Adaptor for drug delivery

A drug delivery device is provided for coupling a first container including a beneficial agent to a second member. In an embodiment, the device includes a substantially hollow member having a cannula mounted within a wall that divides the substantially hollow member into a first and second section. The first section includes means for receiving at least a portion of a first container. The substantially hollow member includes a wall that defines an exterior of the first section that is substantially flexible. A number of different cannula and flow path structures within the hollow member are possible pursuant to the present invention.

BACKGROUND OF THE INVENTION 
The present invention relates generally to the delivery of a beneficial 
agent to a patient or into a system for later delivery to a patient. More 
specifically, the present invention relates to an improved drug delivery 
system. 
For many applications, drugs can be mixed with a diluent before being 
delivered, for example, intravenously to a patient. The diluent can be, 
for example, a dextrose solution, a saline solution, or even water. To 
this end, many drugs are supplied in powdered form and packaged in glass 
vials. Other drugs, such as some chemotherapy drugs, are packaged in glass 
vials in a liquid state. 
Powdered drugs can be reconstituted by utilizing a syringe to inject liquid 
into a vial for mixing; the syringe eventually withdrawing the mixed 
solution from the vial. When a drug must be diluted before delivery to a 
patient, the drug is often injected into a container of diluent after it 
is reconstituted; a container can be connected to an administration set 
for delivery to the patient. 
Drugs may be packaged separate from the diluent for various reasons. One of 
the most important reasons is that many drugs do not retain their chemical 
and physical stability when mixed with a diluent and thus cannot be stored 
for any substantial period of time. Also, drugs are often packaged 
separately from the diluent because many companies that manufacture drugs 
are not engaged in the business of providing medical fluids and containers 
for intravenous delivery, and vice versa. 
Therefore, doctors, nurses, pharmacists, or other medical personnel must 
mix the drug and diluent. This presents a number of problems. The 
reconstitution procedure is time consuming and requires aseptic 
techniques. The operator must provide the proper diluent and a syringe 
before beginning. The reconstitution procedure should be performed 
preferably or under preferably sterile conditions. This requirement 
requires the operator to be more cautious, thereby consuming more time. 
Additionally, sterile conditions are often hard to maintain. In some 
instances, a laminar flow hood may be required under which the 
reconstitution procedure is performed. 
A further concern is that some drugs, such as chemotherapy drugs, are 
toxic. Exposure of the operator to the drugs during reconstitution can be 
dangerous, especially if the operator works with such drugs on a daily 
basis and is repeatedly exposed to them. 
Although after a drug is reconstituted and withdrawn into a syringe barrel, 
the drug can, in some instances, be injected immediately into a patient, 
more typically, however, the reconstituted drug is injected from the 
syringe into a larger container of solution for connection to an 
intravenous administration set. A larger container of solution may be 
necessary because often the reconstituted drug in the syringe is at such a 
concentration as to cause local toxicity in the veins of a patient near 
the injection site where the needle pierces the skin. This can create 
severe vein irritation which can be harmful. 
Additionally, even though the proper dose of medication may be in the 
syringe, immediate injection into the patient's blood stream can create a 
condition of systemic toxicity wherein the level of drug concentration in 
the patient's entire blood system is dangerously high. Yet another reason 
for not making an injection from the syringe directly into the patient is 
that such an injection creates an additional injection site into the 
patient; this can be painful for the patient and provides another 
opportunity for infection. 
For these reasons, the reconstituted drug is more typically injected into a 
diluent container. 
A number of drug delivery systems are known. 
In one delivery system that is currently used, a drug contained in a vial 
in a solid state is reconstituted with a predetermined volume of diluent 
using a needle and syringe. The vial containing the drug and solution is 
then mated onto an intravenous administration set. The drug is delivered 
to a patient as diluent flows through the vial to the patient carrying 
with it the dissolved drug. 
In another IV drug delivery system, the drug solution is packaged in 
flexible plastic containers. Some drugs packaged in this manner may be 
stored at room temperature and the drug is delivered by connecting the 
container to an intravenous administration set. Some drugs packaged in 
this manner may be stored in a frozen state in order to improve drug 
stability. In these cases, the drug solution must be thawed and then 
connected to an intravenous administration set for delivery to the 
patient. 
