System and methods for local delivery of an agent

• US 6,197,324 B1
• Filed: 07/15/1998
• Issued: 03/06/2001
• Est. Priority Date: 12/18/1997
• Status: Expired due to Term

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Crittenden, James F.
• Primary Examiner(s): AZPURU, CARLOS A
• Application Number:
  US09/116,313
• Time in Patent Office: 965 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 31/00 Medicinal preparations containing organic active ingredients
• 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: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)
• 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 23/02 Local anaesthetics
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

A system and method for implanting pellets containing local anesthetic agents into tissues of the heart for temporary treatment of angina pectoris. The mechanism of delivery can be transcatheter via chambers of the heart, endoscopic epicardial approach via minimally invasive transthoracic access, or intraoperative epicardial approach during open-chest surgery.

Claims

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

implanting a therapeutically effective amount of a local anesthetic agent into a portion of 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

delivering a pellet containing said therapeutic agent into the myocardial tissue.

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

delivering sequentially a plurality of pellets containing said therapeutic agent into the myocardial tissue.

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

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

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

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

8. A method according to claim 1, 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.

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

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

10. A method according to claim 1, 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.

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

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

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

endoscopically delivering said therapeutic agent through the epicardium.

13. 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 for treating angina pectoris, comprising the steps of

identifying a portion of ischemic myocardial tissue, and

implanting a therapeutically effective amount of a therapeutic agent into the portion of ischemic myocardial tissue,

wherein said therapeutic agent is a local anesthetic agent.

15. A method according to claim 14, wherein the ischemic myocardial tissue is accessed transendocardially.

16. A method according to claim 14, wherein the ischernic myocardial tissue is accessed transepicardially.

17. A pellet, comprising

a therapeutically effective amount of a therapeutic agent having a local anesthetic agent surrounding a radio-opaque material, whereby delivery of the therapeutic agent is facilitated by viewing the position of the radio-opaque material relative to a position of a targeted site for implanting the pellet.