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

• US 6,416,510 B1
• Filed: 10/13/1999
• Issued: 07/09/2002
• Est. Priority Date: 03/13/1997
• Status: Expired due to Term

• Current Assignee: BioCardia, Inc
• Original Assignee: BioCardia, Inc
• Inventors: Stertzer, Simon, Altman, John D., Altman, Peter A.
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): MANTIS MERCADER, ELENI M
• Application Number:
  US09/418,205
• Time in Patent Office: 1,000 Days
• Field of Search: 607/120, 607/121, 607/122, 607/123, 607/3, 607/126, 607/127, 607/128, 607/60-61, 607/32-33, 606/41, 606/45, 606/47, 606/48, 606/44, 606/167, 600/508, 600/374, 604/22, 604/264, 604/95, 604/200, 604/73, 604/181, 604/187, 604/131, 604/141, 604/143, 604/148, 604/280
• US Class Current: 606/41
• 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.

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.

13. A catheter for interstitial delivery that has two lumens which connect to one another prior to the distal penetrating element.

14. A drug delivery catheter for injection of small doses of a therapeutic agent into the heart wall, said drug delivery catheter comprising:

a catheter tube adapted for percutaneous insertion into the heart, said catheter having a distal end adapted for insertion in to the heart and a proximal end housed within a housing;

a first lumen extending through the catheter, said lumen having a distal end adapted for fluid injection into the heart and a proximal end adapted for connection to one or more fluid reservoirs;

a first fluid reservoir releasably secured to the housing;

a second fluid reservoir releasably secured to the housing;

a valve communicating with the proximal end of the first lumen, said valve permitting selective connection of the fluid sources to the proximal end of the first lumen;

a first fluid connection connecting the first fluid reservoir to the valve;

a second fluid connection connecting the second fluid reservoir to the valve;

a first actuator for forcing fluid from the first fluid reservoir through the valve and into the first lumen;

a second actuator operably connected to the second fluid reservoir for forcing fluid from the second fluid reservoir through the valve and into the first lumen; and

a penetrating needle disposed on the distal tip of the first lumen, said penetrating needle adapted to penetrate the heart wall.

15. The device of claim 14 wherein the first fluid connection comprises a length of distensible tubing.

16. The device of claim 14 further comprising:

a second lumen extending from the housing to the distal end of the catheter, and a third fluid connection in fluid communication with the proximal end of second lumen and adapted for connection to a fluid source, and a fluid port in the catheter at the distal end of the catheter providing a fluid pathway between the second lumen and the exterior of the catheter.

17. A method of injecting therapeutic agents in to the body, said method comprising:

providing a drug delivery catheter for injection small doses of therapeutic agent into the body, said drug delivery catheter comprising;

a catheter tube adapted for percutaneous insertion into the heart, said catheter having a distal end adapted for insertion in to the heart and a proximal end housed within a housing;

a first lumen extending through the catheter, said lumen having a distal end adapted for fluid injection into the heart and a proximal end adapted for connection to one or more fluid reservoirs;

a first fluid reservoir releasably secured within the housing;

a second fluid reservoir releasably secured within the housing;

a valve communicating with the proximal end of the first lumen, said valve permitting selective connection of the fluid sources to the proximal end of the first lumen;

a first fluid connection connecting the first fluid reservoir to the valve;

a second fluid connection connecting the second fluid reservoir to the valve;

a first actuator for forcing fluid from the first fluid reservoir through the valve and into the first lumen;

a second actuator operably connected to the second fluid reservoir for forcing fluid from the second fluid reservoir through the valve and into the first lumen;

placing a first fluid in the first fluid reservoir;

placing a second fluid in the second fluid reservoir;

forcing a predetermined volume of the first fluid from the first fluid reservoir into the first lumen; and

forcing a volume of the second fluid from the second fluid reservoir into the first lumen.

18. The method of claim 17 wherein;

the step of forcing a volume of second fluid from the second fluid reservoir into the first lumen precedes the step of forcing a predetermined volume of the first fluid from the first fluid reservoir into the first lumen.

19. The method of claim 17 wherein;

the step of forcing a volume of second fluid from the second fluid reservoir into the first lumen is repeated after the step of forcing a predetermined volume of the first fluid from the first fluid reservoir into the first lumen.

20. The method of claim 17 further comprising:

providing a therapeutic agent in the first fluid;

providing a passive agent in the second fluid.

21. The method of claim 17 further comprising:

providing a therapeutic agent in the first fluid;

providing an activating agent in the second fluid, wherein said activating agent interacts with the first fluid to alter the first fluid.

22. The method of claim 17 further comprising:

providing a therapeutic agent in the first fluid, wherein said therapeutic agent comprises a therapeutic compound encapsulated in a liposome capsule;

providing an activating agent in the second fluid, wherein said activating fluid has a pH which destabilizes the liposome capsules in the first fluid.

23. A drug delivery catheter for injection of small doses of a therapeutic agent into the heart wall, said drug delivery catheter comprising:

a catheter tube adapted for insertion into the heart, said catheter having a distal end adapted for insertion into the heart and a proximal end housed within a housing;

a first lumen extending through the catheter, said lumen having a distal end adapted for fluid injection into the heart through a fixating penetrating element, said fixating penetrating element having a base, and a proximal end connected to a first at least one fluid reservoir; and

a second lumen extending through the catheter, said second lumen having a proximal end connected to a second at least one fluid reservoir, and said lumen having a distal end terminating at the base of a fixating penetrating element.

24. A catheter as in claim 23 where the fixating penetrating element is a hollow helix.