Method for delivery of therapeutic agents to the heart

• US 6,152,141 A
• Filed: 12/08/1997
• Issued: 11/28/2000
• Est. Priority Date: 07/28/1994
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Brewer, Richard B., Gifford, Hanson S. III, Stevens, John H., Rosenman, Daniel C.
• Primary Examiner(s): Millin, V.
• Assistant Examiner(s): O'Hara, Kelly
• Application Number:
  US08/986,917
• Time in Patent Office: 1,086 Days
• Field of Search: 128/898, 604/4-6, 604/500, 604/101, 604/102, 604/280, 604/95, 604/69, 606/16, 606/17, 606/18
• US Class Current: 128/898
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00261 arranged in a line
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/0078 for fluid inflow from the body into the catheter lumen
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/1077 having a system for expelling the air out of the balloon before inflation and use
• CPC Class Codes: A61M 2205/11 with means for preventing cross-contamination when used for multiple patients
• CPC Class Codes: A61M 2205/366 by liquid heat exchangers
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0041 : pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0125 : Catheters carried by the bloodstream, e.g. with parachutes; Balloon catheters specially designed for this purpose
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 : used for angioplasty

Abstract

A method for delivering a therapeutic agent directly to the heart employing minimally invasive techniques and concepts. In particular, the delivery of vascular endothelial growth factors (VEGF) is performed endovascularly or endoscopically to a region of a patient'"'"'s heart treated with transmyocardial revascularization (TMR). A system is provided for inducing cardioplegic arrest. An aortic occlusion device has an inflatable balloon which occludes the ascending aorta when inflated. Cardioplegic fluid may be infused through a lumen of the aortic occlusion device to stop the heart while the patient'"'"'s circulatory system is supported on cardiopulmonary bypass. A side-firing fiberoptic laser is introduced through the aortic occlusion device in the endovascular technique to perform TMR. Subsequently, a therapeutic agent delivery catheter is directed into one of the coronary arteries to deliver and dissipate the VEGF into the surrounding vascular plexus to promote angiogenesis stimulation. Alternatively, a therapeutic agent delivery material saturated or coated with VEGF could be sutured to the epicardial surface of the heart, using thoracoscopic techniques, for timed release delivery of the agent to the TMR treated site.

Claims

1. A method for delivering a therapeutic agent to the heart of a patient comprising the steps of:

placing an aortic occlusion device in a location within a patient'"'"'s ascending aorta, the aortic occlusion device having an occluding member and a lumen extending therethrough having an outlet in fluid communication with the patient'"'"'s ascending aorta;

expanding said occluding member within the patient'"'"'s ascending aorta to occlude the ascending aorta;

infusing a cardioplegic agent into a coronary vasculature of said patient to arrest the patient'"'"'s heart;

maintaining circulation of oxygenated blood in the patient while the patient'"'"'s heart is arrested; and

delivering a therapeutic agent into the coronary vasculature through the aortic occlusion device.

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

advancing a laser catheter through the aortic occlusion device;

positioning the laser catheter in the patient'"'"'s heart; and

performing a transmyocardial revascularization with the laser catheter.

3. The method of claim 1 wherein,

said agent includes vascular endothelial growth factors.

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

delivering a stent through the aortic occlusion device.

5. The method of claim 4 wherein,

the stent includes vascular endothelial growth factors and a fibrin based glue.

6. The method of claim 1 wherein,

said delivering step is performed by:

passing a distal end of a needle sheath through said lumen of said elongated aortic catheter;

passing a needle of an injection catheter through a lumen of said needle sheath; and

piercing the coronary artery wall with the needle upon advancement thereof through an opening in the needle sheath into the coronary artery; and

injecting the agent through the needle.

7. The method of claim 1 further comprising the step of:

occluding the patient'"'"'s superior vena cava and inferior vena cava to substantially isolate the delivery of the agent to the patient'"'"'s heart and prevent systemic circulation thereof.

8. The method of claim 1 further comprising the step of:

withdrawing the agent from the coronary vasculature through a coronary sinus catheter;

occluding the patient'"'"'s coronary sinus with the coronary sinus catheter.

9. The method of claim 1 wherein said delivering step is performed by:

passing a distal end of a catheter through said lumen of said aortic occlusion device, said catheter having an expandable member at the distal end of thereof,

expanding the expandable member to radially expand a flexible infusion array, coupled therearound, against the coronary artery interior wall; and

infusing the agent into the coronary artery interior wall through a plurality of orifices in the infusion array while the infusion array remains in contact with the coronary artery interior wall.