programmed temperature schedule and with transitions between the alkaline, detergent, and enzyme solutions.

[0199] Detail 23: The method of detail 1 , wherein scouring is performed on a large-area knit textile prior to cutting into individual textile units.

[0200] Detail 24: The method of detail 1 , wherein scouring is performed on precut textile units each having a longest dimension less than thirty inches.

[0201] Detail 25: The method of detail 1 , further comprising joining portions of the knit textile to form two-ply textile units prior to scouring.

[0202] Detail 26: The method of detail 1 , further comprising introducing the textile after the scouring solution is complete and at a temperature at which a primary portion of the scouring will be performed.

[0203] Detail 27: The method of detail 1 , wherein the textile is introduced prior to the scouring solution being complete and / or prior to reaching a predetermined scouring temperature.

[0204] Detail 28: The method of detail 1 , wherein during the enzyme-containing solution stage rotation is temporarily stopped for a soak at a held drum temperature before agitation resumes.

[0205] Detail 29: The method of detail 1 , wherein water is added for a washing stage without draining the previous composition.

[0206] Detail 30: The method of detail 1 , wherein each of the washing subprocess portions preceding the rinse is performed for about one to two minutes.

[0207] Detail 31 : The method of detail 1 , wherein a rinse cycle includes rotating in water and then, during and / or after draining, rotating at a different speed.

[0208] Detail 32: The method of detail 1 , wherein each rinse cycle consumes about five minutes.

[0209] Detail 33: The method of detail 1 , wherein the subsequent spin-dry is performed from the drained state achieved at the end of the rinse.

[0210] Detail 34: The method of detail 1 , wherein the spin-dry is performed without applying additional heating so that the drum temperature during the spin-dry corresponds to the rinse temperature or natural cool-down.

[0211] Detail 35: The method of detail 1 , wherein dynamic drum rotation is used during scouring, rinsing, and spinning.Docket No.: 410640-506001 WO

[0212] Detail 36: A knit hemostatic textile comprising: a first plurality of glass fibers arranged as pile loops exposed on at least one surface; and a second plurality of rayon fibers interknit with the glass fibers, wherein the textile is stretch-enhanced as a result of scouring and drying and is optionally configured for wound packing.

[0213] Detail 37: The knit hemostatic textile of detail 36, wherein the textile has a tubular shape in the absence of additional sewing or attachment.

[0214] Detail 38: The knit hemostatic textile of detail 36, wherein the textile comprises two plies joined together to form a two-ply bandage structure.

[0215] Detail 39: The knit hemostatic textile of detail 36, wherein the textile is provided as a flat knit panel comprising multiple pre-shaped portions joined by linking threads that are configured to be cut to separate individual portions.

[0216] Detail 40: The knit hemostatic textile of detail 36, wherein the glass fibers and the rayon fibers are each provided as single-end yams.

[0217] Detail 41 : The knit hemostatic textile of detail 36, wherein a knit gauge is between 10 and 30 stitches per inch, optionally between 18 and 22 stitches per inch.

[0218] Detail 42: The knit hemostatic textile of detail 36, wherein an as-knit areal weight density is between 250 gsm and 310 gsm.

[0219] Detail 43: The knit hemostatic textile of detail 36, wherein a postprocessed areal weight density is between 300 gsm and 375 gsm.

[0220] Detail 44: The knit hemostatic textile of detail 36, wherein adjacent courses interleaving the glass fibers and the rayon fibers form alternating capillary pathways that promote longitudinal wicking while providing lateral distribution reservoirs.

[0221] Detail 45: The knit hemostatic textile of detail 36, wherein a fiber composition varies along a knitting width of the textile to form laterally distinct portions.

[0222] Detail 46: The knit hemostatic textile of detail 36, wherein the textile is single-ply and is obtained by length-wise cutting open a tubular knit to unfold the tube into a single-ply panel.

[0223] Detail 47: The knit hemostatic textile of detail 36, wherein at least one transverse edge of the textile includes fewer than 200 stitches counted along the edge.

[0224] Detail 48: The knit hemostatic textile of detail 36, wherein the textile is knit on a circular knitting machine.Docket No.: 410640-506001 WO

[0225] Detail 49: The knit hemostatic textile of detail 36, wherein stitches in successive courses alternate between one complete stitch of the glass fibers and one complete stitch of the rayon fibers.

[0226] Detail 50: The knit hemostatic textile of detail 36, wherein the textile exhibits an elongation at a 5 N load between 8% and 15%.

[0227] Detail 51 : The knit hemostatic textile of detail 36, wherein the textile exhibits an absorbent uptake capacity between 5 mL / g and 8 mL / g under simulated packing pressure.

[0228] Detail 52: The knit hemostatic textile of detail 36, further comprising an antimicrobial silver component present at 50 ppm to 500 ppm.

[0229] Detail 53: The knit hemostatic textile of detail 36, further comprising a polyhexanide antimicrobial finish on the textile.

[0230] Detail 54: The knit hemostatic textile of detail 36, wherein a hydrophilic surface treatment of the textile increases a wicking rate by at least 15% relative to an untreated knit of otherwise similar construction.

[0231] Detail 55: The knit hemostatic textile of detail 36, further comprising a visible dyed rayon guide line configured to provide a suture or orientation reference along the textile.

[0232] Detail 56: The knit hemostatic textile of detail 36, wherein, after processing, a width tolerance is within ±5% of a target width and an edge curl is less than 3 mm.

[0233] Detail 57: A scouring composition for cleaning a knit hemostatic textile, consisting essentially of water, 0.5-2 wt% sodium carbonate, 0.2-1 wt% fatty-alcohol- ethoxylate non-ionic surfactant, and 50-150 ppm alpha-amylase enzyme, the solution having a pH between 10 and 11 at 135-150 °F.

[0234] Detail 58: The composition of detail 57, wherein the pH between 10 and 11 is provided exclusively by sodium carbonate without added hydroxide or phosphate buffer salts.

[0235] Detail 59: The composition of detail 57, wherein the non-ionic surfactant consists of one or more fatty alcohol ethoxylates and the composition is substantially free of anionic, cationic, and amphoteric surfactants.

[0236] Detail 60: The composition of detail 57, wherein the enzyme component consists of alpha-amylase as the only enzyme present.Docket No.: 410640-506001 WO

[0237] Detail 61 : The composition of detail 57, which is substantially free of oxidizing bleach species including hypochlorite and peroxides.

[0238] Detail 62: The composition of detail 57, wherein the sodium carbonate is present at 0.6-1.5 wt% of the solution.

[0239] Detail 63: The composition of detail 57, wherein the fatty-alcohol- ethoxylate non-ionic surfactant is present at 0.3-0.8 wt% of the solution.

[0240] Detail 64: The composition of detail 57, wherein the alpha-amylase enzyme is present at 75-120 ppm.

[0241] Detail 65: The composition of detail 57, wherein the temperature of use is 140-150 °F.

[0242] Detail 66: The composition of detail 57, wherein the composition exhibits a pH of 10.2-10.8 at 140-150 °F.

[0243] Detail 67: The composition of detail 57, further comprising up to 0.5 wt% propan-2-ol as a solvent component of the surfactant formulation while consisting essentially of the recited components.

[0244] Detail 68: The composition of detail 57, further comprising up to 0.5 wt% (2-methoxymethylethoxy)propanol as a solvent component of the surfactant formulation while consisting essentially of the recited components.

[0245] Detail 69: The composition of detail 57, further comprising up to 0.1 wt% (R)-p-mentha-l ,8-diene as a component of the surfactant formulation while consisting essentially of the recited components.

[0246] Detail 70: The composition of detail 57, which is free of added alkali metal hydroxides including potassium hydroxide and sodium hydroxide.

[0247] Detail 71 : The composition of detail 57, wherein the water of the composition is dechlorinated prior to use.

[0248] Detail 72: The composition of detail 57, wherein the enzyme component is supplied in an aqueous inert vehicle that is substantially free of organic solvents above 1 wt% of the composition.

[0249] Detail 73: The composition of detail 57, wherein the composition contains no additional enzymes selected from proteases, cellulases, or lipases.

[0250] Detail 74: The composition of detail 57, wherein the composition is free of added fragrances and dyes.Docket No.: 410640-506001 WO

[0251] Detail 75: A toroidal containment bag for scouring textiles, comprising a flexible body configured to zip into a closed loop and to hold a large-area knit textile wound circumferentially to form a stacked loop of fabric.

[0252] Detail 76: The bag of detail 75, wherein the bag zips into a complete circle to provide an enclosed toroid shape.

[0253] Detail 77: The bag of detail 75, wherein the bag is configured to be rotated in a circumferential direction while unzipped to accept a continuously knit textile and, after loading, to be zipped closed.

[0254] Detail 78: The bag of detail 75, wherein the flexible body comprises a mesh construction.

[0255] Detail 79: The bag of detail 75, wherein use of the bag during scouring reduces tangles, knots, and creases.

[0256] Detail 80: The bag of detail 75, configured for placement within a frontloading laundry-machine drum.

[0257] Detail 81 : The bag of detail 75, configured for placement within a toploading laundry-machine drum.

[0258] Detail 82: The bag of detail 75, wherein the bag is sized to hold a long, continuously knit textile produced on a narrow V-bed flat knitting machine.

[0259] Detail 83: The bag of detail 75, wherein the flexible body includes a circumferential zipper that closes the bag into the toroidal shape.

[0260] Detail 84: The bag of detail 75, wherein loading comprises rotating the unzipped bag in its circumferential direction while continuously feeding the knit textile to form the stacked loop.

[0261] Detail 85: The bag of detail 75, wherein the stacked loop extends around a circumferential direction of the bag.

[0262] Detail 86: The bag of detail 75, wherein the bag confines the textile to reduce abrasive effects of agitation during scouring.

[0263] Detail 87: The bag of detail 75, wherein the bag is adapted for use with scouring solutions that at least partially submerge the textile during operation.

[0264] Detail 88: The bag of detail 75, wherein the bag is configured to maintain the stacked loop orientation during rotation of the laundry-machine drum.

[0265] Detail 89: The bag of detail 75, wherein, when zipped closed with the textile inside, the bag forms a doughnut of product.Docket No.: 410640-506001 WO

[0266] Detail 90: The bag of detail 75, wherein the bag is adapted for use while the drum rotates at different speeds during different portions of a scouring process.

[0267] Detail 91 : The bag of detail 75, wherein the bag is adapted for use during rinsing and during spin-drying in the laundry machine.

[0268] Detail 92: The bag of detail 75, wherein the bag is configured to permit liquid flow through the stacked loop during scouring and rinsing.

[0269] Detail 93: The bag of detail 75, wherein the bag reduces formation of knots and creases relative to scouring without the bag.

[0270] Detail 94: The method of any of details 1-35, wherein the alkaline solution comprises an aqueous sodium carbonate solution, the detergent-containing solution comprises a low-foaming non-ionic washing and wetting agent, and the enzymecontaining solution comprises an alpha-amylase enzyme formulation.

[0271] Detail 95: The method of detail 94, wherein the alkaline, detergentcontaining, and enzyme-containing solutions are, respectively, a soda-ash solution containing sodium carbonate, a Rucogen FWK washing and wetting solution, and a Rucolase 180 alpha-amylase solution.

[0272] Detail 96: The method of any of details 1-35, wherein scouring is performed in non-softened water having a hardness of at least 50 ppm as CaCO3, optionally within a range from 50 ppm to 200 ppm and optionally within a range from 70 ppm to 150 ppm.

[0273] Detail 97: The method of any of details 1-35, wherein a scouring bath comprises about 30 gallons of non-softened water, about 5.3 oz of sodium carbonate, about 0.5 oz of the low-foaming non-ionic washing and wetting agent, and about 0.5 oz of the alpha-amylase enzyme formulation, thereby providing a pH between 10 and 11 at a bath temperature between 135 °F and 150 °F.

