METHODS AND DEVICES FOR LOCAL THERAPEUTIC AGENT DELIVERY TO HEART VALVES

• US 20090069789A1
• Filed: 09/05/2008
• Published: 03/12/2009
• Est. Priority Date: 09/06/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Oston Scientific Scimed Incorporated
• Inventors: Cheng, Ruth, Mickley, Tim, Freyman, Toby
• Granted Patent: US 8,556,880 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

Medical devices and methods for delivering a therapeutic agent to a heart valve.

Claims

1. A device for delivering a therapeutic agent to a heart valve, comprising:

a body having a distal end; and

a plurality of delivery members coupled to the body, where each member has a first end and a second end, and the first and second ends of at least one of the delivery members are coupled to the body at locations that are proximal to the distal end of the body.

2. The device of claim 1, where the body is further defined as having a lumen.

3. The device of claim 2, where at least one of the delivery members has a lumen.

4. The device of claim 3, where each of the delivery members has a lumen and one or more openings in communication with that lumen such that fluid can flow out of that delivery member through the one or more openings.

5. The device of claim 1, comprising 2 to 500 therapeutic agent delivery members.

6. The device of claim 1, where the first end and the second end of all delivery members are coupled to the body.

7. The device of claim 1, where at least a portion of at least one delivery member is coated with a therapeutic agent.

8. The device of claim 7, where the therapeutic agent is rapamycin, paclitaxel, sirolimus, a nitric oxide-enhancing agent, a statin, an angiotensin converting enzyme (ACE) inhibitor, a PPAR agonist, an anti-inflammatory agent, an anti-stenotic agent, an antibiotic, atorvastatin, or quinapril.

18. A method for diagnosing or treating a valve disease in a subject, comprising:

a) inserting the device of any of claims 1-11 or catheter of claim 15 into a subject, where at least a portion of at least one delivery member of the device is coated with a therapeutic agent; and

b) positioning the device such that the valve leaflets of the valve are in contact with that delivery member;

where contact results in delivery of therapeutic agent to the valve and diagnosis or treatment of the valve disease.

19. The method of claim 18, where the therapeutic agent is rapamycin, paclitaxel, sirolimus, a nitric oxide-enhancing agent, a statin, an angiotensin converting enzyme (ACE) inhibitor, a PPAR agonist, an anti-inflammatory agent, an anti-stenotic agent, an antibiotic, atorvastatin, or quinapril.

9. A therapeutic agent delivery catheter comprising a plurality of delivery members coupled to the catheter, each having a portion positioned alongside a portion of the catheter.

10. The catheter of claim 9, where at least a portion of at least one delivery member is coated with a therapeutic agent.

11. The catheter of claim 10, where the therapeutic agent is rapamycin, paclitaxel, sirolimus, a nitric oxide-enhancing agent, a statin, an angiotensin converting enzyme (ACE) inhibitor, a PPAR agonist, an anti-inflammatory agent, an anti-stenotic agent, an antibiotic, atorvastatin, or quinapril.

12. The catheter of claim 9, wherein at least one delivery device has a lumen with one or more openings to provide for a communication with that lumen such that fluid can flow out of that delivery member through the one or more openings.

13. The catheter of claim 12, where at least a portion of at least one delivery member is coated with a therapeutic agent.

14. The catheter of claim 13, where the therapeutic agent is rapamycin, paclitaxel, sirolimus, a nitric oxide-enhancing agent, a statin, an angiotensin converting enzyme (ACE) inhibitor, a PPAR agonist, an anti-inflammatory agent, an anti-stenotic agent, an antibiotic, atorvastatin, or quinapril.

20. A method for diagnosing or treating a valve disease in a subject, comprising:

a) inserting a device of any of claims 4 or a catheter of any of claims 12-14 in a blood vessel of a subject;

b) positioning the device such that the valve leaflets of the valve are in contact with that delivery member;

c) infusing a pharmaceutical composition comprising a therapeutic agent and a carrier through the lumen of the device or catheter, where infusion results in release of the composition from that delivery members and diagnosis or treatment of the valve disease.

15. A device for delivering a therapeutic agent to a heart valve, comprising:

a body having a distal end and a therapeutic agent-coated fin longitudinally oriented along a portion of the body, the fin having a distal end located more than 1 mm from the distal end of the body.

16. A device for delivering a therapeutic agent to a heart valve, comprising:

a body having a distal end; and

an expandable balloon coupled to the body, the balloon having a plurality of nanofilaments, where the balloon is located more than 1 mm from the distal end of the body.

21. A method for diagnosing or treating a valve disease in a subject, comprising:

a) inserting the device of claim 16 in a blood vessel of the subject, where the nanofilaments are at least partially coated with a therapeutic agent;

b) positioning the device such that the balloon is in contact with the valve;

c) inflating the balloon, where inflating results in delivery of therapeutic agent to the valve and diagnosis or treatment of the valve disease.

17. A device for delivering a therapeutic agent to a heart valve, comprising:

a body having a distal end; and

an expandable balloon coupled to the body, the balloon having a plurality of openings to provide for a communication such that fluid can flow out of the balloon through the one or more openings, where the balloon is located more than 1 mm from the distal end of the body.

22. A method for diagnosing or treating a valve disease in a subject, comprising:

a) inserting the catheter of claim 17 in a blood vessel of the subject, at least a portion of a delivery member is coated with a therapeutic agent;

b) positioning the device such that the valve leaflets of the valve are in contact with the delivery members;

where contact results in delivery of therapeutic agent to the valve and diagnosis or treatment of the valve disease.