Injection devices that provide reduced outflow of therapeutic agents and methods of delivering therapeutic agents

• US 20040030282A1
• Filed: 08/09/2002
• Published: 02/12/2004
• Est. Priority Date: 08/09/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Naimark, Wendy, Freyman, Toby, Epstein, Samuel J., Mickley, Tim
• Granted Patent: US 7,070,582 B2
• Time in Patent Office: Days
• US Class Current: 604/44
• CPC Class Codes: A61M 5/1582 Double lumen needles

Abstract

Injection devices are provided, which reduce potential outflow of therapeutic agents from an injection site. Devices are provided having at least a first lumen containing one or more therapeutic agents and a second lumen containing a second material for injection into tissue. Other devices are provided having an inner lumen with an injection needle to inject a therapeutic agent and an outer lumen that provides a vacuum seal between the injection needle and the needle track. Further provided are methods of delivering a therapeutic agent to tissue.

Claims

1. An injection device comprising:

a first lumen containing at least one therapeutic agent for injection into a tissue; and

a second lumen containing at least one second material for injection into the tissue;

wherein the injection device is adapted such that the depth and deployment of each lumen to the tissue is controlled independently from one another.

2. The device of claim 1, wherein the first lumen is within the second lumen.

3. The device of claim 1, wherein the first lumen is adjacent to the second lumen.

4. The device of claim 1, further comprising:

a third lumen containing a third material for injection into the tissue.

5. An injection device comprising:

an injection needle at a distal end of an inner lumen, adapted to inject at least one therapeutic agent into tissue;

an outer lumen adapted to provide a vacuum seal between the injection needle and a needle track in tissue formed with the injection needle; and

a vacuum-creating device for creating a vacuum in the outer lumen.

6. The device of claim 5, further comprising:

at least one compliant gasket having a shape and size such that when the gasket is situated between the injection needle and the needle track and a vacuum is created in the outer lumen by the vacuum-creating device, the vacuum pulls tissue from the needle track against the gaskets, substantially preventing the therapeutic agent from flowing out of the needle track.

7. The device of claim 5, wherein

walls of the outer lumen form a tube having a tapered distal end and

at least one gasket is attached to an outside wall of the inner lumen.

8. An injection device comprising:

an inner lumen adapted to inject a therapeutic agent into tissue, wherein walls of the inner lumen form a tube having a tapered distal end;

an outer lumen adapted to provide a vacuum seal between the injection needle and a needle track in tissue formed with the inner lumen, wherein walls of the outer lumen form a tube having a tapered distal end; and

a vacuum-creating device adapted to create a vacuum in the outer lumen;

wherein the outer lumen is shorter than the inner lumen, such that a distal end of the walls of the outer lumen is from about 0.1 mm to about 20 mm from the tapered distal end of a tube formed by the walls of the inner lumen; and

wherein at least one compliant gasket is attached to an outside wall of the inner lumen.

9. The device of claim 8, wherein a proximal end of the at least one gasket is from about 1 mm to about 5 mm from the distal end of the outer lumen and a distal end of the at least one gasket essentially corresponds with the tapered end of the tube formed by the walls of the inner lumen.

10. The device of claim 8, further comprising:

a handle having a port for a vacuum creating device, and

a pressure gauge that indicates vacuum level within the outer lumen.

11. The device of claim 10, wherein the port comprises a valve that substantially maintains a desired vacuum level.

12. The device of claim 8, wherein the vacuum creating device is selected from the group consisting of a plunger, a vacuum pump and a syringe.

13. An injection device comprising:

an injection needle at a distal end of an inner lumen, adapted to inject at least one therapeutic agent into tissue; and

at least one compliant gasket having a shape and size such that when the gasket is situated between the injection needle and a needle track formed in tissue with the injection needle, a sufficient seal is formed between the needle and the needle track that when therapeutic agent is injected into tissue, the gasket reduces outflow from the needle track of therapeutic agent.