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1. (WO2017004268) ÉCHAFAUDAGES IMPLANTABLES POUR LE TRAITEMENT DE LA SINUSITE
Note: Texte fondé sur des processus automatiques de reconnaissance optique de caractères. Seule la version PDF a une valeur juridique

CLAIMS:

1. A scaffold adapted for delivery to a human sinus comprising:

(a) a tubular scaffold comprising a plurality of braided polymeric strands that comprise a first biodegradable polymer material and

(b) a conformal coating over the tubular scaffold that comprises a crosslinked biodegradable elastomer.

2. The scaffold of claim 1, wherein the first biodegradable polymer material comprises poly(lactide-co-glycolide).

3. The scaffold of any of claims 1-2, wherein the scaffold comprises between 8 and 64 polymeric strands.

4. The scaffold of any of claims 1-3, wherein the braided polymeric strands cross each other at a braid angle ranging from 80° to 140°.

5. The scaffold of any of claims 1-4, wherein the biodegradable elastomer material comprises poly(lactide-co-caprolactone).

6. The scaffold of claim 5, wherein the biodegradable elastomer material comprises poly(lactide-co-caprolactone) having molar percentage of lactide ranging from 30 to 50% and a molar percentage of caprolactone ranging from 50 to 70%.

7. The scaffold of any of claims 5-6, wherein the biodegradable elastomer material comprises urethane and/or urea crosslinks.

8. The scaffold of any of claims 1-7, wherein the biodegradable elastomer material is formed by reacting a branched poly(lactide-co-caprolactone) polyol with a diisocyanate crosslinking agent.

9. The scaffold of claim 8, wherein the branched poly(lactide-co-caprolactone) polyol is reacted with the diisocyanate crosslinking agent in the presence of a 1-substitued C8- C18 alcohol.

10. The scaffold of any of claims 1-9, further comprising a therapeutic-agent-containing layer comprising a therapeutic agent and a second biodegradable polymer material which may be the same as or different from the first biodegradable polymer material.

11. The scaffold of claim 10, wherein the second biodegradable polymer material comprises poly(lactide-co-caprolactone).

12. The scaffold of claim 11, wherein the second biodegradable polymer material comprises poly(lactide-co-caprolactone) having molar percentage of lactide ranging from 70 to 95 % and a molar percentage of caprolactone ranging from 5 to 30%.

13. The scaffold of any of claims 11 to 13, wherein the therapeutic agent is a steroid.

14. The scaffold of claim 14, wherein the steroid is mometasone furoate.

15. The scaffold of any of claims 1-14, further comprising a topcoat layer comprising a third biodegradable polymer material disposed over the therapeutic-agent-containing layer, wherein the third biodegradable polymer material may be the same as or different from the first biodegradable polymer material and wherein the third biodegradable polymer material may be the same as or different from the second biodegradable polymer material.

16. The scaffold of any of claims 1-15, wherein the scaffold has an unconstrained diameter selected from (a) an unconstrained diameter ranging from 6 to 10 mm, (b) an unconstrained diameter ranging from 10 to 15 mm, (c) an unconstrained diameter

ranging from 15 to 20 mm, and (d) an unconstrained diameter ranging from 20 to 60 mm.

17. The scaffold of any of claims 1-16, wherein after holding the tubular scaffold in a 34 °C, 80 % relative humidity environment for 10 weeks in a compressed state between two parallel flat plates such that the axis of the tubular scaffold is parallel to the parallel flat plates and such that the tubular scaffold is compressed between the parallel flat plates to a point where a first distance between the parallel flat plates is 17% of the initial unconstrained diameter such that the tubular scaffold has a first minimum width measured perpendicular to the axis that is equal to the first distance, and wherein after removal the tubular scaffold from the compressed state for six hours, the minimum width of the tubular scaffold recovers to a second minimum width measured perpendicular to the axis that is at least 250% of the first minimum width.

18. The scaffold of any of claims 1-16, wherein after holding the tubular scaffold in a 34 °C, 80 % relative humidity environment for 10 weeks in a compressed state between two parallel flat plates such that the axis of the tubular scaffold is parallel to the parallel flat plates and such that the tubular scaffold is compressed between the parallel flat plates to a point where a first distance between the parallel flat plates is 8.5% of the initial unconstrained diameter such that the tubular scaffold has a first minimum width measured perpendicular to the axis that is equal to the first distance, and wherein after removal the tubular scaffold from the compressed state for six hours, the minimum width of the tubular scaffold recovers to a second minimum width measured perpendicular to the axis that is at least 450% of the first minimum width.

19. A scaffold of any of claims 1-16, loaded into a delivery catheter.

20. A method of treatment, wherein a scaffold in accordance with any of claims 1-15 is delivered to a human sinus.

21. The method of claim 20, wherein the scaffold is delivered to an ethomoid sinus of a human patient and wherein the scaffold has an unconstrained diameter ranging from 15 mm to 20 mm.

22. The method of claim 21, wherein the scaffold is delivered to the ethomoid sinus after functional endoscopic sinus surgery (FESS).

23. The method of claim 20, wherein the scaffold is delivered to a frontal sinus ostium, a maxillary sinus ostium or a sphenoid sinus ostium of a human patient and wherein the scaffold has an unconstrained diameter ranging from 6 mm to 10 mm.

