PRE-CUT OR PRE-FORMED MEDICAL BANDAGING PRODUCT WITH TUBULAR-KNITTED SUBSTRATE AND METHOD

Abstract: A medical bandaging product for being dispensed in lengths suitable for a single medical use, and comprising a package formed of a moisture-impervious material and sealable to prevent entry of moisture and a medical material having substantially the same predetermined length as the package and positioned in a continuous layer which coextends within the package in substantially moisture-free conditions and sealed therein against moisture until use. The medical material comprises a tubular substrate having a pair of opposed, major surfaces defining folded side edges characterized by being substantially free of cut fibrous ends. A reactive system is impregnated into or coated onto the substrate. The system remains stable when maintained in substantially moisture-free conditions and hardens upon exposure to sufficient moisture to form a rigid, self supporting structure. A soft, flexible protective padding is provided for enclosing the substrate to provide a cushioning barrier between the substrate and the skin of a patient when the bandage is in use.

Description: PRE-CUT OR PRE-FORMED MEDICAL BANDAGING PRODUCT WITH TUBULAR-KNITTED SUBSTRATE AND METHOD Technical Field and Background of the Invention This invention relates to a relates generally to the field of orthopedic medicine and more specifically to the design of an improved medical bandage, for example, a splint, formed of a moisture-curable synthetic resin material which is pre-cut or pre-formed and packaged in a single-use package for dispensing and use on a single-use basis. Medical bandages for use in the treatment of injuries, such as broken bones requiring immobilization of a body member, are generally formed from a strip of fabric or scrim material impregnated with a substance which hardens into a rigid structure after the strip has been wrapped around the body member. The hardening substance traditionally used in carrying out this procedure is plaster-of-paris. Conventional practice has been to fabricate a cast or splint upon an injured limb by initially applying to the limb a protective covering of a cotton fabric or the like and then overwrapping the covering and limb with a woven cloth impregnated with plaster-of-paris which has been wetted by dipping in water immediately prior to application. This practice is still in widespread use but possesses several significant disadvantages. For example, the above- described application procedure is messy and time-consuming. Several components are required and considerable skill is necessary. In order to alleviate the above-recited disadvantages of the conventional application procedure for plaster-of-paris casts and splints, unitary splinting materials have been devised and are disclosed in, for example, U.S. Pat. Nos. 3,900,024, 3,923,049, and 4,235,228. All of these patents describe a padding material with a plurality of layers of plaster-of-paris impregnated cloth. Such unitary splinting materials are not as messy and can be applied more quickly but still suffer from a number of disadvantages inherent in plaster-of-paris cast materials. All plaster-of-paris splints have a relatively low strength to weight ratio which results in a finished splint which is very heavy and bulky. Plaster-of-paris splints are slow to harden, requiring 24 to 72 hours to reach maximum strength. Since plaster-of-paris breaks down in water, bathing and showering are difficult. Even if wetting due to these causes can be avoided, perspiration over an extended period of time can break down the plaster-of-paris and create a significant problem with odor and itching. A significant advance in the art of casting and splinting is disclosed in U.S. Pat. Nos. 4,411,262 and 4,502,479. The substrate part of the medical materials disclosed in these patents comprise a flexible fabric impregnated with a moisture-curing resin enclosed in a moisture-free, moisture-impervious package. Compared to plaster-of-paris, these products are extremely lightweight, have a very high strength to weight ratio and can be made relatively porous, permitting a flow of air through the medical material. This technology has permitted the development of lightweight, easy to apply splints, as exemplified in United States Patent Nos. 4,770,299, 4,869,046, 4,899,738, 5,003,970 and 5,415,622. Such splints now dominate the market for medical splints. However, there are still some disadvantages to the synthetic splinting system described above. In particular, woven fiberglass fabric is typically used as the substrate which carries the moisture-curable resin. The substrate is formed of several layers of fabric, for example, warp knitted fabric, which have been cut into strips of the correct length and width. The process of cutting the fiberglass fabric to the correct size leaves cut fibers and yarns projecting outwardly from the sides and the ends of the splint. As manufactured, this fabric is relatively soft and flexible. Moreover, the substrate is fully enclosed with the surrounding padding material. After curing, however, the cut fibers and yarns become hard and needle-like. These projections can extend through the thickness of the padding material into contact with the skin of the patient