Method and device for enhanced delivery of a biologically active agent through the spinal spaces into the central nervous system of a mammal
First Claim
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1. A method for enhanced and controlled delivery of a biologically active agent into the spinal structures and/or the brain of a mammal, particularly a human being that circumvents the blood brain barrier, which includes the steps of:
- providing an agent drug delivery device via catheter to the epidural space of the mammal and positioning said device within the epidural space, advancing a donor iontophoresis electrode into the epidural space of the mammal, applying a second electrode or receptor iontophoresis electrode that is constructed and arranged to be positioned at a determined internal or external position of the mammal'"'"'s body but in complementary energy gradient positioning to the first electrode, providing a potential gradient so that delivery of the biologically active agent is accomplished in a direction from said first electrode means directly into the spinal structures and/or the brain thereby essentially bypassing the blood brain barrier of the mammal; and
thereby, delivering said biologically active agent directly to the spinal structures and/or to the brain of said mammal.
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Abstract
A delivery method and implantable apparatus that allows for controlled, enhanced and (pre)-programmable administration of a biologically active agent into the spinal structures and/or the brain via the epidural space of a mammal, particularly of a human being and including a feedback regulated delivery method and apparatus specifically in the treatment of neurological diseases and chronic pain.
143 Citations
23 Claims
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1. A method for enhanced and controlled delivery of a biologically active agent into the spinal structures and/or the brain of a mammal, particularly a human being that circumvents the blood brain barrier, which includes the steps of:
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providing an agent drug delivery device via catheter to the epidural space of the mammal and positioning said device within the epidural space, advancing a donor iontophoresis electrode into the epidural space of the mammal, applying a second electrode or receptor iontophoresis electrode that is constructed and arranged to be positioned at a determined internal or external position of the mammal'"'"'s body but in complementary energy gradient positioning to the first electrode, providing a potential gradient so that delivery of the biologically active agent is accomplished in a direction from said first electrode means directly into the spinal structures and/or the brain thereby essentially bypassing the blood brain barrier of the mammal; and
thereby,delivering said biologically active agent directly to the spinal structures and/or to the brain of said mammal. - View Dependent Claims (3, 4)
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2. A method for enhanced and controlled delivery of a biologically active agent into the spinal structures and/or the brain of a mammal, particularly a human being that circumvents the blood brain barrier, which includes the steps of:
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providing an agent drug delivery device via catheter to the epidural space of the mammal and positioning said device within the epidural space, advancing a phonophoresis device in the epidural space of the mammal, providing an energy gradient so that delivery of the biologically active agent is accomplished in a direction from said phonophoresis device directly into the spinal structures and/or the brain thereby essentially bypassing the blood brain barrier of the mammal, and thereby, delivering said biologically active agent to the spinal structures and/or to the brain of said mammal.
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5. A method, using an implantable device, for enhanced and controlled delivery of a biologically active agent into the spinal structures and/or the brain of a mammal, particularly a human being, and that circumvents the systemic circulation, which comprises the steps of:
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(i) directing at least one end of a catheter containing a delivery device to the epidural space of a mammal and positioning said catheter and delivery device within the epidural space to provide an effective arrangement for delivering a biologically active agent which is contained in said device into the mammal;
(ii) advancing a first electrode from said delivery device that is constructed and arranged to be positioned in the epidural space of a mammal into the epidural space of a mammal and act as a donor electrode;
(iii) applying a second electrode that is constructed and arranged to be positioned at a determined internal or external position of the mammal'"'"'s body and act as a receptor electrode;
(iv) electrically connecting said first and second electrodes to a power control unit that includes an integrated (pre)-programmable power source, the power source being operated by a microprocessor, said power source providing a potential gradient so that delivery of a biologically active agent is accomplished in a direction from said first electrode directly into the spinal structures and/or the brain thereby essentially bypassing the systemic circulation of a mammal; and
(v) delivering said biologically active agent to the spinal structures and/or to the brain of said mammal using an active transport means. - View Dependent Claims (6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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Specification