Another system requires drugs to be contained in a special vial. An 
activated vial is then mated to a special container. The vial stopper is 
removed and the drug is transferred to the container by flushing the vial 
with the diluent in the container. The drug is delivered by connecting the 
container with the dissolved drug to an intravenous administration set. 
Drugs can also be delivered intravenously via a syringe pump. Briefly, a 
dose of reconstituted drug solution is withdrawn by a syringe. The drug 
solution in the syringe is then refrigerated or frozen until use. The drug 
solution is brought to room temperature and infused into a patient via a 
syringe pump. 
There are some disadvantages with some of the above systems and procedures. 
One of the disadvantages is drug waste. Due to chemical and physical 
instability, once a solid drug is reconstituted with diluent (or a frozen 
formulation is thawed), it cannot be stored for any substantial amount of 
time. Therefore, if the drug solution is not administered to the patient 
within a given period of time, the drug must be discarded. Drug waste can 
be a very costly expense to a hospital pharmacy. 
Some of the current procedures for intravenous administration are labor 
intensive. As previously noted, reconstitution of a drug with a needle and 
syringe is time consuming and requires an aseptic environment. Likewise, 
exposure of the operator to the drug may be dangerous, especially if the 
operator works with the drug on a daily basis. Of course, needle sticks 
may expose healthcare professionals to hazardous diseases and infections. 
A further disadvantage of some of the above procedures is that they require 
a secondary IV administration set for delivery of the drug. The secondary 
set can be cumbersome for both the patient and the clinician. Elimination 
of the secondary set (along with the needle and syringe) may also reduce 
solid waste and disposal costs. 
U.S. Pat. No. 4,850,978 discloses a drug delivery system for delivering 
drugs to patients and/or reconstitution of a drug. The system includes a 
cartridge for introducing a beneficial agent into a fluid conduit for 
delivery of the agent to a patient. The cartridge includes a rigid hollow 
tube and an agent containing chamber slidably mounted at least partially 
within the hollow tube. In a first, pre-use position, the chamber extends 
farther from the hollow tube than it does in a second position. A cannula 
is mounted to the hollow tube extending opposite the chamber. When the 
chamber is in the second position, the cannula pierces the closure means 
creating a flow path. 
U.S. Pat. No. 4,804,366 also discloses a drug delivery system including an 
adapter having an improved flow path means providing both an inlet and an 
outlet to the agent containing chamber of a cartridge. The cartridge and 
adapter permit a single opening through the injection sites at opposite 
ends of the flow path means, while still permitting simultaneous flow both 
into and out of the chamber. An adapter and a cartridge is provided, 
including a rigid cannula with an inlet and an outlet and the shell 
substantially coaxial with and spaced from the cannula intermediate of the 
cannula inlet and the cannula outlet so that the shell of the cannula 
defines a channel therebetween. Both the cannula inlet and the cannula 
outlet are adaptable to form a single piercing opening in a resilient 
injection site associated with the cartridge. 
SUMMARY OF THE INVENTION 
The present invention provides an improved drug delivery system. The system 
facilitates the reconstitution and intravenous administration of a 
beneficial agent. Generally, pursuant to the present invention, an adaptor 
is provided that provides a for connection to an in-line IV set, a site 
for connection to a vial containing a beneficial agent, and the adaptor 
includes at least an upper section for containing a volume of diluent, the 
upper section including portions thereof that can be biased inwardly; in a 
preferred embodiment, the portions that can be biased inwardly are 
flexible walls. A cannula can be mounted within the adaptor. 
To this end, a device is provided for coupling a first container including 
a beneficial agent to a second member. In an embodiment, the device 
includes a substantially hollow member having a spike mounted within a 
wall that divides the substantially hollow member into a first and second 
section. The second section includes means for receiving at least a 
portion of a first container. The substantially hollow member includes a 
wall that defines an exterior of the first section that is substantially 
flexible. In an embodiment, the hollow member has a tube-like shape. 
A number of different cannula and flow path structures within the hollow 
member are possible pursuant to the present invention. In an embodiment, a 
shell circumscribes a portion of the cannula and defines a channel having 
an inlet and an outlet. The shell and cannula can extend for the same 
distance into the upper section or the shell and cannula can extend at 
different distances into the upper section. In an embodiment, the device 
includes two cannulas located therein. 
