Claims for Patent: 7,425,326

Summary for Patent: 7,425,326

Title:	Use of collagenase to facilitate guide wire crossing in total arterial occlusions
Abstract:	The use of a collagenase containing formulation for degrading collagen within an occlusive atherosclerotic plaque in a chronic fibrotic occlusion, chronically occluded animal tube or cavity. A medical-related apparatus is provided comprising a medical-related device having provided thereto a therapeutic amount of a collagen degrading composition comprising a proteiolytic enzyme containing formulation. A method is provided for treating chronically occluded animal tubes and cavities by administering a therapeutic effective amount of a proteolytic enzyme-containing formulation adjacent to an occluding atherosclerotic plaque, waiting for a pre-angioplasty waiting period, followed by crossing the plaque with an angioplasty guide wire.
Inventor(s):	Strauss; Bradley H. (Toronto, ON, CA)
Assignee:
Application Number:	11/534,351
Patent Claims:	1. A method of treating a fibrotic chronic total occlusion associated with atherosclerotic disease of an artery of an animal, which occlusion cannot be crossed by a guide wire, the method comprising the steps of: a) administering a therapeutically effective amount of a collagenase enzyme containing formulation having an amount of the collagenase that softens the occlusion without damaging the arterial wall adjacent the occlusion, and retaining the formulation adjacent the occlusion for a collagenase enzyme treatment period of at least 10 minutes; b) waiting for a pre-angioplasty waiting period to degrade the occlusion sufficiently so as to soften the occlusion to permit crossing thereof by a guide wire; and c) crossing the occlusion with an angioplasty guide wire. 2. The method of claim 1 wherein the collagenase enzyme treatment period is between about 20 minutes and about 100 minutes. 3. The method of claim 2 wherein the collagenase enzyme treatment period is between about 50 minutes and about 80 minutes. 4. The method of claim 3 wherein the collagenase enzyme treatment period is about 60 minutes. 5. The method claim 1 wherein the formulation comprises 50-2000 .mu.g of collagenase. 6. The method claim 5 wherein the formulation comprises a dosage of from about 150 .mu.g to 500 .mu.g of collagenase. 7. The method of claim 1 wherein the duration of the pre-angioplasty waiting period is between about 1 hour and about 108 hours. 8. The method of claim 7 wherein the duration of the pre-angioplasty waiting period is between about 24 hours and about 72 hours. 9. The method of claim 1 wherein the duration of the pre-angioplasty waiting period is about 24 hours. 10. The method of claim 1 wherein the formulation is infused into the artery lumen adjacent to the occlusion. 11. The method of claim 10 wherein the infusion of the collagenase enzyme containing formulation is through the wire port of an angioplasty catheter. 12. The method of claim 10 wherein the infusion of the collagenase enzyme containing formulation is through an infusion needle. 13. The method of claim 10 wherein the infusion of the collagenase enzyme containing formulation is through a catheter. 14. The method of claim 1, wherein the collagenase is type 1A collagenase. 15. The method of claim 5, wherein the collagenase is type 1A collagenase. 16. The method of claim 7, wherein the collagenase is type 1A collagenase. 17. The method of claim 1, wherein the occlusion is at least about 10 weeks old. 18. The method of claim 17, wherein the occlusion is at least 12 weeks old. 19. The method of claim 18, wherein the occlusion is at least about 16 weeks old. 20. The method claim 17 wherein the formulation comprises 50-2000 .mu.g of collagenase. 21. The method claim 18 wherein the formulation comprises 50-2000 .mu.g of collagenase. 22. The method claim 19 wherein the formulation comprises 50-2000 .mu.p of collagenase. 23. The method of claim 17 wherein the duration of the pre-angioplasty waiting period is between about 1 hour and about 108 hours. 24. The method of claim 23 wherein the duration of the pre-angioplasty waiting period is between about 12 hours and about 86 hours. 25. The method of claim 24 wherein the duration of the pre-angioplasty waiting period is between about 24 hours and about 72 hours. 26. The method of claim 5 wherein the duration of the pre-angioplasty waiting period is between about 1 hour and about 108 hours. 27. The method of claim 26 wherein the duration of the pre-angioplasty waiting period is between about 12 hours and about 86 hours. 