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SILICONE FREE PRODUCTS WITH EQUIVALENT ADHESION AND SILICONE-LIKE LOW TRAUMA SKIN CONTACT PROPERTIES

20190134255 ยท 2019-05-09

    Inventors

    Cpc classification

    International classification

    Abstract

    This technology relates to silicone-free gel adhesives with advanced skin properties for low trauma applications. These gel adhesive products provide the benefits of silicone products while improving on the major disadvantages of silicone adhesive products such as being more cost-effective and gamma sterilizable. The adhesives for this technology may be solvent acrylic, hot melt acrylics or modified block rubbers.

    Claims

    1. A medical pressure sensitive adhesive tape comprising a pressure sensitive adhesive material layer formed on at least one side of a release liner, wherein the pressure sensitive adhesive material is silicone-free.

    2. The medical pressure sensitive adhesive tape of claim 1 wherein the tape is perforated.

    3. The medical pressure sensitive adhesive tape of claim 1 having the skin contact properties of silicone-based adhesive products.

    4. The medical pressure sensitive adhesive tape of claim 1, wherein the pressure sensitive adhesive is a rubber pressure sensitive adhesive or an acrylate pressure sensitive adhesive.

    5. The medical pressure sensitive adhesive tape of claim 1, wherein the adhesive strength to bakelite panel is within a range of about 0.6 to 15.0 N/24 mm.

    6. The medical pressure sensitive adhesive tape according to claim 1, wherein the adhesive strength to human skin at an inner lower arm is within a range of about 0.1 to 8.0 N/24 mm.

    7. The medical pressure sensitive adhesive tape according to claim 1, wherein the adhesive strength to stainless steel is within a range of about 0.1 to 10.0 N/24 mm.

    8. The medical pressure sensitive adhesive tape according to claim 4, wherein the pressure sensitive adhesive is an acrylate pressure sensitive adhesive.

    9. The medical pressure sensitive adhesive tape of claim 1, comprising a hybrid silicone-free tape with a modulus range and skin contact properties of silicone products.

    10. The medical pressure sensitive adhesive tape of 1, wherein the base material is a fabric, a nonwoven fabric, a film, a perforated film or a composite material thereof

    11. The medical pressure sensitive adhesive tape according to claim 9, wherein the film is a microporous, air-permeable film.

    12. The medical pressure sensitive adhesive tape of claim 1, comprising a hybrid transfer tape which is not on a fixed carrier.

    Description

    BRIEF DESCRIPTION OF DRAWINGS

    [0014] FIG. 1A depicts a top perspective view of a low trauma perforated roll.

    [0015] FIG. 1B depicts a bottom perspective view of the roll of FIG. 1A.

    [0016] FIG. 1C depicts a partial top plan view of the roll of FIG. 1B, showing a first roll perforation pattern for illustrative purposes.

    [0017] FIG. 1D depicts a cross-sectional view of the roll of FIG. 1A, showing a thickness of each layer of the roll for illustrative purposes.

    [0018] FIG. 2A depicts a top perspective view of another low trauma perforated roll.

    [0019] FIG. 2B depicts a bottom perspective view of the roll of FIG. 2A.

    [0020] FIG. 2C depicts a partial top plan view of the roll of FIG. 2B, showing a second roll perforation pattern for illustrative purposes.

    [0021] FIG. 2D depicts a cross-sectional view of the roll of FIG. 2A, showing a thickness of each layer of the roll for illustrative purposes.

    [0022] FIG. 3A depicts a top plan view of a Silicone-free Foam Border Dressing product with perforation layer.

    [0023] FIG. 3B depicts a bottom plan view of the product of FIG. 3A.

    [0024] FIG. 3C depicts a partial top plan view of the perforation layer of the product of

    [0025] FIG. 3A for illustrative purposes.

    [0026] FIG. 4A depicts a top perspective view of another low trauma perforated roll.

    [0027] FIG. 4B depicts a bottom perspective view of the roll of FIG. 4A.

    [0028] FIG. 4C depicts a partial top plan view of the roll of FIG. 4B, showing a third roll perforation pattern for illustrative purposes.

    [0029] FIG. 4D depicts a cross-sectional view of the roll of FIG. 4A, showing a thickness of each layer of the roll for illustrative purposes.

    DETAILED DESCRIPTION

    [0030] This invention describes the use of hybrid polymeric coatings to produce cost- effective silicone-free products having optimal gel character and the performance and feel of silicone adhesive products. This invention also describes the use of compounded polymeric hybrid adhesives to produce cost-effective silicone-free products with optimal gel character and the performance and feel of silicone adhesive products.

