Classifications

• • A—HUMAN NECESSITIES
  • A41—WEARING APPAREL
  • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
  • A41D19/00—Gloves
  • A41D19/015—Protective gloves
• • A—HUMAN NECESSITIES
  • A41—WEARING APPAREL
  • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
  • A41D19/00—Gloves
  • A41D19/015—Protective gloves
  • A41D19/01505—Protective gloves resistant to mechanical aggressions, e.g. cutting. piercing
• • A—HUMAN NECESSITIES
  • A41—WEARING APPAREL
  • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
  • A41D19/00—Gloves
  • A41D19/001—Linings
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B42/00—Surgical gloves; Finger-stalls specially adapted for surgery; Devices for handling or treatment thereof

Definitions

• the invention relates to gloves and glove systems, particularly surgical gloves and glove systems offering one or more of puncture resistance, a pathogen barrier, and/or suitable dexterity, tactility, and comfort for the wearer.
• Surgical gloves are typically made from natural rubber latex or a synthetic elastomer such as polyisoprene. Gloves manufactured from these highly elastic, low modulus materials closely conform to the wearers hand and bend and stretch easily to allow free hand movement while providing the requisite barrier to penetration by blood and bodily fluids that is an integral function of a surgical glove.
• latex gloves offer a vanishingly small level of resistance to puncture by a hypodermic or suture needle.
• Bloodborne diseases, including HIV and hepatitis may be transmitted from patient to the healthcare worker in the event of a needle stick injury. Due to the fatal and irreversible consequences of contracting HIV, there is a need for a glove that can protect surgeons and healthcare workers by resisting puncture by a medical needle.
• ideal surgical gloves or glove systems need to offer protection against mechanical aggressors, (e.g. needles, sharp bone fragments or other surgical instruments), while also providing the barrier to bloodborne pathogen hazards.
• mechanical aggressors e.g. needles, sharp bone fragments or other surgical instruments
• these gloves should provide this protection while still allowing the wearer to perform his or her job without undue hindrance.
• the high-strength fibrous materials are often present in the form of a woven textile (See, e.g. United States Patent No. 4,742,578 to Seid). These woven textiles are engineered to have high yarn counts with minimal space between yarns to prevent a needle from slipping between yarns without engaging the fabric.
• Dense woven materials can sometimes provide a degree of needle protection, but the high fiber modulus and yarn count means that the materials may be quite stiff compared to a latex surgical glove. Nonetheless, woven materials are often marketed as flexible puncture protection, since the stiffness is not so great as to completely prevent movement of the finger and hand joints.
• the glove material ideally should also conform to fine details and textures and provide a high degree of tactile sensitivity. Such sensitivity is critical to allowing a surgeon to successfully palpate tissue and diagnose the patient. Dense, stiff or thick materials do not afford sufficient tactile sensation to allow unhindered performance of operations requiring tactile feedback.
• Kevlar® gloves only led to small increases in the time to complete simple motor tests, such as manipulations with forceps (Phillips, Birch and ibbans, Ann. R. Coll. Surg. Engl., Vol. 79, p. 124, 1997).
• tests requiring tactile evaluation such as comparing the textures of two objects, surgeons took up to twice as long to complete the task while wearing the puncture-resistant liners as compared to latex gloves.
• liners also increased the frequency of errors to greater than 25%, as compared to less than 5% for latex gloves. While a protective glove may permit the surgeon to perform basic motor operations with an acceptable level of hindrance, such gloves may be detrimental to operations requiring fine tactile sensation.
• Knit textiles are typically more flexible than wovens. Knit high-modulus fibers have therefore been considered for puncture protective materials, but these knits may still lack the close fit and high tactile sensitivity desirable for surgical use.
• U.S. Patent 5,564,127 to Manne describes a surgical glove comprising a panel of knitted textile made from a high strength material, such as steel, affixed to one aspect of a barrier glove, but such a glove is believed to have less-than-ideal flexibility.
• Other references describe gloves that utilize hard, discontinuous plates distributed on or within a fabric or elastomer. Examples of materials or gloves comprising puncture resistant plates on a fabric or polymer backing are described in U.S. Patent No. 5,601,895 to Cunningham, U.S. Patents No. 6,962,739 and No. 7,018,692 to Kim et al. and U.S. Patent No.
• One aspect of the invention comprises a glove or partial glove comprising a palmar portion configured to be worn adjacent the palmar aspect of the wearer's hand and a dorsal portion configured to be worn adjacent the dorsal aspect of the wearer's hand, each of the palmar portion and the dorsal portion comprising one or more finger/thumb extensions, the palmar portion and dorsal portion joined together at a sealed seam, the seam positioned such that when worn by the user, the seam on each of the finger/thumb extensions is positioned adjacent the dorsal aspect of the user's finger/thumb with the palmar aspect extending over the fingertip in a hood-like configuration.
• the portion of the seam closest to the fingertip may be aligned with the middle of each fingernail.
• each of the palmar portion and the dorsal portion may comprise a shear-thickening-fluid-treated textile base.
• the palmar portion and the dorsal portion may each have a multi-ply construction, wherein each ply comprises a shear-thickening-fluid-treated textile base.
• Multi-ply embodiments may comprise at least two plies of calendered, knit textile intercalated with the shear-thickening fluid, with the plies oriented such that warp directions of the two plies are oriented at 90 degrees relative to one another.
