阅读说明：本技术 压迫绷带 (Compression bandage ) 是由 T·S·墨菲 J·博伊尔 于 2019-08-21 设计创作，主要内容包括：提供一种压迫绷带,该压迫绷带包括氧化锌组合物和/或一种或多种其它治疗剂。在使用中,所述绷带可以是压迫式包裹的,直接接触个体的皮肤以施用氧化锌组合物和/或其它治疗剂。(A compression bandage is provided that includes a zinc oxide composition and/or one or more other therapeutic agents. In use, the bandage may be compression wrapped, in direct contact with the skin of the individual to apply the zinc oxide composition and/or other therapeutic agent.)

1. A compression bandage, comprising:

a stretchable, wrappable bandage material for contacting the skin of an individual,

wherein the bandage material comprises a zinc oxide composition.

2. A compression bandage as recited in claim 1, wherein the bandage material includes calamine.

3. A compression bandage, comprising:

a stretchable, wrappable bandage material for contacting the skin of an individual,

wherein the bandage material comprises one or more therapeutic agents.

4. A compression bandage as claimed in any one of claims 1 to 3, wherein the bandage material comprises one or more of: an antibiotic, an antibacterial agent, an antimicrobial agent, an anti-odor agent, an anti-inflammatory agent, an antifungal agent, an antiviral agent, an anticancer agent, an eczema or psoriasis treatment agent, an analgesic, or a combination thereof.

5. A compression bandage as claimed in any one of claims 1 to 4, wherein the bandage material comprises one or more of: aloe vera; menthol; mupirocin; witch hazel, tea tree oil; clindamycin; anthralin; clotrimazole; ketoconazole; terbinafine; benzoyl peroxide; coal tar; a corticosteroid; kribolo; tretinoin; salicylic acid; acyclovir; 5-fluorouracil; 5-fluorouracil, diclofenac; hyaluronic acid; imiquimod; ingenol mebutate; adalimumab; and Youlisha.

6. The compression bandage of any one of claims 1 to 5, wherein the bandage material is impregnated with the zinc oxide composition and/or the one or more therapeutic agents.

7. The compression bandage of any one of claims 1-6, wherein the zinc oxide composition and/or therapeutic agent is substantially uniformly distributed throughout the bandage material.

8. The compression bandage of any one of claims 1-7, wherein the zinc oxide composition and/or therapeutic agent are located at selected areas of the bandage material.

9. The compression bandage of any one of claims 1-7, wherein the zinc oxide composition and/or therapeutic agent is present in a first region of the bandage material and not present in a second region of the bandage material that is different from the first region.

10. A compression bandage of any one of claims 1-9, wherein the bandage has an unstretched length and a maximum stretched length, wherein the maximum stretched length is about 40-80% or greater longer than the unstretched length.

11. A compression bandage as claimed in any one of claims 1 to 10, wherein the bandage is stretchable so as to provide a compressive force when wrapped around a limb of an individual.

12. A compression bandage as claimed in any one of claims 1 to 11, wherein the bandage material comprises latex.

13. A compression bandage as claimed in any one of claims 1 to 12, wherein the bandage material is latex-free.

14. A compression bandage of any one of claims 1-13, wherein the bandage material is in a roll.

15. A compression bandage of any one of claims 1-14, wherein the bandage material is 1 to 6 inches wide and is rolled along the length of the bandage material.

16. A method of treating a subject, the method comprising:

a compression bandage wrapped around an individual with the bandage of any one of claims 1-15, wherein the bandage directly contacts the skin of the individual.

17. The method of claim 16, wherein the bandage is wrapped around a limb, torso, or head of the individual.

18. The method of claim 16 or 17, wherein the wrapped bandage applies a compressive force to the individual.

19. The method of any one of claims 16 to 18, wherein the zinc composition and/or one or more therapeutic agents are administered to the subject transdermally.

20. The method of any one of claims 16-19, wherein the compression bandage is not used with another separate bandage material.

21. The method of any one of claims 16 to 20, further comprising applying a different bandage or protective layer over the wrapped bandage material.