causing skin-sticks, cuts, irritation and itching. Similar problems can exist with substrates fabricated from woven or knitted thermoplastic yarns which must be cut to the proper length and width. Moreover, the splint manufacturing process utilizing flat fabric is relatively labor intensive, since the woven or knitted fabric must be cut to the proper length and width and overlaid with other layers of fabric, usually 4 to 8, to produce the substrate. In order to properly form the substrate, the overlaid layers must be carefully aligned so that the width and thickness are even. In instances where the multiple overlaid layers are stitched together, even more labor is required. More recently, non- woven fabrics have been introduced into the splinting field. Non- woven fabrics do provide a smoother edge that do woven or knitted fabrics. However, non- woven fabrics are thicker, inhibiting the ability of the product to conform to the extremities as easily as does the woven or knitted fabric substrates. The greater thickness also makes the it difficult to evenly impregnate or coat the substrate with resin. Summary of the Invention Therefore, it is an object of the invention to provide a pre-cut or pre-formed medical bandaging product with a moisture-curable resin which hardens the material upon exposure to moisture to form a rigid, self-supporting structure. It is another object of the invention to provide a medical bandaging product which can be dispensed from a single use package, such as a moisture-proof package. It is another object of the invention to provide a unitary medical bandaging product which includes a padding to provide a cushion against the skin of a patient. It is an object of the invention to provide a bandaging product which utilizes a tubular knitted or woven fabric structure as a bandage substrate. It is an object of the invention to provide a bandaging product which is dispensed from a single-use protective container. It is another object of the invention to provide a bandaging product which has a tubular substrate which is uniform in dimension without the requirement for additional fabrication steps after formation of the tube. It is another object of the invention to provide a bandaging product which has a substrate without cut fibers or yarns extending from the sides of the substrate. It is another object of the invention to provide a bandaging product which has a substrate which is preformed into the desired shape before being enclosed in a protective padding. These and other objects and advantages of the present invention are achieved in the preferred embodiment disclosed below by providing a medical bandaging product for being dispensed in lengths suitable for a single medical use, and comprising a package formed of a moisture-impervious material and sealable to prevent entry of moisture and a medical material having substantially the same predetermined length as the package and positioned in a continuous layer which coextends within the package in substantially moisture-free conditions and sealed therein against moisture until use. The medical material comprises a tubular substrate having a pair of opposed, major surfaces defining folded side edges characterized by being substantially free of cut fibrous ends. A reactive system is impregnated into or coated onto the substrate. The system remains stable when maintained in substantially moisture-free conditions and hardens upon exposure to sufficient moisture to form a rigid, self supporting structure. A soft, flexible protective padding is provided for enclosing the substrate to provide a cushioning barrier between the substrate and the skin of a patient when the bandage is in use. According to one preferred embodiment of the invention, the tubular substrate comprises a knitted fabric. According to another preferred embodiment of the invention, the tubular substrate comprises a seamless knitted fabric knitted on a circular knitting machine. According to yet another preferred embodiment of the invention, the tubular substrate comprises a knitted fabric knitted on a flat knitting machine having a seam therein which binds two side edges of the knitted fabric together to form a tube. According to yet another preferred embodiment of the invention, the package comprises a aluminum foil laminate having an outer tear resistant layer, a central aluminum foil layer and an inner heat sealable plastic layer. According to yet another preferred embodiment of the invention, the tubular substrate is formed of fibers selected from the group consisting of fiberglass and synthetic thermoplastic fibers. According to yet another preferred embodiment of the invention, the protective padding encloses the substrate comprises a fibrous nonwoven cushion. Preferably, the protective padding enclosing the substrate comprises a nonwoven polypropylene tube. According to yet another preferred embodiment of the invention, the reactive system comprises a blended polyisocyanate, polyol, catalyst and stabilizer. According to yet another preferred embodiment of the invention, the substrate is formed in a relatively long, continuous length and is cut to individual use lengths before packaging. According to yet another preferred embodiment of the invention, the substrate is knitted in a single