• the glove may have a plurality of panels intercalated with shear-thickening fluid, wherein the shear-thickening-fluid- intercalated panels cover one or more selected sections of the wearer's hand consisting of less than all of the wearer's hand.
• the textile base may comprise a knit fabric, such as a warp knit or an interlock knit, or may comprise a woven or non-woven textile.
• the textile base may be calendered.
• the glove may comprise a pathogen barrier, such as a coating that is impervious to blood and bloodborne pathogens.
• the back portion of the glove may have one or more features for facilitating donning, such as, for example a stretchable donning panel or a slit in the dorsal portion.
• the glove may have an adjustable fit, such as embodiments comprising a drawstring or an elastic band inserted within a casing at or near a lower opening edge of the glove.
• a partial glove embodiment may comprise a calendered, knit textile intercalated with shear-thickening fluid configured to provide puncture protection to the thumb, index finger, middle finger, all or a portion of the palmar aspect of the hand, all or a portion of the dorsal aspect of the hand, or a combination thereof.
• Another aspect of the invention is a glove system comprising a first glove or partial glove component having a sealed seam with the seam on each of the
• the first glove or partial glove component comprises a textile base treated with a shear- thickening fluid.
• the glove system may further comprise a second latex or synthetic surgical glove component worn on top of the first glove component, and, optionally, a third latex or synthetic surgical glove worn underneath the first glove component.
• the second glove is sized and materials of
• the first glove or partial glove component comprises a two-ply palmar portion, a two-ply dorsal portion, and a discrete outer layer configured to serve as a pathogen layer.
• FIG. 1A is a schematic drawing of an exemplary glove embodiment of the present invention, shown from the palm side for a right hand.
• FIG. IB is a schematic drawing of an exemplary glove embodiment, shown from the dorsal side for a left hand.
• FIG. 1C is a schematic drawing of the exemplary glove embodiment of FIG. IB showing in dashed lines a user's hand inserted in the glove.
• FIG. ID is a schematic drawing of an exemplary glove embodiment having a flared cuff.
• FIG. IE is a schematic drawing of an exemplary glove embodiment having elastic bands integrated therein.
• FIG. IF is a schematic drawing of an exemplary glove embodiment having a drawcord integrated therein.
• FIG. 1G is a schematic drawing of an exemplary glove embodiment having a pair of fasteners integrated therein.
• FIG. 1H is a schematic drawing of an exemplary glove embodiment having a slit along a dorsal aspect with a VELCRO® hook and loop closure.
• FIG. II is a schematic drawing of an exemplary glove embodiment having a slit along a dorsal aspect of the hand with a zipper closure.
• FIG. 1J is a schematic drawing of an exemplary glove embodiment having a stretchable donning panel on a dorsal aspect.
• FIG. IK is a schematic drawing of an exemplary partial glove embodiment.
• FIG. 1L is a schematic drawing of the exemplary partial glove embodiment of FIG. IK on a wearer's hand.
• FIG. 2 is a schematic drawing of an exemplary warp knit structure.
• FIG. 3A is a schematic illustration of an exemplary thermal lamination process.
• FIG. 3B is a schematic illustration of an exemplary blade coating process.
• FIGS. 4A-4C are schematic illustrations of exemplary seam configurations.
• FIG. 5A is a schematic illustration of a cross section of an exemplary interlock structure before calendering.
• FIG. 5B is a schematic illustration of a cross section of the exemplary interlock structure of FIG. 5A after calendering.
• FIG. 6 is a schematic illustration of an exemplary test circuit for testing puncture resistance of materials.
• FIG. 7 is a schematic illustration of an exemplary test apparatus for testing puncture resistance of materials.
• the various aspects of the invention comprise a glove, partial glove, or system of gloves having one or more innovative features as described in more detail herein, any one, some, or all of which may be present.
• Each of these features is described herein separately and in combination with one or more of the other features. While each of these features may be suitable for practice in connection with a glove component or glove system having only a single feature as described herein, it should be understood that a glove component or glove system having any one of these features may be combined with the features described in one or more of the other sections, even if not explicitly discussed herein.
• a surgical glove or glove system that: 1) is resistant to needle puncture, 2) affords the wearer a level of tactile sensitivity that is comparable to conventional latex gloves, and 3) provides a barrier to blood, bodily fluids and bloodborne pathogens.
• Various embodiments of the present invention described herein are resistant to puncture by medical needles and have materials and construction geometry selected to provide a higher degree of tactile sensitivity than existing puncture resistant gloves.
• Some embodiments may be constructed from multiple panels of a textile knit from a low modulus, multi-filament yarn, such as polyester.
• the use of a knit textile construction and low modulus fiber for the yarns allows such a glove to conform to fine details or textures of objects and tissues undergoing manipulation, thereby affording the wearer excellent tactile sensitivity.
• the knit is designed to have a high density and minimal stretch.
• the knit textile may be further subjected to a calendering process, in which heat and pressure are applied to decrease space between yarns. Tests showed improved puncture resistance for STF-treated calendered fabrics as compared to the same STF- treated fabrics that had not been subjected to a calendering process.
• the knit textile may be intercalated with a shear-thickening fluid to provide a means for a yarn to locally rigidize upon application of stress via contact with a needle tip.
