US20050277883A1 - Fluid delivery device - Google Patents

Abstract

A compact fluid dispenser for use in controllably dispensing fluid medicaments, such as antibiotics, oncolytics, hormones, steroids, blood clotting agents, analgesics, and like medicinal agents from prefilled containers at a uniform rate. The dispenser uniquely includes a stored energy source that is provided in the form of a compressible-expandable elastomeric member of novel construction that provides the force necessary to continuously and uniformly expel fluid from the device reservoir. The device further includes a fluid flow control assembly that precisely controls the flow of the medicament solution to the patient.

Description

BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention relates generally to fluid delivery devices. More particularly, the invention concerns an improved apparatus for infusing medicinal agents into an ambulatory patient at specific rates over extended periods of time, which apparatus includes a novel energy source, a novel fill means for filling the reservoir of the apparatus and a unique, adjustable, multichannel flow rate control means for precisely adjustably controlling the rate of fluid flow from the reservoir of the device.
• 2. Discussion of the Prior Art
• A number of different types of medicament dispensers for dispensing medicaments to ambulatory patients have been suggested. Many of the devices seek either to improve or to replace the traditional gravity flow and hypodermic syringe methods which have been the standard for delivery of liquid medicaments for many years.
• The prior art gravity flow methods typically involve the use of intravenous administration sets and the familiar flexible solution bag suspended above the patient. Such gravametric methods are cumbersome, imprecise and require bed confinement of the patient. Periodic monitoring of the apparatus by the nurse or doctor is required to detect malfunctions of the infusion apparatus.
• Many medicinal agents require an intravenous route for administration thus bypassing the digestive system and precluding degradation by the catalytic enzymes in the digestive tract and the liver. The use of more potent medications at elevated concentrations has also increased the need for accuracy in controlling the delivery of such drugs. The delivery device, while not an active pharmacologic agent, may enhance the activity of the drug by mediating its therapeutic effectiveness. Certain classes of new pharmacologic agents possess a very narrow range of therapeutic effectiveness, for instance, too small a dose results in no effect, while too great a dose can result in a toxic reaction.
• For those patients that require frequent injections of the same or different amounts of medicament, the use of the hypodermic syringe method of delivery is common. However for each injection, it is necessary to first draw the injection dose into the syringe, then check the dose and, after making certain that all air has been expelled from the syringe, finally, inject the dose either under bolus or slow push protocol. This cumbersome and tedious procedure creates an unacceptable probability of debilitating complications, particularly for the elderly and the infirm.
• As will be appreciated from the discussion which follows, the apparatus of the present invention is uniquely suited to provide precise fluid delivery management at a low cost in those cases where a variety of precise dosage schemes are of utmost importance. An important aspect of the apparatus of the present invention is the provision of novel fill means for filling the reservoir of the device using a conventional medicament vials or cartridge containers of various types having a pierceable septum. Another unique feature of the apparatus of the present invention is an embedded microcapillary multichannel flow rate control means which enables precise control of the rate of fluid flow of the medicament to the patient. More particularly, the apparatus of the present invention, includes a unique, adjustable fluid flow rate mechanism which enables the fluid contained within the reservoir of the device to be precisely dispensed at various selected rates.
• The apparatus of the present invention can be used with minimal professional assistance in an alternate health care environment, such as the home. By way of example, devices of the invention can be comfortably and conveniently removably affixed to the patient's body or clothing and can be used for the continuous infusion of injectable anti-infectives, hormones, steroids, blood clotting agents, analgesics, and like medicinal agents. Similarly, the devices of the invention can be used for most I-V chemotherapy and can accurately deliver fluids to the patient in precisely the correct quantities and at extended microfusion rates over time.
• By way of summary, the apparatus of the present invention uniquely overcomes the drawbacks of the prior art by providing a novel, disposable dispenser of simple but highly reliable construction. A particularly important aspect of the apparatus of the present invention resides in the provision of a novel, self-contained energy source in the form of a substantially constant-force compressible-expandable elastomeric member that provides the force necessary to uniformly and precisely dispense various solutions from standard prefilled vial containers that can be conveniently loaded into the apparatus. Because of the simplicity of construction of the apparatus of the invention, and the straightforward nature of the energy source, the apparatus can be manufactured at low cost without in any way sacrificing accuracy and reliability.
• With regard to the prior art, one of the most versatile and unique fluid delivery apparatus developed in recent years is that developed by the present inventor and described in U.S. Pat. No. 5,205,820. The components of this novel fluid delivery apparatus generally include: a base assembly, an elastomeric membrane serving as a stored energy means, fluid flow channels for filling and delivery, flow control means, a cover, and an ullage which comprises a part of the base assembly.
