LOCAL DELIVERY OF THERAPEUTIC AGENT TO HEART VALVES

• US 20120010589A1
• Filed: 09/22/2011
• Published: 01/12/2012
• Est. Priority Date: 01/30/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Palasis, Maria, Mickley, Timothy J., Freyman, Toby, Naimark, Wendy
• Granted Patent: US 8,808,364 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

The present invention relates to implantable medical devices and methods that employ these medical devices to treat heart valves. In one embodiment, a medical device is provided comprising a body. The body may have a portion thereof including therapeutic agent and can be configured to support the device proximate a heart valve. Methods in accordance with embodiments of the present invention may also include providing a medical device having a body with at least a portion thereof including a therapeutic agent. These methods may also include positioning the medical device in a location proximate to a downstream surface of the heart valve and securing the device. The therapeutic agent released may then be delivered to the heart valve.

Claims

1. A medical device for securing adjacent a heart valve to deliver therapeutic agent to the heart valve, the medical device comprising:

a body having first and second sections,

the first section having at least a portion thereof including a therapeutic agent and the second section configured to support the medical device, the second section adapted to be positioned downstream from a heart valve,

wherein the first section is adapted to deliver therapeutic agent to a target portion of the heart valve.

2. The device of claim 1, wherein the first section is adapted to deliver therapeutic agent to the target portion when the heart valve opens.

3. The device of claim 1, wherein the target portion is a valve leaflet.

4. The device of claim 1, wherein an inner diameter of the first section is roughened.

5. The device of claim 1, wherein the first section is positioned or configured such that blood flow is not obstructed.

6. The device of claim 1, wherein the second section is substantially tubular and the first section includes at least one support leg configured to extend into a pocket of the heart valve.

7. The device of claim 1, wherein the second section is substantially tubular and the first section includes three support legs each configured to extend into a pocket of the heart valve.

8. The device of claim 1, wherein the first section includes a delivery member which retains the therapeutic agent until the delivery member is mechanically strained by fluid flow.

9. The device of claim 1, wherein the body includes at least one removal element to facilitate removal of the medical device.

10. The device of claim 1, wherein the body includes at least one support element to facilitate securing of the device.

11. The device of claim 1, wherein the body is expandable to facilitate securing of the device.

12. The device of claim 1, wherein the portion of the first section including therapeutic is a contact mechanism configured to contact a target portion of the heart valve to deliver therapeutic agent.

13. The method of claim 12, wherein the contact mechanism extends substantially inward and downstream.

14. The method of claim 12, wherein the contact mechanism includes at least one fiber.

15. The method of claim 12, wherein the contact mechanism includes at least one brush.

16. The method of claim 12, wherein the contact mechanism includes at least one ridge.

17. The method of claim 12, wherein the contact mechanism includes at least one fin.

18. The method of claim 12, wherein the contact mechanism includes at least one synthetic leaflet.

19. The method of claim 12, wherein the contact mechanism includes at least one needle.

20. A method of treating a heart valve, the method comprising:

providing at least one medical device having a body with at least a portion thereof including a therapeutic agent; and

securing the at least one medical device proximate a heart valve such that the therapeutic agent releases from the body and is delivered to a target portion of the heart valve.

21. The method of claim 20, wherein the therapeutic agent is delivered to the target portion when the heart valve opens.

22. The device of claim 21, wherein the therapeutic agent is delivered in a recirculation of fluid that occurs between an inner vessel wall of the lumen and a downstream surface of a valve leaflet.

23. The method of claim 20, wherein the body includes at least one support leg and each support leg is configured to fit within a respective valve pocket.

24. The method of claim 20, wherein the at least one medical device is a plurality of medical devices each having a body including a support leg and each support leg configured to fit within a respective valve pocket.

25. The method of claim 20, further comprising expanding the medical device to secure the medical device.

26. The method of claim 20, further comprising inserting a support element located on the body into a vessel lumen wall to secure the medical device.

27. The method of claim 20, further comprising providing a filter to prevent embolisms.

28. The method of claim 20, wherein the portion of the body including therapeutic is a contact mechanism configured to contact a target portion of the heart valve to deliver therapeutic agent.

29. The method of claim 28, further comprising positioning the contact mechanism to contact the target portion of the heart valve to deliver the therapeutic agent when the heart valve flutters in the open position.