• the knit construction and density are such that, when the yarn under stress rigidizes, it is unable to move out of the path of the needle to create a window for puncture.
• the textile construction may be such that the local rigidization aids in the transfer of load from the yarn under primary stress to those fibers that are entangled with the primary yarn in the knit.
• the knit construction and calendering process described above ensure a needle must engage a yarn and cannot pass through inter-yarn spaces in the textile.
• Some preferred embodiments further comprise a barrier to bloodborne pathogens created by wearing a sterile, elastic surgical glove on top of the knit, shear-thickening fluid intercalated glove.
• the elastic glove also applies a compressive force over substantially the entire area of the hand.
• the compression of the textile glove by the outer elastic glove reduces open areas in the knit, thus favorably impacting the puncture resistance and tactile sensitivity.
• the textile glove may be worn between two elastic gloves to provide additional barrier protection in the event of a breach in the outermost elastic glove.
• the barrier to bloodborne pathogens may be created by coating or laminating the textile with a film of a suitable material, such as silicone, polyurethane or natural or synthetic latex.
• a suitable material such as silicone, polyurethane or natural or synthetic latex.
• the coating or laminate may be attached to the textile using a suitable process to minimize the amount by which the coating penetrates into the knit, thereby minimizing any increase in the stiffness of the entire structure.
• Another feature of some preferred embodiments of the invention comprise assembly of a three-dimensional glove shape from multiple panels of flat fabric.
• the shapes of said panels are such that, for the portions enclosing the finger stalls, a single panel covers the volar aspect and a portion of the sides of each finger. Additionally, at the distal end of the finger stall, the panel covering the volar aspect of the finger curves up and around towards the dorsal aspect to permit a single panel to cover substantially all of the fingertip. Panels of this shape allow the seams to be located away from areas of the finger that are critical for tactile tasks like palpation.
• Alternative embodiments may have welded seams in the textile instead of sewed seams to further decrease seam bulk and improve sensitivity.
• the above features create a glove or glove system embodiment in which the wearer has excellent tactile sensitivity and may detect when an imminent threat of needle injury exists.
• the shear-thickening fluid intercalated knit acts to resist initial penetration of the glove to enable the wearer to remove his hand and/or cease the application of force to the needle. It should be understood, however, that gloves or glove systems containing fewer than all, including embodiments with only one of the features described herein, may still be an advance over the prior art and may be advantageous in certain embodiments even without being combined with other features discussed herein.
• one aspect of the invention comprises a glove or glove system, such as to be worn during surgery, that provides an improved level of protection against accidental puncture injury.
• the glove is constructed from a low- modulus yarn with a textile construction sufficient to provide a very high degree of flexibility over short length scales to afford the wearer excellent tactile sensitivity.
• low-modulus is used herein to refer generally to yarns with a You ng's Modulus in a range that includes materials such as polypropylene, polyester, and nylon, which have a very low modulus in a range of 1 - 3 GPa, as well as any material in the range of 1-30 GPa, which is well below the range of relatively high modulus materials such as, for example, Kevlar ( ⁇ 70 GPa) and steel.
• the glove construction locates seams away from critical areas on the fingers.
• one aspect of the invention comprises a textile-based, close-fitting glove or glove-system designed and assembled with as few seams as possible, each seam strategically positioned so as not to hinder the user's dexterity, tactile sensitivity and comfort.
• the system can be thinner and lighter, thereby having a minimal impact on the dexterity and tactile sensitivity of the wearer.
• Single glove embodiments are more convenient to don and are advantageous in situations where gloves may need to be rapidly donned or changed (such as in emergency rooms or if a doctor is moving from one operating room to another) .
• Multi-glove systems as described herein are designed to minimize the number of gloves in the system and maximize dexterity and tactile sensitivity.
• Multi-ply gloves and glove systems as described herein avoid the pitfalls of single ply textile materials that may be more susceptible to penetration because the tip of the needle can slip in between fibers/yarns before the thicker portions of the needle are fully engaged by the protective textile.
• Such multi-ply systems overcome the lack of spatial homogeneity in some knit or woven textiles, which have a relatively greater chance of a sharp needle point finding a small void space in the knit/weave without engaging the fibers.
• Multi-ply constructions disclosed herein counteract the ability of a small needle tip to penetrate the textile with minimal force. Because the two-ply STF-textile composite is more flexible than traditional puncture-resistant materials, it does not interfere with tactile sensitivity.
• one embodiment comprises a glove for wearing on a user's hand, the glove comprising a palmar portion and a back portion, each of the palmar portion and the back portion comprising a plurality of finger/thumb extensions, the palmar portion and back portion joined together at a sealed seam, the seam positioned such that when worn by the user, the seam on the finger/thumb extensions is positioned adjacent the back side of the user's fingers and the palmar portion extends over the fingertips in a hood-like configuration.
• the palmar portion may extend over the wearer's fingertips such that the seam closest to the fingertip is aligned with the middle of each nail.
• the back portion of a glove having any or all of the features described above may further comprise a stretchable donning panel, such a panel comprising an elastomeric film, or other features for improving donning.
• a stretchable donning panel such as a panel comprising an elastomeric film, or other features for improving donning.
• the glove, including the seams and the donning panel, where present, may comprise a barrier that is pathogen resistant.
