WO2000076576A1 - Fluid dispenser with fill adapter - Google Patents

Abstract

An elastomeric bladder (46) stored energy type infusion apparatus that can be filled with a medicinal fluid and, after being filled, can efficiently deliver the medicinal fluid to the patient at a selected, adjustable rate. The apparatus includes a built-in dose dialing mechanism (212) which can be preset by the treating physician or health care worker so that a precise volume of the medicinal fluid can be introduced into the fluid reservoir of the device for delivery to the patient.

Description

FLUID DISPENSER WITH FILL ADAPTER

S P E C I F I C A T I O N

Background of the Invention

This is a Continuation-In-Part Application of co-pending U.S. Serial No.

09/165,709 filed October 2. 1998; which is a Continuation-In-Part of U.S. Se¬

rial No. 08/729,326 filed October 15, 1996 and now issued into Patent No.

5,873,857; which is a Continuation-In-Part of U.S. Serial No. 08/577,496 filed

December 22, 1995 and now issued into Patent No. 5,700,244; which is a Con¬

tinuation-In-Part of U.S. Serial No. 08/192,031 filed February 3, 1994 and now

issued into Patent No. 5,484,415; which is a Continuation-In-Part of U.S. Se¬

rial No. 08/156,685 filed November 22, 1993 and now issued into Patent No.

5,433,709; which is a Continuation-In-Part of U.S. Serial No. 08/053,723 filed

April 26, 1993 and now issued into Patent No. 5,354,278; which is a Continua¬

tion -In Part of U.S. Serial No. 07/870,521 filed April 17, 1992 and now issued

into Patent No. 5,263,940.

Field of the Invention

The present invention relates generally to infusion devices. More particu¬

larly, the invention concerns an elastomeric bladder type infusion apparatus which is used for controllably delivering a beneficial agent to a patient. The device

uniquely includes adjustable flow rate means for adjusting the rate of fluid flow

from the device toward the patient.

Discussion of the Prior Art

Many types of infusion pumps embodying an elastomeric balloon or

bladder for delivery of a quantity of pharmaceutically active material to a patient

have been suggested in the past. For example, U.S. Patent No. 4,915,693 issued

to Hessel discloses an infusion pump comprising an elastomeric bladder having

at least an open end, and an elongate stress member extending concentrically

within the entire length of the hollow portion of the bladder and having a fluid

tight seal therewith. Both a filling port and an exit port are provided in the stress

member, each in fluid communication with the interior of the bladder by way of

an influent and an effluent lumen, respectively. The stress member has a di¬

ameter that is greater than the relaxed internal diameter of the bladder, and has a

length that exceeds the relaxed internal length of the hollow portion of the bladder,

so that it prestresses the bladder in both the axial and radial directions when dis¬

posed therein, substantially filling the bladder in its unfilled state. The Hessel

device also includes a one-way valve on the stress member which permits flow

influent lumen onlv in the direction of the interior of the bladder. Nery early balloon type infusion devices are described in U.S. Patent Νos.

3,468,308 and 3,469,578 issued to Bierman. These patents disclose a device

for expelling a liquid from a bladder member at an extremely slow rate over an

extended period of time.

One of the more advanced elastomeric bladder type devices ever developed

is described in U. S. Patent No. 5,354,278 issued to the present inventor. Because

the present invention comprises an improvement to the devices disclosed in this

latter patent, U.S. Patent No. 5,354,278 is hereby incorporated by reference as

though fully set forth herein. Another advanced elastomeric bladder type device is

disclosed in U.S. Patent No. 5,873,857 also issued to the present inventor. This

patent is also incorporated by reference as though fully set forth herein.

Disclosed in U.S. Patent No. 5,721 ,382, issued to the present inventors, is a

device having a flow indicator means similar to that embodied in the present inven¬

tion. For this reason, U.S. Patent No. 5,721 ,382 is incorporated by reference as

though fully set forth herein.

None of the prior art devices known to applicant have the unique capability

of the present invention for precisely adjusting the rate of fluid flow from the de¬

vice toward the patient using an elegantly simple, built-in, flow-rate adjustment

mechanism. Summary of the Invention

It is an object of the present invention to provide an elastomeric bladder

stored energy type infusion apparatus which can be filled with a medicinal fluid

and after being filled, can efficiently deliver the medicinal fluid to the patient at a

selected, adjustable rate.

More particularly, it is an object of the invention to provide an infusion de¬

vice of the aforementioned character which includes a built-in adjustment mecha¬

nism which can be preset by the treating physician or health care worker so that the

medicinal fluid stored within the device will be delivered to the patient at a precise

rate.

Another object of the invention is to provide an elastomeric bladder type

infusion device of the aforementioned character in which the adjustment mecha¬

nism is operable only through the use of a physician's key which following the set¬

ting of the desired flow rate can be removed and maintained within the control of

the treating physician.

Another object of the invention is to provide a device of the character de¬

scribed in the preceding paragraphs which includes a novel indicator means for

providing a visual indication of the fluid flow status through the device.

Another object of the invention is to provide an infusion device as described

in the preceding paragraphs that includes a built-in dose dialing mechanism which can be preset by the treating physician or health care worker so that a precise vol¬

ume of the medicinal fluid stored within the device will be delivered to the patient.

Still another object of the invention is to provide a device of the character

described in the preceding paragraphs which is highly reliable, inexpensive to pro¬

duce in quantity, easy to use and readily disposable after use.

Brief Description of the Drawings

Figure 1 is a generally perspective exploded view of one form of the

fluid delivery apparatus of the present invention.

Figure 2 is an enlarged, side-elevational, cross-sectional view of the device

shown in figure 1.

Figure 2A is an enlarged, cross-sectional view of the area 2A in figure 2.

Figure 3 is a right end view of the device as shown in figure 2.

Figure 4 is a left end view of the device shown in figure 2

Figure 5 is a cross-sectional view taken along lines 5-5 of figure 2.

Figures 6A and 6B, when considered together, comprise a side-elevational,

exploded view of the device shown in figure 2.

Figure 7 is a generally perspective view of the closure cup of the apparatus

of the invention.

Figure 8 is a generally perspective view of the vial retaining clip of the appa¬

ratus of the invention. Figure 9 is a generally perspective exploded view of one form of the fluid

delivery apparatus of the present invention.

Figure 10 is an enlarged, side-elevational, cross-sectional view of the device

shown in figure 9.

Figure 1 1 is an enlarged, fragmentary, cross-sectional view of the area des¬

ignated as 1 1 in figure 10.

Figure 12 is an exploded, side-elevational, cross-sectional view of the for¬

ward portion of the device of figure 9 showing the construction of the flow rate

control mechanism.

Figure 13 is a view taken along lines 13-13 of figure 12.

Figure 14 is a view taken along lines 14- 14 of figure 12.

Figure 15 is a view taken along lines 15-15 of figure 12.

Figure 16 is a view taken along lines 16- 16 of figure 12.

Figure 17 is an enlarged, fragmentary, cross-sectional view of the forward

portion of an alternate form of the apparatus of the invention showing an adjustable

flow rate control mechanism of a slightly different construction embodying a plu¬

rality of novel, laser drilled microbore rate control wafers.

Figure 18 is an enlarged fragmentary, cross-sectional view of the area desig¬

nated as 18 in fiaure 17. Figure 19 is an enlarged, cross-sectional, exploded view of the flow control

mechanism of the apparatus shown in figure 18.

Figure 20 is a generally perspective view of an alternate form of the appara¬

tus of the invention which includes indicator means for visually indicating fluid

flow through the device.

Figure 21 is a generally perspective, exploded view of the apparatus shown

in figure 20.

Figure 22 is a greatly enlarged perspective, exploded view of the apparatus

shown in figure 20.

Figure 23 is an enlarged, cross-sectional view of the area designated as 23 in

figure 22.

Figure 24 is a cross-sectional view taken along lines 24-24 of figure 22.

Figure 25 is an enlarged view, partly in cross-sectional of the rate control

means of the apparatus shown in figure 22.

Figure 26 is a view taken along lines 26-26 of figure 25.

Figure 27 is a generally perspective exploded view of another form of the

fluid delivery apparatus of the present invention.

Figure 28 is an enlarged, side-elevational, cross-sectional view of the device

shown in figure 27.

Figure 29 is a left end view of the device shown in figure 2. Figure 30 is a cross-sectional view taken along lines 30-30 of figure 28.

Figure 31 is a cross-sectional view taken along lines 31-3 1 of figure 28.

Figures 32A and 32B, when considered together, comprise an exploded view

of the form of the fluid delivery apparatus shown in figure 28.

Figure 33 is a front view of the advancement control knob of the device

shown in figure 32 A

Figure 34 is a cross-sectional view taken along lines 34-34 of figure 33.

Figure 35 is a front view of the advancement control knob of the device

shown in figure 32A.

Figure 36 is a cross-sectional view taken along lines 36-36 of figure 35.

Figure 37 is a generally perspective exploded view of still another em¬

bodiment of the fluid delivery apparatus of the present invention which includes

a pair of fill vials.

Figure 38 is a right end view of the device as shown in figure 37.

Figure 39 is an enlarged, side-elevational, cross-sectional view of the device

shown in figure 37.

Figure 39A is an enlarged, cross-sectional view of the area designated as

39A in figure 39.

Figure 40 is a cross-sectional view taken along lines 40-40 of figure 38.

Figure 41 is an enlarged view taken along lines 41 -41 of figure 38. Figure 42 is an end view of the housing of the apparatus.

Figure 43 is cross-sectional view taken along lines 43-43 of figure 42.

Figure 44 is a left-end view of the housing of the apparatus shown in figure

43.

Figure 45 is a right-side view of the closure cap of the apparatus which is

connected to the housing in the manner shown in figure 39.

Figure 46 is a cross-sectional view taken along lines 46-46 of figure 45.

Figure 47 is a right-end view of the delivery end portion of the housing.

Figure 48 is an enlarged, cross-sectional view taken along lines 48-48 of fig¬

ure 47.

Figure 49 is a fragmentary, exploded, side-elevational view of a portion of

the central support of the device to which the elastomeric stored energy source of

the device is affixed.

Figure 50 is a cross-sectional view taken along lines 50-50 of figure 39.

Figure 51 is an end view of the retaining clip of the apparatus for locking the

adapter assembly in place within the device housing.

Figure 52 is a generally perspective view of the retaining clip.

Figure 53 is a generally perspective view of one of the sealing caps of the

device for sealing the vial receiving chambers of the housing. Figure 54 is a side-elevational view of one form of the fluid delivery quick

coupling component of the apparatus.

Figure 55 is a generally perspective view of yet another embodiment of the

fluid delivery apparatus of the present invention which includes a novel dose dial¬

ing feature.

Figure 56 is an enlarged, side-elevational, cross-sectional view of the device

shown in figure 55.

Figure 57 is a view taken along lines 57-57 of figure 56.

Figure 58 is a cross-sectional view taken along lines 58-58 of figure 57.

Figure 59 is a top plan view of the dial clamp component of the apparatus.

Figure 60 is a view taken along lines 60-60 of figure 59.

Figure 61 is a top plan view of the physician's key of the invention for lock¬

ing the dose dialing mechanism of the device.