[0274] Detail 98: The method of any of details 1-35, wherein scouring includes a gentle reverse-rotation cycle at about 27 rpm with 5 seconds of rotation followed by 10 seconds without rotation, repeated during at least a pre-wash stage, a soda-ash stage, a detergent stage, and an enzyme stage.

[0275] Detail 99: The method of any of details 1-35, wherein rinsing comprises three sequential rinses carried out at about 120 °F, each rinse including drum rotation in the gentle reverse-rotation cycle for about 3 minutes followed by draining at about 99 rpm for about 2 minutes and an extract at about 950 rpm.Docket No.: 410640-506001 WO

[0276] Detail 100: The method of any of details 1-35, wherein the textile is loaded into mesh bags as pre-cut strips having lengths between 30 inches and 100 inches, optionally within a range from 36 inches to 80 inches and optionally within a range from 38 inches to 92 inches, the mesh bags being filled to a target mass between about 1 .5 lb and about 3.0 lb.

[0277] Detail 101 : The method of any of details 1-35, wherein the alpha-amylase enzyme concentration in the scouring solution is between 50 ppm and 150 ppm, optionally between 75 ppm and 125 ppm and optionally between 90 ppm and 130 ppm, relative to water mass, and the sodium carbonate concentration is selected such that the scouring bath has a pH between 10.0 and 11.0, optionally between 10.3 and 10.8 and optionally about 10.5.

[0278] Detail 102: The method of any of details 1-35, wherein drying is performed in a conveyor tunnel dryer at an air temperature between 100 °F and 150 °F, optionally between 110 °F and 130 °F and optionally about 120 °F, with the textile arranged as folded layers on a belt at an entrance of the dryer and conveyed to achieve a final moisture content between 2% and 8% by weight, optionally between 2% and 5% by weight and optionally between 2% and 3% by weight.

[0279] Detail 103: The method of any of details 1-35, wherein drying is alternatively or additionally performed in a tumble dryer at an air temperature between 140 °F and 170 °F, optionally between 145 °F and 160 °F and optionally about 150 °F, to reach the final moisture content defined in detail 102.

[0280] Detail 104: The method of any of details 1-35, wherein process parameters are selected such that, prior to terminal sterilization, a bioburden of the textile is less than or equal to 1000 colony-forming units per device, optionally within a range from 1 colony-forming unit to 300 colony-forming units per device and optionally within a range from 1 colony-forming unit to 100 colony-forming units per device.

[0281] Detail 105: The method of any of details 1 -35, wherein a finished, sterilized hemostatic textile has an endotoxin content of not more than 20 endotoxin units per device when tested by a Limulus Amebocyte Lysate assay, optionally within a range from 0.01 endotoxin units to 10 endotoxin units per device and optionally within a range from 0.05 endotoxin units to 2 endotoxin units per device.

[0282] Detail 106: The method of any of details 1-35, wherein the fabric moisture content after drying and prior to packaging is less than or equal to 5% by weight,Docket No.: 410640-506001 WO optionally within a range from 0.1 % to 4% by weight and optionally within a range from 0.1 % to 3% by weight.

[0283] Detail 107: The knit hemostatic textile of any of details 36-56, when sealed within a moisture-barrier package and sterilized, having an endotoxin content of not more than 20 endotoxin units per device, optionally within a range from 0.01 endotoxin units to 10 endotoxin units per device and optionally within a range from 0.05 endotoxin units to 2 endotoxin units per device.

[0284] Detail 108: The knit hemostatic textile of detail 107, wherein a moisture content of the sterilized textile at package release is less than or equal to 5% by weight, optionally within a range from 0.1 % to 4% by weight and optionally within a range from 0.1 % to 3% by weight.

[0285] Detail 109: The knit hemostatic textile of any of details 36-56, prior to terminal sterilization, having a bioburden of less than or equal to 1000 colony-forming units per device, optionally within a range from 1 colony-forming unit to 300 colonyforming units per device and optionally within a range from 1 colony-forming unit to 100 colony-forming units per device.

[0286] Detail 110: The composition of any of details 57-74, when used in a scouring process according to any of details 1-35, being controlled so that a hemostatic textile produced by the process satisfies the endotoxin, bioburden, and moisture specifications set forth in any of details 104-106.

[0287] In some embodiments, the technology herein provides a scouring solution for cleaning a knit hemostatic textile, consisting essentially of water, 0.5-2 wt % sodium carbonate, 0.2-1 wt % fatty alcohol ethoxylate non-ionic surfactant, and 50- 150 ppm alpha-amylase enzyme, the solution having a pH between 10 and 11 at 135- 150 °F.

[0288] According to some aspects, the scouring solution is further comprising 0.05 wt % to 0.2 wt % ethylenediaminetetraacetic acid (EDTA) to sequester divalent metal ions.

[0289] In some embodiments, the scouring solution is optionally wherein the water source has a hardness less than 50 ppm as CaCO3.

[0290] According to some aspects, the scouring solution is optionally wherein the solution is configured to be used in a front-loading drum operating at 25 rpm to 35 rpm, with a liquor ratio of 20: 1 to 30: 1.Docket No.: 410640-506001 WO

[0291] In any interpretation of the claims appended hereto, it is noted that no claims or claim elements are intended to invoke or be interpreted under 35 U.S.C. 112(f) unless the words “means for” or “step for” are explicitly used in the particular claim.

[0292] In general, any combination of disclosed features, components and methods described herein is possible. Steps of a method can be performed in any order that is physically possible.

[0293] All cited references are incorporated by reference herein. Although embodiments have been disclosed, it is not desired to be limited thereby. Rather, the scope should be determined only by the appended claims.

[0294] While various embodiments of the present disclosure have been described in detail, it is apparent that modifications and alterations of those embodiments will occur to those skilled in the art. However, it is to be expressly understood that such modifications and alterations are within the scope and spirit of the present disclosure, as set forth in the following claims.

[0295] The foregoing discussion of the disclosure has been presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description for example, various features of the disclosure are grouped together in one or more embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed disclosure requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

[0296] Moreover, though the present disclosure has included description of one or more embodiments and certain variations and modifications, other variations and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative embodiments to the extent permitted, including alternate, interchangeable and / or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeableDocket No.: 410640-506001 WO and / or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

[0297] The description of embodiments of the disclosure is not intended to be exhaustive or to limit the disclosure to the precise form disclosed. While specific embodiments of, and examples for, the disclosure are described herein for illustrative purposes, various equivalent modifications are possible within the scope of the disclosure, as those skilled in the relevant art will recognize. For example, while method steps or functions are presented in a given order, alternative embodiments may perform functions in a different order, or functions may be performed substantially concurrently. The teachings of the disclosure provided herein can be applied to other procedures or methods as appropriate. The various embodiments described herein can be combined to provide further embodiments. Aspects of the disclosure can be modified, if necessary, to employ the compositions, functions and concepts of the above references and application to provide yet further embodiments of the disclosure. Moreover, due to biological functional equivalency considerations, some changes can be made in protein structure without affecting the biological or chemical action in kind or amount. These and other changes can be made to the disclosure in light of the detailed description. All such modifications are intended to be included within the scope of the appended claims.

[0298] Specific elements of any of the foregoing embodiments can be combined or substituted for elements in other embodiments. Furthermore, while advantages associated with certain embodiments of the disclosure have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the disclosure. The methods, kits, formulations, and devices disclosed herein can be combined in any way into systems to address the current public health emergency.

[0299] General Combination Detail: Except where a specific incompatibility is expressly stated, the technical features disclosed in the present description, claims, abstract, and drawings — including all values, ranges, options, alternatives, and sub-components — are intended to be disclosed in any and all operative combinations. Any feature described in connection with one embodiment may be used in combination with any other feature(s) described herein, whether or not such combination is explicitly illustrated in the figures.Docket No.: 410640-506001 WO

[0300] Independent Axes of Variation (Pointer to Combinations): For clarity, the disclosure identifies independent axes of variation that are ^individually selectable and combinable** without functional incompatibility:

[0301] (A) Textile construction: knit architecture (e.g., circular or flat knit; tubular or single-ply; half-gauge), fiber sets (glass, rayon, optional radiopaque), edge formation (closed long edges; raw or serged short edges), areal weight and dimensions.

[0302] (B) Scouring chemistry: sequential solutions including alkaline (e.g., sodium carbonate), detergent-containing (e.g., fatty-alcohol ethoxylate), and enzyme-containing (e.g., alpha-amylase), and optional adjuncts (e.g., chelants, buffers, neutralizers).

[0303] (C) Kinematic program: liquid-phase agitation with on / off duty cycles and low rotation; intermediate redistribution; high-speed extraction; low-speed tumble drying.

[0304] (D) Thermal program: temperature setpoints and progressions (e.g., TI¬TS) assigned to corresponding liquid and non-liquid portions.

[0305] (E) Containment and handling: free-drum placement, mesh bags, or toroidal “doughnut” bag for large-area textiles; pre-cut versus post-cut handling.

[0306] (F) Post-processing: rinsing sequences, neutralization (e.g., citrate), drying, sterilization (e.g., gamma or UV), packaging (e.g., EDTA-lined pouches), optional plasma or mineral deposition.

[0307] Explicit Combination Pointers (Non-limiting Examples): To remove any doubt, the following combinations are expressly contemplated and disclosed:

[0308] • (A:tubular knit with closed long edges) + (B:alkaline^detergent^enzyme sequence) + (C:on / off liquid agitation) + (D:monotonic temperature increase) + (E:mesh bag) + (F:gamma sterilization).

[0309] • (A:flat knit panel with linked pre-shaped portions) +(B:alkaline^detergent, enzyme dosed without intervening drain) + (^redistribution before extraction) + (D:temperature holds per portion) + (E:toroidal bag) + (F:EDTA-lined package).

[0310] • (A:single-ply knit with relaxed stitch) + (B:detergent^enzyme with alkaline pre-rinse) + (C:low liquid speed <50 rpm, high extraction speed) + (D:cool-down before rinse) + (E:free-drum placement) + (F:post-rinse neutralization).Docket No.: 410640-506001 WO

[0311] These examples are illustrative and not exhaustive; further permutations across (A)-(F) are intended and supported unless technically incompatible.

[0312] Optionality and Sub-combinations: Unless explicitly required, steps, sub-steps, and constituents are optional and may be omitted, reordered, or repeated. Any disclosed sequence may be implemented partially, provided the remaining steps are operable. Optional features may be combined with each other or with the core features to form sub-combinations that are independently disclosed as embodiments.

[0313] Lists, Alternatives, and Markush-Style Support: Where lists of materials, machine types, bag formats, chemistries, parameters, or process options are provided, each member of a list is disclosed ^individually** and in **any operative combination** with members of other lists. Alternatives linked by “and / or” are to be read as permitting (i) any single member alone, (ii) any plurality of members, and (iii) all members together, unless physically incompatible.

[0314] Ranges, Endpoints, and Intermediate Values: All numeric values and ranges (e.g., temperatures, speeds, times, concentrations, pH, dimensions, areal weight) are disclosed with support for: (i) each endpoint individually; (ii) any sub-range derivable by selecting any disclosed endpoints; and (iii) any specific intermediate value within a range. When “about” or “approximately” is used, it includes ±10% of the value unless a different precision is stated. Combinations of ranges across different parameters are contemplated where operable.

[0315] Additional Functional Definitions and Equivalents: Functional terms (e.g., “alkaline solution,” “detergent-containing solution,” “enzyme-containing solution,” “redistribution,” “extraction,” “tumble drying,” “containment bag”) are intended to encompass known technical equivalents that achieve substantially the same function in substantially the same way with substantially the same result. For example, “alkaline solution” includes carbonate-buffered alkaline media; “detergent-containing” includes non-ionic surfactant solutions of the recited class; “enzyme-containing” includes alpha-amylase solutions formulated for textile scouring.

