AU2005299900A1

AU2005299900A1 - Compression garment with integral donning aid

Info

Publication number: AU2005299900A1
Application number: AU2005299900A
Authority: AU
Inventors: Stefan Bodenschatz; Juergen Friederich Heinz Greve; John David Loveless; Simon Myron Yakopson
Original assignee: BSN Jobst Inc
Current assignee: BSN Medical Inc
Priority date: 2004-10-26
Filing date: 2005-10-18
Publication date: 2006-05-04
Also published as: EP1804752A1; US20060085894A1; MX2007005067A; CA2585158A1; AU2005299900A2; JP2008518123A; WO2006047153A1; ZA200703949B

Description

WO 2006/047153 PCT/US2005/037476 COMPRESSION GARMENT WITH INTEGRAL DONNING AID BACKGROUND OF THE INVENTION This invention relates to a medical compression garment having an integral donning aid. More particularly, this invention relates to compression stockings having a low friction zone made with the addition of or completely from low 5 friction yams or by coating/laminating of the inside surface of a garment with the low friction materials. Description of Related Art Therapeutic medical compression garments have been used on a relatively 10 wide scale to assist in the prevention of venous diseases and/or embolism in a patient. The purpose of such garments is to overcome the elevated internal pressures within a human extremity caused by gravity or disease processes. The pressure gradient garments, such as stockings and their uses are well documented in the literature. 15 The custom pressure gradient stocking was developed by Conrad Jobst, a sufferer of venous disease. Mr. Jobst found relief from his problem while standing in a swimming pool. Mr. Jobst reasoned that the water pressure in the pool, which increases with depth, cancelled out the internal pressure in the veins of his leg. Jobst and others have identified a need to apply a relatively large 20 compressive force in proximity to the ankle. See, J. Homer, et al., Br Med J., pp. zz: 820-821 (1980) wherein it is stated "the greater the compression gradient ,between the ankle and calf produced by the stocking, the lower the ambulatory pressures." Cited in U.S. Patent No. 5,823,195. Therapeutic medical graduated compression stockings are designed to 25 provide sufficient external circumferential counter pressure to maintain the normal WO 2006/047153 PCT/US2005/037476 venous and lymphatic pressures at a given level in the extremity, thus assisting the movement of venous blood and lymph from the extremity. Another important effect of compression is the reduction of the venous volume. Reduction of venous volume leads to an increase of the venous flow velocity. H.J.L. van Gerwen, 5 Pressure gradient tolerance in compression hosiery. Katholike Universiteit Nijmegen, pp.