Figure 62 is an exploded, cross-sectional view of the delivery device portion

of the apparatus shown in figure 56.

Figure 63 is a view taken along lines 63-63 of figure 62.

Figure 64 is a view taken along lines 64-64 of figure 62.

Figure 65 is a view taken along lines 65-65 of figure 62.

Figure 66 is a view taken along lines 66-66 of figure 62.

Figure 67 is a view taken along lines 67-67 of figure 62. Figure 68 is a view taken along lines 68-68 of figure 62.

Figure 69 is a view taken along lines 69-69 of figure 62.

Figure 69 A is a generally perspective, fragmentary view of the support and

locator rings of the device.

Figure 70 is a cross-sectional view taken along lines 70-70 of figure 66.

Figure 71 is a side-elevational, cross-sectional view of one form of the fluid

fill subassembly of the filling means of the invention.

Figure 72 is a view taken along lines 72-72 of figure 71.

Figure 73 is a side-elevational, cross-sectional view similar to figure 71

showing the field fill container being filled with fluid.

Figure 74 is a fragmentary, top plan view of the right-hand portion of the

fluid delivery component having the dose volume indicia provided on the adapter

component.

Figure 75 is a diagrammatic view of the dosing indicia provided on the dose-

dialing component of the apparatus.

Description of One Form of the Invention

Referring to the drawings and particularly to Figures 1 and 2, the fluid

dispenser apparatus of one form of the present invention can be seen to comprise

an elongated housing 40 having a first internal chamber 42. a support 44 disposed

π within internal chamber 42 and extending longitudinally of the housing 40, and a

generally cylindrically shaped, elongated elastomeric member 46.

Housing 40 comprises a cylindrically shaped central portion 40a and inlet

and outlet end closure portions 40b and 40c respectively. Central section 40a and

end portion 40b can be interconnected by any suitable means such as adhesive

bonding or an appropriate sonic weldment. End portion 40c is preferably inte¬

grally formed with central portion 40a although it could be formed as a separate

component. Elastomeric member 46 is securely affixed proximate its ends to sup¬

port 44 by means of suitable ring clamps 50 such as self-locking plastic panduit

strips.

As best seen by referring to figure 2, support 44 is constructed in two parts

44a and 44b which are suitably interconnected in the manner shown in figure 2.

Part 44a has a fluid inlet 56 which is in communication with a reservoir 58 formed

by elastomeric member 46 and support 44 via a fluid passageway 60. Naive

means, shown here as a check valve 62 which is disposed within a chamber formed

in end portion 40c, permits fluid flow in a direction toward reservoir 58 but blocks

fluid flow in the opposite direction.

Second part 44b of support 44 has an outlet passageway 66 which communi¬

cates with the deliver ' means of the invention for delivering fluid to the patient.

The delivery means includes a fluid delivery passageway 70 formed in a quick dis- connect assembly which includes a housing 72. In a manner presently to be de¬

scribed, the quick disconnect assembly can be readily releasably interconnected

with end portion 40b of housing 40. Fluid delivery passageway 66 communicates

with reservoir 58 and also with passageway 70 via a flow rate control means, here

provided as a porous rate control frit 74 which is mounted within quick disconnect

housing 72 and which controls the rate of fluid flow toward the delivery means.

An important feature of the apparatus of the present invention is the provi¬

sion of sampling means for sampling and retrival of fluid contained within reser¬

voir 58. This sampling means here includes a sampling port assembly 78 provided

in end portion 40b of support 40. Sampling port assembly 78 includes a septum

80, which is received within a chamber 82 formed in housing end portion 40b, and

a clamping ring 84 for clamping the septum in place within chamber 82. Through

use of the sampling means such as a conventional syringe, the contents of reservoir

58 can be sampled at any time and, after the delivery step, any medicament

remaining in the reservoir can be retrieved for subsequent use.

Formed in end portion 40c of housing 40 is a first fill means for filling res¬

ervoir 58 with a diluent such as a saline solution or with any other desired fluid.

This first fill means here comprises a first fill port assembly 86 which includes a

chamber 88 formed in end portion 40c of housing 40. Sealably disposed within

chamber 88 is a conventional male luer connector 90 which can be suitably con- nected with a conventional female luer connector and fill line (not shown). A con¬

ventional luer cap 92 sealably closes connector 90 when it is not in use. If desired,

connector 90 can include a conventional check valve to permit fluid flow toward

reservoir 58 but to block flow in the opposite direction. With a suitable female

luer connector, connected to connector 90 and with the fill line connected to a

source of diluent, reservoir 58 can be partially filled in a manner well understood

by those skilled in the art.

Turning particularly to figures 1 , 2, and 6, the important second fill means of

the invention for adding fluid to reservoir 58 is there illustrated. This second fill

means here comprises a container subassembly 96, and an adapter subassembly 98,

the character of which will presently be described. Container subassembly 96 in¬

cludes a body portion 96a having a fluid chamber 96b (figure 2) for containing a

medicament or other fluid "F" which is desired to be added to the diluent or other

fluid contained within reservoir 58. Fluid chamber 96b provided with first and

second open ends 99a and 99b. First open end 99a is sealably closed by closure

means here provided in the form of a pierceable septum assembly 100 (figure 2),

which is held securely in position by a clamping ring 102. A plunger 104 (figure

2) is telescopically movable within chamber 96b of container subassembly 96 from

a first location proximate first open end 99b to a second position proximate second open end 99a. The vial portion of the container subassembly 96 can be constructed

of various materials such as glass and plastic.

The previously mentioned adapter subassembly 98 comprises a hollow hous¬

ing 98a having a first open end 98b (figure 6) and a second closed end 98c (figure

2). Container subassembly 96 is telescopically receivable within open end 101 a of

a vial receiving tube 101 which, in turn, is disposed within an elongated, generally

cylindrically shaped chamber 103 formed in the lower portion 40d of housing 40.

With this construction, hollow housing 98a can be moved from the extended posi¬

tion shown in figure 2 into a vial encapsulation position wherein the vial resides

interiorly of the adapter subassembly. Forming an important part of adapter subas¬

sembly 98 is pusher means shown here as an elongated pusher rod 106 which func¬

tions to move plunger 104 longitudinally of fluid chamber 96b. In the form of the

invention shown in the drawings, pusher rod 106 has a first end 106a intercon¬

nected with the closure wall 98c of housing 98 and an opposite end 106b which

engages plunger 104 and causes telescopic movement of the plunger within cham¬

ber 96b of container subassembly 96 as housing is moved within an annular space

107 formed between vial receiving tube 101 and the outer wall of chamber 103 of

device portion 40d.

As best seen in figure 2 A. a hollow piercing cannula 108 is connected to

support wall 1 10a formed on a vial receiving tube 1 10. Cannula 108 extends into receiving chamber 101 a formed in vial receiving tube 101 in the manner shown in

figures 2A and 6A. A passageway 1 1 1 formed in end portion 40c communicates

with the fluid passageway 108a of hollow cannula 108 via a check valve 1 12,

which is mounted within a chamber 40e formed in housing 40. Check valve 1 12

permits fluid flow from vial reservoir 96b, into passageway 1 1 1 and then into inlet

passageway 60 and then finally into reservoir 58. However, check valve 1 12 effec¬

tively blocks fluid flow into the opposite direction.

In using the apparatus of the invention, reservoir 58 is initially filled by the

first fill means or assembly 86, with a diluent or other fluid. This done, container

subassembly 98 is mated with the adapter subassembly 96 by first telescopically

inserting the container subassembly into vial receiving tube 101. Next, a tear-away

closure cap 103a, which seals chamber 103 of lower housing 40d, is removed (fig¬

ures 6B and 7). This done, housing 68 of adapter the assemblage can be pushed

forwardly within annular space 107. As the adapter subassembly moves forwardly,

pusher rod 106 will engage plunger 104 causing the container assembly to also

move forwardly. As the container assembly approaches a seated position, piercing

cannula 108 will pierce septum assembly 100 of the container assembly. Once the

fluid flow path between the hollow cannula and the fluid reservoir 58 is thus cre¬

ated via passageways 1 1 1 and 60. a continued inward movement of the adapter

subassembly 88 will cause pusher rod 106 thereof to mo\ e plunger 104 forwardly of chamber 96b. As plunger 104 is moved forwardly, the medicament or other

fluid contained within chamber 96b of vial 96 will flow through passageway 108a

of the hollow cannula, past check valve 1 12, into passageway 1 1 1 and then into

fluid reservoir 58 where it will intermix with the diluent or other fluid contained

within the reservoir.

During the initial filling of the reservoir using the first fill means, membrane

46 will have been distended outwardly in the manner shown in figure 2 wherein

the central portion thereof is spaced from support 40. Rings 50 which are in

clamping engagement with support 44 function to seal the membrane against the

end portions of the support and prevent leakage of fluid between the membrane

and the support. As the distendable membrane expands outwardly, the displaced

air within housing 60 will be vented to atmosphere via vent means "V" provided in

housing 40.

After the medicament or other fluid contained within vial 96 has been added

to fluid reservoir 58 using the second fill means, the apparatus will remain in this

filled condition until the outlet flow path of the device is opened. Following open¬

ing of the outlet flow path, the stored energy means or membrane 46 will tend to

return to a less distended condition causing fluid to flow outwardly of the appara¬

tus via passageway 66, through rate control frit 74 and finally outwardly of the de¬

vice via delivery passageway 70. To interconnect passageway 70 with the patient. a conventional infusion set including a delivery line 71 is connected to connector

72 in the manner shown in figure 2. In this regard, it is to be noted that connector

72 includes a body portion 72a having a shoulder 73 and a hollow stem portion 72b

which sealably receives delivery tube 71 (see figure 6B).

End portion 40b of the device housing includes a hollow, generally cylindri¬

cally shaped housing 41 which is provided with a yieldably deformable, hook-like

locking tabs 41a (see also figure 4). Tabs 41a, which are constructed from a yield-

ably deformable plastic, lockably receive shoulder 73 of body portion 72b in the

manner shown in figure 2 so as to releasably secure connector 72 within housing

41 of end portion 40b.

Materials suitable for use in constructing housing 40 and support 44 include

metals, rubber or plastics that are compatible with the liquids they contact and are

preferably non-allergenic type material. Examples of such materials are: stainless

steel, aluminum, latex rubber, butyl rubber, nitrile rubber, polyisipreme, styrene-

butadiene copolymer. silicones, ployolefins such as polypropylene and polyethyl¬

ene, polyesters, polyurethane, polyamides and polycarbonates. Manufactures of

suitable materials for use in constructing the fluid dispensing assembly of the in¬

vention includes: Dow Coming of Midland, Michigan; General Electric of

Scenectadv. New York: and Shell Chemical Company of Houston, Texas; DuPont

.8 Chemical of Wilmington, Delaware; and Eastman Chemical of Kingsport, Tennes¬

see.

In order to securely lock the adapter subassembly 98 within support 44 after

the reservoir has been filled, novel locking means are provided. The locking

means here comprises a series of locking teeth 98d. As indicated in figure 2, these

locking teeth are constructed so that as the adapter subassembly 98 is moved in¬

wardly they will slide under a flexible locking tab 1 13a formed on a clip 1 13 (fig¬

ures 2 and 8) which is disposed proximate the entrance of receiving chamber 103.

