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1. (WO2018225075) DEVICES FOR DELIVERY OF ACTIVE AGENTS TO A TARGET SITE
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CLAIMS:

1. A flexible device for delivery of at least one active agent to a target site, the device comprises a flexible substrate for placing onto the target site with a plurality of spaced-apart cells, each cell containing the at least one active agent and having at least one wall portion made of a film of at least one polymeric material that is at least partially disintegrable upon contact with a fluid to thereby release the active ingredient to the target site.

2. The device of claim 1, wherein said fluid is a bodily fluid.

3. The device of claim 2, wherein the bodily fluid is blood.

4. The device of any one of claims 1 to 3, wherein the cells in said plurality of cells are configured for selective disintegration upon contact with said fluid.

5. The device of claim 4, wherein at least one portion of cells being different in at least one property from at least another portion of cells in said plurality of cells.

6. The device of claim 5, wherein said property being at least one property selected from film thickness, molecular weight of the polymeric material, composition of the polymeric material, film texture, water solubility of the film, volume of cell, geometry of cell, size of disintegrable wall portion, and type of active agent contained therein.

7. The device of any one of claims 1 to 6, wherein said polymeric material is selected from polysaccharide, polyethyleneoxide (PEO), polyvinyl-pyrrolidone (PVP), polyvinyl-alcohol (PVA), polyacrylic acid (PAA), polyacryloamides, polyoxazoline, cellulose ethers (e.g. HPMC, HPC).

8. The device of claim 7, wherein said polymeric material is PVA.

9. The device of claim 7 or 8, wherein said polymeric material has a molecular weight of at least 50,000 g/mole.

10. The device of claim 9, wherein said polymeric material has a molecular weight of between about 10,000 and 200,000 g/mole.

11. The device of any one of claims 1 to 10, wherein said at least one active agent is selected from a coagulant, an antibiotic agent, a clotting factor, a hemostatic agent, an antimicrobial agent, and a disinfectant.

12. The device of claim 11, wherein all of the cells in said plurality of cells contain the same active agent.

13. The device of claim 12, wherein at least one portion of the cells containing an active agent differing from the active agent contained in at least another portion of cells in said plurality of cells.

14. The device of claim 13, wherein said at least one portion of cells and at least another portion of cells being configured to have different disintegration rates to release said active agents therefrom at different rates.

15. The device of any one of claims 1 to 14, wherein said polymeric material is fully disintegrable within between about 5 second and 30 minutes from contact with said fluid.

16. The device of claim 15, wherein said polymeric material is fully disintegrable within between about 5 second and 10 minutes from contact with said fluid.

17. The device of claim 15, wherein said polymeric material is fully disintegrable within between about 5 second and 2 minutes from contact with said fluid.

18. The device of any one of claims 1 to 17, wherein at least a portion of cells further contain a decomposable agent capable of forming a gaseous decomposition product upon contact with said fluid.

19. The device of claim 18, wherein said decomposable material is calcium bicarbonate.

20. The device of any one of claims 1 to 19, wherein said flexible substrate being made of a material substantially non-disintegrable upon contact with said fluid.

21. The device of any one of claims 1 to 20, wherein the cells are spaced apart by substantially non-disintegrable segments.

22. The device of claim 21, wherein said segments being non-uniform in thickness and/or density to permit flexibility and/or foldability of said segments.

23. The device of any one of claims 1 to 22, wherein said delivery is topical delivery.

24. The device of claim 23, being a bandage, a dressing, or a sleeve.

25. The device of claim 23 or 24, further comprising an adhesive on at least a portion of the device's perimeter.

26. The device of claim 25, being a plaster or adhesive bandage.

27. The device of any one of claims 1 to 22, being configured for insertion into a body cavity or lumen.

28. A method of manufacturing a flexible device for delivery of at least one active agent to a target site, the method comprising:

- forming a plurality of spaced-apart cells each cell having at least one wall portion made of a film of at least one polymeric material that is at least partially disintegrable upon contact with a fluid;

- filling said cells with said at least one active material; and

- sealing the cells with a flexible substrate to form the device.

