Drug delivery catheters that attach to tissue and methods for their use

• US 20020177772A1
• Filed: 07/05/2002
• Published: 11/28/2002
• Est. Priority Date: 03/13/1997
• Status: Active Grant

• Current Assignee: BioCardia, Inc
• Original Assignee: BioCardia, Inc
• Inventors: Stertzer, Simon, Altman, John D., Altman, Peter A.
• Granted Patent: US 8,027,740 B2
• Time in Patent Office: Days
• US Class Current: 600/431
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61K 9/127 Liposomes
• CPC Class Codes: A61K 9/1676 having a drug-free core with discrete complete coating layer containing drug adsorbates of liquid drug formulations on inert powders without simultaneous granulation step A61K9/141; with further drug-free outer coating A61K9/5078; drug conjugated to non-active particles A61K47/6921
• CPC Class Codes: A61K 9/50 Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals A61K9/2081 takes precedence; particles with a single coating comprising drug A61K9/167
• 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 25/0084 being one or more injection needles
• CPC Class Codes: A61N 1/0575 with drug delivery
• CPC Class Codes: B82Y 5/00 Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery

Abstract

A drug delivery catheter suited for cardiac procedures. The catheter includes a distal helical coil or other fixation and penetrating element which can be operated from the proximal end of the catheter to engage and penetrate the myocardium. Once delivered to the inside of the heart, the catheter can be used to inject small doses of therapeutic agents to the myocardium. The drug delivery system of the catheter allows for precise control of the dose injected into the heart wall.

Claims

1. The method of delivery of a therapeutic agent selected from the set of macromolecule, gene therapy preparation, microspheres, or micelles to a depth within the myocardium including the steps of:

providing a catheter adapted for insertion into the heart, said catheter having a proximal end and a distal end, said catheter having a fixating penetrating element secured to the distal end thereof, said catheter having a drug delivery lumen extending from the proximal end to the distal end of the catheter and a drug delivery port at the distal end of the catheter communicating from the drug delivery lumen to the exterior of the catheter;

inserting the catheter into the heart, and manipulating the fixating penetrating element to engage the heart wall and releasably connect the catheter distal tip to the heart wall;

manipulating the fixating penetrating element to cause it to penetrate the heart wall; and

infusing the therapeutic agent to a depth within the heart wall; and

leaving the fixating penetrating element in heart wall for a period of time sufficient to prevent substantial leakage of therapeutic agent from the heart wall through the wound created by the fixating penetrating element.

2. The method of claim 1 further comprising the steps of:

providing the fixating penetrating element comprising a helical structure; and

manipulating the fixating penetrating element to engage the heart wall by screwing the helical structure into the heart wall.

3. The method of claim 1 further comprising the steps of:

providing the fixating penetrating element comprising a plurality of intersecting penetrating elements; and

manipulating the intersecting penetrating elements to engage the heart wall by forcing the intersecting penetrating elements into the heart wall.

4. The method of claim 1 further comprising the steps of:

providing the fixating penetrating element comprising a plurality of jaws operable from the proximal end of the catheter to open and close and a penetrating needle longitudinally movable from the catheter into the heart wall; and

manipulating the jaws to engage the heart wall and pushing the penetrating needle into the heart wall.

5. The method of claim 1, 2, 3 or 4 in which a confirmatory step occurs after the catheter is attached and before the agent is infused into the tissue, in which contrast agent is infused into the heart chamber to visually confirm that the catheter is positioned appropriately.

6. The method of claim 1, 2, 3, or 4 in which a confirmatory step occurs after the catheter is attached and before the agent is infused into the tissue, in which contrast agent is infused into the heart tissue to visually confirm that the catheter is positioned appropriately.

7. The method of claim 1, 2, 3 or 4 further comprising the step of:

confirming the position of the catheter distal end within the heart by infusing contrast agent into the heart chamber through the catheter.

8. The method of claim 5 in which the contrast is delivered through an outer guide catheter system.

9. The method of claim 7 further comprising the steps of:

providing a guide catheter adapted for percutaneous insertion into the heart, said guide catheter having a proximal end and a distal end and a lumen extending from the proximal end to the distal end;

inserting the guide catheter into the heart;

inserting the catheter through the guide catheter lumen and into the heart;

delivering contrast agent through the guide catheter lumen to the heart.

10. The method of claim 1 in which the contrast is delivered through a distal port in the drug delivery catheter which is fixed to the heart wall.

11. The method of claim 1 further comprising the steps of:

infusing a passive agent in a volume equivalent to 1 to 5 times the volume of the drug delivery lumen.

12. The method of claim 1 in which the volume of the drug delivery lumen in the delivery catheter is between 0.05 and 0.25 milliliters.

15. The catheter of claim 14 wherein the fixating penetrating element comprises a hollow helical coil, and the drug delivery lumen is connected to the hollow helical coil.

13. The method of delivery of a therapeutic agent selected from the set of macromolecule, gene therapy preparation, microspheres, or micelles to a depth within the myocardium including the steps of:

providing a catheter adapted for insertion into the heart, said catheter having a proximal end and a distal end, said catheter having a resilient coil secured to the distal end thereof, and a fixating penetrating element secured to the distal end of the resilient coil, said catheter having a drug delivery lumen extending from the proximal end to the distal end of the catheter and a drug delivery port at the distal end of the catheter communicating from the drug delivery lumen to the exterior of the catheter;

inserting the catheter into the heart, and manipulating the fixating penetrating element to engage the heart wall and releasably connect the catheter distal tip to the heart wall;

manipulating the fixating penetrating element to cause it to penetrate the heart wall; and

infusing the therapeutic agent to a depth within the heart wall; and

leaving the fixating penetrating element in heart wall for a period of time sufficient to prevent substantial leakage of therapeutic agent from the heart wall through the wound created by the fixating penetrating element.

14. A catheter adapted for insertion into the heart, said catheter comprising:

a catheter body having a proximal end and a distal end;

a resilient coil having a proximal end and a distal end, said proximal end of the resilient coil secured to the distal end of the catheter body;

a fixating penetrating element secured to the distal end of the resilient coil;

a drug delivery lumen extending from the proximal end to the distal end of the catheter and a drug delivery port at the distal end of the catheter communicating from the drug delivery lumen to the exterior of the catheter.