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

• US 6,547,787 B1
• Filed: 10/13/1999
• Issued: 04/15/2003
• Est. Priority Date: 03/13/1997
• Status: Expired due to Term

• Current Assignee: BioCardia, Inc
• Original Assignee: BioCardia, Inc
• Inventors: Hakem, Brian, Altman, Peter A.
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): MANTIS MERCADER, ELENI M
• Application Number:
  US09/418,206
• Time in Patent Office: 1,280 Days
• Field of Search: 606/41, 606/47, 606/85, 606/48, 606/44, 600/374, 600/508, 600/424, 607/3, 607/120-122, 607/126-128, 607/60-61, 607/32-33
• 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: A61N 1/0575 with drug delivery

Abstract

A drug delivery catheter suited for cardiac procedures including transmyocardial revascularization. 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 created several helical wounds in the myocardium, and also inject small doses of therapeutic agents to the wounds. The TMR accomplished by the procedure provides for large wound to penetration ratio, and limits the potential of perforating the heart wall.

Claims

1. A method of treating a human heart by performing transmyocardial revascularization and penetrating the heart wall, said method comprising:

providing a catheter having a distal end adapted for percutaneous insertion into the patient'"'"'s body and further manipulation into the heart of the patient;

providing a helical penetrating structure on the distal tip of the catheter;

inserting the distal end of the catheter into the endocardial space of the heart; and

penetrating the heart wall with the helical penetrating structure at a plurality of sites on the heart wall.

2. The method of claim 1 further comprising:

providing a fluid delivery lumen in the helical penetrating structure and a fluid delivery lumen in the catheter communicating from the proximal end of the catheter to the fluid delivery lumen of the helical penetrating structure;

delivering a contrast agent through the fluid delivery lumen of the catheter and the fluid delivery lumen of the helical penetrating structure into the heart wall;

confirming that the helical penetrating structure has been screwed into the heart wall to a desired depth by viewing the heart under fluoroscopy;

delivering therapeutic agent through the fluid delivery lumen of the catheter and the fluid delivery lumen of the helical penetrating structure into the heart wall.

3. The method of claim 2 further comprising:

repeating the steps of penetrating the heart wall, injecting contrast agent through the fluid delivery lumen, and removing the helical penetrating element from the heart wall;

prior to each repetition of the penetrating step in a subsequent penetration site, viewing the heart under fluoroscopy and identifying prior penetration sites and sites not yet penetrated to assist in selection of the subsequent penetration site.

4. A method of treating a human heart by performing transmyocardial revascularization and penetrating the heart wall, said method comprising:

providing a catheter having a distal end adapted for percutaneous insertion into the patient'"'"'s body and further manipulation into the heart of the patient;

providing a helical penetrating structure on the distal tip of the catheter;

inserting the distal end of the catheter into the endocardial space of the heart; and

penetrating the heart wall with the helical penetrating element by manipulating the helical penetrating element to engage the heart wall and rotating the helical penetrating element to screw it into the heart wall.

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

repeatedly manipulating the helical penetrating element to engage the heart wall and rotating the helical penetrating element to screw it into the heart wall, and removing the helical penetrating element from the heart wall until a region of the heart wall has been wounded with helical wounds from the helical penetrating element.

7. The method of claim 4 further comprising:

providing a fluid delivery lumen in the helical penetrating structure and a fluid delivery lumen in the catheter communicating from the proximal end of the catheter to the fluid delivery lumen of the helical penetrating structure;

delivering a therapeutic agent through the fluid delivery lumen of the catheter and the fluid delivery lumen of the helical penetrating structure into the heart wall.

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

maintaining the helical penetrating structure screwed into the heart wall after delivery of therapeutic agent through the helical penetrating structure for a time sufficient to impede outflow of therapeutic agent from the helical wound caused by penetration of the helical penetrating structure after removal of the helical penetrating structure.

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

repeatedly manipulating the helical penetrating element to engage the heart wall and rotating the helical penetrating element to screw it into the heart wall, and removing the helical penetrating element from the heart wall until a region of the heart wall has been wounded with helical wounds from the helical penetrating element.

10. The method of claim 4 further comprising:

providing a fluid delivery lumen in the helical penetrating structure and a fluid delivery lumen in the catheter communicating from the proximal end of the catheter to the fluid delivery lumen of the helical penetrating structure;

delivering a contrast agent through the fluid delivery lumen of the catheter and the fluid delivery lumen of the helical penetrating structure into the heart wall;

confirming that the helical penetrating structure has been screwed into the heart wall to a desired depth by viewing the heart under fluoroscopy;

delivering therapeutic agent through the fluid delivery lumen of the catheter and the fluid delivery lumen of the helical penetrating structure into the heart wall.

11. The method of claim 10 further comprising:

repeating the steps of penetrating the heart wall by manipulating the helical penetrating element to engage the heart wall and rotating the helical penetrating element to screw it into the heart wall, injecting contrast agent through the fluid delivery lumen, and removing the helical penetrating element from the heart wall;

prior to each repetition of the penetrating step in a subsequent penetration site, viewing the heart under fluoroscopy and identifying prior penetration sites and sites not yet penetrated to assist in selection of the subsequent penetration site.

6. The method of clay further comprising:

screwing the helical penetrating structure into the heart to advanced the helical penetrating structure from about 4 to about 50 turns into the heart wall.