[0316] Claim / Description / Figure Interoperability: Features (and / or details) appearing in the claims, description, and figures are mutually supportive and may be freely cross-applied. A feature shown in a figure but not textually tied to a particular embodiment is nevertheless disclosed for that embodiment unless the contextDocket No.: 410640-506001 WO dictates otherwise. Figure callouts (e.g., S1-S9, T1-T8) are identifiers only and do not limit the scope to particular numeric values unless expressly stated.

[0317] No Admission of Prior Art: Any discussion of background techniques or equipment is provided solely to place embodiments in context and is not an admission that such material constitutes prior art under any jurisdiction. The term “conventional” (if used) denotes availability in the art and does not concede common general knowledge for any jurisdiction.

[0318] Consistency and Support for Future Amendments: The disclosure is structured to provide multiple fall-back positions. Independent aspects can be protected individually or in combination (e.g., chemistry program; drum-speed program; temperature program; containment approach; textile construction; packaging / sterilization). Amendments selecting features from different aspects are supported by the present disclosure as filed, including the explicit combination pointers above.

[0319] Technical Incompatibility and Exclusions: Where a combination would be technically inoperable (e.g., enzyme exposure outside a stability window; an extraction speed used during liquid immersion phases), such a combination is not contemplated. All other combinations across the disclosed aspects are intended to be encompassed.

[0320] Examples of Terminology and Interpretation: “Comprise / including” are open terms; “consisting essentially of” excludes constituents that materially change the stated function. Singular includes plural unless context dictates otherwise. Headings are for convenience and do not limit interpretation. The technology described herein is further illustrated by the following examples which in no way should be construed as being further limiting. The Examples are provided to demonstrate examples of future planned work, which in some experiments is emergency work. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of this disclosure, suitable methods and materials are described below.EXAMPLES

[0321] The invention now being generally described, it will be more readily understood by reference to the following examples which are included merely forDocket No.: 410640-506001 WO purposes of illustration of certain aspects and embodiments of the present invention and are not intended to limit the invention.EXAMPLE 1. TESTING OF IMPLEMENTATION OPTIONS IN METHODS

[0322] Methods are tested for all descriptions above and further as discussed below.

[0323] In some embodiments, FIG. 7 shows exemplary steps of a manufacturing method. In this example, FIG. 7 illustrates the baseline five-step bandage manufacturing pipeline. Glass and rayon yams are knitted, segmented, bagged, scoured through multi-bath rotation, and progressively dried at controlled drum speeds to yield a stretch-enhanced hemostatic textile. Step 1000 involves knit textile. Step 1002 involves segment units. Step 1004 involves enclose mesh bag. Step 1006 involves scour. Step 1008 involves dry.

[0324] In some embodiments, FIG. 8 shows exemplary steps of a three-stage scouring method. In this example, FIG. 8 details the sequential alkaline, detergent, and enzymatic washes. Each bath removes specific contaminants before final rinse and spin-dry, producing a surface-activated knit ready for impregnation or coating. Step 1100 involves alkaline wash. Step 1102 involves detergent wash. Step 1104 involves enzymatic wash. Step 1106 involves rinse. Step 1108 involves spin-dry.

[0325] In some embodiments, FIG. 9 shows exemplary steps of a sterilization process. In this example, FIG. 9 captures the sterilization chain. Packaged bandages undergo gamma or UV irradiation, followed by controlled cooling to mitigate thermal stress, before being transferred to moisture-barrier storage. Step 1200 involves insert bandage. Step 1202 involves seal package. Step 1204 involves radiation sterilize. Step 1206 involves cool. Step 1208 involves store.

[0326] In some embodiments, FIG. 10 shows exemplary steps of a calcium phosphate deposition method. In this example, FIG. 10 maps plasma deposition. Prepared glass fibers enter an RF chamber where tri-ethyl-phosphate plasma coats them with bioactive calcium-phosphate, followed by annealing to fix crystallinity. Step 1300 involves prepare glass fibers. Step 1302 involves load chamber. Step 1304 involves rf plasma deposition. Step 1306 involves anneal. Step 1308 involves unload & cool.

[0327] In some embodiments, FIG. 11 shows exemplary steps of a manufacturing method with one or more buffer rinses. In this example, FIG. 11 adds an optionalDocket No.: 410640-506001 WO citrate buffer rinse after scouring, neutralizing residual alkali for better biocompatibility without affecting textile modulus. Step 1000 involves knit textile. Step 1002 involves segment units. Step 1004 involves enclose mesh bag. Step 1006 involves scour. Step 1008 involves dry. Step 1010 involves buffer rinse. In some embodiments in FIG. 11 and in FIG. 12, both neutralization steps are done before spin / extract and drying (chemistry —> rinse / neutralize — extract — dry). According to some aspects, neutralization occurs immediately after scouring and before spin-dry / dry. Yet further In some embodiments corresponding to FIG. 11 and FIG. 12, each neutralization step is carried out before spin / extraction and drying, so that the overall sequence follows a chemistry — rinse / neutralize — extract — dry order. In such embodiments, the textile is first exposed to the alkaline, detergent, and enzyme chemistries, then subjected to one or more buffer rinses (for example, a citrate buffer rinse) to neutralize residual alkali, followed by spin or extract cycles to remove excess liquid, and only thereafter dried in a tumble dryer or conveyor tunnel dryer.

[0328] In some embodiments, FIG. 12 shows exemplary steps of a scouring method with neutralization. In this example, FIG. 12 expands the scouring sequence with a citrate neutralization step ensuring effluent conductivity below 50 pS cm-1. Step 1100 involves alkaline wash. Step 1102 involves detergent wash. Step 1104 involves enzymatic wash. Step 1106 involves rinse. Step 1108 involves spin-dry. Step 1110 involves citrate neutralization.

[0329] In some embodiments, FIG. 13 shows exemplary steps of a sterilization method with an EDTA pouch. In this example, FIG. 13 introduces an EDTA-lined moisture-impermeable pouch post-sterilization, binding trace metals that catalyze oxidative degradation. Step 1200 involves insert bandage. Step 1202 involves seal package. Step 1204 involves radiation sterilize. Step 1206 involves cool. Step 1208 involves store. Step 1210 involves the EDTA pouch.

[0330] In some embodiments, FIG. 14 shows exemplary steps of a plasma deposition with oxygen control. In this example, FIG. 14 shows plasma deposition with precise oxygen partial-pressure control between 10 Pa and 30 Pa, promoting hydroxyapatite-like phases. Step 1300 involves prepare glass fibers. Step 1302 involves load chamber. Step 1304 involves rf plasma deposition. Step 1306 involves anneal. Step 1308 involves unload & cool. Step 1310 involves oxygen or O2control.Docket No.: 410640-506001 WO

[0331] FIG. 15 depicts an illustrative program map that synchronizes thermal, kinematic, and chemical operations during laundry-machine scouring of a knit hemostatic textile. The primary trace (T1-T8) shows a monotonic temperature progression from an initial pre-wet / rinse (T1 ) into sequential scouring baths — alkaline, detergent, and enzyme — each held at distinct setpoints (T2-T6), followed by a cooler rinse (T7) and a low-temperature extract / dry stage (T8). A secondary trace encodes drum-speed states (S1-S9), highlighting low-shear liquid agitation during scouring, an intermediate redistribution speed before extraction, a high-speed spin segment, and a low-speed tumble for drying. Vertical markers indicate time-registered reagent introductions (alkali —> detergent —> enzyme), emphasizing event-driven control rather than purely time-based dosing. The dotted baseline shows an on / off agitation duty cycle applied only during liquid phases, modeling intermittent shear to enhance mass transfer while limiting yam abrasion and tangling. Together, the overlays articulate a coupled control strategy in which chemistry, temperature, and mechanical work are co-scheduled to produce reproducible cleaning and fabric morphology.

[0332] After testing the above described methods and others; next, major work will be undertaken to implement greater scale up and automated procedures in the form of software with devices such as real-time monitoring.EXAMPLE 2. OVERALL ADDITIONAL EXPERIMENTATION (OVERVIEW) ITH METHODS

[0333] Various aspects of Hemostatic Textiles and Knitting are further experimented with. It is found that glass fibers (e.g., fiberglass) can be knitted with secondary fibers (e.g., rayon such as bamboo-sourced rayon) to form hemostatic textiles. The textile may be knit on circular knitting equipment or a narrow V-bed flat knitting machine. In some implementations, opposite long edges of the flat-knit textile have closed stitches that become long, finished edges of resulting textile units. Radiopaque fibers may be included to aid post-use detection.

[0334] Size Reduction Prior to or After Scouring: The as-knit textile can be supplied as a long roll or as a flat-knit sheet containing multiple linked unit shapes. Size reduction may be performed by cutting a roll into units or by separating linked flat-knit portions. In some implementations, unit dimensions (e.g., width and length) are selected to account for expected area shrinkage during scouring and drying. For example, units formed prior to scouring can have one or more dimensions at least about 50% larger than the corresponding final dimension.Docket No.: 410640-506001 WO

[0335] Laundry-machine scouring can be conducted in a programmable frontloading or top-loading commercial laundry machine and / or in a machine with real-time monitoring. Textile may be freely placed in the drum or enclosed in a bag (e.g., a mesh bag or a doughnut bag for large continuous lengths) to reduce tangling and abrasion. A bleach clean / rinse cycle may be used on the empty drum before processing.

[0336] In some implementations, scouring proceeds through a sequence of solutions with increasing temperature, for example:

[0337] • First solution: alkaline (e.g., sodium carbonate or buffered alkali) at a first temperature.

[0338] • Second solution: add or exchange to a detergent-containing solution at a second, higher temperature.

[0339] • Third solution: add or exchange to an enzyme-containing solution (e.g., alpha-amylase) at a third, higher temperature.

[0340] Agitation can employ repeated on / off cycles (e.g., rotation-on for ti seconds, rotation-off for t2seconds) with low rotational speeds. In some embodiments, the rotational speed during liquid scouring is between about 10 rpm and about 100 rpm, optionally between about 25 rpm and about 75 rpm. After liquid scouring, one or more rinses can be performed (e.g., at a lower temperature), followed by a spin-dry at higher speed. In some embodiments, the spin-dry speed is between about 250 rpm and about 1000 rpm, optionally between about 375 rpm and about 625 rpm.

[0341] Drying and optional post-scour cutting: After rinsing and spin-dry, the textile can be tumble-dried at elevated temperature for a set duration. Drying and / or scouring can desize the textile (e.g., shrink secondary fibers, expose glass fiber loops) and can increase stretchability. Large-area textiles may be cut into units after drying; alternatively, units can be formed before scouring.

[0342] Variants, Controls, and Synchronization: Laundry-machine controls can synchronize drum speed schedules with temperature profiles and solution chemistry changes to reduce textile damage and improve throughput. Different subroutines (e.g., illustrated in FIGs. 7-15) can be used to tailor the process to textile construction and capacity (e.g., choice and timing of chemical additions; rinse count; cool-down; load / unload cycles).Docket No.: 410640-506001 WO

[0343] In some implementations, a method of manufacturing hemostatic textiles includes:

[0344] • Knitting glass fibers, alternating stitches with secondary fibers (e.g., rayon such as bamboo-sourced rayon), to form a hemostatic textile.

[0345] • Optionally incorporating radiopaque fibers.

[0346] • Scouring the hemostatic textile in a laundry machine (front- or toploading), including agitation in one or more scouring solutions with programmable drum speeds / pauses and temperature setpoints.

[0347] • Rinsing and spin-drying to at least partially dry the textile.