• Another prior art patent issued to the present applicant, namely U.S. Pat. No. 5,743,879, discloses an injectable medicament dispenser for use in controllably dispensing fluid medicaments from a prefilled container at a uniform rate. The dispenser, which is quite dissimilar in construction and operation from that of the present invention, includes a stored energy source in the form of a compressively deformable, polymeric elastomeric member that provides the force necessary to controllably discharge the medicament from a prefilled container which is housed within the body of the device. After having been deformed, the polymeric, elastomeric member will return to its starting configuration in a highly predictable manner.
• Another important prior art fluid delivery device is described in the U.S. Pat. No. 6,063,059 also issued to the present inventor. This device, while being of a completely different construction embodies a compressible-expandable stored energy source somewhat similar to that used in the apparatus of the present invention.
• Still another prior art fluid delivery device, in which the present inventor is also named as an inventor, is described in U.S. Pat. No. 6,086,561. This latter patent incorporates a fill system that makes use of conventional vials and cartridge medicament containers.
SUMMARY OF THE INVENTION
• It is an object of the present invention to provide a compact fluid dispenser for use in controllably dispensing fluid medicaments, such as, antibiotics, oncolytics, hormones, steroids, blood clotting agents, analgesics, and like medicinal agents from prefilled containers at a uniform rate.
• Another object of the invention is to provide a small, compact fluid dispenser that includes a housing to which fill vials can be connected for filling the dispenser reservoir with the injectable fluid.
• Another object of the invention is to provide a dispenser of in which a stored energy source is provided in the form of a substantially constant-force, compressible-expandable elastomeric member of novel construction that provides the force necessary to continuously and uniformly expel fluid from the device reservoir.
• Another object of the invention is to provide a dispenser of the class described which includes a fluid flow control assembly that precisely controls the flow of the medicament solution to the patient.
• Another object of the invention is to provide a dispenser that includes precise variable flow rate selection.
• Another object of the invention is to provide a fluid dispenser which is adapted to be used with conventional prefilled drug containers to deliver beneficial agents therefrom in a precise and sterile manner.
• Another object of the invention is to provide a fluid dispenser of the class described which is compact, lightweight, is easy for ambulatory patients to use, is fully disposable, and is extremely accurate so as to enable the infusion of precise doses of medicament over prescribed periods of time.
• Another object of the invention is to provide a device of the character described which embodies a novel fluid volume indicator that provides a readily discernible visual indication of the volume of fluid remaining in the device reservoir.
• Another object of the invention is to provide a point of care, self-contained medicament dispenser which is of very simple construction and can be filled at will at time of use.
• Another object of the invention is to provide a fluid dispenser as described in the preceding paragraphs which is easy and inexpensive to manufacture in large quantities.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a generally perspective view of one embodiment of the fluid delivery apparatus of the present invention for dispensing fluids at a uniform rate.
• FIG. 2 is an enlarged, longitudinal cross-sectional view of the apparatus shown inFIG. 1.
• FIG. 3 is a cross-sectional view similar toFIG. 2, but showing the apparatus in a fluid fill mode.
• FIG. 3A is a cross-sectional view taken alonglines3A-3A ofFIG. 3.
• FIG. 4 is a cross-sectional view of one of the prefilled medicament shell vials that can be used to fill the fluid reservoir of the apparatus.
• FIG. 5 is a view taken along lines5-5 ofFIG. 4.
• FIG. 6 is a view taken along lines6-6 ofFIG. 2.
• FIG. 6A is a view taken alonglines6A-6A ofFIG. 6.
• FIG. 7 is a cross-sectional view taken along lines7-7 ofFIG. 2.
• FIGS. 8A and 8B, when considered together comprise a generally perspective, exploded view of the various internal operating components of the apparatus of the invention.
• FIG. 8C is a generally perspective, exploded view of one form of the indexing means of the invention.
• FIG. 8D is a fragmentary, front view similar to the front view shown inFIG. 6, but better showing the configuration of the indexing means of the invention.
• FIG. 8E is a cross-sectional view taken alonglines8E-8E ofFIG. 8D.
• FIG. 8F is an enlarged, fragmentary, bottom view of the forward portion of the apparatus shown inFIG. 3.
• FIG. 8G is a cross-sectional view taken alonglines8G-8G ofFIG. 8F.
• FIG. 8H is a fragmentary, cross-sectional view similar toFIG. 8G but showing the indexing means in a locked position.