28. The method of claim 27 wherein the duration of the pre-angioplasty waiting period is between about 24 hours and about 72 hours. 29. The method of claim 17 wherein the collagenase enzyme treatment period is between about 20 minutes and about 100 minutes. 30. The method of claim 29 wherein the collagenase enzyme treatment period is between about 50 minutes and about 80 minutes. 31. The method of claim 17, wherein the collagenase is type 1A collagenase. 32. A method of treating a fibrotic chronic total occlusion associated with atherosclerotic disease of an artery of an animal, which occlusion cannot be crossed by a guide wire, the method comprising the steps of: a) advancing an angioplasty balloon catheter on a guide wire into the artery; b) inflating the balloon; c) administering a therapeutically effective amount of a collagenase enzyme containing formulation having an amount of the collagenase that softens the occlusion without damaging the arterial wall into the space between the balloon and the occlusion so as to be adjacent the occlusion; b) removing the balloon after a collagenase enzyme treatment period of at least 10 minutes; e) waiting for a pre-angioplasty waiting period to degrade the occlusion sufficiently so as to soften the occlusion to permit crossing thereof by a guide wire; and f) crossing the occlusion with an angioplasty guide wire. 33. The method of claim 32 wherein the duration of the pre-angioplasty waiting period is between about 1 hour and about 108 hours. 34. The method of claim 33 wherein the duration of the pre-angioplasty waiting period is between about 12 hours and about 86 hours. 35. The method of claim 34 wherein the duration of the pre-angioplasty waiting period is between about 24 hours and about 72 hours. 36. The method of claim 35 wherein the duration of the pre-angioplasty waiting period is about 24 hours. 37. The method of claim 33 wherein the formulation is infused into the artery lumen adjacent to the occlusion. 38. The method of claim 33 wherein the infusion of the formulation is through the wire port of an angioplasty catheter. 39. The method of claim 33 wherein the infusion of the formulation is through an infusion needle. 40. The method of claim 33 wherein the infusion of the formulation is through a catheter. 41. The method of claim 33 wherein the balloon is inflated to a pressure in the range of about 1-5 atmospheres. 42. The method of claim 33 wherein the balloon is inflated to a pressure of about 4 atmospheres. 43. The method of claim 32, wherein the formulation is infused under a pressure of between about 1 and 5 atmospheres. 44. The method of claim 38 wherein the formulation is infused under a pressure in the range of about 0.5 atmospheres to 3.5 atmospheres. 45. The method of claim 44 wherein the formulation is infused under a pressure in the range of about 1 to 2 atmospheres. 46. The method of claim 32 wherein the balloon is inflated to a pressure in the range of about 1-5 atmospheres. 47. The method of claim 32 wherein the formulation is infused under a pressure in the range of about 0.5 atmospheres to 3.5 atmospheres. 48. The method of claim 47 wherein the formulation is infused under a pressure in the range of about 1 to 2 atmospheres. 49. The method claim 32 wherein the formulation comprises 50-2000 .mu.g of collagenase. 50. The method claim 49 wherein the formulation comprises a dosage of from about 150 .mu.g to 500 .mu.g of collagenase. 51. The method of claim 32, wherein the collagenase is type 1A collagenase. 52. The method of claim 33, wherein the collagenase is type 1A collagenase. 53. The method of claim 49, wherein the collagenase is type 1A collagenase. 54. The method of claim 32, wherein the occlusion is at least about 10 weeks old. 55. The method of claim 54, wherein the occlusion is at least 12 weeks old. 56. The method of claim 55, wherein the occlusion is at least about 16 weeks old. 57. The method claim 54 wherein the formulation comprises 50-2000 .mu.g of collagenase. 58. The method claim 55 wherein the formulation comprises 50-2000 .mu.g of collagenase. 59. The method claim 56 wherein the formulation comprises 50-2000 .mu.p of collagenase. 60. The method of claim 54 wherein the duration of the pre-angioplasty waiting period is between about 1 hour and about 108 hours. 61. The method of claim 60 wherein the duration of the pre-angioplasty waiting period is between about 12 hours and about 86 hours. 