However, once the adapter subassembly has reached the fully forward position

shown in figure 2, locking tab 40e will engage one of the teeth 96d and effectively

prevent removal of the adapter subassembly from passageway 107. With this

novel construction, once the reservoir 58 has been filled with the fluid "F" con¬

tained in the container subassembly, the adapter assembly cannot be removed from

the fluid dispensing device and, thereby preventing system adulteration.

Turning next to figures 9 through 26. an alternate form of the fluid dispenser

apparatus of the present invention is there shown. This latest embodiment com¬

prises an elongated housing 1 12 having an internal chamber 1 14, a support 1 16

disposed within internal chamber 1 14 and extending longitudinally of the housing

1 12 and a generally cylindrically shaped, elongated elastomeric member 1 18. Housing 1 12 comprises a cylindrically shaped central portion 1 12a and inlet

and outlet end plates 1 12b and 1 12c respectively. Central section 1 12a and end

plates 1 12b and 1 12c may be interconnected by any suitable means such as adhe¬

sive bonding or an appropriate sonic weldment. Elastomeric member 1 18 is se¬

curely affixed proximate its ends to support 1 16 by means of suitable ring clamps

120 such as self-locking plastic panduit strips.

As best seen by referring to figure 10, support 1 16 is provided with a first

elongated receiving chamber 124. A fluid passageway 126 which, in a manner

presently to be described, is in communication both with chamber and with a res¬

ervoir 128. Reservoir 128 is uniquely formed by elastomeric member 118 and the

central portion 1 16a of support 1 16 and communicates with passageway 126 via a

fluid passageway 130 formed in support 1 16. Naive means, shown here as a check

valve 132, which is carried within a chamber formed in support 1 16. permits fluid

flow toward reservoir 128 but blocks fluid flow in the opposite direction.

Support 1 16 is also provided with a second downstream chamber 134 which

has an inlet passageway 136 that communicates with reservoir 128 via passage¬

ways 136a formed in support 1 16. Chamber 134 is in communication with the

fluid dispensing means of the invention which includes a fluid delivery passage¬

way 138 formed in a luer connector 140 that is provided at the outlet end of sup¬

port 1 16. As indicated in figure 10, fluid delivery passageway 138 of the fluid dis- pensing means communicates with reservoir 128 via a filter means and the previ¬

ously identified passageways 136 and 136a. The filter means here comprises a po¬

rous filter element 144 of conventional construction and functions to filter out any

particulates contained within the fluid to be delivered to the patient.

An extremely important feature of the apparatus of the present invention is

the flow rate control means for adjustably controlling the rate of fluid flow from

the reservoir of the apparatus to the delivery passageway 138. This novel means

here comprises an adjustable rate control mechanism 147 which is carried by hous¬

ing 112. As best seen in figure 1 1 , mechanism 147 includes a body portion 150

having an elongated stem 152 which is receivable within second chamber 134 of

support 1 16 and a forward portion 153 which includes luer like connector 140.

Body portion 150 also includes a fluid passageway 154 which is in communication

with both inlet passageway 136 and fluid delivery passageway 138. Rotatably car¬

ried intermediate forward portion 153 and body portion 150 is a control knob 156.

O-rings 157 carried by portions 147 and 150 sealably engage control knob 156 and

prevent leakage among the various cooperating components.

Mounted within control knob 156 and rotatable therewith is a control mem¬

ber 158. As shown in figure 12, control member 158 carries a plurality of circum-

ferentially spaced apart flow restrictors each of which can be selectively moved

into index with flow passageway 154 of body 150 by rotating knob 156 relative to body portion 150. In the embodiment of the invention shown in figures 9 through

14, the flow restrictors are provided in the form of rate control frits 160 (see fig¬

ures 10 and 12), which are secured in place within apertures 158a formed in mem¬

ber 158 by a moldable elastomer 169 (see figure 12). With the construction

shown, by rotating knob 156 relative to body portion 150, each of the rate control

frits 160 can be moved sequentially into alignment with passageway 154. Because

each of the frits 160 is of a different, preselected porosity, it is apparent that the

rate of fluid flowing outwardly of the device through delivery passageway 138 can

be precisely controlled by positioning a particular frit in the flow path.

Turning to figures 15 through 17, an alternate form of rate control mecha¬

nism 162 is there shown. This rate control mechanism is similar in many respects

to mechanism 147 and like numerals are used to identify like components. The

major difference between mechanisms 147 and 162 resides in the differently con¬

figured control member 163 which here comprises a thin wafer having circumfer-

entially spaced, laser-drilled microbores 163a (figure 17). Member 163 is carried

by a slightly different control knob 164 which includes a central wall 164a which

supports one face of member 163. The other face of member 163 is supported by a

spacer wall 165 which abuts body portion 150 which is of the general configura¬

tion previously described. Members 163 and 165 are provided with indexable ap¬

ertures 163a and 165a respectively, which align with fluid passageway 154 of member 150. By rotating control knob 164, a selected core of the laser drilled mi-

crobores 163a can be moved into alignment with apertures 163a and 165a. by se¬

lecting an aperture of a particular size, the rate of fluid flow toward outlet pas¬

sageway 138 can be precisely controlled.

Turning once again to figure 10, the important fill means of the present form

of the apparatus comprises a container subassembly 166, and an adapter subassem¬

bly 168, the character of which will presently be described. Container subassem¬

bly 166 includes a body portion 166a having a fluid chamber 166b for containing

an injectable fluid "F". Fluid chamber 166b is sealably closed by closure means

here provided in the form of a pierceable septum assembly 170 (figure 10A). Sep¬

tum assembly 170 is held securely in position by clamping ring 170a. A plunger

172 is telescopically movable within chamber 166b of container subassembly 166

from a first location proximate first open end 169b to a second position proximate

second open end 169a. The vial portion of the container subassembly 166 can be

constructed of various materials such as glass and plastic.

Adapter subassembly 168 comprises a hollow housing 168a having a first

open end 168b (figure 1 1) and a second closed end 168c (figure 10). Container

subassembly 166 is telescopically receivable within open end 168b in the manner

shown in figures 10 and 1 1 so that the housing can be moved from an extended po¬

sition into the vial encapsulation position shown in figure 10. Forming an impor- tant part of adapter subassembly 168 is pusher means shown here as an elongated

pusher rod 171 which functions to move plunger 172 within fluid chamber 166b

from a first extended position to the intermediate position shown in figure 10. In

the form of the invention shown in the drawings, pusher rod 171 has a first end

171a interconnected with the closure wall of housing 168a and an opposite end

171b which engages plunger 172 and causes telescopic movement ofthe plunger

within chamber 166b of container subassembly 166 as housing 168a is moved

from the extended position into the vial encapsulating position shown in figure 10.

As best seen in figure 1 1, hollow piercing cannula 176 is connected to sup¬

port 1 16 proximate receiving chamber 124 so that it extends into receiving cham¬

ber 124 a limited distance. Passageway 130 communicates with the fluid passage¬

way 176a of hollow cannula 176 via check valve 132 to enable fluid to flow from

vial 166a through the filter means and then outwardly of the device through outlet

passageway 138. The filter means, which here comprises filter 144, can be con¬

structed from a wide variety of materials, but a material comprising polysulfone

sold by Gelman Sciences under the name and style of SUPOR has proven satisfac¬

tory for the purpose.

In using the apparatus of the invention, mating of the container subassembly

166 with the adapter subassembly 168 is accomplished by a telescopically inserting

the container subassembly into open end 168b of housing 168. This done, the as-

2 semblage thus formed is pushed forwardly of chamber 124. As the adapter subas¬

sembly approaches a seated position, cannula 176 will pierce septum assembly

170. Once the fluid flow path between the hollow cannula and the fluid reservoir

128 is thus created via passageway 126 and 130, a continued inward movement of

the adapter subassembly 188 will cause pusher rod 171 to move plunger 172 for¬

wardly of chamber ϊ 66b. As plunger 172 is moved forwardly of chamber 166b,

fluid contained within the chamber will flow through passageway 176b of the hol¬

low cannula, past check valve 132, into passageway 130, into passageway 126. and

then into fluid reservoir 128. As the fluid under pressure flows into reservoir 128,

membrane 1 18 will be distended outwardly in the manner shown in figure 10

wherein the central portion thereof is spaced from support 1 16. Rings 120 which

are in clamping engagement with support 1 16 function to seal the membrane

against the end portions of the support and prevent leakage of fluid between the

membrane and the support. As the distendable membrane expands outwardly, the

displaced air within housing 160 will be vented to atmosphere via vent means "N"

provided in end plate 1 12b.

Once distendable membrane 1 18 is distended to form fluid reservoir 128, the

apparatus will remain in this filled condition until outlet passageway 138 of the

luer-like connector assembly 140 is opened. With outlet passageway 138 opened,

the stored energy means or membrane 1 18 will tend to return to a less distended condition causing fluid to flow outwardly of the apparatus via passageway 130,

through filter 144, then through passageway 154 and finally outwardly of the de¬

vice via delivery passageway 138.

Materials suitable for use in constructing housing 1 12 and support 1 16 in¬

clude metals, rubber or plastics that are compatible with the liquids they contact

and are preferably non-allergenic type material. Examples of such materials are:

stainless steel. Aluminum, latex rubber, butyl rubber, nitrile rubber, polyisipreme,

styrenebutadine copolymer, silicones, polyolefms such as polypropylene and poly¬

ethylene, polyesters, polyurethane polyamides and polycarbonates. Manufactures

of suitable materials for use in constructing the fluid dispensing assembly of the

invention includes: Dow Corning of Midland, Michigan; General Electric of

Scenectady, New York; and Shell Chemical Company of Houston, Texas; DuPont

Chemical of Wilmington, Delaware; and Eastman Chemical of Kingsport, Tennes¬

see.

In order to securely lock the adapter subassembly 168 within support 1 16

after the reservoir has been filled, novel locking means are provided. The locking

means here comprises a series of locking teeth 180. As indicated in figure 10,

there locking teeth are constmcted so that as the adapter subassembly 168 is moved

inwardly they will slide under a flexible locking tab 182. which is provided proxi¬

mate the entrance of receiving chamber 124. However, once the adapter subas- sembly has reached the fully forward position shown in figure 10, locking tab 182

will engage one of the teeth 180 and effectively prevent removal of the adapter

subassembly from passageway 124. With this novel constmction, once the reser¬

voir 128 has been filled with the fluid "F" contained in the container subassembly,

the adapter assembly cannot be removed from the fluid dispensing device thereby

preventing system adulteration.

Turning next to figures 20 through 26, another form of the apparatus of the

invention is there shown. This apparatus is similar in constmction and operation to

that shown in figures 9 through 17 and includes the previously described adjustable

rate control mechanism. However, this latest form of the invention also uniquely

includes novel flow indicator means. This important flow indicator means, which

is generally designated by the numeral 187, functions to distinguish among three

conditions of operation, namely nom al fluid flow, blockage or occlusion, and res¬

ervoir empty. Turning particularly to figure 21, the flow indicator means here

comprises an indicator base or platform 188, as well as a boot clamping plate 190.

