Super soft foams

Abstract

Super-soft foam materials, optionally for use as medical dressings, are provided. The pads are made of a foam prepared from NCO-terminated prepolymers in combination with an aqueous phase including fatty alcohols and alkyl polysaccharides. The foam may optionally contain at least one medicinal agent.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a depiction of an apparatus which may be utilized to determine the Indentation Force Deflection (IFD) of a foam by indenting the foam 25%.

FIG. 1B is a depiction of an apparatus which may be utilized to determine the Indentation Force Deflection (IFD) of a foam by indenting the foam 65%.

FIG. 1C is a depiction of an apparatus which may be utilized to determine the conformability of a foam of the present disclosure, that is, the measure of the flexural rigidity or the resistance to bending of the foam.

FIG. 1D is a depiction of the apparatus of FIG. 1C in use.

FIG. 2 is a depiction of a super soft pad dressing made with a foam of the present disclosure placed over a wound on the side (sagittal view) of the thigh.

FIG. 3 is an alternate depiction of the super soft pad on the thigh as shown in FIG. 2, wherein the patient is laying on their stomach.

FIG. 4 is an alternate depiction of the super soft pad on the thigh as shown in FIG. 2, wherein the patient is laying on their back.

FIG. 5 is an alternate depiction of the super soft pad on the thigh as shown in FIG. 2, wherein the patient is laying on their back with the leg raised, approximating perpendicularity with the torso.

FIG. 6 is an alternate depiction of the super soft pad on the thigh as shown in FIG. 2, wherein the patient is laying on their side such that the foam pad dressing is transversely exposed.

FIG. 7 is a graph illustrating the efficacy of certain embodiments of the present invention with respect to a first target microorganism.

FIG. 8 is a graph illustrating the efficacy of additional embodiments the present invention with respect to the first target microorganism.

FIG. 9 is a graph illustrating the efficacy of certain embodiments of the present invention with respect to a second target microorganism.

FIG. 10 is a graph illustrating the efficacy of certain embodiments of the present invention with respect to a third target microorganism.

FIG. 11 is a graph illustrating the efficacy of certain embodiments of the present invention with respect to a fourth target microorganism.

FIG. 12 is a graph illustrating the efficacy of certain embodiments of the present invention with respect to a fifth target microorganism.

FIG. 13 is a graph illustrating the efficacy of additional alternative embodiments of the present invention with respect to a sixth target microorganism, according to a first inoculation interval.

FIG. 14 is a graph illustrating the efficacy of additional alternative embodiments of the present invention with respect to the sixth target microorganism, according to a second inoculation interval.

FIG. 15 is a graph illustrating the efficacy of additional alternative embodiments of the present invention with respect to the sixth target microorganism, according to a third inoculation interval.

FIG. 16 is a chart comparing the zone of inhibition behavior of an additional alternative embodiment of the present invention over a period of days with respect to the first target microorganism.

Claims

1. A foam comprising: at least one NCO-terminated hydrophilic urethane prepolymer comprising at least one isocyanate in combination with a polyether polyol comprising an alkylene oxide in combination with a compound containing at least two active hydrogen atoms selected from the group consisting of polyhydric alcohols, polyhydric phenols, amines, polycarboxylic acids, and phosphorous acids; and an aqueous phase comprising deionized water, at least one fatty alcohol, and at least one alkyl polysaccharide.

2. The foam of claim 1, wherein the polyether polyol comprises an ethylene oxide and the at least one isocyanate is selected from the group consisting of aromatic isocyanates, aliphatic isocyanates, and combinations thereof.

3. The foam of claim 1, wherein the polyether polyol has an oxyethylene content from about 50% to about 90% by weight and the at least one isocyanate is selected from the group consisting of p-phenylene diisocyanate, 4,4′-diphenylmethane diisocyanate and position isomers thereof, 2,4-toluene diisocyanate and position isomers thereof, 3,4-dichlorophenyl diisocyanate, dicyclohexylmethane-4,4′-diisocyanate, 1,6-hexamethylene diisocyanate and position isomers thereof, isophorone diisocyanate, and combinations thereof.

