Endoluminal ventricular retention

• US 6,706,065 B2
• Filed: 07/19/2001
• Issued: 03/16/2004
• Est. Priority Date: 01/31/2000
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: EV3 Santa Rosa, Inc. (Medtronic Plc)
• Inventors: Lesh, Michael D., Langberg, Jonathan J.
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): Chattopadhyay, Urmi
• Application Number:
  US09/909,193
• Publication Number:
  US 20010044568A1
• Time in Patent Office: 971 Days
• Field of Search: 623/1.1, 623/1-1-, 623/2--, 606/191, 606/194, 606/151, 606/158, 606/108, 600/37, 128/898
• US Class Current: 623/2.37
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A left ventricle restriction device is designed to be transvenously advanced and deployed within the coronary sinus and in some embodiments other coronary veins. The device places tension on adjacent structures, reducing the diameter and/or limiting diastolic expansion of the left ventricle. This may be beneficial for patients with dilated cardiomyopathy.

Claims

1. A method of limiting diastolic expansion of the left ventricle, comprising positioning a prosthesis in a coronary venous pathway which surrounds at least a portion of the left ventricle;

tensioning the prosthesis; and

attaching a proximal portion of the prosthesis to a distal portion of the prosthesis to form a closed loop for restraining expansion of the left ventricle.

2. The method of limiting diastolic expansion of the left ventricle of claim 1, wherein the prosthesis comprises an elongate, flexible body having a noncircular cross sectional configuration.

3. The method of limiting diastolic expansion of the left ventricle of claim 1, wherein the positioning step comprises advancing a control line attached to the prosthesis through at least a portion of the pathway.

4. The method of limiting diastolic expansion of the left ventricle of claim 3, further comprising the step of harnessing the control line with a snare.

5. The method of limiting diastolic expansion of the left ventricle of claim 3, further comprising the step of proximally retracting the control line to pull the prosthesis into position within the pathway.

6. The method of limiting diastolic expansion of the left ventricle of claim 5, further comprising the step of applying tension to the control line to tension the prosthesis.

7. The method of limiting diastolic expansion of the left ventricle of claim 6, further comprising the step of severing the control line following the tensioning step.

8. The method of limiting diastolic expansion of the left ventricle of claim 7, further comprising the step of locking the prosthesis prior to the severing step.

9. The method of limiting diastolic expansion of the left ventricle of claim 1, wherein the prosthesis has an axial length within the range of from about 6 cm to about 12 cm.

10. The method of limiting diastolic expansion of the left ventricle of claim 1, wherein the prosthesis comprises a proximal control line attached to a proximal end of the prosthesis and a distal control line attached to a distal end of the prosthesis, and implantation of the prosthesis is accomplished by manipulating the control lines.

11. The method of limiting diastolic expansion of the left ventricle of claim 10, wherein the overall length of the proximal control line, prosthesis and distal control line is in excess of about 200 cm.

12. The method of limiting diastolic expansion of the left ventricle of claim 10, wherein the positioning step comprises advancing the distal control line from the great cardiac vein through anastomotic connections and into the middle cardiac vein.

13. The method of limiting diastolic expansion of the left ventricle of claim 12, wherein the positioning step further comprises advancing the distal control line through the ostium of the coronary sinus.

14. The method of limiting diastolic expansion of the left ventricle of claim 13, further comprising the step of snaring the distal control line and pulling it proximally until both the proximal and distal control lines extend outside of the patient.

15. The method of limiting diastolic expansion of the left ventricle of claim 14, further comprising the step of severing the proximal and distal control lines following the attaching step.

16. The method of limiting diastolic expansion of the left ventricle of claim 1, wherein the positioning step comprises advancing the prosthesis through at least a portion of the great cardiac vein and the middle cardiac vein.

17. The method of limiting diastolic expansion of the left ventricle of claim 1, wherein the attaching step comprises advancing a proximal end and a distal end of the prosthesis through a locking clip.

18. The method of limiting diastolic expansion of the left ventricle of claim 1, further comprising the step of monitoring the degree of regurgitation during the tensioning the prosthesis step.

19. The method of limiting diastolic expansion of the left ventricle of claim 1, further comprising the step of monitoring the effect of the prosthesis on hemodynamic function.

20. The method of limiting diastolic expansion of the left ventricle of claim 19, wherein the step of monitoring hemodynamic function is accomplished using transesophageal echo cardiography.

21. The method of limiting diastolic expansion of the left ventricle of claim 19, wherein the step of monitoring hemodynamic function is accomplished using surface echo cardiographic imaging.

22. The method of limiting diastolic expansion of the left ventricle of claim 19, wherein the step of monitoring hemodynamic function is accomplished using intracardiac echo cardiographic imaging.

23. The method of limiting diastolic expansion of the left ventricle of claim 19, wherein the step of monitoring hemodynamic function is accomplished using fluoroscopy with radiocontrast media.

24. The method of limiting diastolic expansion of the left ventricle of claim 19, wherein the step of monitoring hemodynamic function is accomplished using left atrial or pulmonary capillary wedge pressure measurements.

25. The method of limiting diastolic expansion of the left ventricle of claim 1, further comprising the steps of first measuring the coronary venous pathway and then selecting an appropriately sized prosthesis prior to the positioning step.

26. The method of limiting diastolic expansion of the left ventricle of claim 1, further comprising the step of determining an ongoing drug therapy taking into account post implantation hemodynamic function.