• An exemplary seam construction for the glove assembly is a heat- or radio frequency-sealed simple lap seam configuration, whereby the seam is made by overlapping the seam allowances of each ply, each ply extending in the opposite direction from each other. This configuration reduces the amount of bulk in the seam allowance against the skin, making it more comfortable to the wearer and maximizing the wearer's tactile sensitivity.
• Another seam construction takes the traditional "needle- and-thread" assembly approach, utilizing a super-imposed plain seam that is sealed with seam tape or sewn with a low-temperature melting thread.
• a super-imposed plain seam may be assembled whereby the two or more plies are stacked one on top of the other with the edges even and sewing them together near the edge. Meltable thread, when heated, melts to permit the flowing polymer of the melted thread to fill the holes created by a sewing needle and the seam allowance spaces between the holes.
• Seam tape may be of any seam sealing formulation designed to make a seam impermeable.
• the palmar portion and the back portion each may comprise a shear-thickening-fluid-treated (STF-treated) textile base.
• the palmar portion and the back portion each may have a multi-ply construction, such as a two-ply construction, wherein each ply comprises a STF-treated textile base.
• the feature of a glove having a multi-ply STF-treated textile base may be used in conjunction with any type of glove design, including gloves not having only some or none of the other features described herein.
• any of the glove embodiments described herein may further comprise a barrier that is resistant to bloodborne or other bodily-fluid-borne pathogens, such as but not limited to viral or bacterial pathogens (referred to hereinafter generally as a "pathogen barrier”) .
• the pathogen barrier may comprise a coating on one or more of the plies of the palmar portion and the back portion, such as a coating material selected from the group consisting of: silicones, polyurethanes, fluoropolymers, and natural or synthetic latexes.
• the pathogen barrier coating overlaid on the STF-treated textile base may be a product of a blade coating process.
• the pathogen barrier may comprise an outer layer in the form of a laminate, such as a laminate over a seamed two-ply palmar and back portion, all of which together may comprise an underglove component.
• This discrete outer layer pathogen barrier may be in addition to a separate overglove, typically made from a latex material, specifically natural rubber latex, poly(chloroprene), nitrile or, ideally, poly(isoprene), that is donned subsequently after donning the underglove.
• one aspect of the invention is a glove system comprising an overglove and an underglove.
• the seamed two-ply palmar and back textile portions as described herein, optionally having its own pathogen barrier as described herein, may comprise the underglove.
• the pathogen barrier on the textile underglove permits use of a 2-glove system, rather than prior art 3-glove systems in which a cut-resistant textile glove liner is sandwiched between two rubber or synthetic rubber gloves.
• the 2-glove system permits improved tactile sensitivity for the wearer over 3-glove systems.
• the use of an overglove made from a stretchable material also tends to compress the underglove against the hand of the user, thereby further improving sensitivity.
• gloves described herein may still be used in 3-glove systems, and that such systems may have advantages over prior art 3-glove systems.
• Textiles made from low modulus materials generally have a high degree of flexibility and can be made into a comfortable glove.
• Low modulus yarns can easily move out of the path of a needle, however, and may not offer much puncture resistance on their own. It is desirable, therefore, to create a surgical glove made from a material that normally has a very low stiffness to allow superior tactile sensitivity and freedom of movement, but that instantaneously stiffens to provide puncture resistance when a needle contacts the fabric.
• a shear thickening fluid Wor and Brady, Phys. Today, Vol. 62, p. 28, 2009, incorporated herein by reference. Shear thickening is a shear thickening fluid (Wagner and Brady, Phys. Today, Vol. 62, p. 28, 2009, incorporated herein by reference). Shear thickening is a shear thickening fluid (Wagner and Brady, Phys. Today, Vol. 62, p. 28, 2009, incorporated herein by reference). Shear thickening is
• shear-thickening occurs due to hydrodynamic clustering of particles accompanied by very large lubrication forces.
• a material in the shear-thickened state is resistant to flow and is capable of dissipating large amounts of energy.
• Shear-thickening fluids have properties that have been found useful in the design of dampers (US Published Patent Application 2004/0173422 by
• one or more of the features, embodiments, or aspects described herein may be of particular utility when used in connection with composite fabric materials, such as a knit textile material that has been treated with a shear thickening fluid (STF), such as is described in US. Patent App. No. 7,226,878; No.
• STF shear thickening fluid
• the textile material base may comprise a nylon textile treated with STF.
• the textile material base may comprise polyester, nylon, aramid, fiberglass, polyethylene, polypropylene, thermotropic liquid crystal polymer (such as VECTRAN®), or a combination of any of the foregoing.
• High- performance versions of polyester, nylon, and polyethylene may be particularly well suited for use as a textile base material.
• An exemplary shear-thickening fluid comprises a concentrated colloidal suspension of ceramic particles in a polymeric solvent.
• the material behaves as a liquid at low shear rates/stresses, but transitions to solid-like behavior when subjected to high shear rates/stresses, such as those that are experienced at the sharp tip of a needle.
• the amount of STF added varies depending on the textile construction, but, for example, for a knit nylon of 100 g/m 2 , adding a mass of about 100 g/m 2 STF will provide acceptable performance.
• the invention is not limited to any particular formulation or ratio of STF relative to the underlying textile.