For use with an in-line IV set, the present invention also provides a 
cartridge for introducing a beneficial agent into a fluid conduit for 
delivery of the beneficial agent. In an embodiment, the cartridge includes 
a hollow tube having a cannula mounted therein defining a channel having 
an inlet and an outlet. A shell circumscribes a portion of the hollow tube 
and defines a channel also having an inlet and an outlet. The hollow tube 
includes a wall member dividing the hollow tube into an upper section and 
lower section, the channels of the cannula and shell passing through the 
wall. The upper section is so constructed and arranged to receive at least 
a portion of the vial including a beneficial agent. The upper section is 
defined, at least in part, by substantially flexible walls. 
Preferably, the upper section is divided into a section for housing a 
diluent and a top portion for receiving a portion of a vial. 
Preferably, the hollow member includes means for piercing a closure of the 
vial when the vial is received by the upper section. 
A method of delivering a drug is also provided. The method comprises the 
steps of: providing an adaptor including an upper section having at least 
partially flexible walls and a cannula providing fluid communication 
between the upper section and an outlet of the cannula; providing the 
upper section with a diluent; coupling a vial of beneficial agent to the 
upper section and establishing fluid communication between an interior of 
the vial and the upper section; causing fluid to flow into the vial by, at 
least in part, squeezing at least a portion of the walls of the upper 
section; allowing a resultant product to flow from the vial into the upper 
section; and causing the resultant product to flow through the outlet of 
the cannula. 
Due to the flexible walls that define the first section, diluent can be 
easily added to the vial. This allows the drug contained within the vial 
to be reconstituted and/or mixed with the diluent in the vial. The 
resultant product can then be transferred back to the adaptor. 
By utilizing different constructions of the adaptor, including the cannula 
and shell arrangement located therein, drug delivery profiles can be 
modified. This allows a variety of drugs to be delivered utilizing the 
adaptor. 
An advantage of the present invention is that it provides an adaptor that 
allows an in-line IV set to be used with any off-the-shelf drug vial. 
A further advantage of the present invention is that it could shorten 
product developmental times since all drugs contained in their respective 
manufacturer's vials have established expiration. 
Moreover, an advantage of the present invention is that it reduces 
pharmacist's time and the additional expenses with respect to the use of 
needles and syringes. 
And further, an advantage of the present invention is that the adaptor is 
user friendly, for example, a nurse can activate and reconstitute the drug 
in a single step. 
Still further, an advantage of the present invention is that it reduces 
waste, the activation/reconstitution procedure can be done immediately 
prior to administration. 
An advantage of the present invention is that it does not require a 
specially designed vial and accordingly, it eliminates the cost for 
putting drugs into specially designed vials. 
Additionally, an advantage of the present invention is that it reduces 
waste in contrast to some systems wherein once the specially designed vial 
is placed into an on-line IV system, it must be used; because the adaptor 
of the present invention is not activated until immediately prior to 
administration, this greatly reduces the potential for drug waste. 
Furthermore, an advantage of the present invention is that a piggy back is 
not required. 
Another advantage of the present invention is that the adaptor can allow 
the delivery of drugs in volumes as low as a bolus injection with a 
syringe or in volumes and concentrations similar to intravenous drip 
infusion. 
Additional features and advantages of the present invention are described 
in, and will be apparent from, the detailed description of the presently 
preferred embodiments and from the drawings.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS 
The present invention provides adaptors for coupling a vial containing a 
beneficial agent to an in-line IV set. Additionally, the present invention 
provides improved methods for administering a drug to a patient. As set 
forth in detail hereinafter, due to the construction of the adaptor of the 
present invention, it can be utilized with most any intravenous drug. To 
this end, the adaptor can be modified to provide drug delivery profiles 
allowing the administration of many varied drugs. 
Referring now to FIG. 1, an embodiment of the adaptor 10 is illustrated. As 
illustrated, the adaptor 10 preferably comprises a substantially 
tubular-shaped cartridge 12 that is divided by a wall 14 into an upper 
section 16 and a lower section 18. The lower section comprises a 
substantially rigid member having a key wall 20. The wall 14 is mounted 
across the cartridge 12 and defines the starting point for the key wall 
20. 
In the preferred embodiment illustrated, a cannula 26 extends through the 
wall 14. The cannula 26 defines a channel 27. Additionally, a generally 
cylindrical shell 28 extends from both sides of the wall 14. 