Additionally, the indicator means comprises a support or lens plate 192, and a hol¬

low housing 194 within which the platform and the support plate are enclosed (see

also figure 20). As indicated in figures 20 and 21 , plate 192 is viewable through an

aperture 194a provided in housing 194. Disposed between lens plate 192 and platform 188 are first and second indi¬

cia-carrying means shown here as a pair of closely adjacent, thin films. These

films identified here as 196 and 198, are in intimate contact and are preferably con¬

structed from a substantially transparent, flexible polymer material such as mylar.

It is to be understood that the indicia-carrying means need not be thin films, but

rather can be any type of surface presenting member upon which indicia can be

provided. The downstream surface of the inferior or first film 196 is printed with

three integrated symbols (see figures 4,6, and 8 or incorporated by reference Patent

No. 5,721 ,382, which may comprise, by way of example, a blue circle, a green ar¬

row, and a red cross, each consisting of diagonal strips of color printed in an alter¬

nating pattern (blue, green, red, blue, green, red, and so on). The second film 198

serves as a "mask" over film 196 and is printed with a pattern of diagonal alternat¬

ing clear and opaque strips that occur in approximately a 1 :2 ratio. The printed ra¬

tio of the "mask" allows only one colored symbol to appear at a time when viewed

through viewing lens plate 192. The inferior and superior films are provided at

their opposite ends with apertures 200 which receive retention pins 202 provided

on platform 188 (figure 19) which permit attachment of the film to platfomi 188 in

a manner such that the non-pattemed portions of each film covers boot openings

188a and 188b provided proximate each end of platform 188 with the patterned

portions of both the superior and inferior films being maintained in index. With this constmction, each thin film is able to move in response to pressure exerted

thereon by the actuating means of the invention, the character of which will pres¬

ently be described, in opposing directions parallel to the film plane with its range

of motion limited to one axis in the film plane. As the films move, the visible

symbol pattern will, of course, change due to the transverse displacement of the

patterns imprinted thereon.

As will be discussed in greater detail hereinafter and as is apparent from a

study of figure 21, the central portions of both the first and second elastomeric ac¬

tuator elements or boots 204 and 206, which here comprise the actuator means of

the invention, will be deflected outwardly in a direction toward plate 192 when the

device is filled and primed, but not in a state of delivery or when there is a build up

of fluid pressure during delivery that is caused by blockage of the delivery line

downstream from boot 204. While boot 204 can be deflected by normal line pres¬

sure, boot 206 is deflected only by pressure buildup resulting from the downstream

blockage. When both elastomeric boots 204 and 206 are deflected outwardly, both

the superior and inferior films are displaced transversely to a second position re¬

vealing a second symbol, as for example, an X as viewed through the viewing ap¬

erture of the support plate (see also figures 35 and 36 of Patent No. 5,721 ,382

which is incorporated herein by reference). A third alignment of symbol patterns as shown in figure 32 of patent No.

5,721,382 is visible when the device is in an unfilled state or when the delivery line

is open, the reservoir is empty and fluid delivery of the patient has been completed.

In this case, there is no fluid pressure in the line on either the upstream or the

downstream side of the flow control means and thus both the first and second boots

are in a non-deflected position. In this condition, the interior and superior films are

not transversely displaced and thus exhibit a third combination of patterns resulting

in a third symbol as. for example, a circle being visible through the viewing aper¬

ture of the support plate. Boots 204 and 206 can be precisely tailored to deflect

under various pressures thereby permitting great apparatus versatility.

As previously mentioned, the fluid dispenser apparatus of this latest form of

the invention is quite similar to that shown in figures 9 through 16 and includes an

elongated housing 1 12 having an internal chamber 1 14 and extending longitudi¬

nally of the housing 1 12, and a generally cylindrically shaped, elongated elas¬

tomeric member 1 18 (figure 20).

As before, housing 1 12 comprises a cylindrically shaped central portion and

inlet and outlet closure end plates. End plate 1 12b is of identical constmction and

operation to that previously described, but the forward end plate 205 is of a slightly

different construction and carries the flow indicator means 187 (figure 21 ). In the

manner previously described, elastomeric member 1 18 is securely affixed proxi- mate its ends to support 1 16 by means of suitable ring clamps 120 such as self-

locking plastic panduit strips.

As best seen by referring to figures 20 and 21 , end plate 205 is provided

with a chamber 208 which sealably receives plate 190 so that, in a manner pres¬

ently to be described various fluid passageways formed in end plate 205 are placed

in communication with reservoir 128.

As in the earlier describe embodiment of the invention, a novel flow rate

control means is here provided for adjustably controlling the rate of fluid flow

from the reservoir of the apparatus to the delivery passageway 210 of the appara¬

tus. This means here comprises an adjustable rate control mechanism 212 which is

carried by a forwardly extending, hub-like protuberance 214 formed on plate 190.

Rotatably mounted on protuberance 214 is the control knob 216 of the rate control

means. O-rings 218 carried by protuberance 214 sealably engage control knob 216

and prevent leakage therebetween. A flexible tab 216a which is connected to the

housing functions to correctly index the knob (figure 21).

Control knob 216 is somewhat similar to control knob 164 and includes a

central wall 216a which supports one face of member 220 which is provided with a

plurality of circumferentially spaced, laser drilled microbores 220a. The other face

of member 220 is supported by a spacer wall 222 which abuts cover 205 (figure

20). Members 216a and 222 are provided with indexable apertures 223 and 225 respectively, which are aligned with a fluid passageway 226 formed in member

190. By rotating control knob 216, a selected one of the laser drilled microbores

216a can be moved into alignment with apertures 223 and 225. In a manner next

to be described, by selecting an aperture of a particular size, the rate of fluid flow

toward outlet passageway 210 can be precisely controlled.

During the fluid dispensing step, when fluid is forced through reservoir out¬

let 136a by the stored energy means, the fluid will flow into passageway 136,

through filter 144 and then into passageway 154. Next, the fluid will flow in end

portion 205, then through an aperture 246 formed in plate 190 and finally into a

chamber 250 formed in a distendable, elastomeric first boot 206 of the flow indica¬

tor means of the invention. Boot 206 includes a yieldably distendable fluid flow

blocking body portion 252 which is circumscribed by a marginal portion 254.

Marginal portion 254 is clamped between plate 190 and platform 188 so that the

boot extends through opening 188a formed in platform 188. It is to be understood

that, when the fluid flowing from reservoir 128 in the direction of arrow 260 im¬

pinges upon boot 206, the central portion of the boot will be deflected outwardly

into pressural engagement with indicator film 198.

Fluid flowing from reservoir 128 will also flow in the direction of arrow 264

(figure 21 ) into a stub passageway 266 formed in member 205 and then into pas¬

sageway 226 (figure 22 ) when it will pass through the flow restrictor aperture 220a that is aligned with passageway 226. Next, the fluid will flow into passageway

266 and then will be diverted in the direction of arrows 268 of figure 20 rearwardly

toward end portion 205 and into a passageway 270 formed thereon.

Next, the fluid will flow through passageway 270 and then forwardly in the

direction of the arrows 274, through an aperture 275 formed in plate 190 and into

chamber 276 formed in elastomeric, distendable boot 204 which also forms a part

of the indicator means of the invention. The periphery 278 of indicator boot 204,

which is of identical constmction to boot 206, is clamped within opening 188a

formed in platform 188. After impinging on boot 204, the fluid will next flow

back toward plate 190 in the direction of arrow 280, through orifice 284 formed

therein and then in the direction of arrows 286, into a passageway 290 formed in

end portion 205. Upon entering passageway 290, the fluid will flow downwardly

of passageway 210 (figure 22) and finally in the direction of arrow 294 into the de¬

livery line 296 which is connected to the outlet port of the device (figure 20).

It is to be observed that fluid flowing from reservoir 128 into passageway

266, into passageway 290 and then on toward boot 204 is under a lower pressure

than fluid flowing toward boot 206. This is because the pressure of the fluid flow¬

ing toward boot 204 has been reduced as a result of the fluid flowing through the

adjustable rate control means of the invention. As will be discussed more fully in

the paragraphs which follow, this result enables a determination of the various fluid flow operating conditions of the device namely normal fluid flow, fluid flow

blockage or occlusion, and reservoir empty.

In addition to boots 204 and 206, the flow indicator means also comprises

the earlier identified lens 192, and the forward housing 194 within which the plat¬

form 188 and the support plate 192 are enclosed (figure 20). As seen in figure 20,

the viewing lens 194 is viewable through an opening 194a provided in forward

housing 194. Disposed between platform 188 and lens 192 are the earlier men¬

tioned first and second indicia-carrying means, or closely adjacent overlaying then

films 196 and 198. These films are quite similar in constmction and operation to

films 26 and 28 of the device described in incorporated by reference Patent No.

5,721 ,382 and, for a more complete understand of these films, reference should be

made to this patent. Films 196 and 198 are in intimate contact and are preferably

constmcted from a substantially transparent, flexible ploymer material such a my¬

lar. The downstream surface of the inferior or first film 196 is printed with three

integrated symbols (see figure 3 of United States Patent NO. 5,721.382 which may

comprise, by way of example, a blue circle, a green arrow, and a red X, each con¬

sisting of diagonal strips of color printed in an alternating pattern (blue, green, red,

blue, green, red. and so on (see figures 4. 6 and 8 of Patent No. 5,721 ,382). The

second film 198 serves as a "mask" over film 196 and is printed with a pattern of

diagonal alternating clear and opaque strips that occur in approximately a 1 :2 ratio. The printed ratio of the "mask" allows only one colored symbol to appear at a time

when viewed through viewing lens 192. As previously mentioned, the inferior and

superior films are provided at their opposite ends with apertures 200 which receive

retention pins 202 provided on platform 188 which permit attachment of the films

to platform 188 in a manner such that the non-patterned portions of each film cov¬

ers boot openings 188a and 188b provided proximate each end of platform 188

with the patterned portions 188a and 188b provided proximate each end of plat¬

form 188 with the patterned portions of both the superior and inferior films being

maintained in index. With this constmction, each thin film is able to move in re¬

sponse to pressure exerted thereon by the elastomeric boots 204 and 206 in oppos¬

ing directions parallel to the film plane with its range of motion limited to one axis

in the film plane. As more fully described in United States Patent No. 5, 721 ,382,

as the films move, the visible symbol pattern will, of course, change due to the

transverse displacement of the patterns imprinted thereon. As is apparent from a

study of figure 21 , that the central portions of both the first and second elastomeric

actuator elements or boots 204 and 206 will be deflected outwardly toward films

196 and 198 when the device is filled and primed, but not in a state of delivery or

when there is a build up of fluid pressure during delivery that is caused by block¬

age of the delivery line downstream from boot 204. While boot 206 can be de¬

flected by normal line pressure, boot 204 is deflected only by pressure buildup re- suiting from the downstream blockage. When both elastomeric boots 204 and 206

are deflected outwardly, both the superior and inferior films are displaced trans¬

versely to a second position revealing a second symbol, as for example, an X as

viewed through the viewing aperture 194a. When fluid is flowing through the de¬

vice, an indicia, for example, is visable through the viewing window.

