Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F13/00—Bandages or dressings; Absorbent pads
  • A61F13/04—Plaster of Paris bandages; Other stiffening bandages

Definitions

• 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.
• 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.
• 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.
• this fabric is relatively soft and flexible.
• 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.
• Non- woven fabrics do provide a smoother edge that do woven or knitted fabrics.
• 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.
• 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.
• the tubular substrate comprises a knitted fabric.
• the tubular substrate comprises a seamless knitted fabric knitted on a circular knitting machine.
• 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.
• 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.
• the tubular substrate is formed of fibers selected from the group consisting of fiberglass and synthetic thermoplastic fibers.
• the protective padding encloses the substrate comprises a fibrous nonwoven cushion.
• the protective padding enclosing the substrate comprises a nonwoven polypropylene tube.
• the reactive system comprises a blended polyisocyanate, polyol, catalyst and stabilizer.
• the substrate is formed in a relatively long, continuous length and is cut to individual use lengths before packaging.
• the substrate is knitted in a single use length.
• 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.
• 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.
• the tubular substrate is formed of fibers selected from the group consisting of fiberglass and synthetic thermoplastic fibers.
• 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.
• 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.
• a medical bandaging product 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 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.
• the step of forming said substrate comprises the steps of forming a length of substrate material from which can be cut
• the step of forming said substrate comprises the steps of forming the substrate material in a single-use size and shape.
• 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.
• 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.
• the step of forming the substrate comprises the step of knitting the substrate in the size and shape required for a predetermined single-use.
• 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 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
• 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.
• a method of manufacturing a medical bandaging product such as splint 10 is illustrated in Figure 1.
• the method involves the merging of three elements.
• 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.
• 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.
• the united padding and substrate forms a splint bandage which is quickly sealed into a moisture-proof package in Step I.
• 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.
• the padding 12 can be closed by, for example, ultrasonic welding, application of an adhesive or by seaming the padding 12 into a tube.
• the splint 10 is then sealed within a foil package 15 in moisture- proof conditions to form a completed medical bandaging product 20.
• 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.
• knitting the tube is believed to be the most efficient and cost-effective means of forming the substrate.
• 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.
• 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.
• 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.
• 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.
• these side edges 11C, 11D are rounded, smooth, integral and uncut.
• 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.
• 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 .
• 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.
• 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:
• 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.
• 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.
• moisture-curing can take place over a longer period of time by allowing contact between the reactive system on substrate 11 and atmospheric moisture.
• 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.

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Orthopedics, Nursing, And Contraception (AREA)

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• 2001
  • 2001-01-19 EP EP01946781A patent/EP1202695A1/de not_active Withdrawn
  • 2001-01-19 WO PCT/US2001/001836 patent/WO2001054639A1/en not_active Application Discontinuation
  • 2001-01-19 JP JP2001555619A patent/JP2003524491A/ja active Pending
  • 2001-01-19 AU AU2001229645A patent/AU2001229645A1/en not_active Abandoned

Non-Patent Citations (1)

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