[0348] • Drying the textile (e.g., tumble drying).

[0349] • Optionally cutting the textile to obtain multiple separated textile units(e.g., by slicing a roll into units or separating linked flat-knit pieces). In some implementations, unit dimensions are chosen to accommodate post-scour shrinkage.

[0350] In some implementations, scouring employs sequential solutions, such as: a first alkaline solution (e.g., sodium carbonate or buffered alkali), a second detergent-containing solution, and a third enzyme-containing solution (e.g., alphaamylase) with temperature progression. Drum speed programs can alternate rotation and non-rotation and can synchronize speed changes with temperature and chemistry transitionsEXAMPLE 3. CONSIDERATIONS FOR SPECIFICATION SETTING FOR A HEMOSTATIC TEXTILE PRODUCT

[0351] This prophetic example describes establishment of specification ranges for a sterilized hemostatic textile produced by a continuous process that includes enzymatic treatment, washing, drying, and terminal sterilization. The example is intended to illustrate target numerical ranges and associated analytical methods that are suitable for an external hemostatic dressing configured for contact with blood at a wound surface. The example is not based on a particular clinical batch, but instead reflects design targets that can be confirmed and, if appropriate, narrowed during process validation and regulatory submission.

[0352] A woven or knitted hemostatic textile is prepared using a composite of inorganic fibers and biocompatible organic fibers, followed by application or incorporation of one or more hemostatic agents as described elsewhere in this specification. The textile is then subjected to a controlled washing sequence that can include an enzymatic step, mechanical agitation, and rinsing, followed by drying andDocket No.: 410640-506001 WO packaging. Terminal sterilization is performed using gamma irradiation, electronbeam irradiation, ultraviolet irradiation, or combinations thereof. The finished, sterile product is intended for single use as an external hemostatic dressing for lacerations, punctures, abrasions, surgical wounds, or traumatic injuries.

[0353] In this example, the optional ranges were targeted as follows. Endotoxin content is controlled using a Limulus Amebocyte Lysate assay performed according to an appropriate pharmacopeial method. In some embodiments, the range is less than or equal to about 20 endotoxin units (Ell) per device, which corresponds to a commonly accepted limit for external medical devices that contact circulating blood. According to some aspects, an acceptable range is between about 0.01 Ell and about 20 Ell per device, optionally within the range of about 0.05 Ell to about 10 Ell per device, and optionally within the range of about 0.05 Ell to about 2 Ell per device for dressings intended for more sensitive applications. The limit can be expressed per device, per square centimeter of textile surface, or per gram of textile mass, depending on the intended labeling and use pattern.

[0354] Bioburden prior to terminal sterilization is evaluated according to ISO 11737-1 or an equivalent standard. In some embodiments, the range is less than or equal to about 1000 colony-forming units (CFU) per device, optionally within the range of about 1 CFU to about 300 CFU per device, and optionally within the range of about 1 CFU to about 100 CFU per device. According to some aspects, an acceptable range is selected such that, when combined with the validated sterilization dose, a sterility assurance level of 10’6is achieved. Bioburden alert and action levels can be set within the broader range based on ongoing process capability studies.

[0355] Moisture content of the finished sterile textile is determined by a loss-on- drying method conducted at about 100 °C to about 105 °C until constant mass is achieved. In some embodiments, the range is less than or equal to about 11 % by weight, optionally within the range of about 0.1 % to about 8% by weight, and optionally within the range of about 0.1 % to about 5% by weight. According to some aspects, an acceptable range is selected so that the textile remains flexible and conformable while also providing enhanced shelf life and reduced microbial risk relative to higher moisture levels.

[0356] Elemental impurities, including heavy metals, are measured by inductively coupled plasma mass spectrometry or an equivalent technique. The design of the specification can follow ICH Q3D or an analogous guideline for the cutaneous andDocket No.: 410640-506001 WO transcutaneous route of administration. In some embodiments, the range for individual elements such as lead, cadmium, arsenic, and mercury is selected such that patient exposure from a single device remains below the permitted daily exposure value for the relevant route. According to some aspects, an acceptable range for each of these elements is about 0.1 parts per million (ppm) to about 10 ppm in the textile, optionally within the range of about 0.1 ppm to about 1 ppm, and optionally within the range of about 0.1 ppm to about 0.5 ppm, while also ensuring that the calculated daily patient exposure is below the corresponding guideline value.

[0357] Residual organic solvents are assessed according to ICH Q3C or a similar standard. In some embodiments, the range for each Class 3 solvent present in the textile is less than or equal to about 5000 ppm, optionally within the range of about 1 ppm to about 1000 ppm, and optionally within the range of about 1 ppm to about 100 ppm. According to some aspects, an acceptable range is further constrained such that total daily patient exposure to each Class 3 solvent is less than or equal to about 50 mg. When Class 1 or Class 2 solvents are not used in the process, the corresponding limits can be omitted from the routine specification and retained only as periodic verification tests.

[0358] Residual enzyme arising from an optional enzymatic treatment step, for example a polysaccharidase or protease used during fabric preparation, is controlled through both activity and protein measurements. In some embodiments, the range for residual enzyme activity in the finished sterile product is less than or equal to about 1 international unit (III) per device, optionally within the range of about 0.01 IU to about 0.5 IU per device, and optionally within the range of about 0.01 IU to about 0.1 IU per device. According to some aspects, an acceptable range for residual total protein related to the enzyme is about 0.1 micrograms to about 100 micrograms per device, optionally within the range of about 0.1 micrograms to about 10 micrograms per device. The enzyme-related specification is selected so that toxicological risk assessment according to ISO 10993-17 demonstrates a margin of safety greater than or equal to a predetermined value, and so that sensitization and irritation studies according to ISO 10993-10 demonstrate an acceptable biological response.

[0359] Additional functional specifications can be established for clotting performance and absorbency. In some embodiments, the range for clotting time reduction, measured using a modified activated partial thromboplastin time method or a whole-blood clotting assay, is about 10% to about 90% of the clotting time observedDocket No.: 410640-506001 WO with a negative control gauze, optionally within the range of about 20% to about 70% of the control clotting time. According to some aspects, an acceptable range for saline or blood absorbency is about 5 grams to about 25 grams of fluid per gram of textile, optionally within the range of about 8 grams to about 20 grams of fluid per gram of textile.

[0360] The ranges in this prophetic example provide guidance for specification setting during development of a hemostatic textile produced by a continuous process including enzymatic treatment, washing, drying, and terminal sterilization. The broader ranges describe outer design limits that accommodate manufacturing variability and evolving regulatory expectations. The narrower optional ranges describe preferred operation windows that can be confirmed and, if appropriate, further refined during process characterization, clinical evaluation, and commercial scale-up.

[0361] In some embodiments, pyrogens are substances that can cause fever, most importantly bacterial endotoxins (lipopolysaccharides from Gram-negative bacteria), but also non-endotoxin pyrogens such as certain cell-wall fragments, exotoxins, and even some leachables from materials. For hemostatic dressings and other medical devices, the goal is to control total pyrogenic load to a level that will not trigger a clinically significant febrile reaction.

[0362] Historically, pyrogens were characterized using the rabbit pyrogen test, in which a sample extract was injected intravenously, and body temperature was monitored. Today, for most applications, endotoxin is quantified using the Limulus Amebocyte Lysate (LAL) assay in gel-clot, turbidimetric, or chromogenic formats. These tests report results in endotoxin units (EU) and can be run on product extracts (e.g., saline or buffered solutions exposed to the device) or on process waters and intermediates. Non-endotoxin pyrogens may be assessed using additional in vitro assays such as the monocyte activation test, or are indirectly controlled by bioburden, material selection, and leachables / extractables programs.

[0363] According to some aspects, a specification for pyrogens is set by translating relevant regulatory limits into a per-device or per-dose requirement. For example, for many external blood-contacting devices, a limit such as “not more than 20 EU / device” is adopted by analogy to established guidance. The limit may also be normalized per surface area or per mass when product size varies. During development, multiple batches are tested to understand the natural variation inDocket No.: 410640-506001 WO endotoxin levels; the formal specification is then chosen so that routine production remains comfortably below the regulatory maximum, with internal alert and action levels set tighter than the release limit. Validation studies demonstrate that the chosen sampling, extraction, and LAL method are suitable for the specific product, including tests for inhibition or enhancement and definition of the method’s detection limit and quantitation range.EXAMPLE 4. SPECIFIC EXPERIMENTATION FOR PROCESS IMPROVEMENTS AND FUTURE WORK

[0364] In some embodiments, the scour chemicals can comprise a carefully balanced combination of an alkaline builder, a non-ionic washing and wetting agent, and an alpha-amylase enzyme system that together prepare the knit hemostatic textile for subsequent processing. According to some aspects, sodium carbonate (soda ash) is used as an alkaline compound that increases water pH and functions as a wetting agent to enhance a fiber’s ability to absorb and interact with other chemicals. The alkaline environment supports swelling of secondary fibers and facilitates penetration of surfactant and enzyme into the fiberglass-containing knit structure.

[0365] In a non-limiting example, the surfactant component includes Rucogen FWK™ (RUDOLF), described as a low-foaming, non-ionic washing and wetting agent for all fiber types, especially for the removal of weaving and knitting oil stains. In some embodiments, the range of Rucogen FWK is selected so that the liquor remains low foaming at process temperatures while still providing sufficient wetting power to displace residual knitting oils, beam lubricants, and handling soils from the textile. According to some aspects, the combination of sodium carbonate and Rucogen FWK provides both bulk pH control and interfacial tension reduction, allowing rapid and uniform wet-out of densely knitted hemostatic fabrics.

[0366] The enzymatic component is based on an alpha-amylase enzyme that acts as a desizing agent and decomposes starch into soluble components. In this example, the fiberglass raw material contains approximately a 1 % starch binding, which can interfere with wetting, clot-active surface exposure, and uniform scouring if not removed. In some embodiments, the alpha-amylase is supplied as Creative Enzymes Fungal a Amylase (Food Grade) (powder) used in a comparative A process (herein), while in other embodiments the enzyme is supplied as Rudolf Rucolase 180™ (liquid) in the comparative B process. According to some aspects, the enzymeDocket No.: 410640-506001 WO dosage, exposure time, and temperature profile are adjusted so that starch removal is maximized while fiber damage and fuzzing are minimized.

[0367] In a non-limiting example, the scour bath therefore can include water, sodium carbonate (soda ash) at an alkaline pH, Rucogen FWK low-foaming non-ionic washing and wetting agent, and an alpha-amylase enzyme such as Creative Enzymes Fungal a Amylase or Rudolf Rucolase 180. In some embodiments, the sequence of addition places soda ash first to set pH and initiate wetting, Rucogen FWK second to remove weaving and knitting oil stains, and alpha-amylase last to decompose starch binding from the fiberglass component. According to some aspects, the resulting scour removes oils, starch, and loose particulates, enhances the ability of the textile to absorb and interact with hemostatic actives, and yields a clean, uniformly prepared substrate suitable for subsequent washing, drying, and sterilization steps.

[0368] Comparative process A can include equipment examples such as a Hisaki LLB-100 / 22R Beam Dye Jet, a Milnor Extractor Model 42032F7J, a Spartox A30 Ozonator, and a DSI Flat Bed Conveyor Drying Oven.

[0369] The beam dye machine works by pumping a dye solution through a roll of fabric that is wrapped around a perforated beam. The fabric remains stationary while the dye solution is pushed through the holes of the beam and the fabric. In some embodiments, the validated process scours up to an amount of circular knit fabric between about 100 lb and about 400 lb, optionally between about 150 lb and about 250 lb, and up to an amount of flat knit fabric between about 50 lb and about 200 lb, optionally between about 75 lb and about 125 lb, on the beam at a time.

