Remotely adjustable coronary sinus implant

• US 7,993,397 B2
• Filed: 04/05/2004
• Issued: 08/09/2011
• Est. Priority Date: 04/05/2004
• Status: Active Grant

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Taylor, David Mark, Kusleika, Richard S., Lashinski, Randall T.
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): Ganesan; Suba
• Application Number:
  US10/818,186
• Publication Number:
  US 20050222678A1
• Time in Patent Office: 2,682 Days
• Field of Search: 623/2.11, 623 236- 24, 623/1.11, 623/1.23, 623 1313- 1316, 623 2364- 2365, 623603-904, 606/191, 606/192, 606/194, 606/198, 606/232, 604/116, 604/174, 604/175
• US Class Current: 623/2.37
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape

Abstract

Disclosed are methods and devices for applying pressure to an adjacent tissue structure, such as the annulus of the mitral valve. An adjustable implant is provided with an elongate control line having a distal end connected to the implant and a proximal end spaced apart from the implant. The device enables post implantation adjustment, by accessing the proximal end of the control line and manipulating the control line to adjust the implant.

Claims

1. A method of treating a patient, comprising the steps of:

identifying a patient having an implant residing within the patient, wherein the implant comprises an associated connector, and an elongate flexible tubular sleeve connecting the connector to the implant, wherein the elongate flexible tubular sleeve has at least one control line therein, the at least one control line extending from the connector to the implant;

after identifying the patient, the method further comprising;

removing a cover over the connector;

accessing the connector;

connecting an adjustment tool to the connector, the adjustment tool located at least partially outside the patient'"'"'s body; and

actuating the adjustment tool to adjust an amount of force, exerted by at least a portion of the implant against adjacent tissue, from a first force to a second force;

wherein actuating the adjustment tool comprises rotating the adjustment tool in a first direction within the connector and changing the direction of rotation, within the connector, to drive the at least one control line in a second direction of rotation, different than the first direction,

wherein, after the actuating of the adjustment tool, and after the adjustment tool is entirely outside the patient'"'"'s body, the connector remains connected to the implant by the tubular sleeve, the at least one control line remains extending from the connector to the implant, and the at least a portion of the implant continues to exert substantially the second force against the adjacent tissue.

2. A method of treating a patient as in claim 1, wherein the actuating step adjusts force against a heart valve.

3. A method of treating a patient as in claim 2, wherein the actuating step adjusts force against the annulus of the mitral valve.

4. A method of treating a patient as in claim 3, wherein the actuating step adjusts the position of the posterior leaflet of the mitral valve.

5. A method of treating a patient as in claim 1, wherein the actuating step adjusts force against a natural body lumen.

6. A method of treating a patient as in claim 1, wherein the actuating step adjusts force against the lower esophageal sphincter.

7. A method of treating a patient as in claim 1, wherein the actuating step adjusts force against the stomach.

8. A method of treating a patient as in claim 1, wherein the actuating step adjusts force against the urethra.

9. A method of treating a patient as in claim 1, wherein the actuating step adjusts force against a nerve.

10. A method of treating a patient as in claim 1, wherein the actuating step is accomplished at least ten minutes following implantation of the implant into the patient.

11. A method of treating a patient as in claim 10, wherein the actuating step is accomplished at least 24 hours following implantation of the implant into the patient.

12. A method of treating a patient as in claim 11, wherein the actuating step is accomplished at least two weeks following implantation of the implant into the patient.

13. A method of treating a patient as in claim 1, further comprising the step of measuring an indicium of the patient'"'"'s condition prior to the actuating step.

14. A method of treating a patient as in claim 1, additionally comprising the step of monitoring hemodynamic function.

15. A method as in claim 14, wherein the monitoring step is accomplished using transesophageal echocardiography.

16. A method as in claim 14, wherein the monitoring step is accomplished using surface echo cardiographic imaging.

17. A method as in claim 14, wherein the monitoring step is accomplished using intracardiac echo cardiographic imaging.

18. A method as in claim 14, wherein the monitoring step is accomplished using fluoroscopy with radiocontrast media.

19. A method as in claim 14, wherein the monitoring step is accomplished using left atrial or pulmonary capillary wedge pressure measurements.

20. A method as in claim 14, further comprising the step of determining an ongoing drug therapy taking into account hemodynamic function.

21. A method as in claim 1, comprising measuring residual regurgitation following the actuating step and formulating an ongoing drug therapy taking into account the residual regurgitation.

22. A method as in claim 1, wherein the control line is coupled to the implant proximate to the implant'"'"'s distal end.

23. A method as in claim 1, wherein changing the direction of rotation within the connector comprises engaging and rotating, with the adjustment tool, a gear located within the connector.

24. A method, of treating a patient, comprising:

identifying a patient having a control line coupled to an implant that resides in the patient, the control line extending through a tubular sleeve that extends from the implant to a housing implanted at a site in the patient that is remote from the implant, the implant exerting, in a first configuration, a first pressure on an extravascular target site within the patient;

accessing, with an access device located at least partially within the body, the control line, via the implanted housing, at the site; and

transmitting energy, with the access device, through the control line, to a motor, located with the implant, that changes, upon receipt of the transmitted energy, the implant from the first configuration to a second configuration, thereby adjusting a pressure, exerted by the implant, to a second pressure, different from the first pressure;

wherein, after the transmitting energy through the control line and after removing the access device from the body, the control line remains coupled to the implant and extends from the implant to the housing through the tubular sleeve, and the implant maintains exertion of substantially the second pressure on the extravascular target site.

25. A method as in claim 24, wherein the implant is intravascular within the patient.

26. A method as in claim 24, further comprising penetrating the patient'"'"'s skin from outside the body with the access device, after the identifying of the patient and before the transmitting energy through the control line.