use length. According to yet another preferred embodiment of the invention, a medical bandage is provided in a single use length and is adapted for being maintained in substantially moisture-free conditions until use. The medical bandage comprises a tubular substrate defining a pair of opposed major surfaces defining folded side edges extending along the length of the substrate and characterized by being substantially free of cut fibrous ends. A reactive system is impregnated into or coated onto the substrate. The system remains stable when maintained in substantially moisture-free conditions and hardens upon exposure to sufficient moisture to form a rigid, self supporting structure. A soft, flexible protective padding encloses the substrate along its length to provide a cushioning barrier between the substrate and the skin of a patient when the bandage is in use. According to yet another preferred embodiment of the invention, the tubular substrate comprises a knitted fabric knitted on a flat knitting machine having a seam therein which binds two side edges of the knitted fabric together to form a tube. According to yet another preferred embodiment of the invention, the tubular substrate is formed of fibers selected from the group consisting of fiberglass and synthetic thermoplastic fibers. According to yet another preferred embodiment of the invention, the soft, flexible protective padding enclosing the substrate comprises is freely water and air permeable through the thickness thereof for providing a cushioning barrier between the substrate and the skin of a patient when the bandage is in use, and which permits the moisture-curable resin to be quickly and easily exposed to water through the thickness thereof. According to yet another preferred embodiment of the invention, the soft, flexible, protective padding surrounds the substrate so that either of the enclosed major surfaces of the substrate may be placed adjacent the skin of the patient. According to yet another preferred embodiment of the invention, a medical bandaging product is provided in a length suitable for a single medical use, and comprises an package formed of a moisture-impervious material and sealable to prevent entry of moisture, a medical material positioned in the package in substantially moisture-free conditions and sealed therein against moisture until use. A tubular substrate is provided having a pair of opposed, major surfaces defining folded side edges characterized by being substantially free of cut fibrous ends. A reactive system is impregnated into or coated onto the substrate. The system remains stable when maintained in substantially moisture-free conditions and hardens upon exposure to sufficient moisture to form a rigid, self supporting structure. A soft, flexible protective padding encloses the substrate to provide a cushioning barrier between the substrate and the skin of a patient when the material is in use. An embodiment of the method of fabricating a medical bandage according to the invention comprises the steps of comprises the steps of forming a fibrous bandage substrate in a predetermined single-use shape and size adapted for use as a splint on a particular body part, said substrate characterized by having a pair of opposed, major surfaces defining side edges extending along the length of the substrate and by being substantially free of cut fibrous ends, coating or impregnating a reactive system onto said substrate, said system remaining stable when maintained in substantially moisture-free conditions and hardening upon exposure to sufficient moisture to form a rigid, self supporting structure, enclosing the coated or impregnated substrate in a soft, flexible protective padding to provide a cushioning barrier between the substrate and the skin of a patient when the material is in use, and enclosing the assembled protective padding and substrate in a package in substantially moisture-free conditions and sealing therein against moisture until use. According to one preferred embodiment of the invention, the step of forming said substrate comprises the steps of forming a length of substrate material from which can be cut a plurality of substrates having a single-use length. According to another preferred embodiment of the invention, the step of forming said substrate comprises the steps of forming the substrate material in a single-use size and shape. According to yet another preferred embodiment of the invention, the step of forming the substrate comprises the steps of knitting the substrate in a seamless tube and flattening the tube to form a double thickness structure. According to yet another preferred embodiment of the invention, the step of forming the substrate comprises the steps of knitting the substrate as a flat sheet, forming a predetermined size and shape of the sheet into a tube, and flattening the tube to form a double thickness structure. According to yet another preferred embodiment of the invention, the step of forming the substrate comprises the step of knitting the substrate in the size and shape required for a predetermined single-use. Brief Description of the Drawings Some of the objects of the invention have been set forth above. Other objects and advantages of the invention will appear as the invention proceeds when