    [0031] The gel adhesive products that are commercially available in the medical market to address atraumatic removal of wound products are not considered direct replacements for silicone and are distinguishable by both feel of the adhesive and performance limitations of these constructions. Conversely, the modulus of these new gel products has been uniquely tailored to match the modulus of a broad variety of skin types, making these gel adhesive products suitable as direct replacements for silicone gel products involving skin contact. Bench testing shows that perforations are an integral feature of products used in advanced wound care applications and these patterns largely contribute to the function of the product. The perforated patterns of these gel adhesive products was developed to provide the percentage open area and MVTR (moisture vapor transmission rate) for equivalent or much improved function and wear performance vs. current silicone products currently in the market.

    [0032] These new gel adhesive products match the needs of various skin types in the same way as silicone adhesives and are much more cost-effective, positioning them viable options for wound care and applications where silicone products have previously been cost-restrictive or the only option of choice.

    [0033] The modulus range for skin types and a modulus range of optimized gel adhesive products have been identified, where ideal skin contact properties are achieved between the wound care product and skin in order to improve feel and performance of the product during wear and removal. Optimizing the properties in a wound care product to include skin contact properties allows the extension and contraction of skin interfacing with the product to not only reduce mechanical stress on the skin, but to minimize irritation and promote overall comfort.

    [0034] In Examples 5 & 6 the modulus matching effect is achieved by combining bulk adhesive properties of discrete layer 2 gel adhesive and skin contact properties of discrete layer 1 adhesive in various thickness ratios. Since bulk properties of adhesives are very different, when the bulk layer is combined with another discrete skin contacting layer at different thicknesses many versatile combinations and matched moduli are possible. With this method, the overall modulus of the adhesive is controlled not only by the adhesive type used as the bulk layer but also the ratio of the bulk adhesive to the skin contacting layer. Matching the modulus of discrete adhesive layers in this way provides the ability to offer both skin contact properties and bulk adhesive properties that are unique and many varied combinations for different skin types. An example of a preferred modulus would be 1:1, where 3 mils of a non-silicone adhesive gel is combined with 3 mils of a particular bulk adhesive, or another preferred modulus would be 4 mils of a non-silicone adhesive gel is combined with 6 mils of yet a different bulk adhesive. In another preferred modulus, 3 mils of a non-silicone adhesive gel is combined with 7 mils of yet a different bulk adhesive. (Table 1) Data provided in Tables 2A-2C show how the choice of adhesive type (standard acrylic PSA's) and choice of carrier substrate (polyurethane film, polyurethane foam, polyethylene film and polyester nonwoven) can influence the bonding strength of an adhesive and wear times of a product. Table 2A shows the influence of substrate (polyester nonwoven, polyurethane foam, polyurethane film, PE film) on a product's wear time (# days of wear on skin before failure) when the adhesive is constant and it also shows the influence of adhesive on wear duration (# days of wear) when the substrate is constant. Table 2B shows 4 different nonwoven substrates and a single adhesive option (gel adhesive). Table 2C shows a single nonwoven type with 4 different adhesives.

    [0035] In one embodiment of the non-silicone gel development, the modulus of carrier components is taken into consideration and is correlated with the modulus of skin types to create an overall synergistic product where performance equivalence to silicone products such as no pain on removal and comfort during wear is required. These gel adhesive products offer end users not only select adhesion levels but products that are tailored to particular skin properties providing high performance, little to no pain on removal with silicone-free constructions for skin contact applications.