• One feature comprises a glove having seams that are placed in locations away from the fingertip and finger nail regions, and with a reduced number of seams in the fingertip region. Seams generally can interfere with the user's dexterity, tactile sensitivity and comfort.
• the palmar region of the glove and fingers is oversized such that it extends to the back of the user's hand 102. Accordingly, the cut panel 104 corresponding to the back of the glove has a relatively narrower dimension as compared to over-sized palmar region panel 106.
• Panel 106 is attached to the relatively narrower back panel 104 such that the seams 107 are located along the back side of the fingers instead of the traditional way of sewing a glove in which the seams are located along the sides of the fingers and connected at the finger crotch region with a gusset.
• the extended fabric panels create a hood-like effect over the fingertip/nail, and the excess fabric is gathered up or shirred to be attached to the back narrow panel.
• the "hood" 108 around the finger-tip is configured such that the seam 107 is aligned with the middle of the wearer's nail 109, the seam may preferably be located adjacent any portion of the back of the user's finger, or positioned anywhere that is away from the portions of the fingers and hand where tactile sensitivity is important.
• a stretchable section 110 may be provided on the back of the glove as an aid in donning the glove.
• This "donning panel” may comprise a stretchable, resilient fabric, such as but not limited to, a nylon/spandex blended material.
• the donning panel may comprise a stretchable, resilient material that is radio-frequency (RF) sealable and that is water resistant / waterproof for providing resistance to penetration of bloodborne pathogens, such as a thermoplastic elastomer with non-skin-irritating properties, including but not limited to a urethane film.
• RF radio-frequency
• the glove may comprise a placket or linear opening along the dorsal aspect of the hand to facilitate sterile donning of the glove.
• the glove may be flared in the direction of the wrist, permitting the glove material to be cut to form a slit, and a desired width of glove material folded under or over adjacent the slit to create a reinforced area of a desired width on either side of the placket.
• a gusset comprising a fabric facing or other additional materials may also be used for reinforcement.
• Such a design may have an adjustable fit, such as by providing the glove with a closure on opposite sides of slit 112 that permit a wearer of the glove to adjust the fit.
• Exemplary closures may comprise a zipper 114, as shown in FIG.
• the glove may have an adjustable fit as provided by a drawcord or drawstring 118 as illustrated in FIG. IF.
• an elastic cord or elastic band 120, 122 inserted within a casing at or near a lower opening edge 120 and/or at the mid-back of the hand 122 on a dorsal side of the glove may permit a wearer to adjust how the glove fits to the wearer's hand as shown in FIG. IE.
• the glove may have a flared cuff 128, as shown in FIG. ID, or the cuff may comprise other types of fasteners for creating an adjustable and/or tight fit, such as hook and loop fasteners 124 and 126 depicted in FIG. 1G.
• the seams may be joined in a number of ways.
• a first configuration illustrated in FIG. 4A
• the regions 400A, 402A to be seamed may be stacked on top of each other with raw edges 404A, 406A, respectively, even and fastened together with stitching 408A near the edge.
• arrows PI and P2 show the ply direction for the textile corresponding to each portion to be seamed.
• a second configuration illustrated in FIG.
• the seam allowances of the components 400B, 402B may be overlapped with the plies extending in the opposite direction from each other and fastened with stitch 408B in the overlapping region, such as down the center of the overlap, although the invention is not limited to any particular location within the overlap region in which the components may be joined.
• This configuration reduces bulk at the seam, and has been found to enhance comfort and fit to wearer relative to some other configurations.
• the raw edges 404C, 406C of the components to be seamed may be abutted to each other or slightly overlapped and sewn together with stitching 408C. This configuration also reduces bulk at the seam, and has been found to enhance comfort and fit to wearer relative to some other configurations.
• the stitch holes, pores between the stitch holes and raw edges may be sealed tight by taping them with a narrow strip of sealable material, as is known in the art.
• the seams may also or instead be stitched with meltable or fusible thread.
• the seams may be joined by any means known in the art for imparting an impenetrable seam, such as by gluing, ultrasonically bonding, laser welding, radio-frequency (RF) welding, or heat sealing by any means known in the art.
• partial glove 150 may comprise a textile, such as a calendered, knit textile, intercalated with shear-thickening fluid configured to provide puncture protection to one or more selected areas of the hand, such as but not limited to the thumb 151, the index finger 152, the middle finger 153, all or a portion of the palmar aspect (not shown) and dorsal aspects 154 of the hand, or a combination thereof.
• a partial glove may have a strap 155 or other features for securing it to the user's hand 156.
• the partial glove feature is not limited, however, to coverage of any particular region or regions of a wearer's hand.
• the partial glove may be a component in a glove system that includes a first latex or synthetic surgical glove for wearing over the partial glove and a second latex or synthetic surgical glove for wearing under the partial glove.
• the glove may comprise a plurality of panels intercalated with shear-thickening fluid, wherein the shear-thickening-fluid-intercalated panels cover one or more selected sections of the wearer's hand consisting of less than all of the wearer's hand.
• the selected sections to be covered may be those areas most likely to be by a puncture or a cut in the application for which the gloves are designed.
• gloves such as disposable surgical gloves, may have STF panels only in areas where needle sticks or cuts with surgical equipment are most likely to occur.
