Intravenous system for delivering a beneficial agent

Claim 2

An agent formulator for use in a parenteral fluid delivery system, the formulator comprising: (a) a chamber having fluid inlet and outlet means to maintain a continuous flow of the parenteral fluid therethrough, the chamber having a wall portion comprised of a material that is impermeable to a beneficial agent to be delivered into the fluid, the wall portion having an interior surface and an exterior surface which is accessible from the exterior of the formulator; (b) a flow distributor within the chamber for distributing the flow of parenteral fluid along the interior surface of the wall portion; and (c) an agent delivery device attached to the exterior surface of the wall portion, the delivery device comprising a reservoir containing the beneficial agent and a reservoir containing an permeability expanding agent which renders the wall portion permeable to the beneficial agent, the device being releasably attached to the exterior surface of the wall portion; wherein in operation, the permeability enhancing agent is delivered to the wall portion and renders the wall portion permeable to the beneficial agent, but impermeable to convective flow of the parenteral fluid therethrough, the fluid flowing through the chamber is distributed by teh flow distributor along the interior surface of the wall portion, causing the agent to be delivered from the device through the wall portion and into the flowing fluid.

Claim 3

The formulator of claim 1, wherein the delivery device comprises a laminate including: (1) a backing member, (2) a middle reservoir containing the beneficial agent, and (3) an adhesive surface adapted to releasably adhere to the exterior surface of the wall portion.

Claim 4

The formulator of cliam 1, wherein the beneficial agent is a drug and the parenteral fluid is an intravenously acceptable fluid.

Claim 5

The formulator of cliam 1, wherein the beneficial agent is a drug and the parenteral fluid is an intravenously acceptable fluid.

Claim 6

The formulator of claim 1, wherein the delivery device includes a membrane interposed between the beneficial agent reservoir and the wall portion, the membrane controlling the rate at which the delivery device delivers the beneficial agent into the chamber.

Claim 7

The formulator of claim 1, wherein the flow distributor comprises a cylindrically shaped member fixedly positioned within the chamber.

Claim 8

The formulator of claim 1, wherein the flow distributor forms a tortuous flow path along the wall portion within the chamber.

Claim 9

The formulator of claim 1, wherein the flow distributor channels the parenteral fluid flow into a constricted space between the flow distributor and the wall portion.

Claim 10

The formulator of claim 1, wherein said chamber contains an air release vent and is simultaneously employed as a drip chamber for providing a measurable number of drops per minute of the fluid, the fluid transporting the beneficial agent delivered by the delivery device to a beneficial agent receptor site.

Claim 11

The formulator of claim 1, wherein the rate at which the beneficial agent is delivered into the chamber is controlled by the wall portion.

Claim 12

The formulator of claim 1, wherein the permeability enhancing agent is delivered to the wall portion by the beneficial agent delivery device.

Claim 13

The formulator of claim 1, wherein the permeability enhancing agent comprises a plasticizer of the material forming the wall portion.

Claim 14

The formulator of claim 1, wherein the wall portion has a size and shape enabling a plurality of agent delivery devices to be attached to the exterior surface thereof.

Claim 15

The formulator of claim 1, wherein the delivery device is releasably adhered to the wall portion.

Claim 16

The formulator of claim 1, wherein the beneficial agent is osmotically active.

Claim 17

The formulator of claim 1, wherein the beneficial agent comprises a drug and an osmotically active solute.

Claim 18

The formulator of claim 1, wherein the wall portion is comprised of polyvinylchoride and the permeability enhancing agent comprises triethyl citrate.

Claim 19

The formulator of claim 1, wherein the reservoir containing the beneficial agent and the reservoir containing the permeability enhancing agent are one and the same.