4. The foam of claim 1, wherein the fatty alcohol is selected from the group consisting of caproic alcohol, caprylic alcohol, 2-ethylhexyl alcohol, capric alcohol, lauryl alcohol, isotridecyl alcohol, myristyl alcohol, cetyl alcohol, hexyl decanol, palmitoleyl alcohol, stearyl alcohol, cetearyl alcohol, isostearyl alcohol, oleyl alcohol, elaidyl alcohol, petroselinyl alcohol, linolyl alcohol, linolenyl alcohol, elaeostearyl alcohol, arachyl alcohol, gadoleyl alcohol, behenyl alcohol, octyl dodecanol, erucyl alcohol brassidyl alcohol, coconut oil, cetearyl alcohol, behenyl alcohol, and combinations thereof.

5. The foam of claim 4, wherein the fatty alcohol further comprises an ether comprising the reaction product of ethylene oxide with an alcohol selected from the group consisting of caproic alcohol, caprylic alcohol, 2-ethylhexyl alcohol, capric alcohol, lauryl alcohol, isotridecyl alcohol, myristyl alcohol, cetyl alcohol, hexyl decanol, palmitoleyl alcohol, stearyl alcohol, cetearyl alcohol, isostearyl alcohol, oleyl alcohol, elaidyl alcohol, petroselinyl alcohol, linolyl alcohol, linolenyl alcohol, elaeostearyl alcohol, arachyl alcohol, gadoleyl alcohol, octyl dodecanol, behenyl alcohol, erucyl alcohol and brassidyl alcohol and combinations thereof.

6. The foam of claim 1, wherein the alkyl polysaccharide comprises a hydrophobic group having from about 8 to about 20 carbon atoms and a polysaccharide hydrophilic group having from about 1.5 to about 10 saccharide units.

7. The foam of claim 1, wherein the alkyl polysaccharide is selected from the group consisting of glucosides, galactosides, lactosides, fructosides, fructosyls, lactosyls, glucosyls, galactosyls, and mixtures thereof.

8. The foam of claim 1, wherein the aqueous phase comprises deionized water, cetearyl alcohol, polyoxyethylene cetyl/stearyl ether, and an alkyl polyglucoside of the formula: RO(CnH2nO)r(Z)x (I); wherein Z is derived from glucose, R is a hydrophobic group selected from the group consisting of alkyl, alkylphenyl, hydroxyalkylphenyl, and mixtures thereof having from about 10 to about 18 carbon atoms, n is from about 2 to about 3, r is from about 0 to about 10, and x is from about 1.5 to about 8.

9. The foam of claim 1, further comprising a medicinal agent selected from the group consisting of antimicrobials, analgesics, antipyretics, anesthetics, antiepileptics, antihistamines, anti-inflammatories, diagnostic agents, sympathomimetics, cholinomimetics, antimuscarinics, antispasmodics, hormones, growth factors, muscle relaxants, antineoplastics, immunosuppressants, steroids, polysaccharides, enzymes, and combinations thereof.

10. The foam of claim 1, further comprising an antimicrobial agent selected from the group consisting of triclosan, polyhexamethylne biguanide, polyethylene hexamethylene biguanide, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, chlorhexidine hydrochloride, chlorhexidine sulfate, silver, silver acetate, silver benzoate, silver carbonate, silver citrate, silver iodate, silver iodide, silver lactate, silver laurate, silver nitrate, silver oxide, silver palmitate, silver protein, silver sulfadiazine, phosphate glass, polymyxin, tetracycline, tobramycin, gentamicin, rifampicin, bacitracin, neomycin, chloramphenicol, miconazole, oxolinic acid, norfloxacin, nalidixic acid, pefloxacin, enoxacin ciprofloxacin, penicillin, oxacillin, pipracil, nonoxynol 9, fusidic acid, cephalosporins, bovine lactoferrin, and lactoferricin B, and combinations thereof.