[0370] In some embodiments, a scour ratio for the beam process is selected such that water is present in an amount between about 400 gallons and about 1600 gallons, optionally between about 600 gallons and about 1200 gallons; soda ash is present in an amount between about 4.4 lb and about 17.7 lb, optionally between about 6.7 lb and about 13.3 lb; a Rucogen FWK washing and wetting agent (or an analogous low-foaming non-ionic detergent) is present in an amount between about 4.4 lb and about 17.7 lb, optionally between about 6.7 lb and about 13.3 lb; and an alpha-amylase enzyme is present in an amount between about 0.2 lb and about 0.8 lb, optionally between about 0.3 lb and about 0.6 lb.

[0371] In some embodiments, a beam scour process includes a pre-flush step in which the tank is contacted with water at a temperature between about 45 °F andDocket No.: 410640-506001 WO about 180 °F, optionally between about 70 °F and about 135 °F, for a duration between about 2.5 minutes and about 10 minutes, optionally between about 3.75 minutes and about 6.25 minutes. The fabric is then loaded onto the beam and the water is heated through successive setpoints between about 65 °F and about 270 °F, optionally between about 100 °F and about 200 °F, while sequentially adding soda ash, detergent, and an alpha-amylase enzyme. In some embodiments, the bath is finally brought to a temperature between about 75 °F and about 300 °F, optionally between about 135 °F and about 165 °F, and held for a total scour time between about 10 minutes and about 40 minutes, optionally between about 15 minutes and about 25 minutes, before draining. Subsequent rinses can include filling with water at a temperature between about 60 °F and about 180 °F, optionally between about 90 °F and about 135 °F, running for a duration between about 2.5 minutes and about 10 minutes, optionally between about 3.75 minutes and about 6.25 minutes, and draining, with the rinsing steps repeated, for example, to provide three total rinses.

[0372] In some embodiments, a wash / extract process includes placing mesh bags containing an amount of fabric between about 1.5 lb and about 6 lb, optionally between about 2.25 lb and about 3.75 lb, into an extractor unit, filling with cold water, and running a wash cycle for a duration between about 1 .5 minutes and about 6 minutes, optionally between about 2.25 minutes and about 3.75 minutes. A drain cycle can then be operated for a duration between about 0.5 minute and about 2 minutes, optionally between about 0.75 minute and about 1.25 minutes, followed by a final extract for a duration between about 2.75 minutes and about 11 minutes, optionally between about 4 minutes and about 7 minutes; the cycle can be repeated one or more times.

[0373] In some embodiments, a drying process includes placing a number of strands at the dryer entrance between about 3 and about 14, optionally between about 5 and about 9, folded in an accordion-style configuration. A dryer temperature is set within a range between about 55 °F and about 220 °F, optionally between about 80 °F and about 140 °F, and a conveyor speed is selected such that circular knit fabrics move at a speed between about 0.325 yards per minute and about 1.3 yards per minute, optionally between about 0.5 yards per minute and about 0.9 yards per minute, and flat knit fabrics move at a speed between about 0.425 yards per minute and about 1.7 yards per minute, optionally between about 0.6 yards per minute and about 1.1 yards per minute. In some embodiments, the process is controlled so thatDocket No.: 410640-506001 WO the moisture content of exiting fabric is less than or equal to about 16% by weight, optionally less than or equal to about 12% by weight.

[0374] In some embodiments, a continuous hemostatic textile strand exiting a washing, scouring, or impregnation station is delivered to a drying or curing oven using the arrangement schematically shown in FIG. 16 with oven entrance (side view) 420, folded fabric strand 425, guide rail 430, nip roll 435, belt 440, and optional support roll 445. According to some aspects, the wet strand is directed over a guide rail and into a nip defined between a driven roll and an opposing roll that cooperatively advance the strand onto a moving belt positioned at the oven entrance. The strand is allowed to collapse in a serpentine or folded configuration on the belt so that successive portions of the strand overlie one another, thereby increasing residence time within the oven while maintaining a compact footprint. In this example, the folding pattern is selected to limit fabric tension, promote uniform exposure to heated air or radiant energy, and reduce sticking or blocking between adjacent layers. Other guide elements, belt materials, or folding geometries can be used while maintaining the continuous-feed concept illustrated in FIG. 16. In this example, the fabric passes through the entrance of the oven flat and one layer at a time. According to some aspects, the folded configuration before the dryer allows the fabric to feed through the guide rails easily.

[0375] Comparative process B can include equipment such as a Continental Girbau HS-6 / EH Inteli Control Washing Machine, an AO Smith hot water heater (e.g., BTR197), a Culligan 060 HE 1.5 Twin Water Softener (in some instances no longer used), and a Dexter Industrial OLP Dryer DN0080NC or analogous drying equipment.

[0376] Mesh Bag Process: In some embodiments, a mesh-bag process involves rolling an amount of continuous material between about 1 .5 lb and about 6 lb, optionally between about 2.25 lb and about 3.75 lb, into a mesh donut bag. Such bags may be less than ideal for the washing process because the material can become tangled, leading to increased handling during subsequent sewing.

[0377] Alternative Mesh Bag Process: In some embodiments, an alternative mesh-bag process includes pre-cutting material into strips having lengths between about 19 inches and about 184 inches, optionally between about 30 inches and about 120 inches, including, for example, lengths within ranges of about 30-60 inches, about 55-110 inches, and about 70-115 inches selected based on desired finished length. The strips can be grouped into bundles of about 5-20 strips, optionally aboutDocket No.: 410640-506001 WO8-12 strips, and both ends of each strip can be pinned or clamped to the top and bottom of the inside of the mesh bag. In some embodiments, a filled mesh bag target weight is between about 1 .1 lb and about 4.4 lb, optionally between about 1 .65 lb and about 2.75 lb.

[0378] In some embodiments, a scour ratio for the mesh-bag process includes water in an amount between about 15 gallons and about 60 gallons, optionally between about 22.5 gallons and about 45 gallons; soda ash in an amount between about 2.65 oz and about 10.6 oz, optionally between about 4.0 oz and about 6.5 oz, to establish a target pH between about 9 and about 13, optionally between about 10 and about 11 ; a low-foaming non-ionic washing and wetting agent such as Rucogen FWK in an amount between about 0.25 oz and about 1 .0 oz, optionally between about 0.4 oz and about 0.6 oz; and an alpha-amylase enzyme such as Rucolase 180 in an amount between about 0.25 oz and about 1 .0 oz, optionally between about 0.4 oz and about 0.6 oz.

[0379] Scour / Extract Process.

[0380] Process temperature settings and drum motion in one implementation of the scour program can follow a sequence that includes a pre-wash phase, a soda-ash phase, a detergent phase, an enzyme phase, a wash phase, multiple rinses, and a final extract. In some embodiments, during each liquid phase the machine fills to a predetermined level and operates in a gentle reverse on / off cycle in which a rotation- on interval is between about 2.5 seconds and about 10 seconds, optionally between about 3.75 seconds and about 6.25 seconds, and a rotation-off interval is between about 5 seconds and about 20 seconds, optionally between about 7.5 seconds and about 12.5 seconds.

[0381] The drum speed during these liquid phases can be between about 10 rpm and about 60 rpm, optionally between about 20 rpm and about 35 rpm. A pre-wash phase can be run for a duration between about 2.5 minutes and about 10 minutes, optionally between about 3.75 minutes and about 6.25 minutes, followed by draining.

[0382] Subsequent soda-ash, detergent, and enzyme phases can each be run for a duration between about 0.5 minute and about 2 minutes, optionally between about 0.75 minute and about 1.25 minutes, without draining between phases. In some embodiments, bath temperatures during these steps are increased stepwise within a range between about 70 °F and about 300 °F, optionally between about 110 °F andDocket No.: 410640-506001 WO about 190 °F, with each successive step at a higher temperature than the preceding step.

[0383] A wash phase without added chemical can then be carried out at a bath temperature within the same general range, for a duration between about 5 minutes and about 20 minutes, optionally between about 7.5 minutes and about 12.5 minutes, followed by a drain step conducted at a drum speed between about 50 rpm and about 200 rpm, optionally between about 75 rpm and about 125 rpm, for a duration between about 1 minute and about 4 minutes, optionally between about 1 .5 minutes and about 2.5 minutes.

[0384] Rinse phases can be conducted by filling with water to the same level and heating to a target temperature between about 60 °F and about 240 °F, optionally between about 90 °F and about 150 °F, with the drum operated in the gentle reverse on / off cycle defined above at speeds between about 10 rpm and about 60 rpm, optionally between about 20 rpm and about 35 rpm, for a duration between about 1 .5 minutes and about 6 minutes, optionally between about 2.25 minutes and about 3.75 minutes. Each rinse can be followed by a drain step at a speed between about 50 rpm and about 200 rpm, optionally between about 75 rpm and about 125 rpm, for a duration between about 1 minute and about 4 minutes, optionally between about 1.5 minutes and about 2.5 minutes, and by an extract step at a speed between about 500 rpm and about 1900 rpm, optionally between about 700 rpm and about 1200 rpm.

[0385] In some embodiments, a final extract stage without added water or chemicals is performed at a speed between about 500 rpm and about 1900 rpm, optionally between about 700 rpm and about 1200 rpm, for a duration between about 2.5 minutes and about 10 minutes, optionally between about 3.75 minutes and about 6.25 minutes.

[0386] In some embodiments, benchtop scour trials are performed using a smallvessel system with water volumes between about 1 .5 liters and about 6 liters, optionally between about 2.25 liters and about 4.5 liters, and fabric masses between about 37.5 grams and about 150 grams, optionally between about 56 grams and about 112.5 grams. Soda ash can be present in an amount between about 2 grams and about 8 grams, optionally between about 3 grams and about 6 grams; a low- foaming non-ionic washing and wetting agent can be present in an amount between about 2 grams and about 8 grams, optionally between about 3 grams and about 6 grams; and an alpha-amylase enzyme can be present in an amount between aboutDocket No.: 410640-506001 WO0.085 milliliter and about 0.34 milliliter, optionally between about 0.13 milliliter and about 0.26 milliliter. In such conditions, mean clot times can fall within a range between about 4 seconds and about 16 seconds, optionally between about 6 seconds and about 12 seconds.

[0387] A corresponding larger-scale process can use water volumes between about 15 gallons and about 60 gallons, optionally between about 22.5 gallons and about 45 gallons, fabric loads between about 3.3 lb and about 13.2 lb, optionally between about 5 lb and about 8 lb, soda ash between about 2.65 oz and about 10.6 oz, optionally between about 4.0 oz and about 6.5 oz, washing and wetting agent between about 2.65 oz and about 10.6 oz, optionally between about 4.0 oz and about 6.5 oz, and alpha-amylase enzyme between about 0.115 oz and about 0.46 oz, optionally between about 0.17 oz and about 0.34 oz, yielding clot times, for example, between about 6 seconds and about 26 seconds, optionally between about 9.5 seconds and about 16 seconds.

[0388] The technical data sheet for the alpha-amylase enzyme can state an operating pH range in an acidic-to-neutral region, for example between about pH 5.5 and about pH 7.0, optionally between about pH 5.5 and about pH 7.5. Trials in which the wash-cycle pH is adjusted toward this range using an acid such as citric acid can lead to fabrics with noticeable breakage and a fuzzy appearance. Without being bound by theory, such results may be interpreted as indicating that, for a fiberglass substrate having on the order of about 1 % starch binder, optionally within a range from about 0.5% to about 2.0% and optionally within a range from about 0.75% to about 1.25%, enzyme levels effective in the recommended pH range can contribute to damage of the textile.