Claim 20

A parenteral delivery system for administering an beneficial agent parenterally to an animal in which the agent is formulated in situ, comprising in combination: (1) a container of pharmaceutically acceptable parenteral fluid that is a carrier for the agent; (2) a parenteral fluid administration set connected to the container for permitting the fluid to flow from the container through the administration set to the animal, the set comprising a drip chamber, tubing extending from the drop chamber to the animal, and an agent formulator connected into the tubing such that the intravenous fluid flows through the formulator; the formulator comprising: (a) a chamber having fluid inlet and outlet means to maintain a continuous flow of the parenteral fluid therethrough, the chamber having a wall portion that is impermeable to the beneficial agent to be delivered into the fluid, the wall portion having an itnerior surface and an exterior surface which is accessible from the exterior of the formulator; (b) a flow distributor within the chamber for distributing the flow of parenteral fluid along the interior surface of the wall portion; and (c) an agent delivery device attached to the external surface of the wall portion, the delivery device comprising a reservoir containing the beneficial agent and a reservoir containing an permeability exhancing agent which reners the wall portion permeable to the beneficial agent, the device being releasably attached to the external surface of the wall portion; wherein in operation, the permeability enhancing agent is delivered to the wall portion and renders the wall portion permeable to the beneficial agent, but impermeable to convective flow of the parenteral fluid therethrough, the fluid flowing through the chamber is directed by the flow distributor to flow along the internal surface of the wall portion, causing the agent to be delivered from the device through the wall portion and into the flowing fluid.

Claim 21

A parenteral delivery system for administering an beneficial agent parenterally to an animal in which the agent is formulated in situ, comprising in combination: (1) a container of pharmaceutically acceptable parenteral fluid that is a carrier for the agent; (2) a parenteral fluid administration set connected to the container for permitting the fluid to flow from the container through the administration set to the animal, the set comprising a drip chamber, tubing extending from the drop chamber to the animal, and an agent formulator connected into the tubing such that the intravenous fluid flows through the formulator; the formulator comprising: (a) a chamber having fluid inlet and outlet means to maintain a continuous flow of the parenteral fluid therethrough, the chamber having a wall portion that is impermeable to the beneficial agent to be delivered into the fluid, the wall portion having an itnerior surface and an exterior surface which is accessible from the exterior of the formulator; (b) a flow distributor within the chamber for distributing the flow of parenteral fluid along the interior surface of the wall portion; and (c) an agent delivery device attached to the external surface of the wall portion, the delivery device comprising a reservoir containing the beneficial agent and a reservoir containing an permeability exhancing agent which reners the wall portion permeable to the beneficial agent, the device being releasably attached to the external surface of the wall portion; wherein in operation, the permeability enhancing agent is delivered to the wall portion and renders the wall portion permeable to the beneficial agent, but impermeable to convective flow of the parenteral fluid therethrough, the fluid flowing through the chamber is directed by the flow distributor to flow along the internal surface of the wall portion, causing the agent to be delivered from the device through the wall portion and into the flowing fluid.

Claim 22

The parenteral delivery system of claim 18, wherein the delivery device comprises a laminate including: (1) a backing member, (2) a middle reservoir containing the beneficial agent, and (3) an adhesive surface adapted to releasably adhere to the external surface of the wall portion.

Claim 23

The parenteral delivery system of claim 18, wherein a skin piercing means is connected to the tubing for administering the beneficial agent to the animal.

Claim 24

The parenteral delivery system of claim 18, wherein the animal is a human and the beneficial agent comprises a drug.

Claim 25

The parenteral delivery system of claim 18, wherein the parenteral fluid is an intravenously acceptable fluid.

Claim 26

The parenteral delivery system of claim 18, wherein the permeability enhancing agent is delivered to the wall portion by the agent delivery device.

Claim 27

The parenteral delivery system of claim 18, wherein the permeability enhancing agent comprises a plasticizer of the material forming the wall portion.

Claim 28

The parenteral delivery system of claim 18, wherein the delivery device is releasably adhered to the external surface of the wall portion.

Claim 29

The parenteral delivery system of claim 18, wherein the flow distributor comprises a cylindrically shaped member fixedly positioned within the chamber.

Claim 30

The parenteral delivery system of claim 18, wherein the flow distributor forms a tortuous flow path along the wall portion within the chamber.

Claim 31

The parenteral delivery system of claim 18, wherein the flow distributor channels the parenteral fluid flow into a constricted space between the distributor and the wall portion.

Claim 32

The parenteral delivery system of claim 18, wherein the wall portion is comprised of polyvinylchloride and the permeability enhancing agent comprises triethyl citrate.

Claim 33

The parenteral delivery system of claim 18, wherein the reservoir containing the beneficial agent and the reservoir containing the permeability enhancing agent are one and the same.

Claim 36

The method of claim 31, wherein the beneficial agent is released at a rate which is controlled by the delivery device.