• FIG. 9 is a generally perspective, front view of one form of the fluid flow control assembly of the apparatus of the invention.
• FIG. 10 is a generally perspective, exploded front view of the fluid flow control assembly shown inFIG. 9.
• FIG. 11 is a fragmentary cross-sectional view of one of the flow control channels formed in the flow control member shown in the central portion ofFIG. 10.
• FIG. 12 is a generally perspective, rear view of the fluid flow control assembly of the apparatus of the invention shown inFIG. 9.
• FIG. 13 is a generally perspective, exploded rear view of the fluid flow control assembly shown inFIG. 10.
• FIG. 13A is a generally perspective view of an alternate form of the flow control member of the invention.
• FIG. 13B if a generally perspective view of yet another form of the flow control member of the invention.
• FIG. 14 is a front view of the assembly shown inFIG. 9.
• FIG. 15 is a cross-sectional view taken along lines15-15 ofFIG. 14.
• FIG. 16 is a cross-sectional view taken along lines16-16 ofFIG. 15.
• FIG. 17 is a cross-sectional view taken along lines17-17 ofFIG. 15.
• FIG. 18 is a view taken along lines18-18 ofFIG. 15.
• FIG. 19 is a generally perspective view of an alternate embodiment of the fluid delivery apparatus of the present invention for dispensing fluids at a uniform rate.
• FIG. 20 is a generally perspective, exploded rear view of the alternate form of the invention shown inFIG. 19.
• FIG. 21 is a generally perspective front view of the alternate form of the invention shown inFIG. 19.
• FIG. 22 is an enlarged, longitudinal cross-sectional view of the manifold and control apparatus shown inFIG. 19.
• FIG. 22A is a generally perspective, exploded view of the apparatus shown inFIG. 22.
• FIG. 23 is an end view of one of the prefilled medicament shell vials that can be used to fill the fluid reservoir of the apparatus.
• FIG. 24 is a view taken along lines24-24 ofFIG. 23.
• FIG. 25 is cross-sectional view taken along lines25-25 ofFIG. 22.
• FIG. 26 is a view taken along lines26-26 ofFIG. 22.
• FIG. 27 is a view taken along lines27-27 ofFIG. 22.
• FIG. 28 is a cross-sectional view taken along lines28-28 ofFIG. 22.
• FIG. 29 is a bottom view of the apparatus shown inFIG. 19.
• FIG. 30 is a cross-sectional view taken along lines30-30 ofFIG. 22.
• FIG. 31 is a fragmentary, side elevational view of the forward portion of the alternate form of the apparatus shown inFIG. 19.
• FIG. 32 is a generally perspective view of still another embodiment of the fluid delivery apparatus of the present invention for dispensing fluids at a uniform rate.
• FIG. 32A is a cross-sectional view of the fill vial assembly of the form of the invention shown inFIG. 32.
• FIG. 33 is a top plan view of the alternate form of the invention shown inFIG. 32.
• FIG. 34 is a side elevational view of the fill vial cover assembly of the alternate form of the invention shown inFIG. 32.
• FIG. 35 is a view taken along lines35-35 ofFIG. 34.
• FIG. 36 is a right-end view of the apparatus shown inFIG. 32.
• FIG. 37 is cross-sectional view taken along lines37-37 ofFIG. 36.
• FIG. 38 is a bottom plan view of the alternate form of the apparatus shown inFIG. 32.
• FIG. 39 is a cross-sectional view taken along lines39-39 ofFIG. 37.
• FIG. 40 is a view taken along lines40-40 ofFIG. 37.
• FIG. 41 is a cross-sectional view taken along lines41-41 ofFIG. 37.
• FIG. 42 is a cross-sectional view taken along lines42-42 ofFIG. 37.
• FIG. 43 is a generally perspective view of yet another embodiment of the fluid delivery apparatus of the present invention for dispensing fluids at a uniform rate.
• FIG. 44 is an enlarged, longitudinal cross-sectional view of the embodiment of the invention shown inFIG. 43.
• FIG. 45 is a cross-sectional view taken along lines45-45 ofFIG. 44.
• FIG. 46 is a left-end view of the apparatus shown inFIG. 44.
• FIG. 47 is view taken along lines47-47 ofFIG. 44.
• FIG. 48 is a cross-sectional view taken along lines48-48 ofFIG. 44.
• FIG. 49 is an enlarged view of one of the fill vial assemblies shown inFIG. 44.
• FIG. 49A is a view taken alonglines49A-49A ofFIG. 49.