• the base textile such as the textile impregnated with an STF material as described above, may comprise a multiple-bar, warp-knitted structure, composed of a multi-filament, micro-denier textured yarn.
• the multi-bar structure and the multi-filament yarn together produce a tightly packed, multi-layer structure that may be further compacted via a calendering process known in the art, resulting in a
• the calendering process may impart at least two advantages: (1) it compresses the structure to make it thinner and (2) it pushes the yarns together to further reduce the inter-yarn spaces, or pore-size.
• FIG. 2 A lap diagram corresponding to an exemplary suitable warp knit structure is depicted in FIG. 2.
• An exemplary textile base warp knit structure may comprise a lock knit with middle lay-in construction, with a finest gauge (such as 32 or 36), 3-bars, fully threaded machine type.
• the dashed line ( ) represents the back guide bar having a 2-2/0-0// stitch notation
• the dotted line (. . . ) represents the middle guide bar having a 1-0/1-2/// stitch notation
• the solid line ( ) represents the front guide bar, having a 1-0/4-5// stitch notation.
• the base textile such as the textile impregnated with an STF material as described above, may comprise a circular double knit composed of a multi-filament, micro-denier textured yarn.
• the double knit structure and the multifilament yarn together produce a tightly packed, two-layer structure that may be further compacted via a calendering process known in the art, resulting in a "calendered" textile.
• the base textile may comprise an interlock structure as is well known in the art, for example as depicted in Spencer, David J. Knitting
• An exemplary textile base interlock structure may comprise the finest gauge (such as 42 or 50) machine type.
• An important characteristic of an ideal textile base for STF-applications is high yarn density (the number of yarns in a unit area for both the warp and weft directions).
• One way to achieve this is by utilizing a micro-denier yarn.
• the fineness or diameter of a fiber typically directly affects a fabric's handle and flexural rigidity. Very fine filaments and their resultant yarns will produce a fabric with fluid drape. Coarse filaments and their resultant yarns will produce a fabric that is more rigid.
• embodiments of the present invention have been constructed with a 20 denier/17 filament, 30 denier/34 filament and 40 denier/68 filament yarns, and 70 denier/68 filament yarns.
• the invention is not limited, however, to any particular denier or filament values or combinations.
• One aspect of the invention comprises a textile-based surgical glove that offers protection against mechanical aggressors, (e.g. needles, sharp bone fragments or other surgical instruments) while also providing the barrier to bloodborne or other bodily-fluid- borne pathogens, such as but not limited to viruses or bacteria, which is a requirement in a surgical glove.
• mechanical aggressors e.g. needles, sharp bone fragments or other surgical instruments
• pathogens such as but not limited to viruses or bacteria
• Barrier functionality may be created by coating or laminating the textile glove with an appropriate material, such as a polyurethane, silicone, fluorinated polymer, polyisoprene or natural latex.
• the barrier may be present on one or both sides of the textile.
• the barrier material is applied to the textile using a controlled process to ensure that the coating material penetrates only minimally into the textile. Such low degree of barrier penetration creates a material that retains a high degree of flexibility and dexterity when made into a glove.
• a polyurethane laminate is one example of a coating that is capable of providing pathogen barrier functionality with minimal effect on flexibility.
• Polyurethane films are inherently flexible and elastic. Lamination of polyurethane films onto the textile may be accomplished through the use of hot melt lamination or through the use of a suitable adhesive, as is known in the art. Preliminary testing showed that thermal lamination could attach a polyurethane film to a knit polyester textile while maintaining the favorable flexural properties of the base textile.
• a schematic of the thermal lamination process is shown in Figure 3A. Textile 201 and polyurethane film 202 are fed to a set of rollers 203 and 204. The top roller 203 is heated to a temperature that partially melts the polyurethane film or adhesive applied to the film.
• the laminated textile exits the roller zone, cools and the film is securely adhered to the textile.
• textiles were prepared in which the barrier was created by dipping the fabric in latex.
• the latex dipped materials were stiff and would produce a glove with relatively poor dexterity and tactility. The stiffness of the dipped textile is believed to have been a result of the latex penetrating completely through the textile during the dipping process
• An alternative exemplary embodiment comprises a silicone elastomer coating bound onto a knit Nylon textile.
• This coating may be applied using a method such as blade coating, as is known in the art.
• blade coating As is known in the art.
• FIG 3. One such blade coating configuration, a blade- over-roll, is shown in Figure 3.
• a liquid polymer precursor or melt 301 is applied to a fabric 302 that is passed over a roller 303.
• a doctor blade 304 is set to have a controlled blade angle and gap between the roll.
• Properties such as the roller speed, blade gap, blade angle, polymer viscosity, textile porosity and wetting properties can be used to control the thickness of the coating as well as the degree of penetration, as is known in the art. Controlling the process to produce a continuous coating with only a small degree of penetration can be used to produce a textile 305 that retains a high degree of flexibility.
• the glove may be assembled by a cut-and-sew process or by using a heat/ultrasonic/RF sealing method as is known in the art.
• Materials such as seam tapes may be used to seal the seams of a sewn glove.
• Heat-sealed seams may be made water/pathogen proof by selecting the appropriate coating polymer (typically polyurethane) and controlling the heat sealing process to ensure the seams are completely sealed.
• a coating material or lami nate layer as described above may be applied to one or both surfaces of the STF-treated textile.