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10 5 (1994). For compression garments to be most effective, higher pressures are required in the ankle area. The most difficult part of putting compression garments (stockings) on is to pull the narrowest part of the garment over the wider end of a 10 limb (foot-instep-heel for stockings or hand for arm-sleeves). There are special donning devices made from slick fabric that a patient should put on a leg before donning compression stocking. Use of these devices makes putting stocking on more complicated, sometimes requires help from another person and, also, requires purchase of such additional devices. 15 A variety of therapeutic medical graduated compression stockings are on the market today. Stockings of various descriptions have been proposed. Unfortunately, therapeutic stockings, in order to provide the necessary compression, are often thick and rather unsightly or have other drawbacks. An example of a therapeutic stocking is shown in US Patent No. 3,975,929 which 20 describes a thigh length anti-embolism stocking made with alternating courses of covered spandex yarn on a circular hosiery knitting machine. Another example of a therapeutic stocking is described in U.S. Patent No. 4,069,515 to Swallow, et al., which discloses a non-slip therapeutic stocking having a covered elastomeric yarn (spandex core-nylon covering) inlaid into every other course of the jersey knit 25 stitches made of stretch nylon. In particular, the Swallow patent describes the foot portion as having alternating courses ofj ersey knit stitches of non-elastomeric yarn. Because higher compressive forces are used in compression stocking U.S. Patent No. 6,613,007 to Reid, Jr. discloses a multi-layer compression stocking. 30 One of the problems of a multi-layer stocking is that it is difficult to coordinate the compressive pressures applied by each layer to achieve a desired pressure. Reid proposed to solve this problem by including in the layers alignment markings to -2- WO 2006/047153 PCT/US2005/037476 assist a wearer in positioning the layers on the leg. There is disclosed a stocking comprising a plurality of layers including an under-layer and at least one oOver layer, each of which have predetermined amounts of compressive stress at discrete locations. The under-layer may include yams with high strength and low 5 coefficient of friction properties incorporated into the fabric. Areas of the stocking including the toe, top of the instep and heel may be reinforced in such a manner to reduce the chance of skin breakdown and to reinforce the stocking fabric with yams of high strength and low coefficient of friction properties. Several individual stockings are necessary to produce the multi-layered system which increases 10 production costs and price to the customer. Also it is difficult to provide an exact match of the different zones especially for dark colored fabrics, avoid wrinkling and shifting of the underlying stocking, while pulling the upper stocking over it. U.S. Patent No. 6,415,449 to Duplock discloses a survival garment made of high stretch elastomer designed to protect the wearer from the effects of immersion 15 in cold water. The garment has "skin tight" fittings at the cuffs and sleeve s that may be made from an elastic material that comprises a high stretch elastomer coated with a material of low friction, such as neoprene, for allowing easy donning and doffing of the garment. A patch of low friction coefficient material placed either on the skin or on 20 the surface that will be next to the skin in locations where sheer trauma is likely to occur is disclosed in U.S. Patent No. 6,362,387 to Carlson et al. Therein is disclosed a patch of low friction material such as a film of polytetrafluoroethylene sized to provide an area of low friction support for a portion of a human body relative to an object such as a shoe or prosthetic sock. The layer of low friction 25 material is adhered to the surface of the object that bears on the skin and faces the skin such as a sock fabric. In a preferred embodiment PTFE is bonded to a fabric layer of Lycra. U.S. Patent No. 5,829,057 to Gunn discloses an article such as clothing, footwear and the like which incorporate fabrics or chemicals having low 30 coefficient of friction. The patent notes that some material fibers inherently have a low coefficient of friction, such as TEFLON*, KYNAR* and GORTEX*. In addition, the use of chemicals to treat material fibers or finished materials that do -3 - WO 2006/047153 PCT/US2005/037476 not inherently have a low coefficient of friction is taught. The articles incorporating fabrics with chemicals with a low coefficient of friction are intended to minimize the development of irritations, blisters and calluses including gloves, shoes and sportswear. 5 BRIEF SUMMARY OF THE INVENTION It is an object of the present invention to provide a medical compression garment having an integral donning aid. Another object of the present invention is to provide a compression 10 garments having a low friction zone made with the addition of or completely from low friction yams or by coating/laminating of the inside surface of a gannent with the low friction materials. Yet another object of the present invention is the provision of an easy donning aid embedded in a stocking at discrete locations that provides more 15 comfort for the patient and increases compliance and use of medical compression garments. It has been found that the foregoing objects may be accomplished in accordance -with this invention by providing compression garments of this invention having a low friction zone made with the addition of low friction 20 material on the inside surface of a garment in discrete locations to decrease friction between skin and fabric, thus providing easier donning of compression garments. Low friction yams may be positioned in a specific pattern or plated together with other yams, or used in combination with other yams, preferably with highly stretchable spandex yams to compensate for low elongation of PTFE yams. 25 Depending on the manufacturing methods, circular or flat-bed knitted, the low friction area should be positioned at the inside of the garment. To provide better contact with the patient's skin it is advantageous to use covered spandex with low friction yarns, "so called" inlay yam in circular knitted products. In a first embodiment, the medical compression garments (stocking, arm 30 sleeve, gauntlet, glove, or other) of this invention have an integral donning aid that is knitted into the main portion of the garment that contains elastic yams and exerts pressure on the corresponding body part. There is at least one integral donning -4- WO 2006/047153 PCT/US2005/037476 area deferring a low friction zone strategically located on the internal surface of the garment (e.g. at the narrowest and critical for donning process parts of the garment) to facilitate donning of the garment and improve patients' compliance. 5 BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) Having thus described the invention in general tenms, reference will now be made to the accompanying drawings, which are not necessarily drawn to scale, and wherein: FIG. 1 illustrates a side view of an embodiment of a garment of the present 10 invention showing courses of low friction yarn encircling the foot between the heel and the calf in a discrete area of the instep; FIG. 2 illustrates a side view of another embodiiient of a garment of the present invention showing courses of low friction yam encircling the foot between the heel and the calf; 15 FIG. 3 illustrates a side view of an embodiment of a garment of the present invention showing courses of inlaid yarn covered with P"TFE yard encircling the area from just above the ankle to the lower calf; FIG. 4 illustrates a side view of an embodiment of a garment of the present invention showing courses of knitting yarn made of sparidex covered with PTFE 20 yard encircling the calf area just above the ankle; FIG. 5 illustrates a side view of another embodiment of a garment of the present invention showing strips of low friction material attached to the inside surface of the knitted fabric in specific areas; FIG. 6 illustrates a side view of an embodiment of a garment of the present 25 invention showing dots of low friction material attached to the inside surface of the knitted fabric; FIG. 7 illustrates a side view of an embodiment of a garment of the present invention showing a patch of elastic fabric containing low friction yarn sewn to the inside of a garment; 30 FIG. 8 illustrates a side view of an embodiment of a garment of the present invention showing a low friction coating applied to the inside of a garment, such as a stocking; -5- WO 2006/047153 PCT/US2005/037476 FIG. 9 illustrates the inner side of