• FIG. 50 is a generally perspective, exploded view of the alternate form of the invention shown inFIG. 43.
• FIG. 51 is a generally perspective view of still another embodiment of the fluid delivery apparatus of the present invention for dispensing fluids at a uniform rate.
• FIG. 52 is an enlarged, longitudinal cross-sectional view of the embodiment of the invention shown inFIG. 51.
• FIG. 53 is a cross-sectional view taken along lines53-53 ofFIG. 52.
• FIG. 54 is a left-end view of the apparatus shown inFIG. 52.
• FIG. 55 is a side view of the vial cover assembly of the apparatus of the invention.
• FIG. 56 is a view taken along lines56-56 ofFIG. 55.
• FIG. 57 is an enlarged, longitudinal, cross-sectional view of one of the fill vial assemblies shown inFIG. 52.
• FIG. 58 is a cross-sectional view taken along lines58-58 ofFIG. 57.
• FIG. 59 is an enlarged, longitudinal, cross-sectional view of the other fill vial assembly of the apparatus of the invention.
• FIG. 60 is a cross-sectional view taken along lines60-60 ofFIG. 59.
• FIG. 61 is a cross-sectional view of an alternate form of fill vial assembly of the invention.
• FIG. 62 is a cross-sectional view taken along lines62-62 ofFIG. 61.
• FIG. 63 is a generally perspective, exploded view of the embodiment shown inFIG. 51.
• FIG. 64 is a generally perspective view of still another embodiment of the fluid delivery apparatus of the present invention for dispensing fluids at a uniform rate.
• FIG. 65 is a top plan view of the embodiment of the invention shown inFIG. 64.
• FIG. 66 is a longitudinal, cross-sectional view of the embodiment of the invention shown inFIG. 64.
• FIG. 67 is a right-end view of the apparatus shown inFIG. 66.
• FIG. 68 is a bottom plan view of the apparatus of the invention.
• FIG. 69 is a cross-sectional view taken along lines69-69 ofFIG. 66.
• FIG. 70 is a generally perspective, exploded view of the apparatus of this latest form of the invention.
• FIG. 71 is a generally perspective front view of yet another embodiment of the fluid delivery apparatus of the present invention for dispensing fluids at a uniform rate.
• FIG. 72 is a generally perspective rear view of the embodiment shown inFIG. 71.
• FIG. 73 is an enlarged, longitudinal cross-sectional view of the apparatus shown inFIG. 71.
• FIG. 74 is an enlarged, cross-sectional view of the area designated as “74” inFIG. 73.
• FIG. 75 is a right end view of the apparatus shown inFIG. 73.
• FIG. 76 is an exploded view of the forward section of the apparatus shown inFIG. 73.
• FIG. 77 is a cross-sectional view taken along lines77-77 ofFIG. 76.
• FIG. 78 is a view taken along lines78-78 ofFIG. 76.
• FIG. 79 is a cross-sectional view taken along lines79-79 ofFIG. 78.
• FIG. 80 is a view taken along lines80-80 ofFIG. 76.
• FIG. 81 is a greatly enlarged cross-sectional view of one form of the rate control assembly of the invention.
• FIG. 82 is an exploded, cross-sectional view of the rate control assembly shown inFIG. 81.
• FIG. 83 is a generally perspective, exploded front view of the rate control assembly shown inFIG. 81.
• FIG. 84 is a generally perspective, exploded rear view of the rate control assembly shown inFIG. 81.
• FIG. 85 is a cross-sectional view taken along lines85-85 ofFIG. 81.
• FIG. 86 is a view similar toFIG. 85, but showing an alternate form of the fluid flow control member of the rate control assembly of the invention.
• FIG. 86A is an enlarged, cross-sectional view taken alonglines86A-86A ofFIG. 86.
• FIG. 87 is an exploded view of still another form of the rate control assembly of the invention.
• FIG. 88 is an exploded view of yet another form of the rate control assembly of the invention.
