Local delivery of therapeutic agent to heart valves

• US 8,038,709 B2
• Filed: 01/30/2008
• Issued: 10/18/2011
• 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, Naimark, Wendy, Freyman, Toby, Mickley, Timothy J.
• Primary Examiner(s): Stigell; Theodore
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US12/022,413
• Publication Number:
  US 20080183143A1
• Time in Patent Office: 1,357 Days
• Field of Search: 604/200, 604/265, 604/507, 623/1.1, 623/1.13, 623/1.15, 623/1.24, 623/1.38, 623/1.42, 623/2.1, 623/2.11, 623/2.12, 623/2.14, 623/2.18, 623/2.36
• US Class Current: 623/1.42
• 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 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, the body further comprising;

a first section including a plurality of support legs, the plurality of support legs being configured such that a space between adjacent legs extends around a connection between adjacent leaflets of the heart valve and a second section;

positioning the least one medical device so that each support leg fits within a respective valve pocket and the second section extends continuously around an inner vessel wall of a lumen at a location downstream from a heart valve, and the first section extends upstream from the second section towards the heart valve; and

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

2. The method of claim 1, wherein the therapeutic agent is delivered to the target portion when the heart valve opens.

3. The method of claim 1, wherein the inner surface of each support leg includes dimples, ridges, or channels.

4. The method of claim 1, wherein each support leg is configured to fit within a respective valve pocket of a respective valve leaflet.

5. The method of claim 1, further comprising providing a filter to prevent embolisms.

6. The method of claim 1, wherein the portion of the body including therapeutic is a contact member configured to contact a target portion of the heart valve to deliver therapeutic agent.

7. The method of claim 6, further comprising positioning the contact member to contact the target portion of the heart valve to deliver the therapeutic agent when the heart valve flutters in the open position.

8. The method of claim 6, wherein the contact member extends substantially inward and downstream.

9. The method of claim 6, wherein the contact member includes at least one fiber.

10. The method of claim 6, wherein the contact member includes at least one brush.

11. The method of claim 6, wherein the contact member includes at least one ridge.

12. The method of claim 6, wherein the contact member includes at least one fin.

13. The method of claim 6, wherein the contact member includes at least one needle.

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

15. The method of claim 1, wherein the first section includes a fiber which retains the therapeutic agent until the fiber is mechanically strained by fluid flow.

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

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

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

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