    TABLE-US-00001 TABLE 1 Skin Contact Adhesive/ Liner Lot # PU Carrier Bulk Adhesive Thickness Description 16-060 Supplier A Non-Si Adhesive B (Skin Contact) 10 mils Liner Supplier A 16-062 Supplier A Non-Si Adhesive B (Skin Contact) 6 mils Liner Supplier B 16-063 Supplier A Non-Si Adhesive B (Skin Contact) 4 mils Liner Supplier B 16-071 Supplier A Non-Si Adhesive A (Skin Contact) 6 mils Liner Supplier B 16-064 Supplier A Non-Si Adhesive A (Skin Contact) 4 mils Liner Supplier B 16-065 Supplier A Non-Si Adhesive C 4 mill + 6 mil Liner Supplier B (Skin Contact) + Bulk Adhesive A 16-208 Supplier B Non-Si Adhesive C 3 mil + 3 mil Liner Supplier C (Skin Contact) + Bulk Adhesive A 16-066 Supplier B Non-Si Adhesive C 4 mill + 6 mil Liner Supplier B (Skin Contact) + Bulk Adhesive A 16-069 Supplier B Non-Si Adhesive C 3 mil + 3 mil Liner Supplier C (Skin Contact) + Bulk Adhesive A 16-070 Supplier A2 Non-Si Adhesive B 5 mil + 5 mil Liner Supplier A2 (Skin Contact) + Bulk Adhesive B 16-071 Supplier A2 Non-Si Adhesive B 6 mil + 4 mil Liner Supplier B2 (Skin Contact) + Bulk Adhesive B 16-215 Supplier B2 Non-Si Adhesive A 7 mil + 3 mil Liner Supplier B2 (Skin Contact) + Bulk Adhesive B 16-216 Supplier A2 Non-Si Adhesive A 5 mil + 5 mil Liner Supplier A2 (Skin Contact) + Bulk Adhesive B 16-217 Supplier A2 Non-Si Adhesive A 6 mil + 4 mil Liner Supplier B3 (Skin Contact) + Bulk Adhesive B 16-218 Supplier A2 Non-Si Adhesive B 7 mil + 3 mil Liner Supplier A3 (Skin Contact) + Bulk Adhesive B 16-219 Supplier A2 Non-Si Adhesive C 10 mils Liner Supplier C (Skin Contact) 16-220 Supplier A2 Non-Si Adhesive B 10 mils Liner Supplier A3 (Skin Contact) 16-221 Supplier A2 Non-Si Adhesive A 10 mils Liner Supplier C (Skin Contact) 16-222 Supplier B2 Non-Si Adhesive A 10 mils Liner Supplier C (Skin Contact) 16-226 Supplier B2 Non-Si Adhesive A 10 mils Liner Supplier C (Skin Contact) 16-209 Supplier B2 Non-Si Adhesive A 3 mil + 3 mil Liner Supplier C2 (Skin Contact) + Bulk Adhesive B 16-223 Supplier B2 Non-Si Adhesive A 10 mils Liner Supplier C2 (Skin Contact) 16-224 Supplier B2 Non-Si Adhesive A 6 mils Liner Supplier C3 (Skin Contact) 16-225 Supplier B2 Non-Si Adhesive B 5 mil + 3 mil Liner Supplier A4 (Skin Contact) + Bulk Adhesive C 16-226 Supplier B2 Non-Si Adhesive A 5 mil + 3 mil Liner Supplier A4 (Skin Contact) + Bulk Adhesive C

    TABLE-US-00002 TABLE 2A Acrylic Adhesive Pressure Type Peel, # Days # Days # Days Sensitive N/in @ 1.sup.st 80% 50% Carrier Type Adhesive 50 gsm Failure Intact Intact PU Film 1 mil A1 16 13 18 18 PU Film 1 mil A2 15 6 13 18 PU Film 1 mil A3 14 3 8 11 PU Film 1 mil A4 20 9 17 18 PU Foam A1 16 2 8 14 10+ mil PU Foam A2 15 9 11 17 10+ mil PU Foam A3 14 2 2 4 10+ mil PU Foam A4 20 12 17 18 10+ mil PE Film A1 16 2 4 8 2+ mil PE Film A2 15 1 3 8 2+ mil PE Film A3 14 1 3 2 2+ mil PE Film A4 20 4 7 16 2+ mil NW PES A1 16 7 10 12 6+ mil NW PES A2 15 4 6 14 6+ mil NW PES A3 14 4 5 8 6+ mil NW PES A4 20 5 6 9 6+ mil

    TABLE-US-00003 TABLE 2B Width Test panel/ Sample Name mm Substrate F.sub.aver. N NW8001_XP110.5 25.0 PUR-0001 0.49 NW8001_XP112.1 25.0 PUR-0001 7.64 NW8001_LK3950 25.0 PUR-0001 10.46 NW8001_LK7565 25.0 PUR-0001 10.86 8001 = Polyester spunbond nonwoven XP 110.5 = Acrylic Si-free gel (Lohmann #1) XP 112.1 = Example 5, Si-free gel LK 3950 = Acrylic adhesive LK 7565 = High Tack Acrylic adhesive Test Panel PUR 0001 = Polyurethane 0001

    TABLE-US-00004 TABLE 2C Test Width panel/ Sample Name mm Substrate F.sub.aver. N NW_8001_XP114.5 25.0 PE-0004 33.17 NW_PETSB60g_XP114.5 25.0 PE-0004 23.98 NW_8004_XP114.5 25.0 PE-0004 29.85 NW_8010_XP114.5 25.0 PE-0004 27.54 Nonwovens 8001 through 8010 8001, PETSB60g, 8004 and 8010 all = polyester spunbond XP 114.5 = Si-free gel (Lohmann #3) Test Panel PE-0004 = Polyethylene 0004