The shell 28 is spaced from the cannula 26 with the shell, in the 
embodiment illustrated in FIG. 1, encompassing the cannula 26 but being 
shorter at either end of the cannula 26. The cannula 26 includes an inlet 
and an outlet 30 and 32, respectively. Preferably, the inlet and the 
outlet 30 and 32 of the cannula 26 are blunt. Of course, if desired, 
either or both of these members could be pointed. 
The shell 28 is intermediate of the cannula inlet and outlet 30 and 32. The 
cannula 26 and shell 28 define a second channel 34 therebetween. In a 
preferred embodiment, the periphery of the cannula 26 is circular along 
its length. Similarly, the internal surface of the shell 28 is preferably 
arcuate and preferably circular along its length. 
The second channel 34 includes a channel inlet 36 defined between the shell 
28 and the cannula 26, short of the cannula 34 outlet 32. Similarly, the 
second channel includes a channel outlet 38 defined by the shell 28 and 
the cannula 26, short of the cannula inlet 30. 
The cannula 26 is secured to the shell 28 whale still maintaining an open 
flow path through the channel inlet 36, the channel 34, and the channel 
outlet 38. Thus, a very small flow path is created outside a single 
cannula with precision. 
The upper section 16 of the cartridge 12 is designed to preferably receive 
a diluent. To this end, in the preferred embodiment illustrated, the upper 
section 16 includes a first and second section 40 and 42, respectively. As 
illustrated in FIG. 2, the first section 40 is designed to house the 
diluent 43. 
In order to prevent the diluent from flowing from the first section 40 out 
through the channels 27 and 34, as illustrated in FIG. 1 a sheath 44 is 
provided for covering the end of the cannula 26 and shell 28. Preferably, 
the sheath 44 is substantially similar to that disclosed in U.S. Pat. No. 
5,167,642 entitled: "SHEATH FOR CANNULA", the disclosure of which is 
incorporated herein by reference. As set forth in that patent application, 
the sheath 44 provides a water tight seal thereby preventing any of the 
diluent from leaking out of either of the channels defined by the cannula 
26 or shell 28. 
However, the sheath 44 is also so constructed and arranged that even when 
used with a blunt ended cannula 26, the sheath will rip, not core, upon 
the exertion a sufficient force by the blunt end of the cannula against 
the walls 46. This allows the blunt end of the cannula 26 to be received 
within an injection site without first having,to manually remove the 
sheath 44. The sheath 44 will fold back along the cannula 26 and shell 28 
in an accordion fashion. This will allow the blunt end of the cannula 26 
and shell 28 to enter the injection site, but prevent the sheath 44 from 
entering the injection site. 
Due to the use of the sheath, the entire first section 40 of the adaptor 12 
can be filled with diluent if desired. Additionally, if desired, a 
removable cover 47 can be provided to protect the sheath 44 prior to use 
of the cartridge. 
To divide the upper section 16 into first and second sections 40 and 42, a 
wall 48 is provided. Preferably, the wall 48 includes means for piercing a 
vial. In the preferred embodiment illustrated, the wall 48 includes a 
spike 50 that provides fluid communication between the first and second 
sections 40 and 42. The wall 48 prevents diluent housed in the adaptor 10 
from leaking out of a top of the first section 40 of the adaptor 10. 
The spike 50 provides means for providing fluid communication between the 
first section 40 of the adaptor 10 and a vial 54 to be docketed on the 
second section 42 of the adaptor 10. Of course, any piercing means that 
allows fluid flow between the vial 54 and the adaptor 10 can be used. As 
illustrated, preferably, the spike 50 includes a foil seal 56 to prevent 
leakage of the diluent prior to docking with a vial 54. Additionally, to 
insure the sterility of the spike 50, a removable cover 58 can be 
provided. 
In the preferred embodiment illustrated, the spike 50 is located so as to 
be recessed from a plane defined by an open end of the second section 42. 
Because the spike 50 is recessed, this acts to reduce accidental "sticks" 
of personnel handling the adaptor 10 as well as prevent touch 
contamination. 
If desired, the second section 42 can include on an interior surface bumps 
(not shown) having a sloped side facing the open end of the second 
section. Such a structure assists in securing a vial 54 to the adaptor 10. 