taken in conj unction with the following drawings, in which: Figure 1 is a flow chart showing steps in the manufacture of a medical bandaging product according to an embodiment of the invention; Figure 2 is a perspective view showing a means of forming the bandage; Figure 3 is a perspective view with parts broken away of a package of the medical material; Figure 4 is a vertical cross-section taken substantially along lines 4—4 of Figure Figure 5 is a perspective view of a length of the medical material with the substrate layer exposed for clarity; Figure 6 is a perspective view of a length of tubular knitted substrate; Figure 7 is a side elevation of the tubular substrate in a flattened condition as it will be incorporated into the medical bandage; Figure 8 is a perspective view of the substrate shown in Figure 7; Figure 9 is a perspective view, with parts broken away, showing the flattened tubular substrate positioned in the padding to form the medical bandage; Figure 10 illustrates the activation of the moisture-curable resin by wetting; Figure 11 shows the medical material after removal from the single-use package being formed to fit the contour of a body member; and Figure 12 is a perspective view of the hardening medical material being secured into place on a body member by means of a covering wrap. Description of the Preferred Embodiment and Best Mode Referring now specifically to the drawings, a method of manufacturing a medical bandaging product such as splint 10 according to one preferred embodiment of the present invention is illustrated in Figure 1. In general, the method involves the merging of three elements. After a general description of the method, further details of the preferred embodiments are provided below in the discussion of the splint and medical bandaging product made according to the method of the invention. A soft cushion padding is formed in Step A and cut to a use length in Step B. Once cut to use length, double sided tape is applied down one side edge in Step C. A woven or knitted tubular fiberglass substrate is produced in a long production length in Step O and subsequently cut to a predetermined use length in Step E , depending on the size of the patient and the limb to be protected. Alternatively, fiberglass is formed in short use lengths and/or shapes in Step D 2 . This may be done automatically by a computer-controlled fabric forming machine. In either case the use lengths of fiberglass are coated or impregnated with a moisture-curable resin in Step F, as described below. The resin coated or impregnated fiberglass is laid into the open padding at Step G. The padding is folded over the fiberglass to encompass it and the tape adheres the two mated side edges together in Step H. Finally, the united padding and substrate forms a splint bandage which is quickly sealed into a moisture-proof package in Step I. Referring now to Figure 2, a medical bandage such as a splint according to the present invention is shown generally at 10. Splint 10 is formed from a length of a tubular substrate 11, such as woven or knitted fiberglass. The substrate 11 is positioned within a soft padding 12 and preferably sealed within the padding 12 by means of double-sided tape 13. The padding 12 is folded over the substrate 11 so that the side edges mate, with the double-sided tape 12 holding the padding in place around the substrate. Alternatively, the padding 12 can be closed by, for example, ultrasonic welding, application of an adhesive or by seaming the padding 12 into a tube. As is shown in Figures 3 and 4, the splint 10 is then sealed within a foil package 15 in moisture- proof conditions to form a completed medical bandaging product 20. Alternatively, substrate 11 may be formed by seaming a length of flat woven or knitted material into a tube with the raw ends of the tube positioned on the inside of the tube by turning the tube inside-out. However, because of the labor involved in these manufacturing steps, knitting the tube is believed to be the most efficient and cost-effective means of forming the substrate. As is shown in Figure 2, the substrate 11 is cut to be somewhat shorter that the padding 12 to insure that any cut edges to not protrude from the ends of the splint 10 after assembly is complete. The splint 10 may be formed in any needed width, for example, between 1 inch and 8 inches. One preferred embodiment comprises a 3 inch wide splint 10 positioned within a 4 inch wide package 15. In general, the package 15 varies between 3 inches to 10 inches and within that range can accommodate a splint 10 having widths of 1 inch to 8 inches. As is shown in Figure 5, the substrate 11 conforms closely to the interior shape of the padding 12, but the tubular configuration of the substrate completely avoids the possibility of cut fibers extending through the side of the padding 12. A preferred embodiment of the substrate 11 is knitted as a tube on a circular knitting machine, according to the following specifications: courses 14-19 wales 11-19 yarn specifications DE 37 1/0 Textured Glass Selection of the particular knitting machine is based on the predetermined specifications for the substrate 11. Variations in the diameter of the substrate 11 can be varied within limits on a particular diameter circular knitting machine