Directional needle injection drug delivery device and method of use

• US 20030233065A1
• Filed: 03/17/2003
• Published: 12/18/2003
• Est. Priority Date: 10/26/2000
• Status: Active Grant

• Current Assignee: Jeffrey Steward, Mina Chow
• Original Assignee: Jeffrey Steward, Mina Chow
• Inventors: Chow, Mina, Steward, Jeffrey
• Granted Patent: US 7,179,249 B2
• Time in Patent Office: Days
• US Class Current: 604/22
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61M 2025/009 the needle having a bent tip, i.e. the needle distal tip is angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis

Abstract

The invention relates to an apparatus and method for imaging and mapping various structures located at a target area within a patient'"'"'s lumen using conventional IVUS technology. The mapped images are used to accurately determine and control the location of the device within the lumen relative to the target area and/or target site. Once the drug delivery device is properly positioned within the lumen, additional ultrasonic images are generated and used to control the position and depth of penetration of a retractable needle of the device. Needle position can be precisely determined, both in relationship to the device as well as the target site for drug delivery. This allows accurate delivery of drug to the target site and, thus, enhanced treatment capabilities.

Claims

1. A device for delivering a drug directly to a target site comprising:

an elongate body surrounding an inner lumen and a needle lumen, whereby said inner lumen surrounds a retractable ultrasonic element;

a retractable needle housed within said needle lumen; and

an intravascular ultrasound (IVUS) system connected to a proximal end of said retractable ultrasonic element.

2. The drug delivery device of claim 1 further comprising an inflatable balloon having a proximal end attached to a distal end of said inner lumen and a distal end of said inflatable balloon attached to a distal end of said inner member.

3. The drug delivery device of claim 1 further comprising a movable guide wire.

4. The drug delivery device of claim 3 further comprising:

a guide wire lumen and an ultrasonic element lumen contained within said inner member, whereby said movable guide wire is housed within said guide wire lumen and said retractable ultrasonic element is housed within said ultrasonic element lumen.

5. The drug delivery device of claim 2 wherein a fluid flows through said inner lumen to inflate and/or deflate said balloon.

6. The drug delivery device of claim 3 further comprising:

an inner member contained within said inner lumen, whereby said inner member houses said guide wire and said ultrasonic element; and

a fluid lumen contained within said inner lumen.

7. The drug delivery device of claim 1 wherein said retractable ultrasonic element further comprises an ultrasound transducer and a co-axial cable.

8. The drug delivery device of claim 7 wherein said ultrasound transducer consists of a piezoelectric crystal having a front surface coated with a conductive material and a backing material partially surrounding said crystal.

9. The drug delivery device of claim 8 wherein said backing material rapidly reduces piezoelectric oscillations.

10. The drug delivery device of claim 8 wherein said ultrasound transducer is covered in a paralyene coating.

11. The drug delivery device of claim 8 wherein said paralyene coating is a quarter wave matching layer that couples ultrasonic energy out and rapidly reduces piezoelectric oscillations.

12. A method of delivering a drug directly to a target site comprising:

positioning a retractable ultrasonic element of a drug delivery device at said target area in a lumen;

generating a real-time image of said target area using said retractable ultrasonic element and an IVUS system;

determining a location of said target site from said image;

locating said drug delivery device at said target site, whereby a balloon of said drug delivery device is inflated to fixedly secure said device at said target site;

extending a retractable needle of said drug delivery device so that said needle penetrates said target site;

tracking said needle movement and depth of penetration into said target site using said retractable ultrasonic element and said IVUS system; and

extending said retractable needle a predetermined depth into said target site for dispensing drug directly to said target site.

13. The method of claim 12 wherein said act of generating a real-time image of said target area comprises locating said retractable ultrasonic element distal to said target area and slowly moving said element in a proximal direction so that approximately hundreds of cross-sectional images are generated and then stacked in real time using said IVUS system.

14. The method of claim 12 wherein said act of generating a real-time image of said target area comprises locating said retractable ultrasonic element proximal to said target area and slowly moving said element in a distal direction so that approximately hundreds of cross-sectional images are generated and then stacked in real time using said IVUS system.

15. The method of claim 12 wherein said act of locating said drug delivery device at said target site comprises mapping an inner surface of said target area adjacent to said balloon and mapping a position of said retractable needle using said retractable ultrasound element and said IVUS system.

16. The method of claim 12 wherein said act of tracking said needle movement and depth of penetration into said target site comprises repeatedly pushing and/or pulling said ultrasonic element across said target area to obtain numerous detailed images that are displayed on said IVUS system.

17. The method of claim 12 whereby said image is a two-dimensional cross-sectional image.

18. The method of claim 12 whereby said image is a three-dimensional longitudinal view.