a flat knitted stocking before sewing the sides together having a low friction zone in the ankle, heel and foot areas; FIG. 10 illustrates the inner side of a flat knitted stocking before se-wing the sides together showing a low friction zone in a discrete portion of the ankle area; 5 and FIG. 11 illustrates the inner side of a flat knitted stocking before sewing the sides together showing a low friction zone surrounding the ankle. DETAILED DESCRIPTION OF THE INVENTION 10 The present inventions now will be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the invention are shown. Indeed, these inventions may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy 15 applicable legal requirements. Like numbers refer to like elements throughout. The compression garments of this invention have a low friction zone made with the addition of or completely from low friction yams or by coating/la-minating of the inside surface of a garment with the low friction materials to decrea-se friction between skin and fabric, thus providing easier donning of compression 20 garments. Medical compression garments can be produced as seamless garments using circular knitting machines, or seamed knitted garments made using flat-bed knitting machines, or sewn from elastic fabric using proportional design to provide necessary compression level at specified positions on the limb or body. The design of compression garments of this invention needs to combine two opposite 25 requirements: provide easy donning and at the same time prevent sliding during wearing. Therefore, it is important to understand that low friction material can be used only at specified locations, because using material through the complete garment will result in sliding of the garment from the limb and losing of its therapeutic effect. 30 In a first embodiment, the medical compression garments (stocking, arm sleeve, gauntlet, glove, or other) of this invention have an integral donning aid that is knitted into the main portion of the garment that contains elastic yams and exerts -6- WO 2006/047153 PCT/US2005/037476 pressure on the corresponding body part. There is at least one integral donning area deferring a low friction zone strategically located on the internal surface of the garment (e.g. at the narrowest and critical for donning process parts of the garment) to facilitate donning of the garment and improve patients' compliance. 5 FIGs. land 2 illustrates an embodiment of a compression stocking 10 of the present invention that includes a toe area 12, a foot area 14, a heel area 16 and calf area 18. The compression stocking 10 includes courses of low friction yam forming a zone 20 encircling the foot and another zone 22 encircling the lower calf. The low friction zone is extended from just above the heel to approximately 10 the point where the Achilles tendon joins to the calf muscle. This point is known as position bl in compression hosiery terminology. Such configuration allows reducing friction at the most critical zones of the highest compression while at the same time providing correct fixation of the product at the toe and heel an4d sufficient grip at the calf to prevent the stocking from sliding. It should be 15 understood that zone 22, while shown in FIG. 1 as encircling the calf, may also be limited to partially encircling the calf as will be appreciated by those skilled in the art. In FIG. 1 there is provided a discrete zone of low friction yarn located between the ankle and the knee area, covering the upper side of the instep in the zone 24. A smooth transition in construction may be accomplished, for example, 20 by programming a knitting machine to include the low friction yams. While stocking 10 is depicted as knee length, stocking of other lengths may also be utilized in accordance with the present invention. Low friction yams made of different materials can be used, including but not limited to polytetrafluoroethylene (PTFE) homopolymer yams: Profilen 25 (Lenzing), Tenara and/or Rastex (Gore) Teflon (DuPont); melt spun fluoropolymeric fibers made of hexafluoropropylene and of tetrafluoro ethylene hexafluoroproplyene copolymers (DuPont U.s. pant No. 6,048,481), polyamide yarns modified with ultra-high molecular weight silicone and known as FreelonTM fiber, yams made: of physical blends of polyamide or polyester with PTFE or with 30 meltable fluoropolymers, nylon and polyester yarns with surface modified with silicone, and other yams with the coefficient of friction at least 30% lower than that of the other yams used to make a garment, i.e. nylon, polyester, cotton, or the -7- WO 2006/047153 PCT/US2005/037476 like. Other materials applicable for the purpose of this invention include, but are not limited to, low friction tapes, films and liquids, including P'TFE suspensions, capable of creation of necessary patterns on specified low friction zones of the garment and made of PTFE, polychlorotrifluoroethylene (PCTFE), 5 poly(vinylidene) fluoride, poly(vinyl) fluoride copolymer, fluorinated ethylene propylene and other copolymer and blends of fluoro- containing polymers, and silicone polymers and copolymers. The low friction material is applied in such a way that it will not affect stretch and compression characteristics of the garment. In one embodiment, low 10 friction material is integrally knitted in the garment or woven in the fabric. Low friction yarns may be positioned in a specific pattern or plated together with other yarns, or used in combination with other yarns, preferably witl1 highly stretchable spandex yarns to compensate for low elongation of PTFE yams. Depending on the manufacturing methods, circular or flat-bed knitted the low friction area should be 15 positioned at the inside of the garment. To provide better contact with the patient's skin it is advantageous to use low friction yarns, as knitting or "so called" inlay yarn in circular and flat-bed knitted products. Another embodiment of a stocking 10 of the present invention is shown in FIG. 3 wherein courses of inlaid yarn covered with low friction material encircles 20 the calf area in zone 22 just above the ankle. To provide easier donning, but prevent the stocking from sliding, the zone is extended from just above the heel to the point where the Achilles tendon joins to the calf muscle known as position bl. FIG. 4 illustrates an embodiment of the present invention showing a stocking 10 having courses of low resistance yarn made of spandex covered with PTFE 25 encircling the ankle area in zone 22 immediately above the heel. In another embodiment a low friction permanent finishing on the inside surface of the fabric, or a narrow strips or dots of low friction material (tape, film, fabric) is attached to the garment by coating, laminating, or any other applicable method. An example of such garment is shown in FIG. 5 wherein strips 30 of low 30 friction material are attached to the inside surface of a stocking 10. FIG. 6 illustrates an embodiment of a garment of the present invention showing dots 40 of low friction material attached to the inside surface of a stocking 10. -8- WO 2006/047153 PCT/US2005/037476 Another embodiment of the garments of the present invention provides sewing a patch 50 of low friction material to the inside of a garment 10 such as shown in FIG. 7. Further, an embodiment of the present invention showing a low friction coating applied to the inside of a garment is shown in FIG. 8 wherein 5 stocking 10 has a low friction coating applied to the inside of the foot zone 60 and the zone encircling the lower calf above the ankle 62. Although a preferred method of making the garments of the present invention is on a circular knitting machine, it should be understood that other methods of manufacturing may be used, such as flat-bed knitting. Examples of the 10 garments of this invention using flat-bed knitting are shown in FIGs. 9-11. For example, in another embodiment, that shown in FIG. 9 illustrates the inner side of a flat knitted stocking 70 before sewing the sides together having a low friction zone 72 in the ankle, heel and foot areas. In FIG. 10 there is illustrated the inner side of a flat knitted stocking 70 15 before sewing the sides together showing a low friction zone 74 in a discrete portion of the ankle zone. FIG. 11 illustrates the inner side of a flat knitted stocking 70 before sewing the sides together showing a low friction zone 76 surrounding the ankle. Many modifications and other embodiments of the inventions set forth 20 herein will come to mind to one skilled in the art to which these inventions pertain having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is to be understood that the inventions are not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope o f the appended claims. 25 Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation. -9-