    [0036] Qualitative assessments of the low trauma effects of the non-silicone gel adhesives conducted in direct comparisons against market leading silicon adhesive products by experienced wound care practitioners indicate the non-silicone gel adhesives are comparable to, or preferred over market leading silicone products. This feedback is based on the ability to reposition these adhesives after initial bonding to the skin, comfort during contact with the skin and lack of pain on removal of the adhesive. (Table 3).

    TABLE-US-00005 TABLE 3 Most No Pain on Reposition- Comfortable Removal ability Silicone Mkt Leader #1 25% 15% 7% Silicone Mkt Leader #2 12% 30% 14% Acrylic Si-free gel 33% 30% 54% (Lohmann #1) Modified rubber Si-free 17% 20% 7% gel (Lohmann #2) Modified rubber Si-free 13% 5% 18% gel (Lohmann #3)

    EXAMPLES

    [0037] The following examples are non-narrowing, illustrative examples of the technology. In all examples, the adhesives used are either solvent acrylic, hot melt acrylics or modified block rubbers. Where gel adhesive is indicated, the preference in these examples is either hot melt acrylic or modified rubbers.

    Example 1

    [0038] The gel layer is either a solvent acrylic, a hot melt acrylate or synthetic rubber based adhesive such as SBS, SIS, or SES. The preferred carrier is a polyurethane film but can be a nonwoven, PET, PE, PP, foam, etc. The PU carrier film has a casting sheet for reinforcement and better handling. The PU used in these examples is inert but could contain an active and is a next generation idea. The thickness of the gel adhesives tend to be >100 gsm without an upper limit. However, 100-300 gsm is the range for the gel character and skin properties that are targeted as optimal. Properties with less gel character (closer to standard PSA) although still relevant, are less pertinent in these examples; thicknesses for these adhesives are optimally in the 30-75 gsm range. The release liner for the gel adhesive can be a standard easy release, controlled release or an ultra-easy release (custom formulation) on the closed (skin) or open sides depending on requirements.

    [00001] 60 .Math. # .Math. .Math. PCK .Math. .Math. Paper = 4.5 .Math. .Math. mils NS .Math. .Math. Gel .Math. .Math. Adhesive = 10 .Math. .Math. mils TPU .Math. .Math. film .Math. .Math. carrier = 1 .Math. .Math. mil PE .Math. .Math. casting .Math. .Math. sheet = 2 .Math. .Math. mils .Math. .Math. ( ** .Math. may .Math. .Math. or .Math. .Math. may .Math. .Math. not .Math. .Math. be .Math. .Math. included ) Total = Approx . .Math. 18 .Math. .Math. mils

    Example 2

    Modulus Matched

    [0039] Modulus matchedModulus of the gel adhesive, modulus of the carrier and modulus of the backing are purposely matched to produce a dressing with optimal skin contact interface and value-add wear properties such as the ability to reposition and remove wrinkles while the dressing is kept in place, ease of removal of the dressing from skin, repositionability of the dressing once applied, conformability & contouring of the layers to skin over time and improved comfort during wear. The gel layer is either a solvent acrylic, a hot melt acrylate or synthetic rubber based adhesive such as SBS, SIS, SES, etc.

    [00002] 60 .Math. # .Math. .Math. PCK .Math. .Math. Paper = 4.5 .Math. .Math. mils NS .Math. .Math. Gel .Math. .Math. Adhesive = 10 .Math. .Math. mils TPU .Math. .Math. film .Math. .Math. carrier = 1 .Math. .Math. mil PE .Math. .Math. casting .Math. .Math. sheet = 2 .Math. .Math. mils .Math. .Math. ( ** .Math. may .Math. .Math. or .Math. .Math. may .Math. .Math. not .Math. .Math. be .Math. .Math. included ) Total = Approx . .Math. 18 .Math. .Math. mils

    Example 3

    High MTVR

    [0040] High MVTR is indicated in this example since surface area of the gel adhesive layer is greatly reduced once perforated and the vapor transmission of the adhesive increases significantly. In this example the perforation pattern and the transmission rate are approximated close to a commercial product in order to demonstrate equivalent % open area. The gel layer is either a solvent acrylic, a hot melt acrylate or synthetic rubber based adhesive such as SBS, SIS, SES, etc. Perforations in the converted dressing example are approximately 1.75 mm with 1 mm tie.