DESCRIPTION OF THE INVENTION
• Referring to the drawings and particularly toFIGS. 1 through 8, one embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral34. As best seen inFIGS. 1 and 2, the apparatus here comprises a snap-together plasticouter housing34 having a first, second andthird portions36,38 and40 respectively. Disposed withinouter housing34 is an inner,expandable housing42 having afluid reservoir44 provided with an inlet46 (FIG. 2) for permitting fluid flow into the fluid reservoir and anoutlet48 for permitting fluid flow from the fluid reservoir.Expandable housing42, which can be constructed from a metal or plastic material, comprises a bellows structure having an expandable and compressible, accordion-like, annular-shapedsidewall42a, the configuration of which is best seen inFIGS. 2 and 3. If the internal materials interface of the bellows structure and other fluid channels or surfaces are not sufficiently compatible with the planned beneficial agent to be delivered, either in terms of its biocompatibility or drug up-take characteristics, application of a surface modification process is appropriate. This surface modification methodology, which may involve one or more layers, may take one of several forms. One process that is extremely clean, fast and efficient is plasma processing. In particular this technique allows for any of the following: plasma activation, plasma induced grafting and plasma polymerization of molecular entities on the internal drug surface of the bellows. For cases where an inert hydrophobic interface is desired, plasmas using fluorine-containing molecules may be employed. That is, the bellows surface as well as other surfaces that may be contacted by the beneficial agent may be cleaned with an inert gas plasma, and subsequently, a fluorine-containing plasma may be used to graft these molecules to the surface. Alternatively, if a hydrophilic surface is desired (e.g. for drug solutions that are highly corrosive or in oil-based solvents) an initial plasma cleaning may be done, followed by a plasma polymerization using hydrophilic monomers.
• Disposed withinsecond portion38 ofouter housing34 is the novel stored energy means of the invention for acting uponexpandable housing42 in a manner to controllably collapse the expandable housing so as to cause the fluid contained withinfluid reservoir44 to controllably flow outwardly of the housing. In the present form of the invention, this important stored energy means here comprises a compressively deformable, generallyhomogeneous member50 that is carried within thesecond portion38 of the outer housing. As used herein, the term “homogeneous” means a member of the same general composition or structure throughout, that is, of the same kind and nature as opposed to a member consisting of different elements. In a manner presently to be describedmember50, which is depicted inFIG. 2, as an elastomeric polymeric member, is first compressed by fluid flowing intoreservoir44 and then is controllably expanded to cause fluid flow from the outer housing through the dispensing means of the invention. It is to be understood that the stored energy means can be constructed from a wide variety of solid, semisolid, and cellular materials including open cell, closed cell, syntactic forms with micro spheres, rubbers, foams, sponges, metalized foams, plastics and other thermoplastic elastomers (TPE). Other suitable materials include latex rubber, rubber polyolefins, polyisoprene (natural rubber), butyl rubber, nitrile rubber, polystyrene, polyethylene, polyvinyl chloride polyurethane, vinyls, vinyl-end-blocked polydimethylsiloxanes, other homopolymer, copolymers (random alternating, block, graft, cross-link and star block), silicones and other flouropolymers, mechanical poly-blends, polymer alloys and interpenetrating polymer networks. Suppliers of elastomeric materials suitable for construction ofmember50 include “2 and 5 Plastics” of Newark, N.J.; Ludlow Composite Corp. of Fremont, Ohio and Polymer Technologies, Inc. of Newark, Del.Member50 can also comprise a ductile metalized foam of the character available from various sources, including “Chemetall” of Frankfurt, Germany.
• Forming an important aspect of the apparatus of the present invention is fill means carried by thethird portion40 ofouter housing34 for filling thereservoir44 with the fluid to be dispensed. As best seen inFIG. 2,third portion40 includes afluid passageway52 in communication withinlet46 offluid reservoir44. Proximate itslower end52a,fluid passageway52 communicates with acavity54 formed within the third portion of thehousing34. Disposed withincavity54 is apierceable septum56 that comprises a part of one form of the fill means of the invention.Septum56 is held in position by aretainer56aand is pierceable by the needle of the syringe which contains the medicinal fluid to be dispensed and which can be used in a conventional manner to fill or partially fillreservoir44 viapassageway52 or to retrieve fluid fromreservoir44.Septum56 can be a slit or a solid septum constructed from an elastomeric material such as silicone rubber. Additionally, a mechanical check valve can function as a septal interface, for drug filling and for residual drug recovery such as valves available from C. R. Bard of Murray Hill, N.J.
• Third portion40 ofhousing34 also includes afirst chamber60 for telescopically receiving a first medicament containingfill vial62 such as a closed-end glass or plastic shell vial, and asecond chamber64 for telescopically receiving a similarly constructed secondmedicament containing vial66. Anelongated support68 is mounted within saidfirst chamber60 and a secondelongated support70 is mounted withinsecond chamber64. Each of the elongated supports68 and70 has an integrally threadedend portion71 and carries a longitudinally extending, elongated hollow needle orcannula72. Each of the hollow needles72 has aflow passageway72athat communicates withfluid passageway52.First chamber60,second chamber64,elongated support68,elongated support70 andhollow needles72 together comprise an alternate form of the fill means of the apparatus of the invention. The method of operation of this alternate form of fill means will presently be described.
