التفاصيل البيبلوغرافية
| العنوان: |
TISSUE PLASMINOGEN ACTIVATOR VARIANT USES |
| Document Number: |
20120270299 |
| تاريخ النشر: |
October 25, 2012 |
| Appl. No: |
12/447838 |
| Application Filed: |
October 30, 2007 |
| مستخلص: |
A method is disclosed for using tenecteplase to restore function in dysfunctional hemodialysis catheters, which have a blood flow rate of less than 300 mL/minute. Kits are also provided with instructions to direct the user to administer tenecteplase in a total dose of about 3 to 4 mg locally into all catheter lumens and allow the tenecteplase to dwell in the catheter for from about one hour to about 72 hours. |
| Inventors: |
Blaney, Martha E. (El Granada, CA, US) |
| Assignees: |
Genentech, Inc. (South San Francisco, CA, US) |
| Claim: |
1. A method for restoring function in a dysfunctional hemodialysis catheter indwelling in a mammal, which catheter has a blood flow rate (BFR) of less than 300 mL/minute, which method comprises administering tenecteplase in a total dose of about 3 to 4 mg locally into all catheter lumens and allowing the tenecteplase to dwell in the catheter for from about one hour to about 72 hours, such that the BFR of the catheter is no longer obstructed. |
| Claim: |
2. The method of claim 1 wherein the dysfunctional hemodialysis catheter additionally has a BFR at least 25 mg/ml below the prescribed BFR at an arterial pressure of −250 mmHg during the first 30 minutes of the hemodialysis. |
| Claim: |
3. The method of claim 1 wherein the tenecteplase is in a solution of sterile water for injection or bacteriostatic water for injection. |
| Claim: |
4. The method of claim 1 wherein the tenecteplase dwells in the catheter until the BFR of the catheter is improved over the BFR before administration of tenecteplase and the improvement maintained for at least 48 hours. |
| Claim: |
5. The method of claim 1 wherein the tenecteplase is in sterile water for injection. |
| Claim: |
6. The method of claim 1 wherein the total dose of tenecteplase is about 4 mg. |
| Claim: |
7. The method of claim 1 wherein the tenecteplase is instilled into the catheter for about one hour. |
| Claim: |
8. The method of claim 1 wherein the tenecteplase is instilled into the catheter as an extended dwell of from over about one hour to about 72 hours. |
| Claim: |
9. The method of claim 8 wherein the dwell is from about 2 to about 48 hours. |
| Claim: |
10. The method of claim 1 wherein the tenecteplase is administered more than once. |
| Claim: |
11. The method of claim 10 wherein the tenecteplase is administered at each hemodialysis session that the mammal undergoes. |
| Claim: |
12. The method of claim 1 wherein the tenecteplase is administered once or twice. |
| Claim: |
13. The method of claim 12 wherein the tenecteplase is administered once. |
| Claim: |
14. The method of claim 1 wherein the mammal undergoes hemodialysis after administration of the tenecteplase. |
| Claim: |
15. The method of any one of claims 1-6 and 14 wherein the mammal is a human. |
| Claim: |
16. A kit comprising a container comprising a solution comprising tenecteplase and instructions for using the solution to restore function in a dysfunctional hemodialysis catheter indwelling in a mammal, which catheter has a blood flow rate (BFR) of less than 300 mL/minute, which instructions direct the user to administer tenecteplase in a total dose of about 2 to 4 mg locally into all catheter lumens and allow the tenecteplase to dwell in the catheter for from about one hour to about 72 hours, such that the BFR of the catheter is no longer obstructed. |
| Claim: |
17. The kit of claim 16 wherein the dysfunctional hemodialysis catheter additionally has a BFR at least 25 mg/ml below the prescribed BFR at an arterial pressure of −250 mmHg during the first 30 minutes of the hemodialysis. |
| Claim: |
18. The kit of claim 17 wherein the total dose of tenecteplase is about 4 mg. |
| Claim: |
19. The kit of any one of claims 16-18 wherein the mammal is a human. |
| Claim: |
20. A method comprising manufacturing tenecteplase for restoring function in a dysfunctional hemodialysis catheter indwelling in a mammal, which catheter has a blood flow rate (BFR) of less than 300 mL/minute. |
| Claim: |
21. The method of claim 20 wherein the dysfunctional hemodialysis catheter additionally has a BFR at least 25 mg/ml below the prescribed BFR at an arterial pressure of −250 mmHg during the first 30 minutes of the hemodialysis. |
| Claim: |
22. The method of claim 20 further comprising directing administration of tenecteplase in a total dose of about 2 to 4 mg locally into all catheter lumens and allowing to dwell in the catheter for from about one hour to about 72 hours, such that the BFR of the catheter is no longer obstructed. |
| Claim: |
23. The method of any one of claims 20-22 wherein the mammal is a human. |
| Claim: |
24. Tenecteplase for use to restore function in a dysfunctional hemodialysis catheter indwelling in a mammal, which catheter has a blood flow rate (BFR) of less than 300 mL/minute. |
| Claim: |
25. The tenecteplase of claim 24 wherein the dysfunctional hemodialysis catheter additionally has a BFR at least 25 mg/ml below the prescribed BFR at an arterial pressure of −250 mmHg during the first 30 minutes of the hemodialysis. |
| Claim: |
26. The tenecteplase of claim 24 wherein the tenecteplase is in a solution of sterile water for injection or bacteriostatic water for injection. |
| Claim: |
27. The tenecteplase of claim 24 wherein the tenecteplase dwells in the catheter until the BFR of the catheter is improved over the BFR before administration of tenecteplase and the improvement maintained for at least 48 hours. |
| Claim: |
28. The tenecteplase of claim 24 wherein the tenecteplase is in sterile water for injection. |
| Claim: |
29. The tenecteplase of claim 24 wherein the total dose of tenecteplase is about 4 mg. |
| Claim: |
30. The tenecteplase of claim 24 wherein the tenecteplase is instilled into the catheter for about one hour. |
| Claim: |
31. The tenecteplase of claim 24 wherein the tenecteplase is instilled into the catheter as an extended dwell of from over about one hour to about 72 hours. |
| Claim: |
32. The tenecteplase claim 31 wherein the dwell is from about 2 to about 48 hours. |
| Claim: |
33. The tenecteplase of claim 24 wherein the tenecteplase is administered more than once. |
| Claim: |
34. The tenecteplase of claim 33 wherein the tenecteplase is administered at each hemodialysis session that the mammal undergoes. |
| Claim: |
35. The tenecteplase of claim 24 wherein the tenecteplase is administered once or twice. |
| Claim: |
36. The tenecteplase of claim 35 wherein the tenecteplase is administered once. |
| Claim: |
37. The tenecteplase of claim 24 wherein the mammal undergoes hemodialysis after administration of the tenecteplase. |
| Claim: |
38. The method of any one of claims 24-29 and 37 wherein the mammal is a human. |
| Current U.S. Class: |
435/226 |
| Current International Class: |
12; 12 |
| رقم الانضمام: |
edspap.20120270299 |
| قاعدة البيانات: |
USPTO Patent Applications |