A third alignment of symbol patterns is visible when the device is in an un¬

filled state or when the delivery line is open, the reservoir if empty and fluid deliv¬

ery to the patient has been completed. In this case, there is no fluid pressure in the

line on either the upstream or the downstream side of the flow control means and

thus both the first and second boots are in a non-deflected position. In this condi¬

tion, the inferior and superior films are not transversely displaced and thus exhibit

a third combination of patterns resulting in a third symbol as for example, a circle

being visible through the viewing aperture of the support plate. Boots 204 and 206

can be precisely tailored to deflect under various pressures thereby permitting great

apparatus versatility. Reference should also be made to United States Patent No.

5,721 ,382, which patent is incorporated by reference herein, for further discussion

of the constmction and operation of the indicator means of the invention.

The fill means of this latest form of the invention is identical in constmction

and operation to that of the earlier described embodiment and includes a container subassembly and an adapter subassembly of the same character as previously de¬

scribed.

Turning next to figures 27 through 36, still another form of the fluid dis¬

penser apparatus of the invention is there illustrated and generally designated by

the numeral 300. This latest form of the invention is similar in many respects to

that shown in figures 1 through 26 and like numerals are used to identify like com¬

ponents. As in the embodiment shown in figures 1 through 8, the present embodi¬

ment comprises an elongated housing 302 having a first internal chamber 304, a

support 306 disposed within internal chamber 304 and extending longitudinally of

the housing 302, and a stored energy means provided in the form of a generally cy¬

lindrically shaped, elongated elastomeric member 308 (figure 28).

Housing 302 comprises a cylindrically shaped central portion 302a and inlet

and outlet closure portions 302b and 302c respectively. Central section 302a can

be connected to end plates portions 302b and 302c by any suitable means such as

adhesive bonding or an appropriate sonic weldment. Elastomeric member 308 is

securely affixed proximate its ends to support 306 by means of suitable ring

clamps 310 such as self-locking plastic panduit strips.

As best seen by referring to figure 28, support 306 is provided with a first

chamber 312 having a fluid inlet 3 13 which, in a manner presently to be described,

is in communication with the first fill means of the invention for filling a reservoir 314 with a diluent or like fluid. Reservoir 314 is formed by elastomeric member

308 and the central portion 306a of support. Naive means, shown here as a check

valve 316 is disposed within chamber 312 and functions to permit, fluid flow to¬

ward reservoir 314, but blocks fluid flow in the opposite direction.

Support 306 is also provided with a second chamber 320 having an inlet pas¬

sageway 322 which includes transversely extending segments 322a. A fluid dis¬

pensing means, including a fluid delivery passageway 324 formed in luer connec¬

tor 326 is provided proximate the outlet end of the device. As shown in figure 28,

delivery passageway 324 is in communication with inlet passageway 322 via the

novel adjustable flow rate control means of the invention. Disposed within cham¬

ber 320 is a filter means, which here comprises a porous filter element 330 of con¬

ventional constmction. Filter element 330 functions to filter particulate matter that

may be contained within the fluid flowing from reservoir 314.

The previously mentioned flow rate control means of this latest form of the

invention is substantially identical to that shown in figures 9 through 14 and earlier

described herein and like numbers are used in the drawings to identify like compo¬

nents. As before, this important means functions to precisely control the rate of

fluid flow from the reservoir of the apparatus to the delivery passageway 324 and

includes the previously described adjustable rate control mechanism which is car¬

ried proximate the outlet of the device. More particularly, as best seen in figure 28, the mechanism here comprises a part of end portion 302c which includes a

hub-like portion 350 having an elongated stem 352 which is receivable within sec¬

ond chamber 320 of support 306. Provided at the forward portion of the assem¬

blage is the previously identified luer-like conductor 326. Hub-like portion 350

and stem portion 352 are provided a with passageway 354 which is in communica¬

tion with both inlet passageway 322 and with fluid delivery passageway 324. Ro¬

tatably carried by hub-like portion 350 is a control knob 356. O-rings 357 carried

by portions 350 sealably engage control knob 356 and prevent leakage among the

various cooperating components.

Mounted within control knob 356 and rotatable therewith is control member

158. As in the earlier described embodiments of the invention, control member

158 carries a plurality of circumferentially spaced apart flow restrictors 160 each

of which can be selectively moved into index with flow passageway 354 of body

350 by rotating knob 356 relative to body portion 350. As in the embodiment

shown in figure 12, the flow restrictors are provided in the form of rate control frits

160 which are secured in place within apertures 158a formed in member 158 by a

moldable elastomer 159. With the constmction shown, by rotating knob 356 rela¬

tive to body portion 350. each of the rate control frits 160 can be selectively moved

into alignment with passageway 254. Because each of the frits 260 is of a differ¬

ent, preselected porosity it is apparent that the rate of fluid flowing outwardly of the device through delivery passageway 224 can be precisely controlled by select¬

ing a frit of the desired porosity.

Turning once again to figure 28, the second fill means of the invention is

somewhat similar to that shown in figures 1 and 2 and, once again, like numbers

are used to identify like components. This second fill means here comprises a con¬

tainer subassembly 166, and an adapter subassembly 332. Container subassembly

166 is identical to that previously described in connection with figures 10 and 1 1

and includes a body portion 166a having a fluid chamber 166b for containing an .

injectable fluid "F". Fluid chamber 166b is provided with first and second open

ends 169a and 169b. First open end 169a is sealably closed by closure means here

provided in the form of a pierceable septum 170 (see also figure 11). Septum 170

is held securely in position by clamping ring 160a. A plunger 172 is telescopically

movable within chamber 166b of container subassembly 166 from a first location

proximate first open end 169b to a second position proximate second open end

169a. As before, the vial portion of the container subassembly 166 can be con¬

stmcted of various materials such as glass and plastic.

Adapter subassembly 332, which is of a slightly different constmction from

that of adapter subassembly 168, here comprises a hollow housing 332a having a

first open end 332d and a second closed end 332e. In using the apparatus of this

latest form of the invention, container subassembly 166 can be telescopically in- serted into the open end 333a of a vial receiving tube 333 which is, in turn, re¬

ceived within an elongated, generally cylindrically spaced chamber 334 formed in

the upper portion 302d of housing 302. With this constmction, hollow housing

332a can be moved from the extended position shown in figure 28 into a vial en¬

capsulation position wherein the vial resides interiorly of the adapter subassembly.

Forming an important part of adapter subassembly 332 is pusher means shown

here as an elongated pusher rod 335 which functions to move plunger 172 longitu¬

dinally of fluid chamber 166b from a first extended position to the position shown

by the solid lines to a second position shown by the phantom lines of figure 28.

Pusher rod 335 has a first end 335a interconnected with the closure wall 332e of

housing 332 and an opposite end 335b which engages plunger 172 and causes tele¬

scopic movement of the plunger within chamber 166b of container subassembly

166 as housing 332a is moved within an annular space 236 formed between vial

receiving tube 333 and chamber 334 of device housing portion 302d.

As best seen in figure 32B, a hollow piercing cannula 338 is connected to a

support wall 340 formed on vial receiving tube 333. Cannula 338 extends into re¬

ceiving chamber 333a formed in vial receiving tube 333 so that it can pierceably

engage septum 170 of the fill vial assembly. A fluid passageway 302d formed in

end portion 302b of device housing 302 communicates with internal the fluid pas¬

sageway of hollow cannula 338 via a check valve 349 which is mounted within a chamber 302e formed in end portion 302b to enable fluid flow from vial 166, past

the check valve, and into an inlet passageway 360 formed in end portion 302b.

The fluid can then flow into reservoir 314 via a check valve 361 and inlet pas¬

sageway 363 (figure 28). Check valve 361 permits fluid flow toward reservoir 214

but blocks fluid flow in the opposite direction.

In using this latest form of the invention, which is shown in figures 28

through 36, the first fill means, which includes a luer-like connected or 364, can be

used, by way of example, to initially fill reservoir 314 with a saline solution. Luer-

like connector 364 comprises a part of the fill port assembly 366 of the invention

which cooperates with end portion 202b of housing 202 to form the earlier identi¬

fied chamber 213. Fill port assembly 366 can be suitably interconnected with a

conventional male luer connector and fill line (not shown) which can be connected

to a suitable source of diluent or like fluid. A conventional luer cap (not shown)

can be used to sealably close connector 360 when it is not in use.

In using the apparatus of the invention, mating of the container subassembly

166 with the adapter subassembly 332 is accomplished by telescopically inserting

the container subassembly into vial receiving tube 333. This done, housing 332a

of the assemblage is controllably moved forwardly within annular space 336. As

the adapter subassembly moves forwardly, pusher rod 335 will engage plunger 172

causing the container assembly to also move forwardly. As the container assembly approaches a seated position, piercing cannula 338 will pierce septum assembly

170 of the container assembly. Once the fluid flow path between the hollow can¬

nula 338 and the fluid reservoir 314 is thus created via passageway 302d, 360 and

363, a continued inward movement of the adapter subassembly 332 can be here ac¬

complished by a novel advancement means, the constmction and operation of

which will presently be described. As the adapter subassembly moves inwardly

pusher rod 335 will move plunger 172 forwardly of chamber 166b. As plunger

172 is moved forwardly, fluid contained within vial chamber 166b, will flow

through hollow cannula 338. past check valve 349, into passageway 302 into inlet

passageways 360 and 363 and finally into fluid reservoir 314 where it will control¬

lably intermix with a saline solution or the like which has previously been intro¬

duced into reservoir 314 using the first fill means of the invention.

Considering the previously identified advancement means of the invention,

this means here comprises a control knob 370, which is rotatably mounted within

an enlarged diameter, mouth-like portion 372 formed on upper device housing por¬

tion 202d (figures 28 and 32B). Control knob 370 is held in place within portion

372 by means of knob engaging tabs 374 provided on a retaining ring 374. The de¬

tails of constmction of knob 370 and retaining ring 374 are illustrated in figures 33,

34, 35 and 36. As indicated in figure 34, control knob 370 is provided with an ex¬

ternal thread 370a which mates with threads 332c fomied on adapter housing 332a of adapter assembly 332. With this construction, as knob 370 is rotated by rota¬

tional forces exerted on finger tabs 370ba, adapter housing 332a will be caused to

controllably move inwardly of annular space 330 causing pusher rod 335 to move

plunger 172 inwardly of vial 166 in the manner previously described. In this way

precise incremental amounts of the medicament contained within vial 166 can be

controllably introduced into reservoir 314 and intermixed with the saline solution

earlier introduced via the first fill means or fill port assembly 366. As shown in

figures 27 and 30, knob 370 is provided with antirotation teeth 370b which engage

ring 374 to prevent reverse rotation of the knob. Additionally, locking teeth are

provided on adapter body 332a, which locking teeth function in the manner earlier

described to prevent removal of the adapter assembly after it has been advanced

into housing portion 302d.