• Forming another very important aspect of the apparatus of the present invention is a novel flow control means that is connected tofirst portion36 ofouter housing34. This flow control means functions to precisely control the outwardly rate of fluid flow fromreservoir44 and toward the patient. In the form of the invention shown inFIGS. 1 through 18 the flow control means comprises a flow control assembly generally designated in the drawings by the numeral76. This novel flow control assembly here comprises anullage defining member78 having afirst portion78adisposed within inner,expandable housing42 and asecond portion78bto which the bellows is bonded.Portion78bextends outwardly fromhousing42 in the manner shown inFIG. 2.Bellows44 cooperates with and is slidably movable relative toullage portion78ain the manner shown inFIGS. 2 and 3. For a purpose presently to be described,member78bhas afluid passageway79 that is in communication with an outlet of theflow control subassembly80, the character of which will next be described.Portion78aof the ullage member functions to ensure that substantially all of the medicinal fluid contained within the bellows reservoir will be dispensed from the device.
• Referring toFIGS. 10 through 13, it can be seen thatflow control subassembly80, which comprises a part offlow control assembly76, includes anouter casing82 having a plurality of circumferentially spaced apartfluid outlets84, aflow control member86 telescopically receivable withincasing82 and aselector knob88 that is interconnected withcontrol member86 in the manner shown inFIGS. 9 and 12. O-rings generally designated in the drawings as “0” sealably interconnect the various components (seeFIG. 15). As best seen inFIGS. 10 and 13,flow control member86 is uniquely provided with a plurality of elongatedflow control channels90, each having aninlet90aand anoutlet90b. Theflow channels90 may be of different sizes, lengths, width and depth and configurations as shown byFIGS. 13A and 13B which depict alternate patterned forms of the flow control member, here identified as86aand86b. The flow control channels identified inFIG. 13B by the numeral90bare formed in individual, spaced-apartcapillary segments91 and define the circuitous flow path depicted inFIG. 13B. Further, the flow control channels may be rectangular in cross-section as illustrated inFIG. 11, or alternatively, they can be semicircular in cross-section, U-shaped in cross-section, or they may have any other cross-sectional configuration that may be appropriate to achieve the desired fluid flow characteristics. As indicated by the designation “C”, when necessary for drug compatibility reasons, the flow channels can be appropriately coated in the manner indicated inFIG. 11. Coating “C” can be of various types and the coating can be applied by several techniques including the earlier-described cold plasma processing technique. When the flow control member is properly positioned withinouter casing82, the inner surface of the outer casing wall sealably cooperates withchannels90 to form a plurality of individual shaped fluid flow passageways of different overall lengths and flow capacities. When the flow control member is positioned within the outer casing in the manner shown inFIG. 12, anotch86bformed inmember86 receives atongue82aprovided oncasing82 so as to precisely align theoutlets90bof theflow channels90 withfluid outlets84 formed incasing82.
• Theflow control channels90 can be made by several techniques including (micro) injection molding, injection-compression molding, hot-embossing and casting. The techniques used to make these imbedded fluid channels are now common-place in the field of microfluidics, which gave rise to the lab-on-a-chip, bio-MEMS and micro-total analysis systems (m-TAS) industries. Additionally, depending on the size of the fluid channels required for a given flow rate, more conventional injection molding techniques can be used.
• The first step in making the channels using an injection molding or embossing process is a lithographic step, which allows a precise pattern of channels to be printed on a “master” with lateral structure sizes down to 0.5 mm. or less. Subsequently, electroforming is performed to produce the negative metal form, or mold insert. Alternatively for larger channel systems, precision milling can be used to make the mold insert directly. Typical materials for the mold insert or embossing tool are nickel, nickel alloys, steel and brass. Once the mold insert of the embossing tool is fabricated, the polymer of choice may be injection molded or embossed to yield the desired part with imprinted channels.
• Alternatively, channels can also be made by one of a variety of casting processes. In general, a liquid plastic resin (e.g. a photopolymer) can be applied to the surface of a metal master (made by the techniques described above) and then cured via thermal or UV means. After hardening, the material is then “released” from the mold to yield the desired part. Additionally, there are similar techniques available that utilize CAD data (of the desired channel configuration) and direct laser curing of a liquid monomer to yield a polymerized and solidified part with imbedded channels. This process is available from multiple sources including MicroTEC MbH of Duisburg, Germany.