by controlling yarn feed and take- up tension, and other variables which are commonplace in the art. As is shown in Figures 6, 7 and 8, substrate 11 is formed by flattening the knitted tube (Figure 6) to form two major, longitudinally-extending sides 11 A, 1 IB (Figures 7 and 8). The flattened tube also forms two opposed, folded side edges 1 IC, 1 ID of the substrate 11. In contrast to prior art constructions which include raw, cut edges with a multitude of exposed and outwardly-projecting yarn and fiber ends, these side edges 11C, 11D are rounded, smooth, integral and uncut. Thus, there are no exposed cut ends to harden into sharp, needle-like projections when the curing of the moisture-curable resin is completed. In addition, the substrate is strengthened by the tubular layers acting as a double layer, continuous structure. No sewing is required to align the layers, and the manufacturer has greater control over the width of the splint 10. While cut edges are formed on the ends of the substrate 11 if severed from a longer length of substrate material, these ends can be folded inwardly and/or covered with a double thickness of the padding 12. See Figure 9. Other fabrics which may be suitable include fabrics made of a composition of aluminum oxide, silicone oxide and boron oxide and sold under the trademark Nextel 440 by Thermostatic Industries, Inc.; silica-based fabrics, high modulus fabrics sold under the DuPont trademark "Kevlar." Another alternative involves the use of a single thickness sheet of random laid non-continuous polyester nonwoven fabric incorporating a styrene-soluble binder filled 60 percent by volume with plastic microspheres. The product is sold under the trademark "Firet Coremat XM by Baltek. This product is available in 2mm, 3mm and 4mm thicknesses. The 2mm thickness has been found suitable, and weighs 2.7 - 3.2 ozyd 2 , has a cured specific gravity of 31.0 -37.0 lb/ft 3 , and a resin consumption of 3.1 - 3.3 oz/ft 3 . Other Firet Coremat grades, such as Firet Coremat XX and Firet Coremat XW may also be suitable. These grades are filled with plastic microspheres to 50 percent by volume. Other products which may be suitable include a low density, nonwoven continuous strand fabric such as BaltekMat T-2000. This product has characteristics which are generally similar to Firet Coremat, but is generally unavailable in small quantities. All of these fabrics can be cut to size, seamed to form a tube and turned inside-out to place the raw edge of the seam on the inside. The padding 12 is formed of a soft, flexible non- woven fiber such as polypropylene or some other suitable hydrophobic fiber such as is presently used on Ortho- Glass® brand synthetic splinting material manufactured by the Casting Division of Smith & Nephew, Inc., assignee of this application. This product provides a cushioning protective layer between the skin of the patient and hardened substrate 11. Substrate 11 is impregnated or coated with a reactive system which remains stable when maintained in substantially moisture-free conditions but which hardens upon exposure to sufficient moisture to form a rigid, self-supporting structure. A typical formulation of the reaction system is set forth in the following table: Typical Formulation: Typical Formulation: Isonatel 143L or Mondurl CD or polyisocyanate 50.0% Rubinate 1 XI168 Pluracoll P1010 polyol 46.6% DC-200 Silicone defoamine agent 0.30% Benzoyl Chloride stabilizer 0.10% Thancatl DM-70 catalyst 3.0% 100% A complete discussion of the parameters of the reactive system, the manner of production and the variables which apply are found in U.S. Pat. No. 4,411,262. The package 15 is formed of a moisture-impervious material, such as two laminated elongate sheets placed in registration and heat sealed along its opposite sides to form a tube. The outer layer is formed of a tear-resistant plastic film. The middle layer comprises aluminum foil and acts as a moisture barrier. The inner layer is a plastic film having thermoplastic properties suitable for heat sealing the interior of package 15 securely against moisture. Once the splint 10 has been removed for use from the package 15, the package 15 is discarded. As is shown in Figure 10, moisture-curing is activated by dipping the splint 10 in water. Then excess moisture is squeezed from the splint 10 by, for example, rolling up in a towel. Alternatively, moisture-curing can take place over a longer period of time by allowing contact between the reactive system on substrate 11 and atmospheric moisture. Referring now to Figure 11, the splint 10 is formed to the shape of the body member to be immobilized. This particular type of splint, known as a posterior short leg splint, is formed by molding the splint 10 to the calf and up over the heel and onto the foot. Then, splint 10 is overwrapped with an conventional elastic bandage, as is shown in Figure 12. A medical bandaging product, splint and method are described above. Various details of the invention may be changed without departing from its scope. Furthermore, the foregoing description of the preferred embodiment of the invention and the best mode for practicing the invention are provided for the purpose of illustration only and not for the purpose of limitation—the invention being defined by the claims.