    [00003] 60 .Math. # .Math. .Math. PCK .Math. .Math. Paper = 4.5 .Math. .Math. mils NS .Math. .Math. Gel .Math. .Math. Adhesive = 10 .Math. .Math. mils TPU .Math. .Math. film .Math. .Math. carrier = 1 .Math. .Math. mil Foam .Math. .Math. Island = 60 .Math. .Math. or .Math. .Math. 137 .Math. .Math. mils TPU .Math. .Math. film .Math. .Math. backing = 1 .Math. .Math. mil Total = Approx . .Math. 80 - 160 .Math. .Math. mils

    Example 4

    Hybrid Adhesive

    [0041] This is a compound of either (2) acrylic hot melt adhesives or a compound of (2) rubber based adhesives. The gel adhesive in this example is an adhesive purchased from a supplier that is compounded with another adhesive from this or another supplier to achieve unique properties.

    [0042] The gel layer is either a solvent acrylic, a hot melt acrylate or synthetic rubber based adhesive such as SBS, SIS, SES, etc. PU is the preferred carrier/backing.

    [00004] 60 .Math. # .Math. .Math. PCK .Math. .Math. Paper = 4.5 .Math. .Math. mils NS .Math. .Math. Gel .Math. .Math. Adhesive = 10 .Math. .Math. mils TPU .Math. .Math. film .Math. .Math. carrier = 1 .Math. .Math. mil PE .Math. .Math. casting .Math. .Math. sheet = 2 .Math. .Math. mils .Math. .Math. ( ** .Math. may .Math. .Math. or .Math. .Math. may .Math. .Math. not .Math. .Math. be .Math. .Math. included ) Total = Approx . .Math. 18 .Math. .Math. mils

    Example 5

    Hybrid Coating

    [0043] Gel A is an acrylic hot melt PSA and Gel B is a different acrylic hot melt. The chemical composition of gel adhesive B is an acrylic hot melt. The gel adhesive layers A and B are discrete layers with different thicknesses. In Example 5, Gel A is 100 gsm and Gel B is 150 gsm. The carrier in Example 5 is PU with no tissue between adhesive layers and it may contain an active.

    [00005] 60 .Math. # .Math. .Math. PCK .Math. .Math. Paper = 4.5 .Math. .Math. mils NS .Math. .Math. Gel .Math. .Math. Adhesive = 10 .Math. .Math. mils TPU .Math. .Math. film .Math. .Math. carrier = 1 .Math. .Math. mil PE .Math. .Math. casting .Math. .Math. sheet = 2 .Math. .Math. mils .Math. .Math. ( ** .Math. may .Math. .Math. or .Math. .Math. may .Math. .Math. not .Math. .Math. be .Math. .Math. included ) Total = Approx . .Math. 18 .Math. .Math. mils

    Example 6

    Hybrid Transfer Coating

    [0044] Hybrid Transfer coating is an adhesive (layers A+B) that can be removed from the release liner (as 1 layer) and applied to a carrier of choice. Hybrid coating is a compounded adhesive (same or 2 different suppliers) that is coated as a single layer. With Example 6, PET or another release liner is used to facilitate the transfer of the hybrid adhesive coating during lamination to another carrier of choice. The chemical composition of gel adhesive A is an acrylic hot melt PSA or synthetic rubber adhesive. The chemical composition of gel adhesive B is an acrylic hot melt PSA or synthetic rubber adhesive.

    [00006] 60 .Math. # .Math. .Math. PCK .Math. .Math. Paper = 4.5 .Math. .Math. mils NS .Math. .Math. Gel .Math. .Math. Adhesive = 10 .Math. .Math. mils TPU .Math. .Math. film .Math. .Math. carrier = 1 .Math. .Math. mil PE .Math. .Math. casting .Math. .Math. sheet = 2 .Math. .Math. mils .Math. .Math. ( ** .Math. may .Math. .Math. or .Math. .Math. may .Math. .Math. not .Math. .Math. be .Math. .Math. included ) Total = Approx . .Math. 18 .Math. .Math. mils

    Example 1

    [0045] Silicone Free Tape/Pad

    Example 2

    [0046] Modulus Matched Tape/Pad

    Example 3

    [0047] High MVTR Tape/Pad

    Example 4

    [0048] Hybrid Adhesive Tape/Pad

    Example 5

    [0049] Hybrid Coating Tape/Pad

    Example 6

    [0050] Hybrid Transfer Coating Tape/Pad