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EP-4245326-B1 - BIOMEDICAL FOAM

EP4245326B1EP 4245326 B1EP4245326 B1EP 4245326B1EP-4245326-B1

Inventors

  • JACOBS, Johannes Jacobus
  • STANLEY, COLIN

Dates

Publication Date
20260513
Application Date
20181220

Claims (13)

  1. A foam nasal dressing (10) for topically administering a drug to a nasal cavity and for absorbing fluid discharge, the nasal dressing comprising: a foamed core portion (12) comprising a first polyurethane, the foamed core portion including amorphous segments and crystalline segments, and a hemostatic agent; a foamed shell portion (14) arranged such that the foamed core portion is disposed within the foamed shell portion, the foamed shell portion having a porosity of greater than 80% and comprising a second polyurethane, the foamed shell portion including amorphous segments and crystalline segments, wherein the first and second polyurethanes are the same or different; a drug disposed in the foamed shell portion; and the nasal dressing having an elongate shape extending from a first end (16) to a second end (18), the nasal dressing having a first half adjacent the first end and a second half adjacent the second end; a foamed base portion (20) at the second end with the foamed shell portion and the foamed core portion extending from the foamed base portion towards the first end such that the foamed base portion and the foamed shell portion cooperate to encapsulate the foamed core portion and define an outer surface of the nasal dressing; wherein a weight of the drug in the first half of the foam nasal dressing is greater than a weight of the drug in the second half of the foam nasal dressing; and wherein the foamed core portion and the foamed base portion are integral and the chemical composition of the foamed base portion is the same as the foamed core portion.
  2. The foam nasal dressing as set forth in claim 1, wherein the drug comprises a steroid, and wherein the foamed shell portion includes the steroid, and the foamed core portion is substantially free of the steroid.
  3. The foam nasal dressing as set forth in claim 2, wherein the steroid includes at least one hydrogen atom which is bound to a nitrogen, oxygen, or fluorine atom, the atom being available to form a hydrogen bond with the crystalline segments of the foamed shell portion.
  4. The foam nasal dressing as set forth in any preceding claim, wherein the foamed shell portion and the foamed core portion are bonded to one another via hydrogen bonding and substantially free of covalent bonds therebetween.
  5. The foam nasal dressing as set forth in any preceding claim, wherein: the crystalline segments in the first and/or the second polyurethane comprise the reaction product of 1,4 butanediol and 1,4 diisocyanatobutane; and/or molecules within the first and/or second polyurethane foam are arranged so that the crystalline segments and the amorphous segments stack in an alternating configuration to provide a 3-dimentional porous structure which is strengthened via hydrogen bonding between the stacked crystalline segments.
  6. The foam nasal dressing as set forth in any preceding claim, wherein the foamed core portion includes the drug at a first concentration, and the foamed shell portion includes a second drug, which is the same as or different than the drug, at a second concentration.
  7. The foam nasal dressing as set forth in any preceding claim, wherein the foamed core portion and/or the foamed shell portion comprise a hemostatic agent.
  8. The foam nasal dressing as set forth in claim 7, wherein the hemostatic agent includes at least one hydrogen atom bonded to a nitrogen atom, and at least one hydrogen atom bonded to an oxygen atom, the hydrogen atoms being available to form a hydrogen bond with the crystalline segments of the first and/or second polyurethane foam.
  9. The foam nasal dressing as set forth in claim 8, wherein molecules of the hemostatic agent and molecules of the second polyurethane foam are bonded to one another via hydrogen bonding and substantially free of covalent bonds therebetween.
  10. The foam nasal dressing as set forth in any one of claims 7-9, wherein the hemostatic agent is insoluble in the first and/or second polyurethane foam and the drug is a steroid that is insoluble in the first and/or second polyurethane foam.
  11. The foam nasal dressing as set forth in any preceding claim, wherein the foam dressing is free from any lumen.
  12. The foam nasal dressing as set forth in any preceding claim, wherein a volume of the foamed shell portion is from about 20 to about 40% of a total volume of the foam nasal dressing and/or the foamed core portion has a porosity of greater than 80%.
