Methods and apparatus for performing valvuloplasty

• US 8,579,962 B2
• Filed: 12/20/2005
• Issued: 11/12/2013
• Est. Priority Date: 12/23/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Salahieh, Amr, Morejohn, Dwight P., Hildebrand, Daniel, Saul, Tom
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US11/314,969
• Publication Number:
  US 20070118214A1
• Time in Patent Office: 2,884 Days
• Field of Search: 623/2.11, 623/2.17, 623 111- 115
• US Class Current: 623/2.11
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

The present invention relates to apparatus and methods for performing valvuloplasty. In some embodiments, the apparatus includes an expandable braid valvuloplasty device. In some embodiments, the methods and apparatus may be used as an adjunct to percutaneous heart valve replacement. In some embodiments, the apparatus and methods may provide a medical practitioner with feedback, monitoring or measurement information, e.g., information relevant to percutaneous transcatheter heart valve replacement.

Claims

1. A method for performing valvuloplasty, the method comprising:

first, percutaneously delivering an expandable braid to a valvuloplasty site within a patient;

second, expanding the expandable braid to perform the valvuloplasty;

third, measuring foreshortening of the expandable braid during the valvuloplasty;

fourth, determining a diameter of the expandable braid during the valvuloplasty from the foreshortening measurement; and

fifth, allowing blood flow through the expandable braid during the valvuloplasty.

2. The method of claim 1, wherein percutaneously delivering an expandable braid further comprises percutaneously delivering a valve to the valvuloplasty site, and wherein allowing blood flow through the expandable braid during the valvuloplasty further comprises regulating blood flow with the valve.

3. The method of claim 1 further comprising anchoring the expandable braid to the patient and supporting a replacement heart valve within the braid.

4. The method of claim 1, wherein expanding the expandable braid comprises foreshortening the device.

5. The method of claim 1 further comprising measuring expansion forces applied to the expandable braid at the valvuloplasty site during the valvuloplasty procedure.

6. The method of claim 1 further comprising monitoring at least one characteristic of the expandable braid during the valvuloplasty.

7. The method of claim 1 further comprising utilizing monitoring data to select an appropriate replacement valve implant for use during percutaneous transcatheter heart valve replacement.

8. The method of claim 7 further comprising utilizing monitoring data to select an expanded size of the expandable braid to use as a valve implant.

9. The method of claim 8 further comprising locking the expandable braid in the expanded size.

10. The method of claim 1, wherein expanding the expandable braid to perform the valvuloplasty further comprises expanding the device until feedback indicative of calcific cracking at the valvuloplasty site is received.

11. The method of claim 1, wherein expanding the expandable braid to perform the valvuloplasty further comprises sealingly engaging the patient'"'"'s native valve structures with the expandable braid valvuloplasty device.

12. The method of claim 1 further comprising:

collapsing the expandable braid; and

retrieving the expandable braid from the patient.

13. The method of claim 12 further comprising performing percutaneous transcatheter heart valve replacement.

14. A method for performing valvuloplasty and delivering a

replacement heart valve, the method comprising:

first, percutaneously delivering a replacement heart valve comprising an expandable anchor and a valve to the vicinity of a native heart valve within a patient;

second, expanding the replacement heart valve to an expanded configuration to perform a valvuloplasty;

third, measuring foreshortening of the expandable braid during the valvuloplasty;

fourth, determining a diameter of the expandable braid during the valvuloplasty from the foreshortening measurement; and

fifth, leaving the replacement heart valve in the patient and regulating blood flow through the replacement heart valve with the valve after performing the valvuloplasty.

15. The method of claim 14 wherein performing the valvuloplasty comprises regulating the flow of blood through the expandable anchor with the valve.

16. The method of claim 14 wherein expanding the replacement heart valve to an expanded configuration to perform a valvuloplasty comprises expanding the expandable anchor to an expanded configuration to perform the valvuloplasty.

17. The method of claim 16 wherein expanding the expandable anchor to an expanded configuration to perform a valvuloplasty comprises foreshortening the expandable anchor.

18. A method for performing valvuloplasty comprising:

first, percutaneously delivering an expandable anchor and a valve to the vicinity of a native heart valve within a patient;

second, expanding the expandable anchor to an expanded configuration to perform a valvuloplasty;

third, measuring foreshortening of the expandable braid during the valvuloplasty;

fourth, determining a diameter of the expandable braid during the valvuloplasty from the foreshortening measurement; and

fifth, regulating blood flow through the anchor with the valve during the valvuloplasty.

19. The method of claim 18 wherein percutaneously delivering an expandable anchor and a valve within a patient comprises percutaneously delivering a replacement heart valve comprising the expandable anchor and the valve;

and further comprising leaving the replacement heart valve in the patient and regulating blood flow through the replacement heart valve with the valve after performing the valvuloplasty.

20. The method of claim 18 further comprising removing the anchor and the valve from the patient after the valvuloplasty.