Once the desired amount of medicament contained within vial 166 has been

mixed with the saline solution or other diluent contained within reservoir 314, the

apparatus will remain in this filled condition until outlet passageway of the device

is opened. Once the outlet passageway has been opened, the stored energy means

or membrane 308 will tend to return to a less distended condition causing fluid to

flow outwardly of the apparatus via passageway 322, through filter 330 and then

through the selected rate control frit of the rate control means and finally out- wardly of the device via delivery passageway 324. For this purpose, a delivery

line 377 can be connected to connector 326 in the manner depicted in figure 27.

Referring to figures 37 through 54, still another form of the apparatus of the

invention is there shown and generally designated by the numeral 400. This appa¬

ratus is somewhat similar to that shown in figures 1 through 8, but here includes

two fill vials rather than one. Because of the similarity between this latent em¬

bodiment and that shown in figures 1 through 8, like numerals are used in figures

37 through 54 to identify like components. As best seen in figures 37, 38, and 39,

this latest form of the invention comprises an elongated housing 401 having an in¬

ternal chamber 402, a support 404 disposed within internal chamber 402 and ex¬

tending longitudinally of the housing 401 and a generally cylindrically shaped,

elongated elastomeric member 46.

Housing 401 comprises a cylindrically shaped central portion 401a and inlet

and outlet end closure portions 401b and 401c respectively. Central section 401a

and end portion 401b can be interconnected by any suitable means such as adhe¬

sive bonding or an appropriate sonic weldment. End portion 401c is preferably in¬

tegrally formed with central portion 401a although it could be formed as a separate

component. The reservoir forming elastomeric member, which is identical to the

previously described elastomeric member 46, is securely affixed proximate its ends to support 404 by means of suitable ring clamps 50 such as the previously identi¬

fied, self-locking plastic punduit strips.

As before, support 404 is constmcted in two parts 404a and 404b which are

suitably interconnected in the manner shown in figures 2 and 3a. Part 404a has a

fluid inlet 407 which is in communication with a reservoir 58 formed by elas¬

tomeric member 46 and support 404 via a fluid passageway 410. Naive means,

shown here as a check valve 62 which is disposed within a chamber 409a formed

in an end cap 409, permits fluid flow in a direction toward reservoir 58 but blocks

fluid flow in the opposite direction.

Second part 404b of support 404 has an outlet passageway 412 which com¬

municates with the delivery means of the invention for delivering fluid to the pa¬

tient. The delivery means includes a fluid delivery passageway 414 formed in a

quick disconnect assembly which includes a housing 72 of the character previously

described. The quick disconnect assembly, which is identical to that shown in fig¬

ure 2, can be readily releasably interconnected with end portion 401b of housing

401. Fluid delivery passageway 412 communicates with reservoir 58 and also with

passageway 414 via a flow rate control means, here provided as a porous rate con¬

trol frit 74 which is identical in constmction and operation to that previously de¬

scribed and which is mounted within quick disconnect housing 72. An important feature of the apparatus of the present invention is the provi¬

sion of a side-mounted sampling means for sampling and retrieval of fluid con¬

tained within reservoir 58. As best seen in figures 37 and 40, the sampling means

hear comprises a sampling port assembly 418 which is carried by end portion 401b

of support 401. Sampling port assembly 418 includes a septum 420, which is re¬

ceived within a chamber 422 formed in housing end portion 401b, and a clamping

ring 424 for clamping the septum in place within chamber 422. As before, the use

of a sampling means such as a conventional syringe, the contents of reservoir 58

can be sampled at any time and, after the delivery step, any medicament remaining

in the reservoir can be retrieved for subsequent use.

Formed in end cap 409 is a first fill means for filling reservoir 58 with a di¬

luent such as a saline solution or with any other desired fluid. This first fill means

here comprises a first fill port assembly 426 which includes a chamber 428 for in

cap 409. Sealably disposed within chamber 428 is a conventional male luer

connector 430 which can be suitably connected with a conventional female luer

connector and fill line (not shown). A conventional luer cap 432 sealably closes

connector 430 which is it not in use. As was earlier the case, connector 430 can

include a conventional check valve to permit fluid flow toward reservoir 58 but to

block flow in the opposite direction. With a suitable female luer connector con¬

nected to connector 430 and with the fill line connected to a source of diluent res- ervoir 58 can be partially filled with the diluent in a manner well understood by

those skilled in the art.

Turning particularly to figures 37, 38, and 39, the second fill means of the

invention for adding fluid to reservoir 58 is there illustrated. This second fill

means is of similar constmction to that shown in figures 1 , 2, and 6 and comprises

a container subassembly 96, and an adapter subassembly 98, which are of identical

constmction and operation to those previously described herein

As in the earlier embodiment, container subassembly 96 is telescopically re¬

ceivable within open end 431 a of a vial receiving tube 431 which, in turn is re¬

ceived within an elongated, generally cylindrically spaced chamber 433 formed in

portion 40 I d of housing 401. With this constmction, hollow housing 98a can be

moved from the extended position shown in figure 39 into a vial encapsulation po¬

sition wherein the vial resides interiorly or the adapter subassembly. Adapter sub-

assembly 98 includes pusher means comprising an elongated pusher rod 106 which

functions to move plunger 104 longitudinally of fluid chamber 96b. As shown in

figure 39, pusher rod 106 has an opposite end 106b which engages plunger 104 and

causes telescopic movement of the plunger within chamber 96b of container subas¬

sembly 96 as housing is moved within chamber 433 which is formed between vial

receiving tube 43 1 and the outer wall of housing portion 40 Id. A hollow piercing cannula 108 is connected to support wall 436 formed on a

vial receiving tube 431 and extends into receiving chamber 43 l a formed in vial re¬

ceiving tube 331. A passageway 438 formed in closure cap 409 communicates

with the fluid passageway of hollow cannula 108 via a check valve 442 which is

mounted within a chamber 409b formed in cap 409. Check valve 442 permits fluid

flow from vial reservoir 96b, into passageway 438 and then into inlet passageway

407 via check valve 62 and then finally into reservoir 58. However, check valve

442 effectively blocks fluid flow into the opposite direction.

Uniquely, this latest embodiment of the invention includes third fill means

for adding fluid to reservoir 58. This third fill means is of similar constmction to

the second fill means and is adapted to receive a container subassembly 96, and an

adapter subassembly 98 of the character previously described.

In using this third fill means, container subassembly 96 is uniquely tele¬

scopically receivable within the open end 445a of a vial receiving tube 445 which,

in turn, is disposed within an elongated, generally cylindrically shaped chamber

447 formed in portion 40 le of housing 401 (figures 37 and 39). As before, a hol¬

low housing 98a can be moved from an extended position into a vial encapsulation

position wherein the vial resides interiorly of the adapter subassembly.

As best seen in figure 39, a second hollow piercing cannula 450 is connected

to a support wail 452 fomied on a vial receiving tube 445. Cannula 450 extends into receiving chamber 445a formed in vial receiving tube 445 in the mariner

shown in figure 39. A passageway 454 formed in closure cap 409 communicates

with the fluid passageway 450a of hollow cannula 450 via a check valve 456,

which is mounted within a chamber 458 formed in cap 409. Check valve 456 per¬

mits fluid flow into passageway 438, into inlet passageway 407 via check valve 62

and finally into reservoir 58. However check valve 456 effectively bloc s the fluid

flow into the opposite direction. When the third fill means is not in use, chamber

447 is sealably closed by a removable sealing cap 460 which is of the constmction

shown in figure 53. Cap 460 includes a pull tab 460a for use in conveniently sepa¬

rating the cap from housing portion 40 l e.

In using the apparatus of this latest form of the invention, reservoir 58 can be

initially filled by the fill means or assembly 86, with a diluent or other fluid. This

done, a first container subassembly 98 can be mated with a first adapter subassem¬

bly 96 in the manner previously described. Next, the tear-away closure cap 60,

which seals chamber 433 of lower housing 40 Id, is removed (figure 39). This

done, housing 68 of adapter the assemblage can be pushed forwardly within cham¬

ber 433. As the adapter subassembly moves forwardly, pusher rod 106 will engage

plunger 104 causing the container assembly to also move forwardly. As the con¬

tainer assembly approaches a seated position, piercing cannula 108 will pierce sep¬

tum assembly 100 of the first container assembly. Once the fluid flow path be- tween the hollow cannula and the fluid reservoir 58 is thus created via passage¬

ways 438 and 407, a continued inward movement ofthe first adapter subassembly

88 will cause pusher rod 106 thereof to move plunger 104 forwardly of chamber

96b. As plunger 104 is moved forwardly, the medicament or other fluid contained

within chamber 96b of first vial 96 will flow through passageway of the hollow

cannula, past check valve 442, into passageway 438, past check valve 6.. and fi¬

nally into fluid reservoir 58 where it will intermix with the diluent or other fluid

introduced into the reservoir using the first fill means.

If desired, a second subassembly can be mated with a second adapter subas¬

sembly 96 in the manner previously described . This done the tear away closure

cap 460, which seals chamber 447 of upper housing 401e is removed (figure 39) so

that the second adapter assemblage can be pushed forwardly within chamber 447.

As the adapter subassembly moves forwardly, pusher rod 106 of the second

adapter assemblage will engage plunger 104 causing the container assembly to also

move forwardly. As the second container assembly approaches a seated position,

piercing cannula 450 will pierce septum assembly 100 of the second assembly.

Once the fluid flow path between hollow cannula 450 and the fluid reservoir 58 is

thus created via passageways 454, 438, and 407, a continued inward movement of

the second adapter subassembly 88 will cause pusher rod 106 thereof to move

plunger 104 forwardly of chamber 96b. As plunger 104 is moved forwardly, the medicament or other fluid contained within chamber 96b of the second vial 96 will

flow through passageway 450a of the hollow cannula 450, past check valve 456,

into passageway 438, past check valve 62 and finally into reservoir 58 where it will

intermix with the diluent or other fluid introduced into the reservoir using the first

and second fill means of the invention.

It is to be understood that with the novel constmction of the apparatus of this

latest form of the invention, reservoir 58 can be fully or partially filled using any

one of the first, second and third fill means. Alternatively various mixtures of fluid

within reservoir 58 can be achieved by using a selected combination of the first,

second and third fill means.

During filling of the reservoir using a selected fill means, or a combination

fill means, membrane 46 will be distended outwardly in the manner shown in fig¬

ure 39 wherein the central portion thereof is spaced from support 404. Rings 50

which are in clamping engagement with support 404 function to seal the membrane

against the end portions of the support and prevent leakage of fluid between the

membrane and the support.

After the reservoir has been appropriately filled with a desired medicament

or other fluid using the first, second, or third fill means of the apparatus, the reser¬

voir will remain in this filled condition until the outlet flow path of the device is

opened. Following opening of the outlet flow path, the stored energy means or membrane 46 will tend to return to a less distended condition causing fluid to flow

outwardly of the apparatus via passageway 412, through rate control frit 74 and fi¬

nally outwardly of the device via delivery passageway 414. To interconnect pas¬

sageway 414 with the patient, a conventional infusion set including a delivery line

71 is connected to connector 72 in the manner previously described in connection

with the embodiments shown in figures 1 through 9. In this regard, end portion

401b of the device housing includes a hollow, generally cylindrically shaped hous¬

ing 40 I f which is provided with a yieldably deformable, hook-like locking tabs

40 lg (see also figure 48). Tabs 40 l g which are constmcted from a yieldably de¬

formable plastic, lockably receive shoulder 73 of body portion 72 in the manner

shown in figure 39 so as to releasably secure connector 72 within housing 40 I f of

end portion 401b.

