Method for verifying position on an angioplasty balloon

• US 20050159802A1
• Filed: 07/28/2004
• Published: 07/21/2005
• Est. Priority Date: 01/15/2004
• Status: Active Grant

• Current Assignee: Mirus LLC
• Original Assignee: ICON Interventional Systems, Inc.
• Inventors: Furst, Joseph G., Brodbeck, William
• Granted Patent: US 7,945,409 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2250/0085 Identification means; Administration of patients

Abstract

A monitoring system and data archive system for a stent crimping process. The information concerning the crimped stent is used in deciding whether the stent is acceptable for insertion into the body cavity of a human or animal.

Claims

1. A monitoring system for a stent crimping process comprising a crimping system that crimps the stent, a monitoring device positioned at least closely adjacent to the crimping system, said monitoring device designed to at least partially capture at least one event relating to the crimping of said stent and to save the captured event on an archiveable media.

2. The monitoring system as defined in claim 1, wherein an angioplasty balloon is at least partially inserted into a body of a stent prior to the stent being fully crimped.

3. The monitoring system as defined in claim 1, wherein said monitoring device includes a camera, a video recorder, a microscope, a visual or electromagnetic wave imaging device, or combinations thereof.

4. The monitoring system as defined in claim 2, wherein said monitoring device includes a camera, a video recorder, a microscope, a visual or electromagnetic wave imaging device, or combinations thereof.

5. The monitoring system as defined in claim 1, wherein said archiveable media includes printed material, developed material, storage medium, or combinations thereof.

6. The monitoring system as defined in claim 3, wherein said archiveable media includes printed material, developed material, storage medium, or combinations thereof.

7. The monitoring system as defined in claim 4, wherein said archiveable media includes printed material, developed material, storage medium, or combinations thereof.

8. The monitoring system as defined in claim 5, wherein said storage medium includes a RFID card or tag, a ROM, an IC plates or boards, a Touch Memory buttons, the body of said stent, or combinations thereof.

9. The monitoring system as defined in claim 6, wherein said storage medium includes a RFID card or tag, a ROM, an IC plates or boards, a Touch Memory buttons, the body of said stent, or combinations thereof.

10. The monitoring system as defined in claim 7, wherein said storage medium includes a RFID card or tag, a ROM, an IC plates or boards, a Touch Memory buttons, the body of said stent, or combinations thereof.

11. The monitoring system as defined in claim 5, wherein said printed material includes a bar code.

12. The monitoring system as defined in claim 6, wherein said printed material includes a bar code.

13. The monitoring system as defined in claim 7, wherein said printed material includes a bar code.

14. The monitoring system as defined in claim 1, wherein said at least one event further includes the insertion of an angioplasty balloon into said stent, the position of an angioplasty balloon in said stent during crimping, the position of an angioplasty balloon in said stent after crimping, the condition of said stent prior to crimping the stent, the condition of said stent during crimping said stent, the condition of said stent after crimping said stent, the condition of a coating on said stent prior to crimping said stent, the condition of a coating on said stent during crimping said stent, the condition of a coating on said stent after crimping said stent, or combinations thereof.

15. The monitoring system as defined in claim 10, wherein said at least one event further includes the insertion of an angioplasty balloon into said stent, the position of an angioplasty balloon in said stent during crimping, the position of an angioplasty balloon in said stent after crimping, the condition of said stent prior to crimping the stent, the condition of said stent during crimping said stent, the condition of said stent after crimping said stent, the condition of a coating on said stent prior to crimping said stent, the condition of a coating on said stent during crimping said stent, the condition of a coating on said stent after crimping said stent, or combinations thereof.

16. The monitoring system as defined in claim 13, wherein said at least one event further includes the insertion of an angioplasty balloon into said stent, the position of an angioplasty balloon in said stent during crimping, the position of an angioplasty balloon in said stent after crimping, the condition of said stent prior to crimping the stent, the condition of said stent during crimping said stent, the condition of said stent after crimping said stent, the condition of a coating on said stent prior to crimping said stent, the condition of a coating on said stent during crimping said stent, the condition of a coating on said stent after crimping said stent, or combinations thereof.

17. A method of making a record of a stent crimping process comprising:

a. providing a stent;

b. crimping the stent;

c. monitoring said stent at least after the crimping of said stent; and

,

d. recording said monitoring on an archiveable media.

18. The method as defined in claim 17, including the step of inserting an angioplasty balloon in a body of the stent and crimping the stent after the angioplasty balloon is at least partially positioned in the body of said stent.

19. The method as defined in claim 17, wherein said step of monitoring includes monitoring said stent prior to insertion of an angioplasty balloon into said body of said stent, monitoring said stent during insertion of an angioplasty balloon into said body of said stent, monitoring said stent after insertion of an angioplasty balloon into said body of said stent, monitoring said stent prior to crimping said stent, monitoring said stent during said crimping of said stent, monitoring said stent after said crimping of said stent, monitoring the condition of a coating on said stent prior to crimping said stent, monitoring the condition of a coating on said stent during crimping said stent, monitoring the condition of a coating on said stent after crimping said stent, or combinations thereof.

