Systems and methods for local delivery of an agent

• US 20010033867A1
• Filed: 06/25/2001
• Published: 10/25/2001
• Est. Priority Date: 12/18/1997
• Status: Abandoned Application

• Current Assignee: James F. Crittenden, John E. Ahern
• Original Assignee: James F. Crittenden, John E. Ahern
• Inventors: Ahern, John E., Crittenden, James F.
• Application Number:
  US09/888,757
• Publication Number:
  US 20010033867A1
• Time in Patent Office: Days
• US Class Current: 424/489
• 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 step of implanting said therapeutic 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 2

, including the step of

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

8. 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.

9. 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.

10. 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.

11. 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.

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 delivering a pellet containing a therapeutic agent, comprising the steps of

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

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

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

15. 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 said 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 implanting said therapeutic agent into the septal wall.

16. A method according to

claim 15

, 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.

17. A method according to

claim 15

, 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.

18. 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 a therapeutic agent into the portion of tissue.

19. A pellet, comprising

a therapeutic 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.

20. Apparatus for implanting a therapeutic agent within a tissue wall, comprising

an elongate flexible body having a proximal end and a distal end,

a delivery chamber coupled to the distal end of the body and having a space for carrying the therapeutic agent, and a port for releasing the therapeutic agent therefrom, and

an actuator coupled to the delivery chamber and capable of driving the therapeutic agent through the port, whereby the therapeutic agent is implanted within a tissue wall.

21. Apparatus according to

claim 20

, further including

a control mechanism coupled to the actuator and the proximal end of the body for providing control of the actuator, whereby a user can operate the control mechanism for controlling the delivery of the therapeutic agent.

22. Apparatus according to

claim 20

, further including

a steering mechanism for turning the distal end of the body, to thereby allow the delivery chamber to be selectively guided through a body lumen.

23. Apparatus according to

claim 20

, wherein the delivery chamber and the distal end of the flexible body are dimensionally adapted to allow for transluminal delivery and for entry into the interior of a patient'"'"'s heart.

24. Apparatus according to

claim 20

, wherein the delivery chamber includes a substantially cylindrical interior housing dimensionally adapted to store in axial alignment a plurality of minispheres containing a therapeutic agent.

25. Apparatus according to

claim 20

, further including

a pointed distal end adapted to penetrate a tissue wall for delivering the therapeutic agent within the tissue wall.

26. Apparatus according to

claim 20

, wherein the actuator includes

a plunger for driving the therapeutic agent from the delivery chamber.

27. Apparatus according to

claim 20

, further including

a ratchet assembly for allowing delivery of discreet volumes of the therapeutic agent.

28. Apparatus according to

claim 20

, wherein the actuator includes

a threaded plunger for advancing into the delivery chamber responsive to a rotating action.

29. Apparatus according to

claim 20

, wherein the delivery chamber is adapted to receive at least one pellet containing the therapeutic agent.

30. Apparatus according to

claim 20

, further including

a lever-action handle mounted at the proximal end of the flexible body and coupled to the control mechanism.

31. Apparatus according to

claim 20

, further including

means for receiving at least one pellet containing the therapeutic agent and having an arcuate shape for facilitating implanting within a body of tissue.