Claim 37

The method of claim 31, wherein the beneficial agent is released at a rate which is controlled by the wall portion.

Claim 38

The method of claim 31, wherein the animal is a human and the beneficial agent is a drug.

Claim 39

The method of claim 31, wherein the permeability enhancing agent is delivered to the wall portion by the delivery device.

Claim 40

The method of claim 31, wherein the permeability enhancing agent comprises a plasticizer of the material forming the wall portion.

Claim 41

The method of claim 31, wherein the wall portion is comprised of polyvinylchloride and the permeability enhancing agent comprises triethyl citrate.

Claim 42

The method of claim 31, wherein the reservoir containing the beneficial agent and the reservoir containing the permeability enhancing agent are one and the same.

Claim 43

A beneficial agent delivery system comprising: (a) a container of parenteral fluid, the container having fluid outlet means to provide a continuous flow of the parenteral fluid out of the container, the container having a wall portion comprised of a material that is impermeable to a beneficial agent to be delivered into the parenteral fluid, the wall portion having an interior surface and an exterior surface which is accessible from the exterior of the formulator; and (b) an agent delivery device attached to the exterior surface of the wall portion, the delivery device comprising a reservoir containing the beneficial agent and a reservoir containing an permeability enhancing agent which renders the wall portion permeable to the beneficial agent, the device being releasably attached to the exterior surface of the wall portion; wherein in operation, the permeability enhancing agent is delivered to the wall portion and renders the wall portion permeable to the beneficial agent, but impermeable to convective flow of the parenteral fluid therethrough, the fluid in the container contacts an interior surface ofthe wall portion, causing the beneficial agent to be delivered from the device through the wall portion and into the fluid.

Claim 44

A beneficial agent delivery system comprising: (a) a container of parenteral fluid, the container having fluid outlet means to provide a continuous flow of the parenteral fluid out of the container, the container having a wall portion comprised of a material that is impermeable to a beneficial agent to be delivered into the parenteral fluid, the wall portion having an interior surface and an exterior surface which is accessible from the exterior of the formulator; and (b) an agent delivery device attached to the exterior surface of the wall portion, the delivery device comprising a reservoir containing the beneficial agent and a reservoir containing an permeability enhancing agent which renders the wall portion permeable to the beneficial agent, the device being releasably attached to the exterior surface of the wall portion; wherein in operation, the permeability enhancing agent is delivered to the wall portion and renders the wall portion permeable to the beneficial agent, but impermeable to convective flow of the parenteral fluid therethrough, the fluid in the container contacts an interior surface ofthe wall portion, causing the beneficial agent to be delivered from the device through the wall portion and into the fluid.

Claim 45

The system of claim 39, wherein the delivery device comprises a lmainate including: (1) a backing member, (2) a middle reservoir containing the beneficial agent, and (3) an adhesive surface adapted to releasably adhere to the external surface of the wall portion.

Claim 46

The system of claim 39, wherein the parenteral fluid is an intravenously acceptable fluid.

Claim 47

The system of claim 39, wherein the animal is a human and the beneficial agent comprises a drug.

Claim 48

The system of claim 39, wherein the rate at which the beneficial agent is delivered into the container is controlled by the wall portion.

Claim 49

The system of claim 39, wherein the delivery device controls the rate at which the beneficial agent is delivered into the container.

Claim 50

The container of claim 39, wherein the permeability enhancing agent is delivered to the wall portion by the agent delivery device.

Claim 51

The container of claim 39, wherein the permeability enhancing agent comprises a plasticizer of the material forming the wall portion.

Claim 52

The system of claim 39, wherein the wall portion is comprised of polyvinylchloride and the permeability enhancing agent comprises triethyl citrate.

Claim 53

The system of claim 39, wherein the reservoir containing the beneficial agent and the reservoir containing the permeability enhancing agent are one and the same.

Claim 54

The system of claim 39, wherein the wall portion has a size and shape enabling a plurlaity of agent delivery devices to be attached to the exterior surface thereof.

Claim 55

The system of claim 39, wherein the delivery device is releasably adhered to the wall portion.

Claim 56

The system of claim 39, wherein the beneficial agent is osmotically active.

Claim 57

The system of claim 39, wherein the beneficial agent comprises a drug and an osmotically active solute.