11. The foam of claim 10, comprising up to about 20,000 ppm of the antimicrobial agent.

12. The foam of claim 1, comprising up to about 20,000 ppm, and at least about 5,000 ppm of PHMB.

13. The foam of claim 12, comprising up to about 20,000 ppm, and at least about 7,500 ppm of PHMB.

14. The foam of claim 13, comprising up to about 20,000 ppm, and at least about 9,000 ppm of PHMB.

15. The foam of claim 14, comprising up to about 20,000 ppm, and at least about 10,000 ppm of PHMB.

16. The foam of claim 15, comprising up to about 20,000 ppm, and at least about 15,000 ppm of PHMB.

17. The foam of claim 16, comprising up to about 20,000 ppm, and at least about 17,500 ppm of PHMB.

18. The foam of claim 12, constructed to provide at least a 2 log reduction in the quantity of one or more common wound pathogens over an exposure period of at least seven days.

19. The foam of claim 18, constructed to provide at least a 6 log reduction in the quantity of one or more common wound pathogens over an exposure period of at least seven days.

20. The foam of claim 19, wherein the one or more wound pathogens comprise one or more of: Pseudomonas aeruginosa; Staphylococcus epidermidis; Staphylococcus auereus; Escherichia coli; Enterococcus faecalis; and Candida albicans.

21. The foam of claim 12, constructed to provide at least a 2 log reduction in the quantity of one or more common wound pathogens after an exposure period of no more than about 10 minutes.

22. The foam of claim 21, constructed to provide at least a 6 log reduction in the quantity of one or more common wound pathogens after an exposure period of no more than about 10 minutes.

23. The foam of claim 21, constructed to provide at least a 2 log reduction in the quantity of one or more common wound pathogens after an exposure period of no more than about 5 minutes.

24. The foam of claim 23, wherein, the one or more wound pathogens comprise one or more of: Pseudomonas aeruginosa; Staphylococcus epidermidis; Staphylococcus auereus; Escherichia coli; Enterococcus faecalis; and Candida albicans.

25. The foam of claim 12, constructed to provide a zone of inhibition upon exposure to one or more common wound pathogens that increases after a period of exposure of at least 3 days.

26. The foam of claim 1, wherein the foam has an IFD 25% of from about 1 pound to about 2 pounds, an IFD 65% of from about 3.5 pounds to about 9 pounds, a support factor from about 3.5 to about 4.5, and a conformability value of from about 0.01 N/cm3 to about 0.1 N/cm3.

27. The foam of claim 1, wherein the foam has a fluid capacity under compression equivalent to 18 mm Hg of about 4 to about 8 cc/in2.

28. The foam of claim 1, wherein the foam has a fluid capacity under compression equivalent to 40 mm Hg of about 3 to about 7 cc/in2.

29. A medical product comprising the foam of claim 1.

30. The medical product of claim 29, wherein the medical product comprises a wound dressing.

31. The dressing of claim 30, further comprising a backing layer selected from the group consisting of polyurethanes, acetate fibers, acrylic fibers, cellulose ester fibers, modacrylic fibers, polyamide fibers, polyester fibers, polyolefin fibers, polyvinyl alcohol fibers, rayon fibers, polyethylene foam, and combinations thereof.

32. The dressing of claim 30, further comprising a backing layer selected from the group consisting of polyurethanes, polyester fibers, rayon fibers, and combinations thereof, optionally in combination with an adhesive selected from the group consisting of acrylic adhesives, hydrocolloid adhesives, hydrogel adhesives, polyurethane adhesives, and silicone adhesives.

33. The dressing of claim 30, wherein any exudate within the dressing migrates away from a wound to which the dressing is applied.