Claims: I claim: 1. A medical bandaging product for being dispensed in a lengths suitable for a single medical use, comprising: (a) a package formed of a moisture-impervious material and sealable to prevent entry of moisture; (b) a medical material having substantially the same predetermined length as said package and positioned in within the package in substantially moisture-free conditions and sealed therein against moisture until use, said medical material comprising: (i) a tubular substrate having a pair of opposed, major surfaces defining folded side edges extending along the length of the elongate package and characterized by being substantially free of cut fibrous ends; (ii) a reactive system impregnated into or coated onto said substrate, said system remaining stable when maintained in substantially moisture-free conditions and hardening upon exposure to sufficient moisture to form a rigid, self supporting structure; and (iii) a soft, flexible protective padding enclosing said substrate along its length to provide a cushioning barrier between the substrate and the skin of a patient when the medical material is in use. 2. A medical bandaging product according to claim 1 , wherein said tubular substrate comprises a knitted fabric. 3. A medical bandaging product according to claim 1 , wherein said tubular substrate comprises a seamless knitted fabric knitted on a circular knitting machine. 4. A medical bandaging product according to claim 1 , wherein said tubular substrate comprises a knitted fabric knitted on a flat knitting machine and having a seam therein which binds two side edges of the knitted fabric together to form a tube. 5. A medical bandaging product according to claim 1, 2, 3 or 4, wherein said package comprises a aluminum foil laminate having an outer tear resistant layer, a central aluminum foil layer and an inner heat sealable plastic layer. 6. A medical bandaging product according to claim 5 , wherein said tubular substrate is formed of fibers selected from the group consisting of fiberglass and synthetic thermoplastic fibers. 7. A medical bandaging product according to claim 5, wherein said protective padding enclosing the substrate comprises a fibrous nonwoven cushion. 8. A medical bandaging product according to claim 5, wherein said protective padding enclosing the substrate comprises a nonwoven polypropylene tube. 9. A medical bandaging product according to claim 5 , wherein said reactive system comprises a blended polyisocyanate, polyol, catalyst and stabilizer. 10. A medical bandaging product according to claim 1, wherein said substrate is formed in a relatively long, continuous length and is cut to individual use lengths before packaging. 11. A medical bandaging product according to claim 1, wherein said substrate is knitted in a single use length. 12. A medical bandage in a single use length for being maintained in substantially moisture-free conditions until use, said medical bandage comprising: (i) a tubular substrate defining a pair of opposed major surfaces defining folded side edges extending along the length of the substrate and characterized by being substantially free of cut fibrous ends; (ii) a reactive system impregnated into or coated onto said substrate, said system remaining stable when maintained in substantially moisture-free conditions and hardening upon exposure to sufficient moisture to form a rigid, self supporting structure; and (iii) a soft, flexible protective padding enclosing said substrate along its length to provide a cushioning barrier between the substrate and the skin of a patient when the bandage is in use. 13. A medical bandage according to claim 12, wherein said tubular substrate comprises a knitted fabric. 14. A medical bandage according to claim 12, wherein said tubular substrate comprises a seamless knitted fabric knitted on a circular knitting machine. 15. A medical bandage according to claim 12, wherein said tubular substrate comprises a knitted fabric knitted on a flat knitting machine, and having a seam therein which binds two side edges of the knitted fabric together to form a tube. 16. A medical bandage accordingto claim 12, 13, 14, or 15, wherein medical bandage is packaged until use in a package comprising an aluminum foil laminate having an outer tear resistant layer, a central aluminum foil layer and an inner heat sealable plastic layer. 17. A medical bandage according to claim 16, wherein said tubular substrate is formed of fibers selected from the group consisting of fiberglass and synthetic thermoplastic fibers. 