CA2420746A1 - Closed-loop drug delivery system - Google Patents

Closed-loop drug delivery system Download PDF

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Publication number
CA2420746A1
CA2420746A1 CA002420746A CA2420746A CA2420746A1 CA 2420746 A1 CA2420746 A1 CA 2420746A1 CA 002420746 A CA002420746 A CA 002420746A CA 2420746 A CA2420746 A CA 2420746A CA 2420746 A1 CA2420746 A1 CA 2420746A1
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CA
Canada
Prior art keywords
drug
sensor
subject
drug delivery
control unit
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Granted
Application number
CA002420746A
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French (fr)
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CA2420746C (en
Inventor
William L. Rohr
Alan J. Dextradeur
David D. Konieczynski
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Codman and Shurtleff Inc
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Codman and Shurtleff Inc
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Publication of CA2420746A1 publication Critical patent/CA2420746A1/en
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Publication of CA2420746C publication Critical patent/CA2420746C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14503—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14553—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases specially adapted for cerebral tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M5/16836—Monitoring, detecting, signalling or eliminating infusion flow anomalies by sensing tissue properties at the infusion site, e.g. for detecting infiltration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
    • A61B5/4076—Diagnosing or monitoring particular conditions of the nervous system
    • A61B5/4082—Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
    • A61B5/4076—Diagnosing or monitoring particular conditions of the nervous system
    • A61B5/4088—Diagnosing of monitoring cognitive diseases, e.g. Alzheimer, prion diseases or dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
    • A61M2005/1726—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure the body parameters being measured at, or proximate to, the infusion site
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3306—Optical measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804—Flow controllers

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 ox 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 system tissue. The sensed material may be the agent itself, a metabolite, or a related native material, tissue state or condition.

Claims (25)

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 a sensor output signal representative of a sensed biochemical parameter; and a control unit in communication with the sensor and the pump, wherein the control unit receives the sensor output signal and communicates a delivery signal 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.
2. The drug delivery system of claim 1, wherein the sensor includes an optical fiber, and the sensor output signal is a spectral output signal.
3. The drug delivery system of claim 1, wherein the sensor includes an electrochemical sensor, and the sensor output signal is an electrical signal or characteristic.
4. The drug delivery system of claim 1, wherein the drug is selected from among the group of drugs consisting of a pain killer, a chemotherapeutic agent, a neuroprotectant, a neurologically active material, an agonist to a neurologically active material, an antagonist to a neurologically active material, and combinations thereof.
5. The drug delivery system of claim 1, wherein the control unit comprises a processor operative to monitor and store dose-response information.
6. The drug delivery system of claim 1, 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.
7. The drug delivery system of claim 1, wherein the sensor implanted in the subject at a location remote from location of the distal end of the delivery conduit.
8. The drug delivery system of claim 1, wherein the delivery conduit is selected from the group consisting of a catheter,a needle, and a porous fiber.
9. The drug delivery system of claim 2, wherein the optical fiber is adapted to be implanted directly in nervous system tissue, and a portion of the optical fiber includes a bioactive chromophore effective to absorb or bind to an analyte of interest to alter color or saturation such that the return light from the fiber provides spectral data indicative of the local presence or concentration of the analyze of interest.
10. The drug delivery system of claim 9, wherein the analyte of interest is a neurotransmitter.
11. The drug delivery system of claim 2, wherein the sensor includes an array of optical fibers adapted to be implanted directly into nervous system tissue, such that the return light from the array of optical fibers provides spectral data locally indicating tissue distribution of a probed analyte or tissue state.
12. The drug delivery system of claim 1, wherein the sensor responds to a drug-related material selected from among the group consisting of a chemical, an ion, a biological molecule, a gas, and combinations or spectral indications thereof.
13. The drug delivery system of claim 2, wherein the sensor includes an enzyme immobilized at a sensing surface.
14. A method of drug treatment, comprising the steps of:
providing an infusion pump implantable 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.
15. The method of claim 14, wherein the step of providing a sensor includes providing an optical or electrochemical sensor.
16. The method of claim 14, wherein the control unit includes a processor and a memory, and the processor compiles a database of sensed data and response data for modeling treatment.
17 17. The method of claim 14, wherein the control unit is contained within or is separate from the infusion pump.
18. The method of claim 17, wherein drug delivery is timed to synchronize with periods within the subject's Circadian rhythm.
19. The method of claim 18, wherein drug delivery is preprogrammed to synchronize with periods within the subject's Circadian Rhythm.
20. Use of a delivery system for drug treatment in a subject, the system comprising:
an infusion pump implantable at a site in the 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;

a delivery pathway from the infusion pump to a target tissue site within the subject; and 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 a control unit, implantable at a site in the 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.
21. The use of claim 20, wherein the sensor includes an optical or electrochemical sensor.
22. The use of claim 20, wherein the control unit includes a processor and a memory, and the processor compiles a database of sensed data and response data for modeling treatment.
23. The use of claim 20, wherein the control unit is contained within or is separate from the infusion pump.
24. The use of claim 23, wherein drug delivery is timed to synchronize with periods within the subject's Circadian rhythm.
25. The use of claim 24, wherein drug delivery is preprogrammed to synchronize with periods within the subject's Circadian Rhythm.
CA2420746A 2002-03-06 2003-03-04 Closed-loop drug delivery system Expired - Lifetime CA2420746C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/092,955 2002-03-06
US10/092,955 US7108680B2 (en) 2002-03-06 2002-03-06 Closed-loop drug delivery system

Publications (2)

Publication Number Publication Date
CA2420746A1 true CA2420746A1 (en) 2003-09-06
CA2420746C CA2420746C (en) 2011-08-02

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CA2420746A Expired - Lifetime CA2420746C (en) 2002-03-06 2003-03-04 Closed-loop drug delivery system

Country Status (6)

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US (1) US7108680B2 (en)
EP (2) EP1342482B1 (en)
JP (1) JP4722380B2 (en)
AU (1) AU2003200923B2 (en)
CA (1) CA2420746C (en)
DE (2) DE60302264T2 (en)

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