• A number of materials can be used to fabricateflow control member86. While medical grade polymers are the most appropriate materials, other materials can be used including: Thermoplastics (embossing & injection molding); Duroplastics (injection molding); Elastomers (injection compression molding and soft lithography); Polyurethanes (castings); and Acrylics and Epoxies.
• Selector knob88, which comprises a part of the selector means of the invention, is rotatably connected tosecond portion78bofullage defining member78 and, in a manner presently to be described, functions to rotate the assembly made up ofouter casing82 andflow control member86. In this way, a selectedoutlet84 incasing82 can be selectively aligned withflow passageway79 provided in the ullage defining member (seeFIG. 2).
• Turning once again toFIG. 1, also forming a part of the fluid dispensing apparatus of the present invention is dispensing means for dispensing fluid to the patient. In the present form of the invention this dispensing means comprises an administration set94 that is connected to thefirst portion36 ofhousing34 in the manner shown in the drawings. Theproximal end95aofadministration line95 of the administration set orchannel94 is in communication withfluid passageway79 in the manner best seen inFIG. 2. Disposed between theproximal end95aand thedistal end95bof the administration line is a conventional gas vent andparticulate filter96 andclamp97. Provided at thedistal end95bis aluer connector98 of conventional construction.
• Turning now toFIGS. 4 and 5, the details of construction of a glass orplastic shell vial62, which vial is identical in construction to fillvial66, is there shown. As indicated in these figures, each of the fill vials includes abody portion100, having afluid chamber102 for containing an injectable fluid.Chamber102 is provided with a firstopen end100aand secondclosed end100b. Firstopen end100ais sealably closed by closure means here provided in the form of an externally threadedelastomeric plunger104 which is telescopically movable within the vial from a first location shown inFIG. 4, where the plunger is disposed proximate firstopen end100a, to a second device-fill location shown inFIG. 2 where the plunger is disposed proximate secondclosed end100b.
• After opening ofclosure103, which forms a part of thethird portion40 of housing34 (FIG. 3),vials62 and66 can be inserted intochambers60 and64 respectively. As the fill vials are so introduced and theplungers104 are threadably interconnected with ends71 ofsupports68 and70, the sharp ends of the elongated needles will pierce thecentral walls104aof the elastomeric plungers. Continuous longitudinal movement of the vials intochambers60 and64 will cause thestructural supports68 and70 to move the elastomeric plungers inwardly of the vial chambers in a direction toward the secondclosed end100bof the vials. As the plunger is move inwardly of the vial in the manner shown in the lower portion ofFIG. 3, wherein onlyvial66 is shown being used, the fluid contained within the vial chamber will be expelled therefrom into thepassageway72aof hollow elongated needles72. As best seen inFIG. 2, the fluid will then flow past umbrellatype check valves108 and intopassageways110 formed inthird portion40 of the apparatus housing. Elastomeric umbrellatype check valves108 will function to substantially block reverse fluid flow fromfluid passageways110. Frompassageways110 the fluid will flow intopassageway52, intostub passageway52band then into thereservoir portion44 of thebellows component42 viainlet46 which comprises microchannels formed inullage78a. It is to be understood that thevials62 and66 can contain the same or different medicinal fluids or diluents and can be installed into their respective chambers in the manner shown inFIGS. 2 and 3.
• As the fluid flows into the reservoir portion of the bellows, the bellows will be expanded from the collapsed configuration shown inFIG. 2 into an expanded configuration such as shown inFIG. 3. As the bellows member expands it will simultaneously urge a telescopically movablevolume indicator member112 that is carried within second portion of the housing into engagement with the stored energy source, or compressible-expandable member50 causing it to compress. It is also to be understood that, if desired, the reservoir portion of the bellows component can also be filled by alternate filling means of the character previously described which comprises a syringe having a needle adapted to pierce thepierceable septum56 which is mounted withinthird portion40 of the apparatus housing. Fluid can also be retrieved from the reservoir using a syringe in conjunction with a mechanical septum or, alternatively,septum56.
• As thereservoir44 fills with fluid either from the fill vials or from the filling syringe, any gases trapped within the reservoir will be vented to atmosphere via vent means “V” mounted inportion78bof the ullage member. This vent means here comprises agas vent113 that is bonded to the housing and can be constructed of a suitable hydrophobic porous material such as a porous plastic.Bonded gas vent113 is held in position within the housing by aretainer ring113a(FIG. 8B). This alternate fill means can be used to initially fill the reservoir or alternatively can be used to add an injectible fluid such as an adjuvant fluid.