22. The method of claim 21, wherein the different layer is of the cuff or sock type.

23. The method of any one of claims 16-22, wherein the individual is identified as having a disease or disorder that can be treated with the compression bandage.

24. The method of any one of claims 16-23, wherein the individual is identified as having skin cancer or a pre-skin cancer.

25. The method of any one of claims 16 to 24, wherein the individual is identified as having hypertrophic solar keratosis, actinic keratosis, and/or squamous cell carcinoma.

26. The method of any one of claims 16 to 25, wherein the compression bandage comprises one or more of: 5-fluorouracil, diclofenac and/or hyaluronic acid, imiquimod and ingenol mebutate.

27. A kit, the kit comprising:

(a) a compression bandage as claimed in any one of claims 1 to 15.

28. The kit of claim 27, further comprising (b) written instructions for using the compression bandage and/or information identifying the compression bandage.

29. The kit of claim 27 or 28, wherein the compression bandage is in roll form.

30. The kit of any one of claims 27 to 29, wherein the compression bandage is in roll form.

31. The kit of any one of claims 27 to 30, wherein the kit does not contain a separate additional bandage material.

32. The kit of any one of claims 27 to 31, wherein the kit comprises a cartridge unit comprising: 1) a roll of the compression bandage and 2) written instructions for using the compression bandage and/or information identifying the compression bandage.

33. A kit according to any one of claims 26 to 30, wherein the kit comprises 1) a roll of the compression bandage and 2) written instructions for using the compression bandage and/or information identifying the compression bandage in a sealed package.

34. The kit of any one of claims 26 to 32, wherein the kit consists essentially of: 1) a roll of the compression bandage and 2) written instructions for using the compression bandage and/or information identifying the compression bandage.

35. The kit of any one of claims 26 to 32, wherein the kit consists of: 1) a roll of the compression bandage and 2) written instructions for using the compression bandage and/or information identifying the compression bandage.

Technical Field

The present invention generally relates to a compression bandage comprising a zinc oxide composition and/or one or more other therapeutic agents. In use, the bandage may be compression wrapped, in direct contact with the skin of the individual to apply the zinc oxide composition and/or other therapeutic agent.

Background

Compression bandages are commonly used in medical and athletic applications, which require a strong, reliable yet comfortable and easy to implement method of securing a limb or other body part for long periods of time. For example, strains and sprains can cause inflammation and the accompanying accumulation of fluid around the joints of the sprains. Securely wrapping the affected joint with an elastic bandage prevents excessive fluid accumulation and causes additional tissue damage.

Certain tapes and bandages may be used for such applications.

Improved compression bandages are desired.

Disclosure of Invention

We now provide new compression-type elastic bandages comprising one or more agents for transdermal contact or administration to an individual. The bandage may suitably be used as the sole bandage or material for the subject to be treated.

More particularly, in a first preferred aspect, there is provided a compression bandage comprising a stretchable, wrappable bandage material for contacting the skin of an individual, wherein the bandage material comprises a zinc oxide composition. Calamine is the preferred zinc oxide composition.

In a preferred further aspect, there is provided a compression bandage comprising a stretchable, wrappable bandage material for contacting the skin of an individual, wherein the bandage material comprises one or more therapeutic agents other than a calamine composition, for example one or more antibiotics, antibacterial agents, antimicrobial agents, anti-odour agents, anti-inflammatory agents, antifungal agents, antiviral agents, anticancer agents (including for the treatment of skin cancer and pre-skin cancer), eczema or psoriasis therapeutic agents, analgesics or combinations thereof. Preferably, such therapeutic agents may be effectively administered transdermally to an individual.

In some embodiments, the zinc oxide composition and/or therapeutic agent is present substantially throughout the bandage material, e.g., impregnated within and/or on the bandage material.

In some other embodiments, the zinc oxide composition and/or therapeutic agent may be present in selected regions of the bandage material, for example in one or more striped regions extending the length and/or width of the bandage material, wherein the zinc oxide and/or therapeutic agent is not present outside of the striped regions.

