Systems and methods for local delivery of an agent

• US 6,251,418 B1
• Filed: 12/18/1997
• Issued: 06/26/2001
• Est. Priority Date: 12/18/1997
• Status: Expired due to Fees

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Crittenden, James F., Ahern, John E.
• Primary Examiner(s): Azpuru, Carlos A.
• Application Number:
  US08/993,586
• Time in Patent Office: 1,286 Days
• Field of Search: 424/423
• US Class Current: 424/423
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61K 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/0091 the single injection needle being fixed
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

A system and method for implanting pellets into myocardial tissue for treatment of coronary artery restenosis, ischemic heart disease, or cardiac conduction of disturbances. The mechanism of delivery can be transcatheter via chambers of the heart, endoscopic pericardial approach via minimally invasive transthoracic access, or intraoperative pericardial approach during open-chest surgery. Noncardiac tissues can also be treated.

Claims

1. A method for providing local delivery of a therapeutic agent comprising the steps of

delivering and implanting sequentially a plurality of pellets containing a therapeutically effective amount of said therapeutic agent into the myocardial tissue.

2. A method according to claim 1, including the steps of

providing a catheter having a distal end adapted for delivering said therapeutic agent,

guiding said catheter into the interior of a patient'"'"'s heart, and

disposing said distal end against an endocardial wall of the heart for implanting said therapeutic agent into the myocardial tissue.

3. A method according to claim 1 including the further step of,

providing a steerable catheter having a drilling element for penetrating an endocardial wall.

4. A method according to claim 1, including the step of

providing a pellet containing said therapeutic agent and a radio-opaque material.

5. A method according to claim 2, including the step of

steering said catheter through the femoral artery and into the heart.

6. A method according to claim 2, including the step of

positioning a marker in a selected portion of a coronary artery, for providing a marker to identify a location for receiving said therapeutic agent.

7. A method according to claim 2, including the step of

penetrating said distal end of said catheter through said endocardial wall, for delivering said therapeutic agent into said myocardial tissue.

8. A method according to claim 2, including the step of

delivering through said distal end of said catheter, a pellet having a pointed or helical, conical end adapted to penetrate said endocardial wall.

9. A method according to claim 2, including the step of

delivering pellets containing said therapeutic agent and having an outer surface adapted to adhere said pellets to said endocardial wall.

10. A method according to claim 1, including the step of

endoscopically delivering said therapeutic agent through the epicardium.

11. A method according to claim 1, including the step of

implanting said therapeutic agent into the myocardial tissue during open-chest surgery.

14. A method according to claim 3, wherein the step of disposing said distal end of the catheter includes a step of

delivering a pellet containing said therapeutic agent from said distal end with sufficient force to implant said pellet within the septal wall.

12. A method for delivering a pellet containing a therapeutic agent, comprising the steps of

providing a plurality of pellets each containing a therapeutically effective amount of a therapeutic agent,

providing a catheter having a distal end adapted for delivering said pellets,

guiding said catheter through a body lumen and disposing said distal end proximate a tissue wall, and

delivering sequentially the pellets through said distal end with sufficient force to implant said pellet within said tissue wall.

13. A method for delivering a therapeutic agent to a septal artery, comprising the steps of

providing a catheter having a distal end adapted for delivering a therapeutically effective amount of a therapeutic agent,

guiding said catheter into the interior of a patient'"'"'s heart, and

disposing said distal end against a septal wall of the heart for sequentially implanting a plurality of pellets containing said therapeutic agent into the septal wall.

15. A method according to claim 13, wherein the step of disposing said distal end of the catheter includes a step of,

delivering from said distal end of the catheter a pellet containing said therapeutic agent and having a surface adapted to adhere to a tissue wall.

16. A method for treating vascular restenosis, comprising the steps of

identifying a portion of tissue proximate to a site of a patient'"'"'s vasculature to be treated for restenosis, and

implanting sequentially a plurality of pellets containing a therapeutically effective amount of a therapeutic agent into the portion of a tissue.