Method and apparatus for delivery of therapeutic agents
First Claim
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1. A method for intracellular delivery of a therapeutic agent to predetermined tissue site within a patient comprising the steps of:
- a. providing an apparatus comprising (i) a main unit comprising at least one injection needle comprising at least one injection orifice, (ii) a sub-assembly unit comprising a plurality of penetrating electrodes, and (iii) an electrical field generator operatively connected to said plurality of penetrating electrodes which provides an electric signal to facilitate the intracellular delivery of said therapeutic agent, and increases intracellular uptake of said therapeutic agent;
wherein a first penetration depth of said plurality of penetrating electrodes is such that said plurality of penetrating electrodes are located within tissue of said patient to encompass said predetermined tissue site, and a second penetration depth of the at least one injection orifice is such that said at least one injection orifice is located within tissue region bounded by said plurality of penetrating electrodes;
wherein the second penetration depth is controllable by a depth controller and controllable independently from and relative to the first penetration depth of the plurality of penetrating electrodes; and
wherein said sub-assembly unit is removably attached to said main unit;
b. inserting said plurality of penetrating electrodes in the tissue of said patient to substantially encompass said predetermined tissue site;
c. contacting said patient with the at least one injection orifice of said at least one injection needle;
d. administering the therapeutic agent through said at least one injection orifice such that the therapeutic agent is distributed within said predetermined tissue site encompassed by said plurality of penetrating electrodes; and
e. applying the electrical signal to at least two of said plurality of penetrating electrodes such that 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.
59 Citations
20 Claims
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1. A method for intracellular delivery of a therapeutic agent to predetermined tissue site within a patient comprising the steps of:
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a. providing an apparatus comprising (i) a main unit comprising at least one injection needle comprising at least one injection orifice, (ii) a sub-assembly unit comprising a plurality of penetrating electrodes, and (iii) an electrical field generator operatively connected to said plurality of penetrating electrodes which provides an electric signal to facilitate the intracellular delivery of said therapeutic agent, and increases intracellular uptake of said therapeutic agent; wherein a first penetration depth of said plurality of penetrating electrodes is such that said plurality of penetrating electrodes are located within tissue of said patient to encompass said predetermined tissue site, and a second penetration depth of the at least one injection orifice is such that said at least one injection orifice is located within tissue region bounded by said plurality of penetrating electrodes; wherein the second penetration depth is controllable by a depth controller and controllable independently from and relative to the first penetration depth of the plurality of penetrating electrodes; and wherein said sub-assembly unit is removably attached to said main unit; b. inserting said plurality of penetrating electrodes in the tissue of said patient to substantially encompass said predetermined tissue site; c. contacting said patient with the at least one injection orifice of said at least one injection needle; d. administering the therapeutic agent through said at least one injection orifice such that the therapeutic agent is distributed within said predetermined tissue site encompassed by said plurality of penetrating electrodes; and e. applying the electrical signal to at least two of said plurality of penetrating electrodes such that 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 intracellular delivery of a therapeutic agent to predetermined tissue site within a patient comprising the steps of:
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a. providing an apparatus comprising (i) a main unit comprising at least one injection needle comprising at least one injection orifice, (ii) a sub-assembly unit comprising a plurality of penetrating electrodes, and (iii) an electrical field generator operatively connected to said plurality of penetrating electrodes which provides an electric signal to facilitate the intracellular delivery of said therapeutic agent, and increases the intracellular uptake of said therapeutic agent; wherein a first tip of said at least one injection needle is proximal to a second tip of said plurality of penetrating electrodes; wherein a penetration depth of the at least one injection orifice is such that said at least one injection orifice is located within tissue region bound by said plurality of penetrating electrodes; and wherein said sub-assembly unit is attachable to said main unit; b. inserting said plurality of penetrating electrodes in tissue of said patient to substantially encompass said predetermined tissue site; c. contacting said patient with at least one of the at least one injection orifice of the at least one injection needle; d. administering the therapeutic agent through at least one of said at least one injection orifice such that the agent is distributed within said predetermined tissue site encompassed by said electrodes; and e. applying the electrical signal to at least two of said plurality of penetrating electrodes such that 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)
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17. A method for intracellular delivery of a therapeutic agent to predetermined tissue site within a patient comprising the steps of:
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a. providing an apparatus comprising (i) a main unit comprising at least one injection needle comprising at least one injection orifice, (ii) a sub-assembly unit comprising a plurality of penetrating electrodes in a retracted state such that the plurality of penetrating electrodes are not visible to the patient, and (iii) an electrical field generator operatively connected to said plurality of penetrating electrodes which provides an electric signal to facilitate the intracellular delivery of said therapeutic agent, and increases intracellular uptake of said therapeutic agent; wherein said sub-assembly unit is removably attached to said main unit; b. contacting said patient with the at least one injection orifice of the at least one injection needle wherein a penetration depth of the at least one injection orifice is such that said at least one injection orifice is located within the tissue region bounded by said plurality of penetrating electrodes; c. administering the therapeutic agent through said at least one injection orifice such that the agent is distributed within said predetermined tissue site encompassed by said plurality of penetrating electrodes; and d. deploying said plurality of electrodes from their retracted state into tissue of said patient so as to substantially encompass said predetermined tissue site; and e. applying an electrical signal to at least two of said plurality of penetrating 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 (18, 19, 20)
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Specification