Method and apparatus for delivery of therapeutic agents
First Claim
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1. A method for the intracellular delivery of a therapeutic agent to a predetermined tissue site within a patient comprising the steps of:
- providing an injection needle comprising an injection orifice having a penetration depth controllable by a depth controller and controllable independently from and relative to the penetration depth of a plurality of penetrating electrodes;
inserting the plurality of penetrating electrodes in tissue of the patient to substantially encompass said predetermined tissue site;
contacting said patient with the injection orifice of the injection needle wherein the penetration depth of the orifice is such that said injection orifice is located within the tissue region bounded by said electrodes;
administering the therapeutic agent through said orifice such that the agent is distributed within said predetermined tissue site encompassed by said electrodes; and
applying an electrical signal to at least two of said electrodes such that the resulting electric field propagation in said predetermined tissue site is of sufficient magnitude and duration to increase the intracellular uptake of said therapeutic agent.
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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.
43 Citations
38 Claims
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1. A method for the intracellular delivery of a therapeutic agent to a predetermined tissue site within a patient comprising the steps of:
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providing an injection needle comprising an injection orifice having a penetration depth controllable by a depth controller and controllable independently from and relative to the penetration depth of a plurality of penetrating electrodes; inserting the plurality of penetrating electrodes in tissue of the patient to substantially encompass said predetermined tissue site; contacting said patient with the injection orifice of the injection needle wherein the penetration depth of the orifice is such that said injection orifice is located within the tissue region bounded by said electrodes; administering the therapeutic agent through said orifice such that the agent is distributed within said predetermined tissue site encompassed by said electrodes; and applying an electrical signal to at least two of said electrodes such that the resulting electric field propagation in said predetermined tissue site is of sufficient magnitude and duration to increase the intracellular uptake of said therapeutic agent. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A method for the intracellular delivery of a therapeutic agent to a predetermined tissue site within a patient comprising the steps of:
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inserting a plurality of penetrating electrodes in the tissue of the patient to substantially encompass the predetermined tissue site; providing an injection needle comprising an injection orifice, wherein the tip of said injection needle is proximal to the tip of said electrodes; contacting said patient with the injection orifice of the injection needle; administering the therapeutic agent through said orifice to said predetermined tissue site encompassed by said electrodes wherein the depth of insertion of the orifice is such that said injection orifice is located within the tissue region bounded by said electrodes, and wherein the rate of agent administration is controlled by a controlled source of energy; applying an electrical signal to at least two of said electrodes such that the resulting electric field propagation in said predetermined tissue site is of sufficient magnitude and duration to increase the intracellular uptake of said therapeutic agent. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. A method for the intracellular delivery of a therapeutic agent to a predetermined tissue site within a patient comprising the steps of:
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contacting said patient with an injection orifice of an injection needle of a first device; administering the therapeutic agent to said patient through said orifice such that the agent is distributed within the predetermined tissue site; contacting said patient with a second device that houses the plurality of electrodes in a retracted state such that the electrodes are not visible to the patient; deploying said plurality of electrodes from their retracted state into the tissue of said patient so as to substantially encompass said predetermined tissue site; applying an electrical signal to at least two of said electrodes such that the resulting electric field propagation in said predetermined tissue site is of sufficient magnitude and duration to increase the intracellular uptake of said therapeutic agent. - View Dependent Claims (20, 21, 22, 23, 24, 25, 26, 27, 28)
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29. A method for the intracellular delivery of a therapeutic agent to a predetermined tissue site within a patient comprising the steps of:
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contacting said patient with a device that houses an injection needle that comprises an injection orifice, and houses a plurality of electrodes in a retracted state such that the electrodes are not visible to the patient, and wherein the tip of said injection needle is proximal to the tip of said electrodes; deploying said plurality of electrodes from their retracted state into the tissue of said patient to substantially encompass said predetermined tissue site; administering the therapeutic agent through said orifice wherein the depth of insertion of the orifice is such that said orifice is located within the tissue region bounded by said electrodes, and such that the agent is distributed within said predetermined tissue site; applying an electrical signal to at least two of said electrodes such that the resulting electric field propagation in said predetermined tissue site is of sufficient magnitude and duration to increase the intracellular uptake of said therapeutic agent, wherein the rate of agent administration is controlled by a controlled source of energy. - View Dependent Claims (30, 31, 32, 33, 34, 35, 36, 37, 38)
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Specification