29. The method of claim 28, for producing the device of any one of claims 1 to 27.

30. A method of manufacturing a device of any one of claims 1 to 27, the method comprising:

(a) bringing a flexible substrate and a film of at least one fluid disintegrable polymeric material in proximity one to the other;

(b) integrating said flexible substrate with said film to form a plurality of spaced-apart pre-cells, the pre-cells having a portion of their perimeter non-integrated,

(c) introducing at least one active agent into said pre-cells through the non-integrated portion, and

(d) sealing said pre-cells by integrating said flexible substrate with said film along said portion to thereby form said spaced-apart cells.

31. The method of claim 30, wherein steps (a) to (d) are repeated to manufacture a device comprising an array of spaced-apart cells.

32. The method of claim 30 or 31, wherein said integrating is carried out by welding, heat sealing, contact welding, high frequency welding, ultrasonic welding, laser welding, solvent welding.

33. The method of any one of claims 30 to 32, wherein said integrating forms a plurality of cells that are spaced apart by substantially non-disintegrable segments.

34. The method of claim 33, wherein said segments being non-uniform in thickness and/or density to permit flexibility and/or foldability of said segments after integration.

35. The method of any one of claims 30 to 34, wherein said film having cell-forming sections and seal-forming sections, such that integrating is carried out by welding said film to said substrate along said seal-forming sections.

36. The method of claim 35, wherein said cell-forming sections are formed from a disintegrable polymeric material.

37. The method of claim 35 or 36, wherein said seal-forming sections comprise or formed of a non-disintegrable polymeric material.

38. The method of claim 35 or 36, wherein said seal-forming sections comprise a laminate of polymeric layers having different disintegration properties.

39. The method of any one of claims 30 to 38, wherein the cells are spaced apart by substantially non-disintegrable segments constituted by integrated seal-forming sections.

40. The method of claim 39, wherein said segments being non-uniform in thickness and/or density to permit flexibility and/or foldability of said segments after integration.

41. The method of any one of claims 30 to 40, further comprising a step prior to (a) of texturing said film or cell-forming sections of said film.

42. The method of claim 41, wherein said texturing is carried out by embossing.

43. The method of any one of claims 28 to 42, further comprising associating the device with at least one fabric layer.

44. The method of claim 43, wherein said fabric layer is an elastic fabric layer.

45. A method of delivering at least one active agent to a target site, comprising contacting a flexible device of any one of claims 1 to 27 with said target site, such that at least a portion of the plurality of cells comes into contact with a bodily fluid to cause selective disintegration of cells for releasing said active agent to said target site.

46. The method of claim 45, wherein contacting with said fluid causes (i) a portion of said cells to disintegrate and release a first active agent to the target site, followed by (ii) disintegration of another portion of cells for releasing a second active agent to the target site.

47. A method of reducing hemorrhage from a wound, comprising contacting a flexible device of any one of claims 1 to 27 with the wound, at least a portion of cells in the device comprise at least one hemostatic agent or coagulant, said cells being selectively disintegrable upon contact with blood to release said hemostatic agent or coagulant to said wound.

48. An application device for delivery of at least one active agent to a target site, the device comprising:

at least one container holding a plurality of disintegrable carriers, each carrier comprising at least one active agent contained within at least one polymeric material that is at least partially disintegrable upon contact with a fluid to thereby release the active ingredient to the target site; and

at least one application means to extract the disintegrable carriers from the container for application onto or into the target site.

49. The device of claim 48, wherein said fluid is a bodily fluid.

50. The device of claim 49, wherein the bodily fluid is blood.

51. The device of any one of claims 48 to 50, wherein the carriers may be selected from capsules, particles and mixtures thereof.

52. The device of any one of claims 48 to 51, wherein the carriers are in the form of particles, said at least one active agent being embedded or dispersed within a matrix made of said at least one polymeric material.

53. The device of any one of claims 48 to 51, wherein the carriers are in the form of capsules, wherein the active agent is encapsulated by a shell having at least one shell portion made of said at least one polymeric material.

54. The device of any one of claims 48 to 53, wherein the carriers are configured for selective disintegration upon contact with said fluid.

55. The device of claim 54, wherein at least one portion of carriers being different in at least one property from at least another portion of carriers in said plurality of carriers.