In order to securely lock the adapter subassemblies 98 within portions 40 Id

and 40 l e, after the reservoir has been filled, novel locking means are provided.

These locking means are identical to those described in connection with the em¬

bodiment shown in figures 1 through 8 and operate in the same way. More par¬

ticularly, the locking means comprise a series of locking teeth 98d which are con¬

structed so that, as the adapter subassembly 98 is moved inwardly, they will slide

under flexible tabs 1 13a formed on a pair of clips 1 13 (figures 51 and 52) which is

disposed proximate the entrance of receiving chambers 433 and 447. As before. once the adapter subassemblies have reached the fully forward position within the

device housing, locking tabs 465 will engage one of the teeth 96d and effectively

prevent removal of the adapter subassemblies from passageways 433 and 447.

With this constmction, once the reservoir 58 has been filled with the fluid "F" con¬

tained in the two container subassemblies, the adapter assemblies cannot be re¬

moved from the fluid dispensing device and, thereby prevent system adulteration.

Turning next to figures 55 through 73, still another form of the fluid dis¬

penser apparatus of the invention is there illustrated and generally designated by .

the numeral 470. This latest form of the invention is similar in some respects to

that shown in figures 27 through 36 and like numerals are used to identify like

components. As in the embodiment shown in figures 27 through 36, the present

embodiment comprises an elongated housing 472 having a first internal chamber

474, a support 476 disposed within internal chamber 474 and extending longitudi¬

nally of the housing 472, and a stored energy means provided in the form of a gen¬

erally cylindrically shaped, elongated elastomeric member 308 (figure 56).

Housing 472 comprises a cylindrically shaped central portion 472a and inlet

and outlet closure portions 472b and 472c respectively. Central section 472a can

be connected to end plate portions 472b and 472c by any suitable means such as

adhesive bonding or an appropriate sonic weldment. Elastomeric member 308 is securely affixed proximate its ends to support 476 by means of suitable ring

clamps 310 such as self-locking plastic panduit strips.

As best seen by referring to figure 56 , support 476 is provided with a

receiving chamber 482 which, in a manner presently to be described, telescopically

receives the first fill means of the invention for filling a reservoir 484 with a se¬

lected fluid. Reservoir 484 is formed by elastomeric member 308 and the central

portion of support 476. Naive means, shown here as a check valve 475 is disposed

within a chamber 477 and functions to permit, fluid flow toward reservoir 484, but

blocks fluid flow in the opposite direction.

Support 476 is provided with an inlet passageway 486 which communicates

with a transversely extending passageway 488. A second fill means which in¬

cludes a luer connector 490 having a fluid passageway 492 is provided as a part of

closure portion 472c. When the device is not in use, passageway 492 is suitably

closed by a closure cap 492a (figures 56). As shown in figure 56, passageway 492

is in communication with passageway 488 via a passageway 494 and a first flow

control means here provided as a check valve 496. As will presently be described,

the second fill means can also be used to fill or partially fill reservoir 484 with a

selected fluid.

Provided at the opposite end of the assemblage from luer-like connector 492

is the important dose dial means for this latest form of the invention for introduc- ing a precise dose volume of medicament to be introduced into reservoir 484 from

the second fill means of the invention, the character of which will next be de¬

scribed.

Considering once again the first fill means of the invention and turning to figures

56, 71 and 73, this important fill means, which is generally designated as 500, here

comprises a container subassembly 502, and an adapter subassembly 504. Con¬

tainer subassembly 502 includes a container or vial portion 502a having a fluid

chamber 503 for containing an injectable fluid "F". Fluid chamber 503 is provided

with first and second open ends 503a and 503b. First open end 503a is sealably

closed by closure means here provided in the form of a pierceable septum 508.

Septum 508, which may be a slit septum, is held securely in position by clamping

ring 510. Second end 503b is closed by an apertured, removable peel away cover

505 (figure 72). A plunger 512 is telescopically movable within chamber 503 of

container subassembly 502 in the manner indicated in the drawings. Slit septum

508 is accessible by lifting a hingeably mounted end panel 505 which forms a part

of adapter subassembly 504. Panel 505 is connected by means of a living hinge

505a to an adapter sleeve 504a that forms a part of adapter subassembly 504.

When panel 505 is lifted in the manner shown in figure 73, slit septum 508 can be

penetrated by a blunt end cannula "C" of a conventional syringe assembly "S" or

like filling means. As chamber 503 is filled with fluid, plunger 512 will be moved from the first position shown in figure 71 to the second position shown in figure

73.

As best seen in figure 56, adapter subassembly 504 includes an adapter

sleeve 504a that has a first open end 506 that telescopically receives the container

subassembly in the manner best seen in figure 56. Following removal of peel-

away cover 505, adapter sleeve 504a is telescopically receivable within receiving

chamber 482 of support 476 and is moved by the advancement means of the inven¬

tion from a first extended position shown in figure 56 into a second fluid filling po¬

sition. Support 476 also includes pusher means shown here as an elongated pusher

member 514 (figure 56) which functions to move plunger 512 within the fluid

chamber 503 of the container subassembly upon operation of the dose dialing

means of the invention.

As indicated in figure 56, pusher member 514 is radially spaced from the in¬

terior wall of receiving chamber 482 so as to define a longitudinally extending an¬

nular space 516. With this constmction, during the mating of the first fill means

with the fluid delivery component, the outer wall of adapter subassembly 504 and a

portion of the container 502a are closely received within annular space 516 as the

adapter subassembly is moved inwardly or forwardly of the device housing by the

dose dialing means of the advancement means of the invention. When the adapter

assembly is originally mated with the delivery component in the manner shown in figure 56, a pierceable wall 512a of plunger 512 of container assembly 502 will

move into piercing engagement with a hollow cannula 518 which is disposed cen¬

trally of pusher member 514.

Once the fluid flow path between the hollow cannula 518 and the fluid res¬

ervoir 484 of the apparatus is thus created via check valve 475, passageway 486

and a passageway 488, an inward movement of the adapter subassembly can be ac¬

complished using the novel dose dialing means of the invention. As the dose dial¬

ing means controllably moves the adapter subassembly inwardly, pusher member

514 will move plunger 512 inwardly of fluid chamber 503 causing fluid contained

within vial chamber 503 to flow through hollow cannula 518, past umbrella check

valve 475 into passageway 486, into passageway 488 and into fluid reservoir 484

(figure 56). As fluid reservoir 484 is filled, air trapped within housing 472 is

vented to atmosphere via vent "N" (figure 56). As will be discussed hereinafter, in

certain instances, reservoir 484 may be prefilled using the second fill means of the

invention with a solution with which the fluid contained in vial subassembly 502

will be controllably intermixed as the adapter subassembly is moved inwardly. It

is to be understood that cannula 518 can also be a blunt end cannula and wall 512

can be manufactured with a slit portion.

Considering now the previously mentioned dose dialing means of the inven¬

tion, this important means here comprises advancement means connected to clo- sure plate 472b of the fluid delivery component and functions to controllably ad¬

vance adapter subassembly 504 into annular space 516. In the form of the inven¬

tion shown in the drawings, this important advancement means can be seen to

comprise an advancing subassembly 520 that includes an advancing dial 522 which

is rotatably connected to end wall 472b in the manner indicated in figure 56. Ad¬

vancing subassembly 520 also includes a dial support component 524, which is of

the configuration best seen in figures 62, 67, and 68. Additionally, advancing sub-

assembly 520 includes a locating ring 526 of the character illustrated in figures 62

and 65. Locating ring 526 is provided with a yieldably deformable, reverse rota¬

tion blocking tab 526b (figure 65) which engages teeth 522a provided on advanc¬

ing dial or ring 522 to prevent reverse rotation thereof (figure 70). Teeth 522a also

provided a tactile response upon rotation of advancing dial 522.

Dial support component 524 includes a skirt like portion 524a which is re¬

ceivable within an opening 527 formed in support 476 (figure 62) and a flange por¬

tion 524b. Locating ring 526 is provided with a locating tab 526a (figure 65)

which is receivable within a locating slot 524c formed in skirt portion 524a of dial

support component 524 (figure 68). When the various components of the ad¬

vancement means are assembled in a manner shown in figure 56. advancing dial

522 is held captive between flange 524b and locating ring 526. As shown in figures 56 and 62, advancing dial 522 includes teeth engaging

means here provided as threads 530 formed on the interior wall of advancing dial

522. Upon insertion of adapter sleeve 504 into annular space 482, threads 530 will

mate with a plurality of longitudinally spaced advancing teeth 531 formed on the

exterior wall of adapter sleeve 504 ( figures 56, 71 and 73). With this constmction

it is apparent that rotation of the advancing dial 522 will cause adapter s_eeve 504

to be incrementally advanced into annular space 482. As the adapter sleeve so ad¬

vances, pusher member 514 will urge plunger 512 inwardly of fluid chamber 503

of container subassembly 502. As shown in figures 57, 67, 68 and 69A, dial sup¬

port component 524 is provided with a guide slot 525 (figure 67). Similarly, locat¬

ing ring 526 and support 476 are both provided with guide slots 526g and 476g re¬

spectively, which index with guide slot 525. These guide slots function to guide

the travel of teeth 531 as adapter sleeve 504 advances into annular space 482.

After the container of the container subassembly has been filled using sy¬

ringe "S'\ either in the field or at the time of manufacture, and following removal

of peel-away cover 505, the container subassembly can be coupled with the fluid

delivery component in the manner shown in figure 56. As the container subassem¬

bly is coupled with the delivery device, threads 512b formed on plunger 512

threadably engage threads 5 14a formed on a head portion 514b of pusher member

5 14 (figure 62) causing hollow cannula 518 to pierce wall 512a of the plunger 512. An inward movement of the plunger resulting from one rotation of dial 522 will

then cause one-tenth of the fluid contained within fluid chamber 503 of the con¬

tainer subassembly 502 to flow into the hollow cannula, past umbrella-like check

valve 475, into passageway 486, into passageway 488 and then into reservoir 484

via inlet 484a. It should be noted that once adapter sleeve 504 is advanced into an¬

nular space 482, it cannot be retracted, thereby preventing system adulteration.

