Method and apparatus for delivery of therapeutic agents

• US 6,912,417 B1
• Filed: 04/05/2002
• Issued: 06/28/2005
• Est. Priority Date: 04/05/2002
• Status: Active Grant

• Current Assignee: Ichor Medical Systems, Inc.
• Original Assignee: Ichor Medical Systems, Inc.
• Inventors: Bernard, Brady M., Bernard, Robert M., Hannaman, Andrew W.
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US10/117,457
• Time in Patent Office: 1,180 Days
• Field of Search: 604/890.1, 604/891.1, 604 68- 72, 604/131, 604134-137, 604/140, 604/141, 604143-147, 604149-157, 604/20, 604/21, 604/205, 604/187, 604/501, 4351735-1737, 204/450, 607/115, 607/116, 607/120
• US Class Current: 604/20
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/2053 Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• CPC Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body

Abstract

Methods and apparatus for the reproducible, consistent and efficacious delivery of a therapeutic agent to a patient. The invention comprises means for the controlled administration of the therapeutic agent through an orifice to the patient, a plurality of penetrating electrodes arranged with a predetermined spatial relationship relative to the orifice, and means for generating an electrical signal operatively connected to the electrodes.

Claims

1. An apparatus for the intracellular delivery of a therapeutic agent to a predetermined site within the tissue of a patient comprising:

means for the administration of said therapeutic agent to said patient comprising a reservoir for the therapeutic agent, at least one orifice through which the agent is administered, and an inanimate source of energy sufficient to transfer a predetermined amount of the therapeutic agent from said reservoir through said orifice to the predetermined site within the tissue of the patient;

a plurality of penetrating electrodes arranged with a predetermined spatial relationship relative to said orifice; and

means configured for generating an electrical field which facilitates the intracellular delivery of said therapeutic agent said means operatively connected to said electrodes.

2. The apparatus as recited in claim 1 wherein the electrodes comprise a subassembly that can be separated from the orifice.

3. The apparatus as recited in claim 1 further comprising means for adjusting the predetermined spatial relationship between said electrodes and said orifice.

4. The apparatus as recited in claim 3 wherein said means for adjusting the spatial relationship comprises a source of energy.

5. The apparatus as recited in claim 1 wherein the electrodes comprise a conductive, electrochemically stable compound.

6. The apparatus as recited in claim 1 wherein the electrodes comprise a conductive metal coated with a conductive, electrochemically stable compound.

7. The apparatus as recited in claim 5 wherein said conductive, electrochemically stable compound consists of at least one of the following materials:

titanium nitride, platinum, platinum iridium, iridium oxide.

8. The apparatus as recited in claim 1 wherein the means for administration of the therapeutic agent is a jet injector.

9. The apparatus as recited in claim 8 wherein the source of energy to transfer the therapeutic agent is at least one compressed gas.

10. The apparatus as recited in claim 8 wherein the source of energy to transfer the therapeutic agent is at least one spring.

11. The apparatus as recited in claim 8 wherein the jet injector comprises means for controlling the rate at which the agent is transferred through the orifice.

12. The apparatus as recited in claim 1 wherein the means for administration of the therapeutic agent is an automatic injection device.

13. The apparatus as recited in claim 12 wherein said reservoir is a syringe including a penetrating hypodermic needle.

14. The apparatus as recited in claim 12 wherein the source of energy to transfer the therapeutic agent is at least one compressed gas.

15. The apparatus as recited in claim 12 wherein the source of energy to transfer the therapeutic agent is at least one spring.

16. The apparatus as recited in claim 13 wherein the automatic injection device comprises means for controlling the depth of penetration of said needle into the patient.

17. The apparatus as recited in claim 12 wherein the automatic injection device comprises means for controlling the rate at which the agent is transferred through the orifice.

18. The apparatus as recited in claim 6 wherein said conductive, electrochemically stable compound consists of at least one of the following materials:

titanium nitride, platinum, platinum iridium, iridium oxide.

19. The apparatus as recited in claim 1 wherein the means for generating an electrical field is configured to induce an electrical field of from approximately 50 to approximately 300 V/cm between at least two of said electrodes.

20. The apparatus as recited in claim 1 wherein die means for generating an electrical field is configured to deliver a signal for a duration of from approximately 1 microsecond to approximately 100 milliseconds and at a frequency of from approximately 0.1 Hertz to approximately 1 megahertz to at least two of said electrodes.