34. The foam of claim 1, wherein the at least one NCO-terminated hydrophilic urethane prepolymer is selected from the group consisting of aromatic isocyanates, aliphatic isocyanates, and combinations thereof; wherein the at least one fatty alcohol is selected from the group consisting of caproic alcohol, caprylic alcohol, 2-ethylhexyl alcohol, capric alcohol, lauryl alcohol, isotridecyl alcohol, myristyl alcohol, cetyl alcohol, hexyl decanol, palmitoleyl alcohol, stearyl alcohol, cetearyl alcohol, isostearyl alcohol, oleyl alcohol, elaidyl alcohol, petroselinyl alcohol, linolyl alcohol, linolenyl alcohol, elaeostearyl alcohol, arachyl alcohol, gadoleyl alcohol, behenyl alcohol, octyl dodecanol, erucyl alcohol brassidyl alcohol, coconut oil, cetearyl alcohol, behenyl alcohol, and combinations thereof; andwherein the at least one alkyl polysaccharide is of the formula: RO(CnH2nO)r(Z)x  (I)wherein Z is derived from glucose, R is a hydrophobic group selected from the group consisting of alkyl, alkylphenyl, hydroxyalkylphenyl, and mixtures thereof having from about 10 to about 18 carbon atoms, n is from about 2 to about 3, r is from about 0 to about 10, and x is from about 1.5 to about 8.

35. The foam of claim 34, further comprising a medicinal agent selected from the group consisting of antimicrobials, analgesics, antipyretics, anesthetics, antiepileptics, antihistamines, anti-inflammatories, diagnostic agents, sympathomimetics, cholinomimetics, antimuscarinics, antispasmodics, hormones, growth factors, muscle relaxants, antineoplastics, immunosuppressants, steroids, polysaccharides, enzymes, and combinations thereof.

36. The foam of claim 34, further comprising an antimicrobial agent selected from the group consisting of triclosan, polyhexamethylene biguanide, polyethylene hexamethylene biguanide, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, chlorhexidine hydrochloride, chlorhexidine sulfate, silver, silver acetate, silver benzoate, silver carbonate, silver citrate, silver iodate, silver iodide, silver lactate, silver laurate, silver nitrate, silver oxide, silver palmitate, silver protein, silver sulfadiazine, phosphate glass, polymyxin, tetracycline, tobramycin, gentamicin, rifampicin, bacitracin, neomycin, chloramphenicol, miconazole, oxolinic acid, norfloxacin, nalidixic acid, pefloxacin, enoxacin ciprofloxacin, penicillin, oxacillin, pipracil, nonoxynol 9, fusidic acid, cephalosporins, bovine lactoferrin, and lactoferricin B, and combinations thereof.

37. The foam of claim 34, wherein the foam has an IFD 25% of from about 1 pound to about 2 pounds, an IFD 65% of from about 3.5 pounds to about 9 pounds, a support factor from about 3.5 to about 4.5, and a conformability value of from about 0.01 N/cm3 to about 0.1 N/cm3.

38. A dressing comprising the foam of claim 34 in combination with a backing layer selected from the group consisting of polyurethanes, acetate fibers, acrylic fibers, cellulose ester fibers, modacrylic fibers, polyamide fibers, polyester fibers, polyolefin fibers, polyvinyl alcohol fibers, rayon fibers, polyethylene foam, and combinations thereof.

39. A dressing comprising the foam of claim 34 in combination with a backing layer selected from the group consisting of polyurethanes, polyester fibers, rayon fibers, and combinations thereof, optionally in combination with an adhesive selected from the group consisting of acrylic adhesives, hydrocolloid adhesives, hydrogel adhesives, polyurethane adhesives, and silicone adhesives.

40. A medical product comprising the foam of claim 34.

41. The medical product of claim 40, wherein the medical product comprises a wound dressing.

42. The dressing of claim 41, further comprising up to about 20,000 ppm of PHMB.

43. A method of reducing the count of one or more pathogens comprising: identifying a source of exudate containing one or more pathogens;applying a medical product comprising the foam of claim 42 to the source;absorbing exudate into the foam; andkilling pathogens contained in the exudate absorbed into the foam, thereby rendering cleaned exudate.

44. The method of 43, further comprising releasing cleaned exudate from inside the foam back out into the source.

45. The method of claim 44, wherein the step of releasing further comprising releasing antimicrobial agent along with the cleaned exudate back out into the source.