In each configuration, preferably, the combination with the bandage material is such that the zinc oxide composition and/or therapeutic agent can be readily contacted and administered to the skin of the individual when the bandage is applied (for compression wrap).

The compression bandage may be made from a variety of materials, and suitably may be a stretchable polymeric composition. Suitable bandage materials include those comprising latex as well as bandage materials that are substantially or completely free of latex.

The compression bandage is suitably stretchable so as to apply a compression force to the individual during use, i.e. the individual's limbs, torso, head may be wrapped with the bandage and thereby apply a compression force. In some embodiments, the bandage material may have a maximum stretched length that is at least 30, 40, 50, 60, 70, 80, 90, or 100% or more greater than the unstretched length of the material. In some preferred materials, the bandage material may have a maximum stretched length that is at least 40 to 80%, 90%, or 100% or more greater than the unstretched length of the material.

The compression bandage of the present invention may be wound into a roll, for example, for convenient storage and transport prior to use.

Also provided are methods of treating an individual, suitably comprising: the individual is wrapped around using a compression bandage as described herein, wherein the bandage directly contacts the skin of the individual. Thus, in these preferred methods, the cushioning or absorbent material or other material is not used and, therefore, is not interposed between the compression bandage of the present invention and the individual's skin. Instead, the compression bandage is applied directly to and in direct contact with the skin of the individual. In some applications, it may be desirable to apply a different material (e.g., an oversleeve or a sock layer) over the wrapped compression bandage.

Various individuals can be appropriately identified for use of the compression bandage of the present invention. Thus, for example, a person suffering from a sprain, strain or bruise, such as a joint or muscle sprain, strain or bruise, may be relieved by the compressive force provided by the wrap bandage disclosed herein. In addition, the presence of the zinc oxide composition, particularly calamine, in the bandage can provide a beneficial feel to the skin of the individual. Other therapeutic agents that may be present in the bandage may also provide beneficial effects to the individual. In particular, such one or more other therapeutic agents may be effectively administered transdermally to an individual.

In some aspects, the individual does not suffer from any type of wound, skin ulcer, cancer (e.g., skin cancer or pre-skin cancer), psoriasis, eczema, infection, and the like, at least in the area of the skin to which the compression bandage is applied.

In other aspects, the individual may have one or more of such wounds, skin ulcers, psoriasis, eczema, cancer (including skin cancer or precancerous skin), infection, and the like, and the compression bandage of the present invention is applied directly to the injured or painful skin area.

Also provided are kits containing the compression bandages described herein. Suitably, the kit may also contain written material for use in applying and/or identifying the compression bandage. The compression bandage is suitably packaged in roll form, i.e. the wound bandage strips are for example 1 to 6 inches or more wide, for example 1, 2, 3, 4, 5 or 6 inches wide, and stored in roll form, for example at least one yard in length, more usually 2, 3, 4, 5, 6, 7, 8, 9, 10 yards or more.

The term "zinc oxide-containing composition" as referred to herein is intended to include any composition containing zinc oxide as an active ingredient and suitable for impregnating bandage materials. The zinc oxide-containing compositions herein may include calamine, ichthyol, or both. In some aspects, the zinc oxide-containing composition can optionally include an antimicrobial agent and/or can be used with or without an antimicrobial agent. If antimicrobial agents are present, either as part of the zinc oxide-containing composition or as a separately applied antimicrobial agent or formulation, such antimicrobial agents can be any antimicrobial agent suitable for topical administration, including organic or inorganic antimicrobial agents.

Terms such as stretchable bandage, elastic layer, compression bandage, compression layer, and the like, are intended to include both short and long stretch bandages, unless otherwise specified.

Other aspects of the invention are discussed below.

Detailed Description

As discussed above, a novel compression-type elastic bandage suitable for direct skin contact is provided. In a preferred aspect, when used on an individual's leg (e.g., ankle, foot, calf, knee, thigh), torso, arm (e.g., hand, forearm, elbow, upper arm), neck or head, the bandage is wrapped circumferentially around a selected area of the individual and is in direct (without intervening material) contact with the individual's skin to completely encircle that area of the individual, e.g., completely encircle the individual's leg (e.g., any of ankle, foot, calf, knee, thigh), torso, arm (e.g., any of hand, forearm, elbow, upper arm), neck or head.

