Closed-loop drug delivery system
First Claim
1. A drug delivery system capable of delivering an effective amount of a drug to a subject, comprising:
- a delivery pump having a chamber capable of housing at least one drug;
a delivery conduit connected to the pump and adapted to extend into a tissue site in the subject, the delivery conduit being effective to deliver the drug from a distal end thereof to the tissue site;
a sensor, implantable within a subject, and capable of providing sensor output signals representative of sensed biochemical parameters; and
a control unit in communication with the sensor and the pump and effective to compile and store a database of the sensor output signals, and to communicate a delivery signal that is continuously adjusted based on the database of sensor output signals to the pump to deliver the drug at a rate and for a duration effective to achieve a desired biochemical parameter within a predetermined rangewherein both the delivery conduit and the sensor are adapted to be implanted in the central nervous system, and the sensor measures a biochemical parameter indicative of drug delivery.
1 Assignment
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Accused Products
Abstract
A delivery system for a drug or bioactive agent includes an implantable pump and a delivery conduit that may be implanted in an organ or other tissue (e.g., the central or the peripheral nervous system) of a subject. A sensor is also implanted, and a controller unit receives the sensor output and directs drug delivery from within the patient pump accordingly. The sensor directly measures a primary biochemical material or state in the tissue or organ system, and the monitoring unit effects closed loop feedback control of the pump to achieve a desired end. The end may be the regulation of metabolism or maintenance of a stable metabolic or other state, or may be treatment regimen, e.g., by delivery of a dosage level or distribution of a drug in specific brain or nervous an system tissue. The sensed material may be the agent itself, a metabolite, or a related native material, tissue state or condition.
328 Citations
18 Claims
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1. A drug delivery system capable of delivering an effective amount of a drug to a subject, comprising:
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a delivery pump having a chamber capable of housing at least one drug; a delivery conduit connected to the pump and adapted to extend into a tissue site in the subject, the delivery conduit being effective to deliver the drug from a distal end thereof to the tissue site; a sensor, implantable within a subject, and capable of providing sensor output signals representative of sensed biochemical parameters; and a control unit in communication with the sensor and the pump and effective to compile and store a database of the sensor output signals, and to communicate a delivery signal that is continuously adjusted based on the database of sensor output signals to the pump to deliver the drug at a rate and for a duration effective to achieve a desired biochemical parameter within a predetermined range wherein both the delivery conduit and the sensor are adapted to be implanted in the central nervous system, and the sensor measures a biochemical parameter indicative of drug delivery. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A method of drug treatment, comprising the steps of:
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providing an infusion pump adapted to be implanted at a site in a subject, wherein the pump includes a housing having a chamber for containing one or more drugs and being operable to deliver the drug from the infusion pump; providing a delivery pathway from the infusion pump to a target tissue site within the subject; and providing a sensor configured for implantation at a sensing location in the subject, wherein the sensor is adapted to detect a biochemical parameter or event at the sensing location and to produce an output signal indicative thereof; and providing a control unit, implantable at a site in a subject, wherein the control unit is able to receive the output signal from the sensor and wherein the control unit is in communication with the infusion pump; wherein the control unit controls drug delivery from the infusion pump, responding to data provided by the output signal in a closed loop feedback cycle to regulate delivery of the drug from the infusion pump so as to release the drug at the target site to maintain the sensed biochemical parameter or event within a predetermined range; and wherein the control unit includes a processor and a memory, and the processor compiles and stores a database of sensed data and response data, and responds to the compiled and stored data to create and adjust a treatment model. - View Dependent Claims (14, 15, 16, 17)
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18. A method for delivering an effective amount of a drug to a subject, comprising:
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sensing one or more biochemical parameters related to the central nervous system of a subject in response to the delivery of a drug to produce sensed signals; creating a dose-response database from the sensed signals; modeling appropriate pump control parameters for maintaining desired conditions based on the dose-response database; delivering a drug to a subject from a drug delivering pump operated under the appropriate pump control parameters; and repeating the step of sensing one or more biochemical parameters to modify the dose-response database and to model appropriate pump control parameters.
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Specification