24. The method of claim 23, wherein the scaffold is delivered after functional endoscopic sinus surgery (FESS).

25. The method of claim 20, wherein the scaffold is delivered to a middle meatus sinus space of a human patient and wherein the scaffold has an unconstrained diameter ranging from 10 mm to 15 mm.

26. A scaffold adapted for delivery to human sinus comprising:

(a) a tubular scaffold comprising a first biodegradable polymer material and

(b) a therapeutic-agent-containing layer comprising a therapeutic agent and a second biodegradable polymer material which may be the same as or different from the first biodegradable polymer material.

27. The scaffold of claim 26, wherein the first biodegradable polymer material comprises poly(lactide-co-glycolide).

28. The scaffold of any of claims 26-27, wherein the scaffold comprises a plurality of braided polymeric strands.

29. The scaffold of any of claims 26-28, further comprising a conformal coating disposed between the tubular scaffold and the therapeutic-agent-containing layer, the conformal coating comprising a crosslinked biodegradable elastomer.

30. The scaffold of claim 29, wherein the biodegradable elastomer material comprises

poly(lactide-co-caprolactone).

31. The scaffold of any of claims 26-30, wherein the second biodegradable polymer material comprises poly(lactide-co-caprolactone).

32. The scaffold of claim 31, wherein the poly(lactide-co-caprolactone) has a molar

percentage of lactide ranging from 60 to 95 % and a molar percentage of caprolactone ranging from 5 to 40%.

33. The scaffold of any of claims 31-32, wherein the second biodegradable polymer material further comprises an additional polymer selected from a homopolymer of lactide and a copolymer comprising lactide and an additional monomer.

34. The scaffold of any of claim 31-32, wherein the second biodegradable polymer material further comprises an additional polymer selected from copolymer of lactide and glycolide having molar percentage of lactide ranging from 45 to 99% and a molar percentage of glycolide ranging from 1 to 55%

35. The scaffold of any of claims 26-34, wherein the therapeutic agent is a steroid.

36. The scaffold of claim 35, wherein the steroid is mometasone furoate.

37. The scaffold of any of claims 26-36, wherein the therapeutic agent is present in an amount ranging from ranging from 0.1 to 20 μg of therapeutic agent per square mm of scaffold area, A, where scaffold area is calculated as A = wDL, where D \s the manufactured diameter of the scaffold and L is the manufactured length of the scaffold.

38. The scaffold of any of claims 26-36, wherein the therapeutic agent is present in an amount ranging from ranging from 1 to 10 μg of therapeutic agent per square mm of scaffold area, A, where scaffold area is calculated as A = wDL, where D \s the manufactured diameter of the scaffold and L is the manufactured length of the scaffold.

39. The scaffold of any of claims 26-38, wherein the thickness of the therapeutic-agent- containing layer ranges from 1 μιτι to 25 μιτι.

40. The scaffold of any of claims 26-39, wherein cumulative release of therapeutic agent, based on total amount of therapeutic agent in the scaffold, ranges from 1% to 70% after one week, when the scaffold is submerged in a pH 7.4 PBS buffer solution containing 2% wt% SDS at 37 °C under gentle shaking on a rotary shaker, wherein a volume of the buffer solution in which the scaffold is submerged is at least 10 times greater that a volume of the buffer solution at which a quantity of therapeutic agent corresponding to the total amount of therapeutic agent in the scaffold is at a saturation point in the buffer solution, and wherein buffer is removed completely weekly for quantification and replaced with fresh buffer.

41. The scaffold of claim 40, wherein cumulative release of therapeutic agent based on total amount of therapeutic agent in the scaffold ranges from 5% to 80% after two weeks.

42. The scaffold of any of claims 40-41, wherein cumulative release of therapeutic agent based on total amount of therapeutic agent in the scaffold ranges from 10% to 90% after four weeks.

43. The scaffold of any of claims 40-42, wherein cumulative release of therapeutic agent based on total amount of therapeutic agent in the scaffold ranges from 25% to 100% after eight weeks.

44. The scaffold of any of claims 26-39, wherein after being implanted one week in a human sinus or a rabbit sinus, in vivo release of therapeutic agent based on total amount of therapeutic agent in the scaffold, ranges from 1% to 45%.

45. The scaffold claim 44, wherein after being implanted two weeks in a human sinus or a rabbit sinus, in vivo release of therapeutic agent based on total amount of therapeutic agent in the scaffold, ranges from 3% to 50%.

46. The scaffold of any of claims 44-45, wherein after being implanted four weeks in a human sinus or a rabbit sinus, in vivo release of therapeutic agent based on total amount of therapeutic agent in the scaffold, ranges from 7% to 60%.

47. The scaffold of any of claims 44-46, wherein after being implanted eight weeks in a human sinus or a rabbit sinus, in vivo release of therapeutic agent based on total amount of therapeutic agent in the scaffold, ranges from 15% to 70%.

48. The scaffold of any of claims 26-47, further comprising a topcoat layer comprising a third biodegradable polymer material disposed over the therapeutic-agent-containing layer, wherein the third biodegradable polymer material may be the same as or different from the first biodegradable polymer material and wherein the third biodegradable polymer

material may be the same as or different from the second biodegradable polymer material.

49. A method of treatment, wherein a scaffold in accordance with any of claims 26-48 is delivered to a sinus of a human patient.