Claims

1. A medical compression garment having an integral donning aid comprising a knitted or sewn main portion of elastic yams and exerting pressure on 5 the corresponding body part and having at least one integral low resistance donning zone strategically located on the internal surface of the garment to facilitate donning of the garment.

2. The medical compression garment according to Claim 1, wherein 10 said garment is a compression stocking and said low resistance donning zone is located between the ankle and the knee area.

3. The medical compression garment according to Claim 1, wherein said garment is a compression stocking and said low resistance donning zone is 15 located between the ankle and the knee area, covers the upper side of the instep.

4. The medical compression garment according to Claim 1 wherein at least one low friction yam is knit or woven into the fabric. 20

5. The medical compression garment according to Claim 1 wherein said low resistance zone includes courses of inlay yarn covered with PTFE yam.

6. The medical compression garment according to Claim 1 wherein said knitted yam is made of spandex covered with PTFE. 25

7. The medical compression garment ac cording to Claim 4 wherein said low resistance zone comprises strips of low friction material adhered to the inside of side garment. 30

8. The medical compression garment according to Claim 4 wherein said low resistance zone comprises dots of low friction material adhered to the inside of said garment. -10- WO 2006/047153 PCT/US2005/037476

9. The medical compression garment according to Claim 4 wherein said low friction material is coated to the inside of the garment. 5

10. The medical compression garment according to Claim 4 wherein said garment is a knee length stocking.

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