The bandage material includes one or more medicaments for contacting the skin of an individual.

Zinc oxide compositions, particularly calamine, are preferred agents for incorporation into bandage materials for contacting the skin of an individual. Calamine may include zinc oxide and iron oxide.

Other preferred agents incorporated into the bandage material for contacting the skin of an individual include one or more of the following: an antibiotic, an antibacterial agent, an antimicrobial agent, an anti-odor agent, an anti-inflammatory agent, an antifungal agent, an antiviral agent, an anticancer agent (including for treatment of skin cancer and pre-skin cancer), an eczema or psoriasis treatment agent, an analgesic, or a combination thereof.

More specifically, preferred other agents incorporated into the bandage material for contacting the skin of an individual include one or more of the following: aloe vera; menthol; mupirocin; witch hazel, tea tree oil; clindamycin; anthralin; clotrimazole; ketoconazole; terbinafine; benzoyl peroxide; coal tar; a corticosteroid; kribolo; tretinoin (retinoids); salicylic acid; acyclovir; 5-fluorouracil; 5-fluorouracil, diclofenac; hyaluronic acid (alone or in combination with diclofenac); imiquimod; ingenol mebutate (ingenol mebutate); adalimumab; and eucrisa (eucrisa).

Suitable anti-odor agents for incorporation into bandage materials for contacting the skin of an individual include, inter alia, activated carbon, cyclodextrin/modified cyclodextrin, activated alumina, metal powders, aluminum silicates, metal oxides, zeolites, ceramics, diatomaceous earth, macroporous polymers, aerogels, cellulose and cellulose derivatives, starch and starch derivatives, clays, talc, sodium bicarbonate, silica, and combinations thereof.

Suitable antimicrobial agents for incorporation into bandage materials for contacting the skin of an individual include, inter alia, any suitable antimicrobial composition for preventing or inhibiting the growth or proliferation of microorganisms, such as bacteria, fungi, viruses or protozoa, for example selected from the group consisting of beta hemolytic streptococcus (streptococcus pyogenes), enterococcus (enterococcus faecalis), staphylococcus (staphylococcus aureus/MRSA), pseudomonas aeruginosa, enterobacter, escherichia coli, klebsiella, proteus, bacteroides, clostridium, candida, aspergillus. In a preferred embodiment, the antimicrobial agent may be based on inorganic metal/organic antimicrobial agents and the like, although it will be appreciated that the antimicrobial agent may be other antimicrobial agents known in the art, including antibiotics, antibacterial agents, antiviral agents, antifungal agents, and disinfectants. In a particularly preferred embodiment, the antimicrobial agent is silver nanoparticles or silver nitrate.

Suitable antibiotics and antimicrobials for incorporation into the bandage material for contact with the skin of an individual include, inter alia, methicillin, neomycin sulfate, bacitracin, neomycin sulfate, and polymyxin B sulfate.

In some preferred embodiments, the bandage material will include one or more agents for treating skin cancers and skin precancers, such as hypertrophic solar keratosis (which includes dysplastic hypertrophic solar keratosis and bowen-like hypertrophic solar keratosis), actinic keratosis, and squamous cell carcinoma. In particular, to treat such skin cancers and precancerous stages, the bandage material may include one or more of the following: 5-fluorouracil, diclofenac and/or hyaluronic acid, imiquimod and ingenol mebutate.

In some methods of the invention, individuals suffering from or susceptible to a particular disease or disorder will be identified and selected for use with a particular compression bandage.

For example, individuals with a strain or sprain (e.g., a strain or sprain at the ankle, elbow, knee, calf, thigh, forearm, upper arm, etc.) can be identified and selected, and the identified and selected subject's sprain/strain area can be wrapped with a calamine-containing compression bandage disclosed herein.