An example of such a structure is set forth in PCT Published Application 
No. WO91/11152, the disclosure of which is hereby incorporated herein by 
reference. 
As illustrated in FIG. 2, in use, a vial 54 is mated with the adaptor 10. 
To this end, at least the top portion 56 of the vial 54 is received in the 
second section 42 of the adaptor 10. This causes the spike 50 to pierce a 
rubber stopper 58 of the vial 54, establishing fluid communication between 
the cartridge 12 and the vial 54. Due to the construction of the cartridge 
12, the cartridge can mate with any standard off-the-shelf vial 54 
containing a beneficial agent. 
Pursuant to the present invention, at least a portion of the walls 60 that 
define the first section 40 can be biased inwardly, as illustrated in 
phantom lines in FIG. 1. Preferably, at least a portion of the walls 60 
are constructed from a flexible material. The material, however, should be 
sufficiently rigid to provide stability to the adaptor 10, but allow the 
walls 60 to be biased inward. In a preferred embodiment, the entire walls 
60 are flexible. Conversely, the walls 61 that define the second section 
42, if desired, can be rigid. 
As illustrated in FIG. 3, in order to reconstitute or dilute a drug 65 
contained in the vial 54, the adaptor 10 is turned upside down. Diluent 43 
contained in the adaptor 10 is then forced into the vial 54 by squeezing 
the flexible walls 60 of the adaptor. This forces the diluent 62 from the 
adaptor 10 into the interior of the mated drug vial 54. 
The drug 65 contained within the vial 54 is then allowed to dissolve and/or 
mix with the diluent. The resultant drug solution is then transferred back 
into the adaptor 10 by holding the adaptor 10 in an upright position such 
that the solution is at the stopper end of the vial 54. The adaptor 10 is 
then compressed forcing air into the vial 54. The higher pressure in the 
vial 54 then forces the liquid from the vial into the adaptor 10. 
Referring now to FIG. 4, the adaptor 10 can then connected to an IV 
administration set, for example, the Mainstream.TM. administration set 
available from Baxter Healthcare of Deerfield, Illinois. The drug that was 
contained in the vial 54 can now be delivered to the patient. To 
accomplish this, the adaptor 10 is docketed on a receptacle 64. The 
receptacle 64 includes upper and lower fitments 66 and 68. The upper 
fitment 66 includes an inlet 70. The lower fitment 68 includes the outlet 
72. A pierceable resealable injection site 73 is mounted within the upper 
fitment 66 of the receptacle 64. An example of such an IV administration 
set is disclosed in U.S. Pat. No. 4,804,366, the disclosure of which is 
incorporated herein by reference. 
The receptacle 64 includes a resilient divider 74 trapped between the upper 
and lower fitments 66 and 68 of the receptacle 64. The resilient divider 
74 defines a narrow through bore 75 directly below the resilient 
pierceable injection site 70. Before the cartridge 10 of the present 
invention is engaged with the receptacle 64, fluid flowing from a 
parenteral container 76 flows through the fluid conduit 78 and through a 
receptacle inlet 79 whereon it flows into the receptacle 64 above the 
dividing plate 74, through the through bore 75 and downstream to the 
receptacle outlet 72. Fluid then flows downstream to the patient. 
As illustrated in FIG. 4, when the cartridge 12 is mounted on the 
receptacle 64, the cannula 26 and the shell 28 pierce the resilient 
injection site 70. The cartridge 12 continues to be urged downwardly so 
that the cannula outlet 30 enters the through bore 75 and is 
liquid-sealingly engaged by the resilient divider 74 around the periphery 
of the cannula outlet 32. 
Upon engagement of the cartridge 10 and receptacle 64, as illustrated in 
FIG. 4, liquid flowing into the receptacle 64 at the inlet 79 is prevented 
from passing through the through bore 75 and the receptacle 64 because the 
resilient divider 74 has been sealed about the cannula outlet 32 portion 
at the through bore 75. Thus, liquid entering the receptacle 64 enters the 
channel inlet 36, flows through the channel 34, and enters the first 
section 40 at the channel outlet 38. 
