Drug delivery apparatus and method preventing local and systemic toxicity
First Claim
1. Apparatus for the safe delivery of a beneficial agent to a patient, comprising:
- (a) means defining a chamber adapted for receiving a beneficial agent, said chamber having a fluid pathway therethrough, said chamber-defining means including an inlet and an outlet defining part of said fluid pathway; and
(b) means for controlling the rate of delivery of the beneficial agent out of said outlet and into a patient, said control means being capable of producing first and second delivery modes for the beneficial agent when the beneficial agent is being delivered to a patient, such that in said first delivery mode the fluid flow rate through said chamber is high enough that the rate of delivery of the beneficial agent is substantially independent of the fluid flow rate through said chamber, wherein the rate of delivery of the beneficial agent, when the agent delivery rate is independent of fluid flow rate, is at a rate high enough to create, but for said second delivery mode, a locally toxic concentration of beneficial agent in the fluid delivered to the patient, and such that in said second delivery mode, the fluid flow rate through said chamber is slow enough that the rate of delivery of the beneficial agent is at least partially dependent upon the fluid flow rate through said chamber;
(c) said control means causing said second delivery mode to include fluid flow rates high enough to prevent a locally toxic concentration of beneficial agent in the fluid delivered to the patient, said control means furthermore causing said first delivery mode to include fluid flow rates low enough to prevent a systemically toxic concentration of beneficial agent in the bloodstream of the patient.
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Accused Products
Abstract
An apparatus is provided for the safe, passive reconstruction of a drug or other beneficial agent, without requiring manual reconstitution steps. The apparatus includes a housing, preferably having a receptacle "in-line" in an administration set and forming part of an intravenous delivery system, and a cartridge adapted for receiving a beneficial agent or beneficial agent and carrier. The cartridge is plugged into the receptacle to initiate reconstitution of the agent. The apparatus creates first and second delivery modes, in which the delivery rate of the agent to a patient is independent from and dependent upon, respectively, the fluid flow rate through the intravenous delivery system.
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Citations
42 Claims
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1. Apparatus for the safe delivery of a beneficial agent to a patient, comprising:
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(a) means defining a chamber adapted for receiving a beneficial agent, said chamber having a fluid pathway therethrough, said chamber-defining means including an inlet and an outlet defining part of said fluid pathway; and (b) means for controlling the rate of delivery of the beneficial agent out of said outlet and into a patient, said control means being capable of producing first and second delivery modes for the beneficial agent when the beneficial agent is being delivered to a patient, such that in said first delivery mode the fluid flow rate through said chamber is high enough that the rate of delivery of the beneficial agent is substantially independent of the fluid flow rate through said chamber, wherein the rate of delivery of the beneficial agent, when the agent delivery rate is independent of fluid flow rate, is at a rate high enough to create, but for said second delivery mode, a locally toxic concentration of beneficial agent in the fluid delivered to the patient, and such that in said second delivery mode, the fluid flow rate through said chamber is slow enough that the rate of delivery of the beneficial agent is at least partially dependent upon the fluid flow rate through said chamber; (c) said control means causing said second delivery mode to include fluid flow rates high enough to prevent a locally toxic concentration of beneficial agent in the fluid delivered to the patient, said control means furthermore causing said first delivery mode to include fluid flow rates low enough to prevent a systemically toxic concentration of beneficial agent in the bloodstream of the patient. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36)
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37. A method for mixing a beneficial agent with a fluid and safely delivering the agent to a patient, the steps comprising:
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(a) providing an intravenous delivery system including a fluid source and a fluid conduit connected to the fluid source for delivering fluid in the source to the patient; (b) providing a housing within the fluid conduit, the housing defining a chamber with the beneficial agent therein, the chamber having a fluid pathway therethrough in fluid communication with the fluid conduit both upstream and downstream of the housing; and (c) automatically controlling the rate of delivery of the beneficial agent out of the housing outlet and into a patient, said control step including (i) providing capability for producing a first delivery mode to a patient in which the rate of delivery of the beneficial agent is substantially independent of the fluid flow rate through the chamber, wherein the rate of the delivery of the beneficial agent, when the agent delivery rate is independent of fluid flow rate, is at a rate high enough to create, but for a second delivery mode, a locally toxic concentration of beneficial agent in the fluid delivered to the patient, (ii) providing capability for producing a second delivery mode to a patient at fluid flow rates lower than the first delivery mode, in which the rate of delivery of the beneficial agent is at least partially dependent upon the fluid flow rate through the chamber and (iii) separating the first and second delivery modes at a fluid flow rate transition region high enough to prevent a toxic concentration of beneficial agent in the fluid delivered to the patient. - View Dependent Claims (38)
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39. Apparatus for the safe delivery of a beneficial agent to a patient, comprising:
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(a) means defining a chamber adapted for receiving a beneficial agent, said chamber having a fluid pathway therethrough, said chamber-defining means including an inlet and an outlet defining part of said fluid pathway; and (b) means for controlling the rate of delivery of the beneficial agent out of said outlet and into a patient, said control means being capable of producing first and second delivery modes for the beneficial agent when the beneficial agent is being delivered to a patient, (i) such that in said first delivery mode the fluid flow rate through said chamber is high enough that the rate of delivery of the beneficial agent is substantially independent of the fluid flow rate through said chamber such that said apparatus, when in said first delivery mode, enables a therapeutic dose of the beneficial agent to be delivered to the patient in a time period of approximately thirty minutes, and (ii) such that in said second delivery mode, the fluid flow rate through said chamber is slow enough that the rate of delivery of the beneficial agent is at least partially dependent upon the fluid flow rate through said chamber; (c) said control means causing said second delivery mode to include fluid flow rates high enough to prevent a locally toxic concentration of beneficial agent in the fluid delivered to the patient, said control means furthermore causing said first delivery mode to include fluid flow rates low enough to prevent a systemically toxic concentration of beneficial agent in the bloodstream of the patient.