  13. The foam nasal dressing as set forth in any preceding claim, wherein: the foamed core portion is cylindrically-shaped; and/or a cross-section of the foamed shell portion has a square or rectangular shape and is the same shape as a cross-section of the foamed base portion.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application claims the benefit of U.S. Provisional Patent Application No. 62/608,256, filed December 20, 2017. TECHNICAL FIELD The subject disclosure relates to a biomedical foam article (e.g. a foam nasal dressing) and a method of forming the biomedical foam article. Nasal packings or dressings are known. KR 2016 0083779 A discloses a nasal packing comprising a porous core portion and a porous shell portion, wherein said packing can release a drug. SUMMARY The invention relates to a foam nasal dressing (10) for topically administering a drug to a nasal cavity and for absorbing fluid discharge, the nasal dressing comprising:a foamed core portion (12) comprising a first polyurethane, the foamed core portion including amorphous segments and crystalline segments, and a hemostatic agent;a foamed shell portion (14) arranged such that the foamed core portion is disposed within the foamed shell portion, the foamed shell portion having a porosity of greater than 80% and comprising a second polyurethane, the foamed shell portion including amorphous segments and crystalline segments, wherein the first and second polyurethanes are the same or different;a drug disposed in the foamed shell portion; and the nasal dressing having an elongate shape extending from a first end (16) to a second end (18), the nasal dressing having a first half adjacent the first end and a second half adjacent the second end;a foamed base portion (20) at the second end with the foamed shell portion and the foamed core portion extending from the foamed base portion towards the first end such that the foamed base portion and the foamed shell portion cooperate to encapsulate the foamed core portion and define an outer surface of the nasal dressing;wherein a weight of the drug in the first half of the foam nasal dressing is greater than a weight of the drug in the second half of the foam nasal dressing; and wherein the foamed core portion and the foamed base portion are integral and the chemical composition of the foamed base portion is the same as the foamed core portion. Also disclosed is a * method of forming the foam nasal dressing for topically administering a drug to a nasal cavity and for absorbing fluid discharge is also provided. The method comprises providing a mold. The method also comprises placing a spacer and a first liquid in the mold, such that the first liquid and spacer are in contact in the mold. The first liquid comprises the first polyurethane and the drug. The method further comprises cooling the first liquid to freeze the first liquid and removing the spacer from the frozen first liquid to expose a cavity in the frozen first liquid. The method further comprises placing a second liquid in the cavity of the frozen first liquid. The second liquid comprises the second polyurethane that is the same as or different than the first polyurethane. The method further comprises cooling the second liquid to freeze the second liquid. The method further comprises drying the first and second frozen liquids to form the foam nasal dressing comprising the foamed core portion at least partially disposed within the foamed shell portion. Disclosed, but not according to the invention as claimed, is a method of simultaneously treating inflammation and absorbing fluid discharge from the sinus cavity with the foam nasal dressing is also disclosed. The method comprises the steps of providing the foam nasal dressing, compressing the foam nasal dressing such that the foam dressing assumes an insertion configuration, and positioning the foam nasal dressing within the nasal cavity while the foam nasal dressing is in the insertion configuration such that the second end of the foam nasal dressing is farther from the user than the first end. BRIEF DESCRIPTION OF THE DRAWINGS Advantages of the present disclosure will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings wherein: Figure 1A is a perspective view of an example of the foam nasal dressing;Figure 1B is a perspective view of the example of Figure 1A along line BC with a foamed shell portion shown in cross-section;Figure 1C is a cross-sectional view of the example of Figures 1A and 1B along line BC;Figure 2 is a top left perspective view of an example of the foam nasal dressing with a foamed shell portion shown in cross-section;Figure 3 is a cross-sectional view of another example of the foam nasal dressing;Figure 4 is a cross-sectional view of another example of the foam nasal dressing;Figure 5 is a cross-sectional view of another example of the foam nasal dressing;Figure 6 is a cross-sectional view of another example of the foam nasal dressing;Figure 7 is perspective view of a mold and a spacer;Figure 8 is a cross-sectional view of the mold and the spacer of Figure 7;Figure 9 is a cross-sectional view of the mold of Figure 8 including a fr