18. A medical bandage according to claim 16, wherein said protective padding enclosing the substrate comprises a fibrous nonwoven cushion. 19. A medical bandage according to claim 16, wherein said protective padding enclosing the substrate comprises a nonwoven polypropylene tube. 20. A medical bandage according to claim 16, wherein said reactive system comprises a blended polyisocyanate, polyol, catalyst and stabilizer. 21. A medical bandage according to claim 12, wherein said substrate is formed in a relatively long, continuous length and is cut to individual use lengths before packaging. 22. A medical bandaging product according to claim 12, wherein said substrate is knitted in a single use length. 23. A medical bandage according to claim 12, wherein said soft, flexible protective padding enclosing said substrate comprises is freely water and air permeable through the thickness thereof for providing a cushioning barrier between the substrate and the skin of a patient when the bandage is in use, and which permits the moisture-curable resin to be quickly and easily exposed to water through the thickness thereof. 24. A medical bandage according to claim 12, wherein said soft, flexible, protective padding surrounds the substrate so that either of the enclosed major surfaces of the substrate may be placed adjacent the skin of the patient. 25. A medical bandaging product in a length suitable for a single medical use, comprising: (a) an package formed of a moisture-impervious material and sealable to prevent entry of moisture; (b) a splint positioned in the package in substantially moisture-free conditions and sealed therein against moisture until use, said splint comprising: (i) a tubular substrate having a pair of opposed, major surfaces defining folded side edges extending along the length of the substrate and characterized by being substantially free of cut fibrous ends; (ii) a reactive system impregnated into or coated onto said substrate, said system remaining stable when maintained in substantially moisture-free conditions and hardening upon exposure to sufficient moisture to form a rigid, self supporting structure; and (iii) a soft, flexible protective padding enclosing said substrate along its length to provide a cushioning barrier between the substrate and the skin of a patient when the splint is in use. 26. A method of fabricating a medical bandaging product, comprising the steps of: (a) forming a tubular fibrous bandage substrate in a predetermined single-use shape and size for use on a particular body part, said substrate characterized by having a pair of opposed, major surfaces defining side edges extending along the length of the substrate and by being substantially free of cut fibrous ends; (b) coating or impregnating a reactive system onto said substrate, said system remaining stable when maintained in substantially moisture-free conditions and hardening upon exposure to sufficient moisture to form a rigid, self supporting structure; (c) enclosing the coated or impregnated substrate in a soft, flexible protective padding to provide a cushioning barrier between the substrate and the skin of a patient when the bandage is in use; and (d) enclosing the assembled protective padding and substrate in a package in substantially moisture-free conditions and sealing therein against moisture until use. 27. A method according to claim 26, wherein the step of forming said substrate comprises the steps of forming a length of substrate material from which can be cut a plurality of substrates having a single-use length. 28. A method according to claim 26, wherein the step of forming said substrate comprises the steps of forming the substrate material in a single-use size and shape. 29. A method according to claim 27 or 28, wherein the steps of forming the substrate comprises the steps of knitting the substrate in a seamless tube and flattening the tube to form a double thickness structure. 30. A method according to claim 27 or 28, wherein the step of forming the substrate comprises the steps of: (a) knitting the substrate as a flat sheet; (b) forming a predetermined size and shape of the sheet into a tube; and (c) flattening the tube to form a double thickness structure. 31. A method according to claim 27 or 28, wherein the step of forming the substrate comprises the step of knitting the substrate in the size and shape required for a predetermined single-use.

Inventors: DARCEY THOMAS D, DARCEY, THOMAS, D.
Applicants: SMITH & NEPHEW INC, SMITH & NEPHEW, INC.
Application year: 2001
Main classification: A61F13
IPC codes: A61F13