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40. Apparatus for the safe delivery of a beneficial agent to a patient, comprising:
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(a) means defining a chamber adapted for receiving a beneficial agent, said chamber having a fluid pathway therethrough, said chamber-defining means including an inlet and an outlet defining part of said fluid pathway; and (b) means for controlling the rate of delivery of the beneficial agent out of said outlet and into a patient, said control means producing first and second delivery modes for the beneficial agent when the beneficial agent is being delivered to a patient, such that in said first delivery mode the fluid flow rate through said chamber is high enough that the rate of delivery of the beneficial agent is substantially independent of the fluid flow rate through said chamber, wherein the rate of delivery of the beneficial agent, when the agent delivery rate is independent of fluid flow rate, is at a rate high enough to create, but for said second delivery mode, a locally toxic concentration of beneficial agent in the fluid delivered to the patient, and such that in said second delivery mode, the fluid flow rate through said chamber is slow enough that the rate of delivery of the beneficial agent is at least partially dependent upon the fluid flow rate through said chamber; (c) said control means causing said second delivery mode to include fluid flow rates high enough to prevent a locally toxic concentration of beneficial agent in the fluid delivered to the patient, said control means furthermore causing said first delivery mode to include fluid flow rates low enough to prevent a systemically toxic concentration of beneficial agent in the bloodstream of the patient.
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41. A method for mixing a beneficial agent with a fluid and safely delivering the agent to a patient, the steps comprising:
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(a) providing an intravenous delivery system including a fluid source and a fluid conduit connected to the fluid source for delivering fluid in the source to the patient; (b) providing a housing within the fluid conduit, the housing defining a chamber with the beneficial agent therein, the chamber having a fluid pathway therethrough in fluid communication with the fluid conduit both upstream and downstream of the housing; and (c) automatically controlling the rate of delivery of the beneficial agent out of the housing outlet and into a patient, said control step including (i) producing a first delivery mode to a patient in which the rate of delivery of the beneficial agent is substantially independent of the fluid flow rate through the chamber, wherein the rate of the delivery of the beneficial agent, when the agent delivery rate is independent of fluid flow rate, is at a rate high enough to create, but for a second delivery mode, a locally toxic concentration of beneficial agent in the fluid delivered to the patient, (ii) producing a second delivery mode to a patient at fluid flow rates lower than the first delivery mode, in which the rate of delivery of the beneficial agent is at least partially dependent upon the fluid flow rate through the chamber and (iii) separating the first and secon delivery modes at a fluid flow rate trnasition region high enough to prevent a toxic concentration of beneficial agent in the fluid delivered to the patient.
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42. Apparatus for the safe delivery of a beneficial agent to a patient, comprising:
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(a) means defining a chamber adapted for receiving a beneficial agent, said chamber having a fluid pathway therethrough, said chamber-defining means including an inlet and an outlet defining part of said fluid pathway; and (b) means for controlling the rate of delivery of the beneficial agent out of said outlet and into a patient, said control means producing first and second delivery modes for the beneficial agent when the beneficial agent is being delivered to a patient, (i) such that in said first delivery mode the fluid flow rate through said chamber is high enough that the rate of delivery of the beneficial agent is substantially independent of the fluid flow rate through said chamber such that said apparatus, when in said first delivery mode, enables a therapeutic dose of the beneficial agent to be delivered to the patient in a time period of approximately thirty minutes, and (ii) such that in said second delivery mode, the fluid flow rate through said chamber is slow enough that the rate of delivery of the beneficial agent is at least partially dependent upon the fluid flow rate through said chamber; (c) said control means causing said second delivery mode to include fluid flow rates high enough to prevent a locally toxic concentration of beneficial agent in the fluid delivered to the patient, said control means furthermore causing said first delivery mode to include fluid flow rates low enough to prevent a systemically toxic concentration of beneficial agent in the bloodstream of the patient.
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Specification