Individuals who are suffering from skin cancer or precancerous conditions such as hypertrophic solar keratosis (which includes dysplastic and bowen-like hypertrophic solar keratosis), actinic keratosis, and/or squamous cell carcinoma may be identified and selected, and a compression bandage comprising one or more anti-cancer agents may be wrapped around the area of skin cancer of the selected individual. The one or more anticancer agents present in the compression bandage may be, for example, 5-fluorouracil, diclofenac and/or hyaluronic acid, imiquimod and ingenol mebutate.

The preferred bandage material may be in the form of a strip or tape and is relatively easy to tear by hand to any length across the width, but at the same time should have sufficient longitudinal strength. CoFlex tape and bandages (Andover Healthcare, Salisbury, MA; see U.S. Pat. No. 3,575,782) may suitably be used and have a laminate structure comprising two outer nonwoven layers between which a longitudinally extending elastic yarn is sandwiched. POWERLEX bandage (Andover Healthcare; see U.S. Pat. No. 5,762,623) may also be suitably used as a bandage material and includes a layer having elasticity in the direction of longitudinal extension laminated to one side of a warp-knitted, sometimes referred to as warp-knitted (weft insertion), fabric oriented with the longitudinally extending knitted yarns.

In some embodiments, the bandage material is a "short stretch" elastic bandage, and preferably a short stretch cohesive elastic bandage, which when wrapped in an overlapping manner, cohesively bonds to itself, thereby eliminating the need for a bandage clip or other bandage fastener. The term "short stretch" as used herein refers to a bandage that is capable of stretching, for example, about 25% to 80% beyond its original unstretched length. Unlike "long stretch" products which are capable of stretching longitudinally about 100% to several times beyond their original length to provide a constant pressure at rest and in service, i.e., a low Static Stiffness Index (SSI), short stretch bandages are capable of providing more effective compression, i.e., a high SSI, e.g., greater than about 10mm Hg, by low rest pressure and high standing or working pressure. The use of a low stretch compression bandage as an outer layer is particularly advantageous for patients with poor venous function, because the low resting pressure provides comfort when the patient is in a recumbent position, while also preventing expansion of the muscle diameter when the patient is ambulatory, thereby increasing venous blood and lymphatic return upon contraction of the leg muscles.

In some embodiments, the bandage material may be a latex-free adhesive elastic bandage, as disclosed in U.S. patent 6,156,424. In other embodiments, the bandage material may be a layer that does not require bandage scissors by facilitating manual tearing, as disclosed in U.S. patent 5,762,623.

One suitable bandage material is available from Andover Healthcare, Inc. (Salisbury, Mass.) under the trade designation "CoFlex NL". CoFlex NL is intended for controlled compression, which does not shrink over time, i.e. short stretch bandages.

Optionally, an additional outermost layer, such as socks, tubes, sleeves, and the like, preferably nylon socks, may be provided and worn over the wrapped bandage material to provide a desired appearance or look to the bandage system.

Preferably, a zinc oxide composition and/or other therapeutic agent or agents are distributed throughout the bandage material. Such distribution may allow the calamine or other zinc oxide composition or other therapeutic agent to be more widely applied to the skin of an individual wrapping the bandage material.

Alternatively, the zinc oxide composition and/or other therapeutic agent or agents may be present only in selected areas of the bandage material, for example, only in spaced-apart strip regions extending across the width and/or along the length of the bandage material. In one particular design, one or more polymeric strips comprising a zinc oxide composition and/or other therapeutic agent(s) may be applied (e.g., laminated) along the length or width of the bandage material.

The bandage material can be easily prepared. For example, the formed bandage material may be impregnated with a composition comprising zinc oxide or a composition comprising one or more other therapeutic agents by immersing the bandage material in a bath containing the composition comprising zinc oxide. The impregnated bandage material is then formed into a roll at any desired length, width and winding tension.

Mixtures of polymers and compositions containing zinc oxide or compositions containing one or more other therapeutic agents may also be prepared. See, for example, example 1 below. The mixture can then be used to form a stretchable bandage material that includes a composition containing zinc oxide or a composition containing one or more other therapeutic agents.

