US5024657A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Drug delivery apparatus and method preventing local and systemic toxicity
Assignee: Baxter International Inc
•
Filing: 1990-05-04
•
Granted: 1991-06-18
•
Expires: 2010-05-04
Abstract
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.
Inventors
- 👤 Thomas E. Needham
- 👤 Jeremy C. Wright
- 👤 Steve Pearson
- 👤 Rao Chilamkurti
- 👤 Clinton V. Kopp
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-08 04:45
CPC Classifications
A; A61; A61M; A61M5/00; A61M5/14; A61M5/1407; A61M5/1409
Claims Analysis
Total Claims: 48
Claim 1
Independent Claim
281 words
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.
Claim 2
Dependent Claim
281 words
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.
Claim 3
Dependent Claim
56 words
The apparatus in accordance with claim 1, wherein said apparatus is adapted for placement in a fluid delivery system including a fluid source and a fluid conduit, wherein said inlet and said outlet of said chamber-defining means are adapted for connection to the fluid conduit, such that said fluid pathway forms aprt of the fluid conduit.
Claim 4
Independent Claim
17 words
The apparatus in accordance with claims 1 or 2, further comprising the beneficial agent within said chamber.
Claim 5
Dependent Claim
18 words
The apparatus in accordance with claim 3, further comprising a carrier for said beneficial agent, within said chamber.
Claim 6
Dependent Claim
24 words
The apparatus in accordance with claim 4, in which said control means comprises the local velocity profile of fluid passing over the beneficial agent.
Claim 7
Dependent Claim
28 words
The apparatus in accordance with claim 4, in which said control means comprises the thickness of the diffusional boundary layer of the fluid passing over the beneficial agent.
Claim 8
Dependent Claim
21 words
The apparatus in accordance with claim 4 wherein said control means comprises the percentage of void volume of said beneficial agent.
Claim 9
Dependent Claim
20 words
The apparatus in accordance with claim 4 wherein said control means comprises the rate of dissolution of said beneficial agent.
Claim 10
Dependent Claim
27 words
The apparatus in accordance with claim 4 wherein said beneficial agent comprises separable particles and wherein said control means comprises the particle size of said beneficial agent.
Claim 11
Dependent Claim
30 words
The apparatus in accordance with claim 4 wherein said control means comprises the amount of surface area of said beneficial agent in contact with fluid flowing through said fluid pathway.
Claim 12
Dependent Claim
22 words
The apparatus in accordance with claim 4 in which said control means comprises the shape of said beneficial agent within said chamber.
Claim 13
Dependent Claim
23 words
The apparatus in accordance with claim 4, in which said control means comprises the weight ratio of said beneficial agent to said carrier.
Claim 14
Dependent Claim
26 words
The apparatus in accordance with claim 4, in which said control means comprises the percentage of void volume of said carrier with said beneficial agent therein.
Claim 15
Dependent Claim
28 words
The apparatus in accordance with claim 4, in which said control means comprises the percentage of void volume of said carrier as measured without said beneficial agent therein.
Claim 16
Dependent Claim
27 words
The apparatus in accordance with claim 4, in which said carrier is dissolvable and in which said control means comprises the rate of dissolution of said carrier.
Claim 17
Dependent Claim
27 words
The apparatus in accordance with claim 4, in which said carrier includes separable particles and in which said control means comprises the size of said carrier particles.
Claim 18
Dependent Claim
34 words
The apparatus in accordance with claim 4, wherein said control means comprises the amount of surface area of said carrier, with said beneficial agent therein, in contact with fluid flowing through said fluid pathway.
Claim 19
Dependent Claim
23 words
The apparatus in accordance with claim 4, in which said control means comprises the shape of said carrier, with said beneficial agent therein.
Claim 20
Dependent Claim
11 words
The apparatus as in claim 4, wherein said carrier is mannitol.
Claim 21
Dependent Claim
14 words
The apparatus as in claim 4, wherein said carrier comprises a porous polypropylene tablet.
Claim 22
Dependent Claim
12 words
The apparatus as in claim 4, wherein said carrier comprises polypropylene beads.
Claim 23
Dependent Claim
27 words
The apparatus in accordance with claim 4, in which said control means comprises the thickness of the diffusional boundary layer of the fluid passing over said carrier.
