Claims for Patent: 8,021,660

Summary for Patent: 8,021,660

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, CA)
Assignee:
Application Number:	12/211,574
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: administering a therapeutically effective amount of a collagenase enzyme containing formulation into the occlusion, and retaining the formulation at the site of the occlusion for a collagenase enzyme treatment period of at least 10 minutes; waiting for a pre-angioplasty waiting period sufficient to degrade the occlusion and permit crossing thereof by a guide wire; and crossing the occlusion with an angioplasty guide wire. 2. 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: advancing an angioplasty balloon catheter on a guide wire into the artery; inflating the balloon; removing the guide wire; administering a therapeutically effective amount of a collagenase enzyme containing formulation into the occlusion; removing the balloon after a collagenase enzyme treatment period of at least 10 minutes; waiting for a pre-angioplasty waiting period sufficient to degrade the occlusion and permit crossing thereof by a guide wire; and crossing the occlusion with an angioplasty guide wire. 3. The method of claim 1 wherein the duration of the pre-angioplasty waiting period is between 1 hour and 108 hours. 4. The method of claim 3 wherein the duration of the pre-angioplasty waiting period is between 12 hours and 86 hours. 5. The method of claim 4 wherein the duration of the pre-angioplasty waiting period is between 24 hours and 72 hours. 6. The method of claim 4 wherein the duration of the pre-angioplasty waiting period is about 24 hours. 7. The method of claim 3 wherein the administration of the formulation is through the wire port of an angioplasty catheter. 8. The method of claim 3 wherein the administration of the formulation is through an infusion needle. 9. The method of claim 3 wherein the administration of the formulation is through a catheter. 10. The method of claim 3 wherein the balloon is inflated to a pressure in the range of 1-5 atmospheres. 11. The method of claim 1 wherein the formulation is administered under a pressure of between 1 and 5 atmospheres. 12. The method of claim 2 wherein the balloon is inflated to a pressure in the range of 1-5 atmospheres. 13. The method claim 1 wherein the formulation comprises 50-2000 .mu.g of collagenase. 14. The method claim 13 wherein the formulation comprises a dosage of from 150 .mu.g to 500 .mu.g of collagenase. 15. The method of claim 1, wherein the collagenase is type 1A collagenase. 16. The method of claim 1, wherein the occlusion is at least 10 weeks old. 17. The method of claim 16, wherein the occlusion is at least 12 weeks old. 18. The method of claim 14, wherein the occlusion is at least 16 weeks old. 19. The method claim 16 wherein the formulation comprises 50-2000 .mu.g of collagenase.

Details for Patent 8,021,660

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