62. The method of claim 61 wherein the duration of the pre-angioplasty waiting period is between about 24 hours and about 72 hours. 63. The method of claim 49 wherein the duration of the pre-angioplasty waiting period is between about 1 hour and about 108 hours. 64. The method of claim 63 wherein the duration of the pre-angioplasty waiting period is between about 12 hours and about 86 hours. 65. The method of claim 64 wherein the duration of the pre-angioplasty waiting period is between about 24 hours and about 72 hours. 66. The method of claim 32 wherein the collagenase enzyme treatment period is between about 20 minutes and about 100 minutes. 67. The method of claim 66 wherein the collagenase enzyme treatment period is between about 50 minutes and about 80 minutes. 68. The method of claim 54 wherein the collagenase enzyme treatment period is between about 20 minutes and about 100 minutes. 69. The method of claim 68 wherein the collagenase enzyme treatment period is between about 50 minutes and about 80 minutes. 70. The method of claim 54, wherein the collagenase is type 1A collagenase. 71. The method of claim 55, wherein the collagenase is type 1A collagenase. 72. A method of treating a fibrotic chronic total occlusion associated with atherosclerotic disease of an artery of an animal, and which occlusion cannot be crossed by a guide wire, the method comprising the steps of: a) administering a therapeutically effective amount of a collagenase enzyme containing formulation having an amount of the collagenase that softens the occlusion without damaging the arterial wall to be in direct contact with the occlusion; b) retaining the formulation adjacent the occlusion for a collagenase enzyme treatment period of at least about 10 minutes; c) waiting for a pre-angioplasty waiting period to degrade the occlusion sufficiently so as to soften the occlusion to permit crossing thereof by a guide wire; and b) crossing the occlusion with an angioplasty guide wire. 73. The method of claim 72, wherein the collagenase is type 1A collagenase. 74. The method of claim 72, wherein the occlusion is at least about 10 weeks old. 75. The method of claim 74, wherein the occlusion is at least 12 weeks old. 76. The method of claim 75, wherein the occlusion is at least about 16 weeks old. 77. The method claim 72 wherein the formulation comprises 50-2000 .mu.g of collagenase. 78. The method claim 74 wherein the formulation comprises 50-2000 .mu.g of collagenase. 79. The method claim 75 wherein the formulation comprises 50-2000 .mu.g of collagenase. 80. The method claim 76 wherein the formulation comprises 50-2000 .mu.p of collagenase. 81. The method of claim 72 wherein the duration of the pre-angioplasty waiting period is between about 1 hour and about 108 hours. 82. The method of claim 81 wherein the duration of the pre-angioplasty waiting period is between about 12 hours and about 86 hours. 83. The method of claim 82 wherein the duration of the pre-angioplasty waiting period is between about 24 hours and about 72 hours. 84. The method of claim 74 wherein the duration of the pre-angioplasty waiting period is between about 1 hour and about 108 hours. 85. The method of claim 84 wherein the duration of the pre-angioplasty waiting period is between about 12 hours and about 86 hours. 86. The method of claim 85 wherein the duration of the pre-angioplasty waiting period is between about 24 hours and about 72 hours. 87. The method of claim 77 wherein the duration of the pre-angioplasty waiting period is between about 1 hour and about 108 hours. 88. The method of claim 87 wherein the duration of the pre-angioplasty waiting period is between about 12 hours and about 86 hours. 89. The method of claim 88 wherein the duration of the pre-angioplasty waiting period is between about 24 hours and about 72 hours. 90. The method of claim 72 wherein the collagenase enzyme treatment period is between about 20 minutes and about 100 minutes. 91. The method of claim 90 wherein the collagenase enzyme treatment period is between about 50 minutes and about 80 minutes. 92. The method of claim 74 wherein the collagenase enzyme treatment period is between about 20 minutes and about 100 minutes. 93. The method of claim 92 wherein the collagenase enzyme treatment period is between about 50 minutes and about 80 minutes. 94. The method of claim 81, wherein the collagenase is type 1 A collagenase. 95. The method of claim 77, wherein the collagenase is type 1A collagenase.

Details for Patent 7,425,326

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2021-10-01