56. The device of claim 55, wherein said property being at least one property selected from film thickness, molecular weight of the polymeric material, composition of the polymeric material, film texture, water solubility of the film, volume of capsule, geometry of capsule, size of disintegrable shell portion, and type of active agent contained therein.

57. The device of any one of claims 48 to 56, wherein said polymeric material is selected from polysaccharide, polyethyleneoxide (PEO), polyvinyl-pyrrolidone (PVP), polyvinyl-alcohol (PVA), polyacrylic acid (PAA), polyacryloamides, polyoxazoline, cellulose ethers (e.g. HPMC, HPC).

58. The device of claim 57, wherein said polymeric material is PVA.

59. The device of claim 57 or 58, wherein said polymeric material has a molecular weight of at least 50,000 g/mole.

60. The device of claim 59, wherein said polymeric material has a molecular weight of between about 10,000 and 200,000 g/mole.

61. The device of any one of claims 48 to 60, wherein said at least one active agent is selected from a coagulant, an antibiotic agent, a clotting factor, a hemostatic agent, an antimicrobial agent, and a disinfectant.

62. The device of claim 61, wherein all of the carriers in said plurality of carriers contain the same active agent.

63. The device of claim 61, wherein at least one portion of the carriers containing an active agent differing from the active agent contained in at least another portion of carriers in said plurality of carriers.

64. The device of claim 63, wherein said at least one portion of carriers and at least another portion of carriers being configured to have different disintegration rates to release said active agents therefrom at different rates.

65. The device of any one of claims 48 to 64, wherein said polymeric material is fully disintegrable within between about 5 second and 30 minutes from contact with said fluid.

66. The device of claim 65, wherein said polymeric material is fully disintegrable within between about 5 second and 10 minutes from contact with said fluid.

67. The device of claim 66, wherein said polymeric material is fully disintegrable within between about 5 second and 2 minutes from contact with said fluid.

68. The device of any one of claims 48 to 67, wherein at least a portion of carriers further contain a decomposable agent capable of forming a gaseous decomposition product upon contact with said fluid.

69. The device of claim 68, wherein said decomposable material is calcium bicarbonate.

70. The device of any one of claims 48 to 69, wherein said application means is in the form of a piston, fitted within the container, and displaceable between an extended state and a retracted state and configured to extract said plurality of carriers through an opening in the container during the piston's displacement from the extended state to the retracted state.

71. The device of claim 70, wherein said opening has a closed state and an open state, and is configured to switch from the open state to the closed state by the pressure applied by the piston during displacement from the extended state to the retracted state.

72. The device of claim 70, wherein said opening is sealed by a removable sealing member, configured for removal by a user prior to use.

73. The device of any one of claims 48 to 72, comprising two or more sub -containers, each sub-container holding capsules containing a different active agent, the sub-container being arranged to extract carriers from each sub-container in a sequence of extraction.

74. The device of any one of claims 48 to 72, wherein the container is divided into two more compartments, each compartment holding carriers containing a different active

agent, the compartments being arranged to extract carriers from each compartment in a sequence of extraction.

75. The device of any one of claims 48 to 74, wherein said delivery is topical delivery.

76. The device of any one of claims 48 to 74, being configured for insertion into a body cavity or lumen.

77. A method of delivering at least one active agent to a target site, comprising bringing the application device of any one of claims 48 to 76 into vicinity to the target site, and extracting the carriers from the container by the application means, such that at least a portion of the plurality of carriers comes into contact with a bodily fluid to cause selective disintegration of carriers for releasing said active agent to said target site.

78. The method of claim 77, wherein contacting with said fluid causes (i) a portion of said carriers to disintegrate and release a first active agent to the target site, followed by (ii) disintegration of another portion of carriers for releasing a second active agent to the target site.

79. A method of reducing hemorrhage from a wound, comprising bringing the application device of any one of claims 48 to 76 into vicinity to the wound, and extracting the carriers from the container by the application means, at least a portion of carriers in the device comprise at least one hemostatic agent or coagulant, such that said at least portion of carriers selective disintegrates upon contact with blood to release for releasing said hemostatic agent or coagulant to said wound.

80. The method of claim 79, wherein said wound is a topical wound.

81. The method of claim 79, wherein said wound is a wound within a body cavity.