Referring next to figures 74 and 75 it is to be noted that advancing dial 522

is provided with circumferentially spaced incremental indicating indicia 532. As

advancing dial 522 is rotated, the indicia 532 will move sequentially past an indi¬

cating arrow 534 imprinted on end plate 472b (figure 57). As shown in figure 75,

the hollow housing of the adapter subassembly 504 is provided with longitudinally

spaced dose volume indicating indicia 536. Each of the indicia 536 indicates one-

tenth of the volume of the container or vial of the vial subassembly 502. Similarly

the indicating indicia 532 imprinted on advancing dial 522 indicate a 1/4 division

of the indicia 536 imprinted on the hollow housing of the adapter sleeve 504, that

is 0.25, 0.50 and 0.75. Accordingly when advancing dial 522 is rotated a full 360

degrees, one-tenth of the fluid contained within the vial will be introduced into res¬

ervoir 484. In similar fashion when the advancing dial 522 is rotated 1/4 of a rum

as indicated by the indicia 532 ,0.025 of the fluid contained within the vial will be

introduced into reservoir 484 (figure 56). With this arrangement, the volume of fluid introduced into reservoir 484 by the rotation of advancing dial 522 can be

precisely controlled. It is to be understood that indicia indicating alternate dosing

parameters can be used if desired with corresponding alternate thread configura¬

tions on the adapter sleeve and advancing dial.

Once the reservoir has been filled, the apparatus will remain in this readied

condition until the line clamp 542a provided on the delivery line 542 of ihe device

is opened (figure 55). Once the line clamp is opened, the stored energy means or

membrane 308 will tend to return to a less distended condition causing fluid to

flow outwardly of the apparatus via passageways 344 formed in support 476,

through the novel flow control means of the invention, here shown as porous flow

control elements 544 (figure 56) which may comprise filter elements of a character

well known to those skilled in the art and finally outwardly of the device via the

infusion line 542.

Provided at the outboard end of the delivery line 542 is a luer connector 546

which is closed by a removable cap 548. Disposed intermediate line clamp 542

and the outlet 540 of the device is a Y-site 545 that can be used for bolus injections

and a conventional filter and gas vent 547 (figure 55).

Referring particularly to figures 58 through 61 , the novel locking means of

the invention is shown. This locking means prevents further adjustment of the

dose dialing means once the dosing regimen has been set by the physician or care- giver. The locking means here comprises a locking member 550 that threadably

connects dial clamp 556 to closure wall 472b in the manner illustrated in figure 58.

Dial clamp 556 includes a flange portion 556a that frictionally contacts a matching

surface of flange portion 522b on advancing dial 522 to prevent further rotation of

the dial when locking member 550 is in its fully threaded position. In this regard,

it is to be noted that the dimension "a" in figure 58 is less than dimension "b" so

that when member 550 is tightened, clamp 556 will engage flange portion 522b

causing a friction type brake. As indicated in figure 57, locking member 550 is

provided with spaced apart spanner receiving openings 552 which are adapted to

receive spanner elements 554a of a physician's key 554 of the character shown in

figure 61. Using the physician's key, the physician or caretaker can rotate locking

member 550 so that it moves dial clamp 556 into locking engagement with flange

portion 522b of dose dial 522 thereby preventing further operation of the ad¬

vancement means.

As previously mentioned, reservoir 484 can also be filled using the second

fill means of the invention which comprises luer-like connector 490 and check

valve 496. This is accomplished by interconnecting with connector 490 an appro¬

priate fill line having a luer connector 561 that is matable with connector 490. The

fill line, identified by the numeral 563 in figure 62, can be interconnected with any desired source of fluid 565 which may be a diluent or an appropriate beneficial

agent.

Having now described the invention in detail in accordance with the re¬

quirements of the patent statutes, those skilled in this art will have no difficulty in

making changes and modification s in the individual parts or their relative assem¬

bly in order to meet specific requirements or conditions. Such changes and modi¬

fications may be made without departing from the scope and spirit of the invention,

as set forth in the following claims.

Claims

I CLAIM:

1. A fluid delivery apparatus having a fluid delivery passageway, said

apparatus comprising:

(a) an elongated housing having walls defining an internal cham¬

ber;

(b) a support assembly connected to said housing an including an

elongated body disposed within said internal chamber, said body having a

receiving chamber, an inlet passageway and an outlet passageway in com¬

munication with said fluid delivery passageway;

(c) an elongated tubular shaped, elastomeric member connected

proximate its ends to said elongated body, said elastomeric member having a

central portion disposed within said internal chamber of said housing and

overlaying said inlet and outlet passageways, said central portion of said

elastomeric member being distendable by fluid flowing through said first

fluid passageway from a first position in proximity with said support to a

second position to form a fluid reservoir;

(d) fill means interconnected with said housing for filling said res¬

ervoir, said fill means comprising: (i) a container subassembly including a container having a

fluid chamber and displacement means movable relative to said fluid

chamber for dispensing fluid from said chamber;

(ii) an adapter subassembly comprising a hollow housing for

telescopically receiving at least a part of said container subassembly

and means for moving said displacement means relative to said fluid

chamber of said container; and

(iii) advancement means connected to said housing for con¬

trollably advancing said adapter subassembly into said receiving

chamber of said housing, said advancement means comprising an ad¬

vancing dial rotatably connected to said housing for movement be¬

tween first and second positions.

2. The fluid delivery device as defined in claim 1 in which said hollow

housing of said adapter subassembly is provided with longitudinally spaced apart

advancing teeth and in which said advancing dial of said advancing means includes

teeth engaging means for engagement with said teeth of said hollow housing to in¬

crementally advance said hollow housing into said receiving chamber upon rota¬

tion of said advancing dial from said first position to said second position.

3. The fluid delivery device as defined in claim 1 further including lock¬

ing means for locking said advancing means to prevent advancing of said the

adapter subassembly.

4. The fluid delivery device as defined in claim 1 further including infu¬

sion means connected to said housing and being in fluid communication with said

reservoir for infusing medicinal fluids into a patient.

5. The fluid delivery device as defined in claim 1 further including sec¬

ond fill means connected to said housing for introducing fluids into said reservoir.

6. The fluid delivery device as defined in claim 5 in which said second

filling means comprises a luer connector affixed to said housing and a check valve

for controlling fluid flow toward said reservoir.

7. A fluid delivery device having a fluid delivery passageway, said appa¬

ratus comprising:

(a) an elongated housing having walls defining an internal cham¬

ber;

(b) a support assembly connected to said housing and including an

elongated body disposed within said internal chamber, said body having a

receiving chamber, a pusher member disposed within said receiving cham¬

ber and an inlet passageway and an outlet passageway, said outlet passage¬

way being in communication with said fluid delivery passageway; (c) an elongated tubular shaped elastomeric member connected

proximate its ends to said elongated body, said elastomeric member having a

central portion disposed within said internal chamber of said housing and

overlaying said inlet and outlet passageways, said central portion of said

elastomeric member being distendable by fluid flowing through said first

fluid passageway from a first position in proximity with said support to a

second position to form a fluid reservoir;

(d) fill means interconnected with said housing for filling said res¬

ervoir, said fill means comprising:

(i) a container subassembly including a container having a

fluid chamber and displacement means movable relative to said fluid

chamber for dispensing fluid from said chamber;

(ii) an adapter subassembly comprising a hollow housing for

telescopically receiving at least a part of said container subassembly,

said hollow housing having longitudinally spaced-apart advancing

teeth;

(iii) advancement means connected to said housing for con¬

trollably advancing said adapter subassembly into said receiving

chamber of said housing, said advancement means comprising an ad¬

vancing dial rotatably connected to said housing for movement be- tween first and second positions, said advancing dial having teeth en¬

gaging means for engaging said advancing teeth of said hollow hous¬

ing of said adapter subassembly.

8. The fluid delivery device as defined in claim 7 in which said advanc¬

ing dial of said advancement means includes circumferentially spaced, incremental

indicating indicia and in which said hollow housing of said adapter subassembly

includes longitudinally spaced dose volume indicating indicia.

9. The fluid delivery device as defined in claim 7 further including

locking means for locking said advancement means to prevent advancing of said

adapter subassembly.

10. The fluid delivery device as defined in claim 7 further including infu¬

sion means connected to said housing and in fluid communication with said reser¬

voir for infusing medicinal fluids into a patient.

1 1. The fluid delivery device as defined in claim 7 in which said dis¬

placement means of said container subassembly includes a plunger having a pier¬

ceable wall and in which said support assembly includes a piercing cannula for

piercing said pierceable wall of said plunger, said piercing cannula being in com¬

munication with said inlet to said reservoir.

12. The fluid delivery device as defined in claim 7 in which said container

subassembly further includes a pierceable septum.

13. The fluid delivery device as defined in claim 7 in which said hollow

housing of said adapter subassembly has first and second open ends and a closure

panel hingeably connected to said hollow housing for closing said first open end.

14. The fluid delivery device as defined in claim 7 further including sec¬

ond fill means connected to said housing for introducing fluid into said reservoir.

15. A fluid delivery device having a fluid delivery passageway, said appa¬

ratus comprising:

(a) an elongated housing having walls defining an internal cham¬

ber;

(b) a support assembly connected to said housing and including an

elongated body disposed within said internal chamber, said body having a

receiving chamber, a pusher member disposed within said internal chamber

and an inlet passageway and an outlet passageway, said outlet passageway

being in communication with said fluid delivery passageway;

(c) an elongated tubular shaped elastomeric member connected

proximate its ends to said elongated body, said elastomeric member being

distendable by fluid flowing through said inlet passageway from a first posi¬

tion in proximity with said support to a second position to form a fluid res¬

ervoir; (d) fill means interconnected with said housing for filling said res¬

ervoir, said fill means comprising:

(i) a container subassembly including a container having:

a. a fluid chamber;

b. displacement means movable relative to said fluid

chamber for dispensing fluid from said chamber; and

c. a pierceable septum closing one of said first and

second ends of said fluid chamber;

(ii) an adapter subassembly comprising a hollow housing for

telescopically receiving at least a part of said container subassembly,

said hollow housing having:

a. first and second ends and longitudinally spaced-

apart advancing teeth; and

(iii) advancement means connected to said housing for con¬

trollably advancing said adapter subassembly into said receiving

chamber of said housing, said advancement means comprising an ad¬

vancing dial rotatably connected to said housing for movement be¬

tween first and second positions, said advancing dial having:

a. teeth engaging means for engaging said advancing

teeth of said hollow housing of said adapter subassembly; and b. circumferentially spaced, incremental indicating indi¬

cia.

16. The fluid delivery device as defined in claim 15 further including

locking means for locking said advancing means to prevent advancing of said

adapter subassembly.

17. The fluid delivery device as defined in claim 15 further including in¬

fusion means connected to said housing and in fluid communication with said res¬

ervoir for infusing medicinal fluids into a patient.

18. The fluid delivery device as defined in claim 15 further including sec¬

ond fill means for introducing fluid into said reservoir.

19. The fluid delivery device as defined in claim 15 further including flow

control means for controlling fluid flow between said reservoir and said fluid de¬

livery passageway.

20. The fluid delivery device as defined in claim 15 in which one of said

first and second ends of said adapter subassembly is sealably closed by a peel-

away cover.

21. The fluid delivery device as defined in claim 15 in which said dis¬

placement means of said container subassembly includes a plunger having a pier¬

ceable wall and in which said support assembly includes cannula means for piercing said pierceable wall of said plunger, said piercing cannula being in com¬

munication with said inlet to said reservoir.

22. The fluid delivery device as defined in claim 20 in which said cannula

means comprises a bunt end cannula.

23. The fluid delivery device as defined in claim 22 in which said pierce¬

able wall of said plunger comprises a slitted portion to accept said biuni end can¬

nula.