20. The method as defined in claim 18, wherein said step of monitoring includes monitoring said stent prior to insertion of an angioplasty balloon into said body of said stent, monitoring said stent during insertion of an angioplasty balloon into said body of said stent, monitoring said stent after insertion of an angioplasty balloon into said body of said stent, monitoring said stent prior to crimping said stent, monitoring said stent during said crimping of said stent, monitoring said stent after said crimping of said stent, monitoring the condition of a coating on said stent prior to crimping said stent, monitoring the condition of a coating on said stent during crimping said stent, monitoring the condition of a coating on said stent after crimping said stent, or combinations thereof.

21. The method as defined in claim 17, wherein said step of monitoring includes a monitoring device, said monitoring device includes a camera, a video recorder, a microscope, a visual or electromagnetic wave imaging device, or combinations thereof.

22. The method as defined in claim 19, wherein said step of monitoring includes a monitoring device, said monitoring device includes a camera, a video recorder, a microscope, a visual or electromagnetic wave imaging device, or combinations thereof.

23. The method as defined in claim 20, wherein said step of monitoring includes a monitoring device, said monitoring device includes a camera, a video recorder, a microscope, a visual or electromagnetic wave imaging device, or combinations thereof.

24. The method as defined in claim 17, wherein said archiveable media includes printed or developed material, storage media, or combinations thereof.

25. The method as defined in claim 22, wherein said archiveable media includes printed or developed material, storage media, or combinations thereof.

26. The method as defined in claim 23, wherein said archiveable media includes printed or developed material, storage media, or combinations thereof.

27. The method as defined in claim 21, wherein said archiveable media includes printed or developed material, storage media, or combinations thereof.

28. The method as defined in claim 24, wherein said storage media includes said stent, a RFID card or tag, a ROM, an IC plate or board, a Touch Memory button, a hard disk, a DVD, a memory stick, a CD, film, a floppy disk, a magnetic tape, a zip disk, the body of said stent, or combinations thereof.

29. The method as defined in claim 26, wherein said storage media includes said stent, a RFID card or tag, a ROM, an IC plate or board, a Touch Memory button, a hard disk, a DVD, a memory stick, a CD, film, a floppy disk, a magnetic tape, a zip disk, the body of said stent, or combinations thereof.

30. The method as defined in claim 24, wherein said printed material includes a bar code.

31. The method as defined in claim 26, wherein said printed material includes a bar code.

32. A crimped stent system comprising a stent for insertion in a body cavity of a human or animal and an archiveable data record associated with said stent that contains information on said stent after said stent has been crimped.

33. The crimped stent system as defined in claim 32, including an angioplasty balloon in a body of said stent.

34. The crimped stent system as defined in claim 32, where said archiveable data record further includes information on a shape of the stent prior to crimping, information of a shape of the stent during crimping, a shape of said stent after crimping, the position of an angioplasty balloon in said body of said stent prior to crimping, the position of an angioplasty balloon in said body of said stent prior during crimping, the position of an angioplasty balloon in said body of said stent after crimping, the condition of a coating on said stent prior to crimping, the condition of a coating on said stent during crimping, the condition of a coating on said stent after crimping, a condition of said body of said stent prior to crimping, a condition of said body of said stent during crimping, a condition of said body of said stent after crimping, or combinations thereof.

35. The crimped stent system as defined in claim 33, where said archiveable data record further includes information on a shape of the stent prior to crimping, information of a shape of the stent during crimping, a shape of said stent after crimping, the position of an angioplasty balloon in said body of said stent prior to crimping, the position of an angioplasty balloon in said body of said stent prior during crimping, the position of an angioplasty balloon in said body of said stent after crimping, the condition of a coating on said stent prior to crimping, the condition of a coating on said stent during crimping, the condition of a coating on said stent after crimping, a condition of said body of said stent prior to crimping, a condition of said body of said stent during crimping, a condition of said body of said stent after crimping, or combinations thereof.

36. The crimped stent system as defined in claim 32, wherein said archiveable data record is at least partially saved on printed or developed material, storage media or combinations thereof.

37. The crimped stent system as defined in claim 34, wherein said archiveable data record is at least partially saved on printed or developed material, storage media or combinations thereof.

38. The crimped stent system as defined in claim 35, wherein said archiveable data record is at least partially saved on printed or developed material, storage media or combinations thereof.

39. The crimped stent system as defined in claim 36, wherein said storage media includes said stent, a RFID card or tag, a ROM, an IC plate or board, a Touch Memory button, a hard disk, a DVD, a memory stick, a CD, film, a floppy disk, a magnetic tape, a zip disk, the body of said stent, or combinations thereof.

40. The crimped stent system as defined in claim 38, wherein said storage media includes said stent, a RFID card or tag, a ROM, an IC plate or board, a Touch Memory button, a hard disk, a DVD, a memory stick, a CD, film, a floppy disk, a magnetic tape, a zip disk, the body of said stent, or combinations thereof.

41. The crimped stent system as defined in claim 36, wherein said printed material includes a bar code.

42. The crimped stent system as defined in claim 38, wherein said printed material includes a bar code.

43. A method of analyzing a condition of a crimped stent prior to insertion of said crimped stent into a body cavity of a human or animal comprising:

a. obtaining a crimped stent;

b. analyzing archiveable information associated with said crimped stent; and

,

c. deciding whether said stent is acceptable for insertion into the body cavity based on a visual inspection of said crimped stent and a review of said archiveable information.