In an embodiment, as liquid rises within the first section 40, it will 
continue to rise until it reaches the cannula inlet 30, whereupon liquid 
begins to exit the chamber through the cannula 26 downstream through the 
cannula outlet 32. Liquid exiting the cannula 26 has an appropriate 
concentration for the beneficial agent mixed therewith for delivery to the 
patient. In the illustrated embodiment, the upward liquid flow path 
created within the first section 40 by the shell 28, channel 34, and 
cannula 26 creates a density gradient within the first section 40 such 
that the concentration of drug within the liquid exiting at the cannula 
outlet 32 will not be so high as to create local toxicity of the patient. 
As illustrated in the FIGS., many embodiments of the adaptor 12 are 
possible. The drug delivery to the patient must meet clinical guidelines. 
For IV therapy, these guidelines may include parameters such as delivery 
rate, delivery volume, and delivery concentration. Typically, the clinical 
guidelines for drug delivery specify a range in which the drug delivery 
parameters should lie. Drug delivery rates, concentrations, and volumes 
can be controlled by modification of the adaptor 10. 
The geometry of the adaptor 10, diluent flow path, drug solution density, 
and drug solution volume all can be tailored to yield a desired drug 
delivery profile for a particular drug. Adaptor 10 design modifications 
can yield drug delivery rates which range from bolus IV injection to IV 
drip infusion. 
The density of the drug solution relative to that of the diluent has a 
major impact on the rate of drug delivery from the adaptor 10. For a given 
adaptor design, the relative density of the diluent and drug solution 
determine the mixing characteristics in the adaptor 10 during delivery to 
the administration set. The adaptor 10 may be designed so that by varying 
only the relative density of the drug solution and diluent, the delivery 
rate from the adaptor can range from bolus IV to injection to IV drip 
infusion. 
Drug delivery rates, volumes (volume required to deliver the dose), and 
concentrations are functions of the volume of solution in the adaptor 10. 
Therefore, by controlling the solution volume in the adaptor 10 drug 
delivery to the patient can be governed. 
The drug delivery rate, volume, and maximum effluent concentration from a 
"well stirred vessel" can be expressed as: 
Delivery rate: dD/dt=D F/V 
Delivery volume: L=-V 1n(D/D.sub.o) 
Maximum effluent concentration: M=D.sub.o /V 
D: amount of drug in the adaptor 
D.sub.o : initial amount of drug in the adaptor 
t: time 
F: diluent flow rate 
V: volume of solution in the adaptor 
The drug delivery rate, volume, and maximum effluent concentration from a 
vessel exhibiting plug flow can be expressed as: 
Delivery rate: dD/dt=F D.sub.0 /V 
Delivery volume: L=V (D.sub.o -D)/D.sub.o 
Maximum effluent concentration: M=D.sub.0 /V 
D: amount of drug in the adaptor 
D.sub.o : initial amount of drug in the adaptor 
t: time 
F: diluent flow rate 
V: volume of solution in the adaptor 
The above expressions for rate of delivery from the two vessel types show 
that the delivery rate is directly proportional to the flow rate and 
inversely proportional to the volume of solution in the vessel. Therefore, 
as the mixing in the adaptor 10 approaches either of the two ideal systems 
described, by adjusting the volume of the solution in the adaptor, the 
delivery rate to the administration set can be governed. 
The above expressions also indicate that the delivery volume is directly 
proportional to the volume of solution in the adaptor 10; and the maximum 
effluent concentration is inversely proportional to the solution volume in 
the adaptor. Therefore, as the mixing in the adaptor 10 approaches either 
of the two ideal systems described, both parameters for a given drug can 
be controlled by adjusting the solution volume in the adaptor. 
The internal geometry of the adaptor 10 can be designed to effect mixing of 
the diluent and drug solution in the adaptor 10 which will consequently 
affect the rate of drug delivery from the adaptor 10 to the administration 
set. The fluid path of the adaptor 10 can be designed to affect the mixing 
and consequently the delivery kinetics from the adaptor. By changing the 
positions of the fluid inlet and outlet, the mixing of the adaptor 10 for 
a given drug solution can range from approximately plug flow to 
approximating a well-stirred vessel. 
Referring now to FIGS. 5 and 6, an embodiment of the fluid path within the 
adaptor is illustrated. In the illustrated embodiment, the fluid path of 
the adaptor 10 illustrated in FIGS. 1 and 4 is modified. To this end, the 
fluid flow paths in the lower section 118 of the embodiment of FIGS. 5 and 
6 are substantially similar to that of the sleeve and cannula illustrated 
in FIGS. 1-4. However, the fluid flow paths of the fluid outlet within the 
first section 140 are modified. 