In a particular aspect, a compression bandage may include multiple layers, for example, one or more woven or nonwoven fabric layers, an inner elastic layer, and a knit fabric layer, all of which are saturated and bonded with an adhesive formulation impregnated with a zinc oxide composition described herein, such as calamine and/or one or more other therapeutic agents. In a preferred embodiment, the woven or nonwoven layer is from 8 to 10g/m²Spun bonded materials such as polypropylene, polyethylene terephthalate, or other materials. Polypropylene is generally preferred. Other polymeric woven or non-woven layers may also be used. Although a preferred weight is 8-10g/m²But other weights may be suitable. Preferred elastic layers may comprise laterally spaced, longitudinally extending coalesced multifilament elastic polyurethane threads such as Lykra or Spandex. In a preferred aspect, suitably, the denier of the yarnThe number is 210 and the spacing is 5-15/inch. Other deniers and spacings may also be suitable. Suitably, the knitted fabric layer is a warp knitted (weft inserted) polyester fabric which is oriented with the knitting yarns extending in the machine direction, generally parallel to the direction of the elastic threads. Warp knitting of other polymeric or natural fibers may also be suitable. Suitably, the weight of the warp knitted (weft insertion) fabric is less than about 50g/m²(e.g., about 1.5 ounces per square yard) and most preferably less than about 25 to 30g/m²(about 0.7 to 0.9 ounces per square yard). Preferred fibers include those of 12X12 fibers/inch, although other configurations may be suitable. The above layers are then laminated with an adhesive formulation comprising the zinc oxide composition described herein and/or one or more other therapeutic agents and metered to the desired coating weight. The base polymer of the adhesive formulation may suitably be, for example, a natural rubber latex, polychloroprene or polyurethane. In such formulations, there may suitably be one or more tackifying resins, surfactants, fillers, crosslinking agents, dyes, thixotropic agents, preservatives and the like. The zinc oxide composition described herein, such as calamine and/or one or more other therapeutic agents, is suitably added to the adhesive formulation. Such incorporation of the zinc oxide composition and/or one or more other therapeutic agents can result in the zinc oxide composition and/or other therapeutic agents being substantially uniform throughout the bandage material. Thus, in a preferred aspect, the bandage material may be wrapped around the skin of the patient in either direction. The resulting composite bandage preferably can have a good appearance and be manually torn cleanly across the bandage.

The following non-limiting examples illustrate the invention.

Example 1:

suitable compression bandages with added medicament (calamine) can be prepared as described in examples 1 and 2 below.

At the beginning, polychloroprene dispersion (57.050lb) was added to a clean container. When the polychloroprene reached the bottom of the blade, the mixer was opened. Serdas 7005 antifoam (0.011lb) was added. And finally adding the rest of the polychloroprene. Snowtack 880G-rosin ester (13.910lbs) was added. Aquatac 6085 rosin ester (21.720lbs) was added through a 800 micron filter. Bostex 24 antioxidant (1.086lbs) was added. Roven 4301 carboxy styrene butadiene (0.434lbs) was added. Calamina (5.625lbs) was sieved in using a hopper or hand sifting. Dyes were added according to the color specification. Calamina was red (0.043lb) and pale yellow (0.130 lb). Mixing is continued until use to form a stretchable bandage material.

Example 2:

preferred compression bandage systems consist of 8-10g/m²Spunbond polypropylene nonwoven fabrics are provided having transversely spaced, longitudinally extending elastic layers of coalesced multifilament yarns Lykra or Spandex. The yarns had a denier of 210 and a pitch of 5-15/inch. The knitted fabric layer is a warp-knitted (weft-inserted) polyester fabric that is oriented with knitting yarns extending in a longitudinal direction, generally parallel to the direction of the elastic strands. The warp-knitted (weft-inserted) fabric has a weight of less than about 50g/m²(about 1.5 ounces per square yard) and most preferably less than about 25 to 30g/m²(about 0.7 to 0.9 ounces per square yard). The preferred fiber is 12X12 fibers/inch. The above layers were then laminated with the adhesive formulation described in example 1 above and metered to the desired coat weight.