[0389] In some embodiments, soda ash is reintroduced or maintained in a benchtop formulation similar to that used in the comparative beam process, with water volumes between about 1 .5 liters and about 6 liters, optionally between about 2.25 liters and about 4.5 liters, fabric masses between about 37.5 grams and about 150 grams, optionally between about 56 grams and about 112.5 grams, soda ash amounts between about 2 grams and about 8 grams, optionally between about 3 grams and about 6 grams (corresponding to a bath pH, for example, between about 9.0 and about 12.0, optionally between about 10.0 and about 11.0), and washing and wetting agent and alpha-amylase amounts within ranges similar to those described above.Docket No.: 410640-506001 WO

[0390] Under such conditions, clot times can be reduced to values between about 1 .75 seconds and about 7 seconds, optionally between about 2.5 seconds and about 4.5 seconds, on one knit fabric, and between about 2.15 seconds and about 8.6 seconds, optionally between about 3 seconds and about 5.5 seconds, on another knit fabric variant. Scaling of this chemistry to larger-batch processes can initially produce higher clot times, which can then be further optimized.

[0391] Further benchtop and large-scale trials can be conducted with and without use of softened water while keeping the chemical ratio within ranges described above. Trials conducted without softened water can yield lower clot times. In some embodiments, process scale-up involves fabric quantities between about 7.5 lb and about 30 lb, optionally between about 10 lb and about 20 lb, in the wash cycle, with monitoring to identify the load range in which performance metrics such as clot time begin to trend upward.

[0392] In some embodiments, a drying process includes placing mesh bags containing scoured fabric into a dryer, setting a dryer temperature between about 75 °F and about 300 °F, optionally between about 110 °F and about 190 °F, and continuing drying until a moisture content between about 1 % and about 16% by weight, optionally between about 1 .5% and about 12% by weight and optionally between about 1 % and about 6% by weight, is achieved.

[0393] For example, a batch of fabric with a mass between about 3.3 lb and about 13.2 lb, optionally between about 5 lb and about 8 lb, can reach a moisture range between about 1 % and about 6% by weight, optionally between about 1 .5% and about 4% by weight, in a drying time between about 20 minutes and about 80 minutes, optionally between about 30 minutes and about 50 minutes. After drying, the product can be cooled to room temperature over a period between about 0.5 hour and about 2 hours, optionally between about 0.75 hour and about 1 .25 hours.

[0394] In some embodiments, a conveyor tunnel dryer is operated at a set temperature between about 60 °F and about 240 °F, optionally between about 90 °F and about 150 °F, with the textile laid flat on a belt for passage through the dryer. Flat drying in such a conveyor tunnel dryer can result in less fraying of the fabric compared to certain tumble-drying processes. Additional experiments can be conducted with larger-scale conveyor dryers to identify belt speeds, residence times, and loadings that maintain low fraying and acceptable moisture profiles at increased throughput.Docket No.: 410640-506001 WO

[0395] From our experience, it is contemplated that the following methods of drying can be included: Hot-air convection belt oven; Continuous fabric on a perforated or solid belt, dried by heated circulating air.

[0396] Loop I festoon dryer: Long, hanging or folded loops of fabric passed through a heated chamber for extended residence time.

[0397] Through-air dryer: Heated air blown through the fabric thickness (up-flow or down-flow) for faster, more uniform moisture removal.

[0398] Tenter-frame I stenter drying: Fabric held at the edges and conveyed through a hot-air chamber, with controlled width and over-feed.

[0399] Rotary cylinder I drum dryer: Fabric contacted with large heated cylinders that both transport and dry by conduction and convection.

[0400] Infrared (IR) radiant drying: Gas or electric IR emitters above the strand or belt, optionally combined with warm air flow.

[0401] Radio-frequency (RF) dielectric drying: High-frequency electromagnetic field heats water inside the fabric volumetrically, often coupled with mild hot air.

[0402] Microwave drying: Microwave energy used to heat internal moisture directly, optionally in a tunnel with air flow and exhaust.

[0403] Vacuum oven or vacuum belt dryer: Reduced pressure lowers the boiling point of water so drying proceeds at lower temperatures; fabric can be laid on shelves, drums, or a moving belt.

[0404] Freeze-drying (lyophilization): Fabric frozen and then subjected to vacuum so ice sublimes; highly suitable once thrombin or other temperature-sensitive actives are on the textile.

[0405] Fluidized-bed drying of cut pieces: If the knit fabric is slit into pads or strips, particles or small pieces can be suspended in a rising stream of hot air.

[0406] Desiccant dehumidification dryer: Air first dehumidified with a desiccant wheel or bed, then slightly heated and passed over or through the fabric for low- temperature drying.

[0407] Superheated-steam drying: Fabric exposed to steam above its saturation temperature, which behaves as a drying gas and can improve energy efficiency.

[0408] Contact hot-plate or platen drying: Fabric pressed or laid against a heated metal plate or platen, with or without vacuum on the opposite side.

[0409] Heated calender or nip dryer: Heated rolls in a nip both squeeze out liquid and deliver conductive heat for final moisture removal and calendering.Docket No.: 410640-506001 WO

[0410] Conduction belt (steel-belt) dryer: Fabric transported on a heated metal belt where heat is supplied mainly by conduction from below.

[0411] Hybrid systems: Any combination of the above, for example: IR plus hotair convection, RF pre-heating followed by belt oven, or vacuum-assist on a hot-air loop dryer.

[0412] In some embodiments, a continuous hemostatic textile is pre-cut into lengths between about 12 inches and about 240 inches prior to drying, so that each strand segment can be guided and folded within the available oven footprint.According to some aspects, an acceptable range for pre-cut length is between about 24 inches and about 120 inches, optionally within the range of about 36 inches to about 96 inches for compatibility with common belt widths and folding patterns. In this non-limiting example, shorter lengths in the range of about 24 inches to about 48 inches are selected when tighter control of tension and alignment is desired, whereas longer lengths in the range of about 72 inches to about 120 inches are selected when maximizing throughput and minimizing cutting frequency is preferred.

[0413] In future experiments, in some contemplated embodiments, further process-improvement experiments are conducted following the initial series of benchtop scour trials that began with the equivalent of the current scour process used in the comparative A process and the scaled comparative B formulation that produced clot time averages of about 8 s and about 12.8 s, respectively.

[0414] According to some aspects, a structured experimental matrix is established to dissect the contributions of soda ash concentration, surfactant dosage, alpha-amylase activity, pH profile, water quality, and fabric loading on both clotting performance and fabric integrity.

[0415] In this non-limiting example, soda ash concentration is varied in a first set of trials while Rucogen FWKTMand Rucolase 180™ levels are held constant at values comparable to those used in the improved benchtop trial (for example, 0.68 mL Rucogen FWK and 0.34 mL Rucolase 180 per 3 L scour liquor).

[0416] In some embodiments, soda ash is evaluated over a range of about 1 g to about 8 g per 3 L, optionally within the range of about 2 g to about 5 g per 3 L, and optionally within the range of about 3.5 g to about 4.5 g per 3 L, corresponding to pH values between about 9.0 and about 11 .5. According to some aspects, alpha-amylase activity is monitored across this pH window to identify conditions that provideDocket No.: 410640-506001 WO sufficient starch removal from fiberglass having about 1 % starch binding while minimizing attack on secondary fibers.

[0417] In a second set of experiments, the ratio of Rucogen FWK to Rucolase 180 is modulated at fixed soda ash charge. In some embodiments, the total surfactant plus enzyme concentration is maintained between about 0.5 mL and about 6 mL per 3 L, optionally within the range of about 1 mL to about 4 mL per 3 L, and optionally within the range of about 1 .2 mL to about 2.0 mL per 3 L. According to some aspects, the Rucogen FWK fraction is increased relative to Rucolase 180 in order to probe whether enhanced oil removal and wetting can permit lower enzyme usage while maintaining or improving clot times. Clot time measurements, visual inspection for fuzzing and filament breakage, and residual starch quantification are used as response variables.

[0418] In a non-limiting example, pH adjustment trials with citric acid are revisited using the knowledge that enzyme over-activity at near-neutral pH previously produced noticeable breakage and a fuzzy appearance.

[0419] In some embodiments, the pH during the enzyme stage is limited to a range between about 7.0 and about 10.5, optionally within the range of about 7.5 to about 9.5, and optionally within the range of about 8.0 to about 9.0. According to some aspects, this moderated pH is achieved by partial neutralization of soda ash with citric acid or another organic acid, while retaining sufficient alkalinity to protect cellulose-based components and attenuate enzyme aggressiveness on non-starch substrates.

[0420] Water quality is addressed in a separate factorial series based on the observation that trials performed without softened water resulted in lower clot times.

[0421] In some embodiments, scour liquors are prepared with softened water, partially softened water, and non-softened water, spanning calcium plus magnesium hardness values between about 0 ppm and about 200 ppm, optionally within the range of about 30 ppm to about 150 ppm, and optionally within the range of about 50 ppm to about 100 ppm. According to some aspects, the presence of divalent cations is hypothesized to influence surfactant aggregation, enzyme conformation, and residual surface charge on the glass fibers, which together affect protein adsorption during subsequent hemostatic loading. Clot time, wicking rate, and protein-binding capacity are measured to identify an optimal hardness window.Docket No.: 410640-506001 WO

[0422] Scale-up effects are evaluated by systematically increasing fabric loading in the comparative B washer from the initial 6.6 lbs. to higher masses.

[0423] In some embodiments, fabric mass per batch is varied between about 3 lbs. and about 30 lbs., optionally within the range of about 6 lbs. to about 18 lbs., and optionally within the range of about 10 lbs. to about 15 lbs. According to some aspects, liquor ratio, mechanical agitation (for example, 5 seconds on and 10 seconds off at 27 rpm), and temperature ramp (135-150°F) are held constant, while endpoint properties and spatial uniformity across the load are assessed. Sampling from inner and outer layers of the mesh bags allows evaluation of whether chemical penetration, starch removal, and scour uniformity are load-dependent.

[0424] In this non-limiting example, the mesh-bag geometry and pre-cut strip length (for example, 38", 72", or 92") are also incorporated into the experimental design.

[0425] In some embodiments, strip lengths are evaluated between about 24 inches and about 120 inches, optionally within the range of about 36 inches to about 96 inches, and optionally within the range of about 38 inches to about 92 inches, while bundle sizes of 5-20 strips per bag are tested. According to some aspects, the goal is to minimize tangling and handling defects while maintaining efficient liquor exchange around each strand.

[0426] Drying conditions are then optimized in light of the observation that flat drying in a conveyor tunnel dryer at about 120°F resulted in less fraying than tumble drying at about 150°F.

[0427] In some embodiments, dryer temperature is varied between about 100°F and about 180°F, optionally within the range of about 110°F to about 160°F, and optionally within the range of about 120°F to about 150°F. Residence time is adjusted so that final moisture content lies between about 2% and about 8%, optionally within the range of about 2% to about 5%, and optionally within the range of about 2% to about 3%. According to some aspects, comparative trials between tumble and conveyor configurations are performed at matched moisture endpoints, with fray scores, dimensional stability, and clot times measured after subsequent hemostatic treatment.

[0428] In a further series, benchtop findings are cross-validated on larger-scale loads, for example 15 lbs. and higher, using the optimized scour chemistry (soda ashDocket No.: 410640-506001 WO at about pH 10.5, reduced but non-zero Rucolase 180 dosage, adjusted Rucogen FWK level, and non-softened water) together with the preferred drying profile.

[0429] In some embodiments, acceptable performance is defined as a mean clot time between about 2 s and about 8 s, optionally within the range of about 2 s and about 6 s, and optionally within the range of about 3 s and about 5 s on both circular knit and Yarrington fabrics, with no visually significant fuzzing. According to some aspects, process capability indices are calculated for clot time and key physical attributes to confirm robustness of the improved scour and drying conditions.