To this end, in the embodiment of the adaptor 110 illustrated in FIG. 5, 
instead of a cannula structure that extends into the first section 140, a 
T-shaped fluid flow path 126 is provided. The fluid flow path 126 includes 
a lower cannula structure 127 but includes an upper T-shaped structure 
129. Fluid flow out of the first section 140, as illustrated in FIGS. 5 
and 6, is through two openings 130 and 131 of the T-shaped structure 126. 
Instead of the shell structure 28 of FIGS. 1-4, fluid flows into the first 
section 140 through an extended flow path 128. The extended flow path 
includes an outlet 138 located near a top of the first section 140. This 
creates a fluid flow within the first section 140 illustrated in FIG. 5. 
Accordingly, the fluid inlet, with respect to the first section, is distal 
and the fluid outlet is proximal relative to the docking site. The 
distance D can be modified to yield optimal drug delivery parameters for a 
given drug. 
FIGS. 7 and 8 illustrate another embodiment of the adaptor 210. In this 
embodiment, the cannula 226 and shell 228 extend for substantially the 
same distance into the first section 240. However, a tube 229 is connected 
to the inlet 230 of the cannula 226 allowing the fluid outlet path to be 
modified within the first section 240. 
In the illustrated embodiment, the tube 229 and thereby fluid outlet path 
is positioned near the wall 214 at a bottom of the first section 240. In 
this version, again, the fluid inlet, into the first section 240, is 
distal and the fluid outlet is proximal relative to the docking site. The 
distance D can be modified to yield optimal drug delivery parameters for a 
given drug. 
FIG. 9 illustrates a further embodiment of the adaptor 310 present 
invention. In this embodiment, again, the fluid outlet path 326 is defined 
by a T-shaped member. The fluid inlet path is defined by an extended 
member 328 that extends near a top of the first section 340. 
The fluid inlet 338 is therefore distal and the outlet 330 proximal to the 
docking site. The inlet 338 is positioned above the solution levels. The 
fluid inlet 338 is constructed so that it creates droplets of fluid 
accordingly, as diluent enters the adaptor 310, it drops into the 
solution. The drops of diluent falling into the adaptor solution will 
increase the mixing in the adaptor 310. The location of the fluid outlet 
can be modified so as to optimize drug delivery for a given drug. 
In an embodiment, it is possible for the adaptor 10 to be designed to 
contain drug in a liquid state within the first section 40. The drug 
formulation can thereby be stored in the adaptor body. A site for vial 54 
access therefore would not be necessary. 
If desired, the fluid, drug or diluent, can be a frozen solution stored in 
the adaptor 10. The solution then being thawed and the adaptor 10 docketed 
to the Mainstream.TM. access site. 
Although the adaptor 10 in a preferred embodiment, is provided to the end 
user containing diluent, the adaptor may be provided to the end user 
without diluent. As illustrated in FIGS. 10-12, a method for filling the 
adaptor 410 with diluent is illustrated. 
In the illustrated embodiment, the adaptor 410 includes a conduit 411 that 
is in fluid communication with the first section 440. The operator plugs 
the conduit 411 from the adaptor 410 into an access site 413 of an IV 
container 415. This can be the IV container that is used to administer the 
drug to the patient in the IV administration set. The operator then 
squeezes the flexible chamber 460 of the adaptor body 410 expelling air 
into the IV container 415, as illustrated in FIG. 10. 
Referring now to FIG. 11, by releasing the walls 460 of the adaptor 410, 
diluent 421 will be drawn into the adaptor 410. As illustrated in FIG. 12, 
after the desired amount of diluent is transferred into the adaptor 410, 
the conduit 411 would be clamped off, using a clamp 450 or other means, 
and the adaptor used as described above. 
Of course, a variety of other means can be used for filling the adaptor. 
It should be understood that various changes and modifications to the 
presently preferred embodiments described herein will be apparent to those 
skilled in the art. Such changes and modifications can be made without 
departing from the spirit and scope of the present invention and without 
diminishing its attendant advantages. It is therefore intended that such 
changes and modifications be covered by the appended claims.