Claim 24
Dependent Claim
30 words
The apparatus in accordance with claim 4, in which said control means comprises the thickness of the diffusional boundary layer of the fluid passing over said agent and said carrier.
Claim 25
Dependent Claim
14 words
The apparatus in accordance with claim 1, in which said carrier does not dissolve.
Claim 26
Dependent Claim
42 words
The apparatus in accordance with claim 1, in which said control means provides for a first delivery mode enabling a therapeutic dose of the beneficial agent to be delivered in a time period not greater than the maximum therapeutically acceptable time period.
Claim 27
Dependent Claim
32 words
The apparatus in accordance with claim 2, in which said first delivery mode enables a therapeutic dose of the beneficial agent to be delivered in a time period of approximately thirty minutes.
Claim 28
Dependent Claim
20 words
The apparatus in accordance with claim 1, in which said control means comprises the cross-sectional area of said fluid pathway.
Claim 29
Dependent Claim
42 words
The apparatus in accordance with claim 1, in which said control means compriss a plurality of non-series connecting fluid pathway segments forming said fluid pathway, in which at least one fluid pathway segment is exclusive of flow-path communication with the beneficial agent.
Claim 30
Dependent Claim
15 words
The apparatus in accordance with claim 1, further wherein said chamber-defining means comprises housing means.
Claim 31
Dependent Claim
28 words
The apparatus in accordance with claim 29, further wherein said apparatus is adapted for placement in an intravenous delivery system including a fluid source and a fluid conduit.
Claim 32
Dependent Claim
74 words
The apparatus in accordance with claim 29, further comprising a fluid conduit having proximal anddistal ends, said proximal end being adapted for communicating with a fluid source, said distal end being adapted for communicating with the intravenous system of the patient, said housing means being interposed in and forming part of said fluid conduit, such that said chamber fluid pathway, including said inlet and said outlet, are in fluid communication with said fluid conduit.
Claim 33
Dependent Claim
18 words
The apparatus in accordance with claim 1 in which said control means comprises the volume of said chamber.
Claim 34
Dependent Claim
22 words
The apparatus in accordance with claim 1, in which said control means comprises the configuration of the flow path through said chamber.
Claim 35
Dependent Claim
46 words
The apparatus as in claim 1, wherein said control means causes said first and second delivery modes to be separated by a fluid flow rate transition region wherein the degree of dependence of the rate of beneficial agent delivery upon the fluid flow rate changes significantly.
Claim 36
Dependent Claim
26 words
The apparatus as in claim 34, wherein the fluid flow rate transition region is between fluid flow rates of about thirty and sixty milliliters per hour.
Claim 37
Dependent Claim
27 words
The apparatus as in claim 1, wherein said apparatus operates in the first delivery mode at fluid flow rates at or above about sixty milliliters per hour.
Claim 38
Independent Claim
273 words
A method for mixing a beneficial agent with a fluid and safely delivering the agent to a patient, the steps comprising: (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.
Claim 39
Independent Claim
273 words
A method for mixing a beneficial agent with a fluid and safely delivering the agent to a patient, the steps comprising: (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.
Claim 40
Dependent Claim
44 words
The method as in claim 37, wherein said control step further comprises producing a first delivery mode such that the rate of delivery of the beneficial agent is low enough to prevent a toxic concentration of beneficial agent in the bloodstream of the patient.
Claim 41
Dependent Claim
267 words
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, (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.
Claim 42
Dependent Claim
267 words
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, (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.
Claim 43
Dependent Claim
278 words
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 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.
Claim 44
Dependent Claim
278 words
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 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.
Claim 45
Independent Claim
267 words
A method for mixing a beneficial agent with a fluid and safely delivering the agent to a patient, the steps comprising: (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.
Claim 46
Independent Claim
267 words
A method for mixing a beneficial agent with a fluid and safely delivering the agent to a patient, the steps comprising: (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.
Claim 47
Dependent Claim
264 words
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 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.
Claim 48
Dependent Claim
264 words
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 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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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1994-06-17 | 1994-12-17 | 1995-06-18 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1998-06-17 | 1998-12-17 | 1999-06-18 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2002-06-17 | 2002-12-17 | 2003-06-18 | $7700.00 | Window Closed / Lapsed |