• Exemplary coatings may comprise a silicone, polyurethane, fluoropolymer, natural or synthetic latex, or any other material that is capable of forming a pathogen barrier.
• the invention is not limited to any particular type of pathogen barrier material, when present.
• An additional aspect of the invention comprises a glove system in which an additional latex or synthetic surgical glove is donned over a puncture-resistant textile glove.
• the textile itself may not be coated with a pathogen barrier, such that the outer glove provides primary barrier functionality.
• the textile glove may be worn in between two latex gloves to provide additional barrier protection.
• the outermost glove may be of a size that permits the outer glove to apply a compressive force when donned. The compressive force will act on the textile glove to urge a close fit with the wearer's hand. The compression will also act in a manner that may decrease spacing between yarns in the textile and therefore favorably impact the tactility and puncture resistance offered by the glove system.
• the void space between fibers/yarns may be referred to as a window, and the ability to penetrate such a window may be referred to as "windowing.”
• a multi-ply construction is used to counteract the ability of a small needle tip to penetrate the textile with minimal force.
• a second or subsequent layer of the textile maintains a barrier even if the first layer is defeated via a void.
• the layers of the textile may be assembled such that the orientation of the fabric in the top layer is rotated, such as at an angle of 90 degrees, relative to the bottom layer. The 90-degree rotation minimizes the chance of the holes in each layer aligning because of some pattern of the knit construction or direction.
• the needle is likely to penetrate with minimal resistance 5% of the time, for a single ply.
• the chance of hitting no fibers on the way through the textile is reduced to 0.25%, particularly if the orientation of the weave in adjacent plies are 90 degrees rotated relative to one another to minimize the possibility of the windows in one ply aligning with the windows in the other.
• denser fabric constructions having less void space, a larger relative reduction in the incidence of unhindered puncture is expected.
• a two-ply STF-textile composite is more flexible than the traditional puncture- resistant materials and does not interfere with tactile sensitivity.
• one embodiment comprises a glove constructed from two layers of knit Nylon textile treated with shear-thickening fluid.
• the nylon textile is lightweight, thin and flexible and thus allows for good dexterity and tactile sensitivity. Knit nylon does not have significant resistance to puncture by a surgical or hypodermic needle, however, so adding a shear- thickening fluid increases the puncture resistance of the glove. While a two-ply construction with each ply offset 90 degrees from one another may be adequate to impart a desirable amount of additional protection while maintaining flexibility for most applications, the invention is not limited to any particular number of plies or orientation of those plies.
• a two-point discrimination test administered to surgeons showed that 2-ply gloves as described herein scored markedly better than published scores for other puncture resistant products. Puncture testing performed on an artificial finger, such as using the exemplary puncture testing apparatus referenced herein previously, showed that the puncture resistance of the 2-ply construction showed substantial increase over a 1-ply construction. More importantly, the minimum force required to puncture the material (i.e. the force when a needle slips through the void space) for the two-ply construction increased from effectively zero for the one ply textile, to a value exceeding the one-ply average.
• the plies may be joined at the seams in a number of ways, such as those shown in FIGS. 4A-4C and described previously.
• the stitch holes, pores between the stitch holes and raw edges may be sealed tight by taping them with a narrow strip of sealable material, as is known in the art.
• the seams may also or instead be stitched with meltable or fusible thread.
• the seams may be joined by any means known in the art for imparting an impenetrable seam, such as by gluing, ultrasonically bonding, laser welding, radio-frequency (RF) welding, or heat sealing by any means known in the art.
• the underglove preferably comprises a textile or textile-composite material that is engineered to have enhanced resistance to puncture in the form of a glove or partial glove having one or more of the various features described above.
• the underglove component may comprise a full glove or a partial glove covering less than all the wearer's hand, as described above.
• the underglove is worn underneath a conventional latex or non-latex surgical glove, which may or may not be attached to the underglove.
• another conventional latex or non-latex surgical glove may be worn underneath the textile or textile-composite underglove component.
• a textile was made from a 70 denier polyester yarn with 68 filaments per yarn.
• the textile was an interlock knit prepared on a 42-gauge machine with the final knit having 62 wales/inch and 58 courses/inch.
• the shear thickening fluid was prepared by dispersing amorphous, spherical, silica particles in 200 average molecular weight polyethylene glycol.
• the pa rticles were Nan- O-Sil silica, supplied by Energy Strategy Associates of Old Chatham, NY. The particles were dispersed to 60 wt% in the suspension.
• the rheology of the suspension was measured using an AR2000 rheometer from TA Instruments with a 40 mm 2 degree cone and plate geometry. Rheological measurements showed that the suspension shear thickened at an applied shear stress of approximately 30 Pa.
• Silica/polyethylene glycol shear thickening fluid was intercalated into the knit textile using the following process.
• the shear thickening suspension was diluted in ethanol at a ratio of 1.05 grams of ethanol to 1 grams of suspension.
• Pieces of interlock knit textile were dipped into an agitated bath containing ethanol-diluted shear thickening fluid for 1 minute.
• the textile was removed from the bath and run through a set of nip rollers to remove excess liquid. Textile samples were then hung in a convection oven at 60 °C for one hour to remove the ethanol. Samples were stored in a sealed bag with desiccant to maintain dryness.