[0430] In experiments, various optional (and established) ingredients are then tried. In some embodiments, a series of prophetic bench-scale experiments is conducted to evaluate enzyme systems suitable for preparing a knit hemostatic textile that contains glass fibers and secondary rayon or other cellulosic fibers. According to some aspects, each experiment uses a programmable washer with non-softened water and a liquor ratio between about 20:1 and about 30:1 , while enzyme identity and dosage are varied across trials.

[0431] In this non-limiting example, a baseline desizing formulation employs an a- amylase as the primary enzyme to remove approximately 1 % starch binder from the fiberglass component. The a-amylase is charged at 50-150 ppm, optionally within 75-125 ppm and optionally within 90-130 ppm, at a bath pH between 10.0 and 11.0 and a temperature between 135 °F and 150 °F. In some embodiments, paired trials introduce glucoamylase (amyloglucosidase) at 10-50 ppm to further hydrolyze oligosaccharides generated by a-amylase, with pull samples analyzed for residual starch and liberated glucose.

[0432] According to some aspects, additional trials incorporate [3-amylase at IQ- 50 ppm and pullulanase at 10-40 ppm as debranching enzymes in order to accelerate breakdown of highly branched starches or blended polysaccharide sizes. In this non-limiting example, combinations of a-amylase, glucoamylase, [3-amylase, and pullulanase are arranged in a matrix to compare single-enzyme and multienzyme performance on desizing efficiency, fabric tensile strength, and fuzz scores.

[0433] In some embodiments, a “bioscour-plus” series is performed in which the desizing cocktail is supplemented with hemicellulases such as xylanase and mannanase (5-50 ppm each) and pectinases I pectate lyases (10-100 ppm). According to some aspects, these enzymes are expected to loosen hemicellulosic and pectic materials that may be present as gum residues or minor components ofDocket No.: 410640-506001 WO natural fiber blends, thereby improving wetting and wash-off of lubricants and particulates. Evaluations include wicking height, absorbency, and microscopic inspection of fiber surfaces.

[0434] In this non-limiting example, controlled trials with low-level endoglucanase- type cellulases (1-20 ppm) are conducted to explore gentle surface bio-polishing. In some embodiments, cellulase contact time is limited to 5-15 minutes and the pH is maintained near 7.0-8.5 to reduce risk of rayon strength loss. Fabrics are tested for tensile retention, elongation, and visual smoothness; conditions that produce more than 10% strength loss are excluded from further consideration.

[0435] According to some aspects, parallel experiments address removal of oils and synthetic finishes. For this purpose, lipases, cutinases, and broad-spectrum esterases are included at 10-100 ppm, optionally within 20-60 ppm. These enzymes are introduced into baths that also contain a low-foaming non-ionic surfactant and soda ash, and performance is assessed by measuring residual oil content, contact angle, and detergent demand in subsequent rinses. In some embodiments, a phospholipase is added at 5-20 ppm in trials focused on removal of phospholipid-rich lubricants or biological contaminants.

[0436] In this non-limiting example, additional enzyme systems are evaluated for bioburden reduction and residue control. Neutral or mildly alkaline proteases are introduced at 20-80 ppm in early wash stages that occur prior to any hemostatic protein loading, targeting proteinaceous soils and early biofilms. Lysozyme is optionally added at 5-25 ppm to attack bacterial cell walls. After any oxidizing stages that use hydrogen peroxide, catalase is dosed at 50-200 ppm to decompose residual peroxide and protect subsequent proteins and fibers. In some embodiments, laccase or peroxidase systems are tested at 10-50 ppm together with mediators to explore partial decolorization or modification of persistent organic contaminants, with careful monitoring to avoid damage to rayon or coatings.

[0437] According to some aspects, the outcome of these prophetic experiments is a ranked set of enzyme cocktails that balance desizing efficiency, oil and finish removal, fiber integrity, and downstream hemostatic performance. Candidate formulations that meet preselected criteria for clot time, absorbency, tensile strength, bioburden control, and low residual enzyme are advanced for scale-up and specification setting.Docket No.: 410640-506001 WO

[0438] The experimental framework described in this prophetic experiment above provides a systematic route to transform qualitative observations from early benchtop work into quantitatively defined operating windows for industrial-scale fabric preparation.REFERENCES:1MedlinePlus. Spinal fusion - series — Pedicle screw. https: / / medlineplus.gov / ency / presentations / 100121_6.htm. Accessed Jan. 30, 2024.2IIIPAC. International Union of Pure and Applied Chemistry GoldBook. https: / / goldbook.iupac.org / .3Merriam-Webster's Online Dictionary, https: / / www.merriam-webster.com / .4Porter R. S., & Kaplan, J. L. (Eds.). The Merck manual of diagnosis and therapy (19th ed.).Merck Sharp & Dohme Corp.. 2011 , (978-0-911910-19-3).5Robert S. Porter et al., (eds.). The Encyclopedia of Molecular Cell Biology and MolecularMedicine. Blackwell Science Ltd.; 1999-2012, (9783527600908).6Robert A. Meyers (ed.). Molecular Biology and Biotechnology: A Comprehensive DeskReference. VCH Publishers, Inc.; 1995, (1-56081-569-8).7Luttmann Werner. Immunology. Elsevier; 2006,8Kenneth Murphy Allan Mowat, Casey Weaver (eds.). Janeway's Immunobiology. Taylor &Francis Limited; 2014, (9780815345305).9Krebs Jocelyn E., et al. Lewin's genes XI. 11th ed. Burlington, Mass.: Jones & BartlettLearning; 2014, (1449659055).10Green Michael R. Molecular cloning : a laboratory manual / Michael R. Green, JosephSambrook. Cold Spring Harbor, N.Y: Cold Spring Harbor Laboratory Press; 2012, (1936113414).11Davis et al. Basic Methods in Molecular Biology. Elsevier Science Publishing, Inc.; 2012,(044460149X).12Jon Lorsch (ed.). Laboratory Methods in Enzymology: DNA. Elsevier; 2013,(0124199542).13Frederick M. Ausubel (ed.). Current Protocols in Molecular Biology (CPMB). John Wiley and Sons 2014, (9780471503385).14John E. Coligan (ed.). Current Protocols in Protein Science (CPPS). John Wiley andSons, Inc.; 2005,15John E. Coligan ADA M Kruisbeek, David H Margulies, Ethan M Shevach, Warren Strobe,(eds.) Current Protocols in Immunology (CPI). John Wiley and Sons, Inc.; 2003, (9780471142737).PCT Patent ApplicationDocket No.: 410640-506001 WO

[0439] All patents and other publications; including literature references, issued patents, published patent applications, and co-pending patent applications; cited throughout this application are expressly incorporated herein by reference for the purpose of describing and disclosing, for example, the methodologies described in such publications that might be used in connection with the technology described herein. These publications are provided solely for their disclosure prior to the filing date of the present application. Nothing in this regard should be construed as an admission that the inventors are not entitled to antedate such disclosure by virtue of prior invention or for any other reason. All statements as to the date or representation as to the contents of these documents is based on the information available to the applicants and does not constitute any admission as to the correctness of the dates or contents of these documents.

[0440] The foregoing written specification is considered to be sufficient to enable one skilled in the art to practice the present aspects and embodiments. The present aspects and embodiments are not to be limited in scope by examples provided, since the examples are intended as a single illustration of one aspect and other functionally equivalent embodiments are within the scope of the disclosure. Various modifications in addition to those shown and described herein will become apparent to those skilled in the art from the foregoing description and fall within the scope of the appended claims. The advantages and objects described herein are not necessarily encompassed by each embodiment. Those skilled in the art will recognize or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments described herein. Such equivalents are intended to be encompassed by the following exemplary claims.

Claims

Docket No.: 410640-506001 WOCLAIMSWe claim:1 . A method of manufacturing a hemostatic textile, the method comprising:(a) knitting glass fibers with secondary fibers to form a knit textile;(b) scouring the textile in a programmable laundry machine through sequential solutions comprising an alkaline solution, a detergent-containing solution, and an enzyme-containing solution while applying drum-rotation cycles including on / off agitation at a drum speed below 50 rpm and a controlled temperature progression across the sequential solutions;(c) rinsing and spin-drying the textile; and(d) drying the textile to yield a hemostatic textile.

2. The method of claim 1 , wherein the enzyme comprises an alpha-amylase.

3. The method of claim 1 or 2, wherein the on / off rotation comprises rotation-on for t1 seconds followed by rotation-off for t2 seconds with t2 greater than t1 .

4. The method of any of claims 1 -3, wherein the temperature progression comprises holding a first bath at about 130-140 °F and a subsequent bath at a temperature at least 4 °F higher than the first bath.

5. The method of any of claims 1-4, further comprising operating the laundry machine during draining at about 50-150 rpm and during spin-drying at about 500- 1500 rpm.

6. The method of any of claims 1-5, wherein the textile is enclosed in a containment bag during scouring, the containment bag comprising a mesh bag or a toroidal doughnut bag.

7. The method of any of claims 1 -6, wherein the secondary fibers comprise rayon and the textile optionally includes radiopaque fibers.Docket No.: 410640-506001 WO8. The method of any of claims 1 -7, further comprising cutting a roll of the knit textile into multiple textile units prior to scouring to reduce post-scour handling and contamination.

9. The method of claim 8, wherein the roll is pre-cut into textile strips having prescour lengths in a range from 30 inches to 100 inches, optionally within a range from 36 inches to 80 inches and optionally within a range from 38 inches to 92 inches, the strips being grouped into bundles of about ten strips and secured within mesh bags having a target filled bag weight between 1 .5 lb and 3.0 lb.

10. The method of any of claims 1 -9, wherein the sequential solutions are prepared from non-softened water having a hardness of at least 50 ppm as CaCO3, optionally within a range from 50 ppm to 200 ppm and optionally within a range from 70 ppm to 150 ppm, and wherein an alkaline scouring bath comprises sodium carbonate, a low-foaming non-ionic detergent, and an alpha-amylase enzyme concentrate present at a weight ratio of about 10:1 :1 (sodium carbonate:detergent:enzyme), optionally wherein, for a bath volume between about 15 gallons and about 45 gallons, the alkaline scouring bath comprises sodium carbonate in an amount between about 2.5 oz and about 8.0 oz, the low-foaming non-ionic detergent in an amount between about 0.25 oz and about 0.75 oz, and the alpha-amylase enzyme concentrate in an amount between about 0.25 oz and about 0.75 oz, optionally within a narrower range in which, for a bath volume between about 22 gallons and about 38 gallons, the alkaline scouring bath comprises sodium carbonate in an amount between about 4.0 oz and about 6.5 oz, the low-foaming non-ionic detergent in an amount between about 0.4 oz and about 0.6 oz, and the alpha-amylase enzyme concentrate in an amount between about 0.4 oz and about 0.6 oz, thereby providing a bath pH between 10 and 11 .11 . The method of any of claims 1 -10, wherein scouring in the programmable laundry machine comprises:(a) a pre-wash phase in which water fills to a preset level, soda ash is added, and the drum is operated at a speed between about 10 rpm and about 60 rpm, optionally between about 20 rpm and about 35 rpm, in a gentle reverse on / off cycle in which a rotation-on interval is between about 2.5 seconds and about 10 seconds and aDocket No.: 410640-506001 WO rotation-off interval is between about 5 seconds and about 20 seconds, optionally with a rotation-on interval between about 3.75 seconds and about 6.25 seconds and a rotation-off interval between about 7.5 seconds and about 12.5 seconds, for a total pre-wash duration between about 2.5 minutes and about 10 minutes, optionally between about 3.75 minutes and about 6.25 minutes;(b) a soda-ash phase in which water is at a temperature between about 70 °F and about 270 °F, optionally between about 120 °F and about 160 °F and optionally between about 130 °F and about 140 °F, is supplemented with soda ash, and is agitated in the gentle reverse on / off cycle defined in step (a) for a duration between about 0.5 minute and about 2 minutes, optionally between about 0.75 minute and about 1.25 minutes, without draining;(c) a detergent phase in which water is at a temperature between about 70 °F and about 280 °F, optionally between about 120 °F and about 170 °F and optionally between about 135 °F and about 145 °F, a low-foaming non-ionic washing and wetting agent is added, and the drum is operated in the gentle reverse on / off cycle defined in step (a) for a duration between about 0.5 minute and about 2 minutes, optionally between about 0.75 minute and about 1.25 minutes, without draining;(d) an enzyme phase in which water is at a temperature between about 70 °F and about 290 °F, optionally between about 120 °F and about 180 °F and optionally between about 135 °F and about 155 °F, an alpha-amylase enzyme is added, and the drum is operated in the gentle reverse on / off cycle defined in step (a) for a duration between about 0.5 minute and about 2 minutes, optionally between about 0.75 minute and about 1.25 minutes, without draining; and(e) a wash phase in which the bath temperature is increased to a temperature between about 75 °F and about 300 °F, optionally between about 130 °F and about 190 °F and optionally between about 140 °F and about 160 °F, and the drum is operated in the gentle reverse on / off cycle defined in step (a) for a duration between about 5 minutes and about 20 minutes, optionally between about 7.5 minutes and about 12.5 minutes, prior to draining, optionally wherein the alpha-amylase enzyme comprises a Rucolase 180 alphaamylase formulation.

