Local delivery of therapeutic agent to heart valves

• US 8,808,364 B2
• Filed: 09/22/2011
• Issued: 08/19/2014
• Est. Priority Date: 01/30/2007
• Status: Expired due to Fees

• 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
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US13/240,792
• Publication Number:
  US 20120010589A1
• Time in Patent Office: 1,062 Days
• Field of Search: 604/200, 604/265, 604/507, 604/104, 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 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 provided with a therapeutic agent and having one or more generally rectangular support legs each configured to extend into a pocket of the heart valve, the first section having open clearance space between adjacent support legs, and the second section being substantially cylindrical and configured to secure the medical device to an inner vessel wall of a lumen by extending continuously around the inner vessel wall and by exerting radial force to the inner vessel wall at a location downstream from the heart valve,

wherein the second section is substantially free of the therapeutic agent.

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 first section includes a delivery member which retains the therapeutic agent until the delivery member is mechanically strained by fluid flow.

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

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

9. The device of claim 1, wherein the body is self-expandable to facilitate securing of the device.

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

11. The device of claim 10, wherein the contact mechanism extends substantially inward and downstream.

12. The device of claim 10, wherein the contact mechanism includes at least one fiber.

13. The device of claim 10, wherein the contact mechanism includes at least one brush.

14. The device of claim 10, wherein the contact mechanism includes at least one ridge.

15. The device of claim 10, wherein the contact mechanism includes at least one fin.

16. The device of claim 10, wherein the contact mechanism includes at least one needle.

17. The device of claim 1, wherein the first section includes three support legs, and wherein the therapeutic agent of the first section is located in the three support legs.