• Puncture resistance was measured on an Instron 4021 load frame controlled by a computer with Bluehill 2 software. Puncture probes were 21 gauge Precision-GlideTM hypodermic needles manufactured by Becton-Dickinson, part number 305167. Needles were attached to a +/- 100N load cell connected to the load frame. Test samples were mounted on a custom sample holder consisting of a steel base plate upon which was placed the elastic conductive backing material. Samples were placed between the conductive backing and a top plate with 1 cm holes at the puncture test sites. The top plate was secured using four bolts located at 0, 90, 180 and 270 degree positions.
• the apparatus provides an electronic indication when barrier properties are lost during puncture testing.
• the electronic puncture detection circuit provides a clear indication of when a test material has been punctured, even if the puncture point is not noticeable on a force-displacement curve.
• a schematic illustration of the puncture detection circuit is shown in the circuit diagram of Fig. 6, the apparatus comprises a simple circuit 600 comprising an electronic buzzer or other electrical detector/alarm 602 connected to a battery or voltage source 604 and two leads 606 and 608.
• the circuit and software were configured to apply a 10V excitation voltage to the detection circuit.
• One test lead was connected to the needle and the other was connected to the conductive backing.
• the circuit was calibrated in the Bluehill 2 software so that the Strain 1 channel indicated a value of 0 when the circuit was open and 1 when the needle contacted the backing and completed the circuit. Since the materials in the puncture tests were non-conductive, there was a sharp jump in the Strain 1 signal when the needle breached the test sample that allowed precise determination of the puncture point. Testing has shown that the puncture forces determined using the current test method with electronic puncture detection are lower than the puncture forces found using standard test methods which determine the puncture force solely from force-displacement curve data.
• FIG. 7 An exemplary testing apparatus is shown in Figure 7. Testing was conducted on a load testing frame 40 consisting of a crosshead 41 connected to a drive apparatus 42, such as a screw drive, on each end that was capable of lowering or raising the crosshead at a fixed rate.
• a load cell 43 was securely affixed to the mobile crosshead.
• the puncture probe 44 was securely attached to the load cell. Electrical connections were made between the load cell 43 and a signal acquisition connection on the load frame 46 through wire 51.
• the puncture probe 44 and conductive backing 45 were each connected to separate terminals on another signal acquisition connection through wires 52 and 53, respectively. Wires 52 and 53 connected to a channel on the load frame suited to recording a strain gage signal.
• the apparatus described herein provides an indication, such as an alarm, when barrier properties are lost during puncture testing.
• a processor attached to the mechanism for measuring force and to the apparatus for measuring displacement of the probe was configured to calculate force-displacement as the conductive probe was advanced.
• the apparatus further comprised a display for displaying the force-displacement curve in real time.
• the electrical signal from the indicator circuit was also provided to the processor so that the point when the material is breached may be correlated with the force and displacement at the time of the breach.
• test specimen 70 was placed on top of the conductive backing 45.
• the computer processor 60 programmed with appropriate software was used to control the load frame to lower the crosshead 41 and attached puncture probe 44 into the specimen at a controlled rate.
• Connection 50 also enables the computer 60 to record the load cell and puncture detection circuit signals to produce curves of force and detection circuit signal as a function of probe displacement.
• the elastic conductive backing was a silicone rubber containing 25 wt% milled carbon fibers (Fortafil 341 from TohoTenax).
• the filled rubber was prepared by dispersing the carbon fibers in the base poly(dimethyl siloxane) of a two-part Sylgard® 184 kit manufactured by Dow-Corning. The fiber filled base was degassed under vacuum. Curing agent from the Sylgard® kit was added in the ratio of 1 part curing agent to 10 parts base and was throughly mixed into the silicone base/carbon fiber. The mixture was then gently poured into a dish-shaped mold and was degassed under gentle vacuum. The filled silicone rubber was cured at 70 °C for 2 hours. Electrical resistance was measured by gently pressing the leads of a digital multimeter into the surface of the carbon fiber PDMS at a spacing of approximately 2 cm . The measured resistance was approximately 300 ohm .
• Puncture testing was performed on the knit textile with the textile sample placed between two pieces of latex to simulate the actual clinical use conditions in which the textile will reside between latex gloves or have an elastomeric barrier coating. Each test recorded the force and puncture probe displacement as the probe was lowered into the test specimen at a speed of 10 mm/min. The puncture force for each specimen was defined as the force measured by the load cell at the point when the puncture detection circuit attached to the Strain 1 channel showed a jump in signal. Tests were performed on a single textile layer and with two textile layers, with the layers offset by 90 degrees. Table 2 summarizes the average puncture forces from 12 puncture tests on the various configurations. The puncture resistance of latex double gloving is shown for comparison.
• a two-point discrimination test was administered with a Disk-Criminator apparatus to measure the tactile sensitivity offered by the various glove configurations.
• the methodology of such a test is described in Fry et al., "Influence of Double-Gloving on Manual Dexterity and Tactile Sensation of Surgeons," J. Am. Coll. Surg. , 210: 325-30, March 2010, incorporated herein by reference.

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• 2011
  • 2011-04-07 US US13/639,740 patent/US20130139294A1/en not_active Abandoned
  • 2011-04-07 WO PCT/US2011/031546 patent/WO2011127259A2/en active Application Filing
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