12. The method of any of claims 1-11 , wherein rinsing comprises three sequential rinses, each rinse being carried out at a water temperature between about 60 °F andDocket No.: 410640-506001 WO about 240 °F, optionally between about 90 °F and about 150 °F and optionally between about 110 °F and about 130 °F, and wherein each rinse includes drum rotation at a speed between about 10 rpm and about 60 rpm, optionally between about 20 rpm and about 35 rpm, in the gentle reverse on / off cycle defined in claim 11 for a duration between about 1 .5 minutes and about 6 minutes, optionally between about 2.25 minutes and about 3.75 minutes, followed by draining at a speed between about 50 rpm and about 200 rpm, optionally between about 75 rpm and about 125 rpm, for a duration between about 1 minute and about 4 minutes, optionally between about 1 .5 minutes and about 2.5 minutes, and an extract step at a speed between about 500 rpm and about 1900 rpm, optionally between about 700 rpm and about 1200 rpm; and wherein a final extract step is performed at a speed between about 500 rpm and about 1900 rpm, optionally between about 700 rpm and about 1200 rpm, for a duration between about 2.5 minutes and about 10 minutes, optionally between about 3.75 minutes and about 6.25 minutes.

13. The method of any of claims 1-12, wherein the scouring solution in the laundry machine provides an alpha-amylase concentration between about 25 ppm and about 200 ppm, optionally between about 50 ppm and about 150 ppm and optionally between about 75 ppm and about 125 ppm, relative to a mass of water, and wherein the sodium carbonate concentration is selected such that the scouring bath has a pH between about 10.0 and about 11.0, optionally between about 10.3 and about 10.8 and optionally about 10.5.

14. The method of any of claims 1 -13, wherein drying is performed by tumbledrying in a commercial laundry dryer at an air temperature between about 70 °F and about 300 °F, optionally between about 110 °F and about 190 °F and optionally between about 140 °F and about 160 °F, until a fabric moisture content between about 2% and about 8% by weight, optionally between about 3% and about 5% by weight and optionally between about 2% and about 3% by weight, is achieved.

15. The method of any of claims 1 -14, wherein drying is alternatively or additionally performed by feeding a continuous strand of the scoured textile onto a moving belt at an entrance of a hot-air convection oven while using a guide rail and nip roll to fold the strand into stacked layers, the oven being operated at an airDocket No.: 410640-506001 WO temperature between about 60 °F and about 240 °F, optionally between about 90 °F and about 150 °F and optionally between about 100 °F and about 150 °F, and with a belt speed selected to obtain the fabric moisture content defined in claim 14.

16. The method of any of claims 1 -15, wherein drying shrinks the secondary fibers and forms loops of the glass fibers that protrude from at least one surface of the textile and increase exposed glass surface area and textile stretchability.

17. The method of any of claims 1-16, further comprising sterilizing a packaged textile or a packaged textile bandage by gamma irradiation or ultraviolet irradiation.

18. The method of any of claims 1 -17, wherein pre-scour textile unit dimensions are selected to account for about 50% area shrinkage such that at least one prescour dimension is at least 1 .5 times a target finished dimension.

19. The method of any of claims 1-18, wherein the knit textile is produced on a narrow V-bed flat knitting machine in a half-gauge configuration to provide closed long edges, and finished units have a width of about 2-8 inches and a length of at least 24 inches.

20. The method of any of claims 1 -19, further comprising after scouring neutralizing residual alkali with a citrate buffer rinse.21 . The method of any of claims 1 -20, further comprising depositing a calciumphosphate coating on the glass fibers by radio-frequency plasma and annealing, the plasma being conducted with controlled oxygen partial pressure.

22. A scouring composition for cleaning a knit hemostatic textile, the composition consisting essentially of water, 0.5-2 wt% sodium carbonate, 0.2-1 wt% fatty-alcohol- ethoxylate non-ionic surfactant, and 50-150 ppm alpha-amylase enzyme, the solution having a pH between 10 and 11 at 135-150 °F.

23. The composition of claim 22, further comprising 0.05-0.2 wt% ethylenediaminetetraacetic acid (EDTA) to sequester divalent metal ions.Docket No.: 410640-506001 WO24. The composition of claim 22 or 23, wherein the water source has a hardness less than 50 ppm as CaCO3.

25. The composition of any of claims 22-24, configured for use in a front-loading drum operating at about 25-35 rpm with a liquor ratio of about 20:1 to 30:1 .

26. The composition of any of claims 22-25, for use in a process wherein sodium carbonate is added at about 135 °F, detergent at about 140 °F, and the alphaamylase at about 145 °F.

27. The composition of any of claims 22-26, wherein the detergent, enzyme, and sodium carbonate are present at a weight ratio of about 5:1 :5.

28. The composition of any of claims 22-27, wherein sodium carbonate, the low- foaming non-ionic detergent, and the alpha-amylase enzyme concentrate are present in a weight ratio of about 10:1 :1 (sodium carbonate:detergent:enzyme), optionally wherein, for a bath volume between about 15 gallons and about 60 gallons, the composition comprises sodium carbonate in an amount between about 2.65 oz and about 10.6 oz, the low-foaming non-ionic detergent in an amount between about 0.25 oz and about 1 .0 oz, and the alpha-amylase enzyme concentrate in an amount between about 0.25 oz and about 1 .0 oz, optionally within a narrower range in which, for a bath volume between about 22.5 gallons and about 37.5 gallons, the composition comprises sodium carbonate in an amount between about 4.0 oz and about 6.5 oz, the low-foaming non-ionic detergent in an amount between about 0.4 oz and about 0.6 oz, and the alpha-amylase enzyme concentrate in an amount between about 0.4 oz and about 0.6 oz, and wherein the composition is prepared with non-softened water having a hardness within a range from 50 ppm to 200 ppm as CaCO3.

29. The composition of any of claims 22-28, wherein the composition is used while agitating a knit textile with on / off rotation cycles below 50 rpm during liquid scouring.Docket No.: 410640-506001 WO30. A knit hemostatic textile comprising:(a) a first plurality of glass fibers arranged as pile loops exposed on at least one surface; and(b) a second plurality of rayon fibers interknit with the glass fibers, wherein the textile is stretch-enhanced as a result of scouring and drying and is optionally configured for wound packing.31 . The textile of claim 30, further comprising radiopaque fibers.

32. The textile of claim 30 or 31 , wherein the textile comprises about 65% glass fibers and about 35% rayon, the rayon comprising bamboo-sourced rayon.

33. The textile of any of claims 30-32, wherein the knit is produced in a relaxed configuration to promote fluid interaction with pile fibers.

34. The textile of any of claims 30-33, wherein the knit is formed in a half-gauge configuration to produce enlarged carryover loops.

35. The textile of any of claims 30-34, wherein opposite long edges have closed stitches and short edges are left raw or are serged.

36. The textile of any of claims 30-35, wherein loops of the glass fibers protrude as a result of de-sizing of the rayon fibers, thereby increasing exposed glass surface area and textile stretchability.

37. A toroidal containment bag for scouring textiles, comprising a flexible body configured to zip into a closed loop and to hold a large-area knit textile wound circumferentially to form a stacked loop of fabric.

38. The bag of claim 37, wherein the bag reduces tangles, knots, and creases during scouring.

39. The bag of claim 37 or 38, configured for use within a front-loading laundrymachine drum.Docket No.: 410640-506001 WO40. The bag of any of claims 37-39, comprising a mesh construction that reduces abrasive effects of agitation on the textile.41 . The bag of any of claims 37-40, wherein the bag is loaded by rotating the unzipped bag in a circumferential direction while continuously feeding the knit textile to form the stacked loop before zipping closed.

42. The bag of any of claims 37-41 , wherein the bag confines a continuously knit textile produced on a narrow V-bed flat knitting machine.

43. A method of sterile packaging a hemostatic textile or a hemostatic textile bandage, comprising:(a) sealing the textile or bandage in a moisture-barrier pouch;(b) irradiating the sealed pouch to sterilize the textile or bandage; and(c) including in the pouch a metal-ion-sequestering EDTA component to bind trace metals following sterilization.

44. The method of claim 43, wherein irradiating comprises gamma irradiation.

45. The method of claim 43, wherein irradiating comprises ultraviolet irradiation.

46. The method of any of claims 43-45, further comprising controlled cooling after irradiation to mitigate thermal stress.

47. The method of any of claims 43-46, wherein the pouch is EDTA-lined.

48. The method of any of claims 43-47, wherein the pouch is sealed after drying of the textile or bandage and the packaged textile or packaged bandage is stored in a moisture-barrier environment after sterilization.

49. The method of any of claims 1 -19, further comprising controlling process parameters such that, prior to terminal sterilization, a bioburden of the textile is less than or equal to 1000 colony-forming units (CFU) per device, optionally within aDocket No.: 410640-506001 WO range from 1 CFU to 300 CFU per device and optionally within a range from 1 CFU to 100 CFU per device.

50. The method of any of claims 1 -19, further comprising controlling process parameters such that a finished, sterilized hemostatic textile has an endotoxin content of not more than 20 endotoxin units (EU) per device when tested by a Limulus Amebocyte Lysate assay, optionally within a range from 0.01 EU to 10 EU per device and optionally within a range from 0.05 EU to 2 EU per device.51 . The method of claim 14, wherein the fabric moisture content after drying is less than or equal to 5% by weight, optionally within a range from 0.1 % to 4% by weight and optionally within a range from 0.1 % to 3% by weight.

52. The textile of any of claims 30-36, sealed within a moisture-barrier package and sterilized, wherein the sterilized textile has an endotoxin content of not more than 20 endotoxin units per device, optionally within a range from 0.01 endotoxin units to 10 endotoxin units per device and optionally within a range from 0.05 endotoxin units to 2 endotoxin units per device.

53. The textile of claim 52, wherein a moisture content of the sterilized textile at package release is less than or equal to 5% by weight, optionally within a range from 0.1% to 4% by weight and optionally within a range from 0.1 % to 3% by weight.

54. The textile of any of claims 30-36, prior to terminal sterilization, having a bioburden of less than or equal to 1000 CFU per device, optionally within a range from 1 CFU to 300 CFU per device and optionally within a range from 1 CFU to 100 CFU per device.

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