Therapeutic and diagnostic agent delivery

• US 5,840,059 A
• Filed: 06/07/1995
• Issued: 11/24/1998
• Est. Priority Date: 06/07/1995
• Status: Expired due to Term

• Current Assignee: ADVANCED RESEARCH & TECHNOLOGY INSTITUTE, Columbia University, Cryolife Incorporated
• Original Assignee: Columbia University, Cardiogenesis Corporation (Cryolife Incorporated), Indiana University Foundation
• Inventors: Smith, Craig, Kesten, Randy, March, Keith L., Aita, Michael
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): BLYVEIS, DEBORAH
• Application Number:
  US08/483,512
• Time in Patent Office: 1,266 Days
• Field of Search: 604/96-103, 604/49, 604/28, 604/51-53, 604/22, 606/7, 606/15, 606/45, 606/192, 606/194, 607/89, 607/119, 607/120, 607/122
• US Class Current: 604/509
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04

Abstract

A system for treating a patient'"'"'s heart which comprises a means to form channels in the heart wall and a means to deliver a therapeutic or diagnostic agent into the channels. Additionally, the system may comprise a way to retain the agent within the channels for a useful period of time. The system may be configured to be introduced percutaneously or intraoperatively. The system generally comprises an elongated, flexible lasing transmission catheter that emits laser radiation and has delivery lumen opening at the distal end. Practice of the invention comprises forming channels in the heart wall and delivering a therapeutic or diagnostic agent into the channel. Gene therapy agents of this invention comprise vectors for transferring genetic information to the heart tissue in vivo or harvested cells which have been genetically engineered in vitro. Additionally, the invention may comprise retaining the agent within the channels, for example, by incorporating the agent in a viscous carrier.

Claims

1. A method for treating a patient'"'"'s heart comprising the steps of:

a) providing a tissue ablation means to form a channel within a wall of the patient'"'"'s heart which includes a myocardial layer and means to deliver a therapeutic or diagnostic agent into a channel formed by the channel forming means;

b) positioning the channel forming means against a desired region of the heart wall;

c) activating the channel forming means to form a channel in the wall of the patient'"'"'s heart;

d) withdrawing at least in part the channel forming means from the thus formed channel,

e) delivering the agent into the channel.

2. The method of claim 1, wherein the step of positioning the channel forming means comprises advancing the channel forming means intravascularly to the patient'"'"'s left ventricle.

3. The method of claim 2, further comprising the step of retaining the agent within a channel.

4. The method of claim 3, wherein an inflatable occlusion means on a distal portion of a delivery catheter is inserted into the channel and inflated to retain the agent.

5. The method of claim 1, wherein the step of positioning the channel forming means comprises advancing the channel forming means through the patient'"'"'s chest.

6. A system for treating a patient'"'"'s heart, comprising:

a) an elongated laser radiation transmitting and emitting means to form a channel within a wall of the patient'"'"'s heart which includes a myocardial layer; and

b) catheter means to deliver a therapeutic or diagnostic agent into a channel formed by the channel forming means which is disposed about the elongated laser radiation transmitting and emitting means and which has a distal end configured to fit into the channel formed in the wall of the patient'"'"'s heart.

7. A system for treating a patient'"'"'s heart, comprising:

a) ablation means to form a channel within a wall of the patient'"'"'s heart which includes a myocardial layer;

b) means to deliver a therapeutic or diagnostic agent into a channel formed by the ablation means, including a catheter which has a distal end configured to fit within the channel formed by the ablation means, which has a delivery opening in the distal end and which has a lumen extending therein to the delivery opening at the distal end into which the ablation means is disposed; and

c) means to increase the retention of the therapeutic or diagnostic agent within the channel.