• Upon opening the fluid delivery path to the administration set94 in a manner presently be described, the stored energy means, ormember50, will tend to return to its starting configuration thereby controllably urging fluid flow outwardly ofreservoir44 viapassageway114 and the flow control means of the invention.
• As previously discussed, a number of beneficial agents can be contained withinliquid vial containers62 and66 and can be controllably dispensed to the patient including, by way of example, medicaments of various types, injectable drugs, pharmaceuticals, hormones, antibodies, biologically active materials, elements, chemical compounds, or any other suitable material useful in diagnostic cure, medication, treatment or preventing of diseases or the maintenance of the good health of the patient.
• Considering next the important operation of the fluid flow rate control means of the invention, as the fluid contained within thebellows reservoir44 is urged outwardly thereof by the stored energy means, the fluid will flow into afluid passageway114 formed in thefirst portion78aofullage member78. The fluid will then flow under pressure through a filter means shown here as afilter116 that is carried in a cavity provided in theflow control member86 of theflow control subassembly80.Filter116, which functions to filter particulate matter, undissolved drugs or precipitates from the fluid flowing outwardly fromreservoir44 is of a character well known to those skilled in the art and can be constructed from various readily available materials such as polysolfone and polypropylene wafers having a desired porosity. After flowing throughfilter116, the fluid will flow, via a stub passageway118 (FIG. 15) into the distribution means of the invention for distributing fluid from the fluid reservoir to each of the plurality ofspiral passageways90. This distribution means here comprises several radially outwardly extendingflow passageways120 formed inflow control member86. The filtered fluid will fillpassageways120 and then will flow into the plurality ofspiral passageways90 formed inmember86 viaoutlets90b, which communicate with passageways120 (seeFIG. 10). The fluid contained withinspiral passageways90 can flow outwardly of the device housing only when one of thefluid outlets84 formed incasing82 is aligned withreservoir outlet79.
• Selection of thepassageway90 from which the fluid is to be dispensed is accomplished by rotation of theselector knob88 which, as best seen inFIG. 13 includes a reduceddiameter portion88ahaving aslot88bformed therein. As illustrated inFIG. 13,slot88bis adapted to receive aspline86a(FIG. 10) formed anteriorly ofmember86. With this construction, rotation ofselector member88 by gripping a transversally extendingfinger gripping member89 will impart part rotation tomember86. As seen inFIG. 13, casing82 is also provided with an inwardly extendingspline segment82athat is received within aslot86bformed in the rearward periphery ofmember86. Accordingly, rotation ofmember86 will also impart concomitant rotation to casingmember82.
• As illustrated inFIGS. 12 and 13,selector knob88 is provided with a plurality of circumferentially spaced apart indexingcavities88cthat closely receive anindexing finger124 which forms a part of the indexing means of the invention, which means comprises a lockingshaft cover126 that is connected tothird portion40 of the apparatus housing (seeFIGS. 1 and 2).Indexing finger124 is continuously urged into engagement with a selected one of theindexing cavities88cby acoil spring128 that also forms a part of the indexing means of the invention. Coil spring128 (FIG. 2) can be compressed by an inward force exerted on anindexing shaft130 that is mounted in lockingshaft cover126 and is movable from the extended position shown inFIG. 2 to an inward, finger release position whereinspring128 is compressed andfinger124 is retracted from a selectedindexing cavity88c. Withfinger124 in its retracted position it is apparent thatcontrol knob88 can be freely rotated to a position whereinflow rate indicia134 formed on the periphery of knob88 (FIG. 9) can be viewed through aviewing window36aformed in thefirst portion36 of the apparatus housing. Locking means, here provided in the form of a locking tab140 (seeFIG. 8C), is also carried by the locking shaft cover and, when moved from the release position shown inFIG. 8G into the locking position shown inFIG. 8H, prevents inward movements of theindexing shaft130 against the urging of spring128 (FIGS. 6A, 8B,8D,8E and8F). A spring biased retainer pin141 (FIG. 8E) functions to retain the selector knob in position withinhousing34.
• When the selector knob is in the desired position and pressure is released onindexing shaft130,spring128 will urgefinger124 of the indexing means of the invention into locking engagement with one of theindexing cavities88cthereby placing a selected one of the spiral shapedflow control channels90 in communication with thefluid reservoir44 viapassageways120,118 and114. As the fluid flows outwardly of the apparatus due to the urging of the stored energy means50, thebellows structure42 will be collapsed and at thesame time member112 will travel inwardly ofhousing portion38.Member112, which forms a part of the volume indicator means of the invention, includes a radially outwardly extending indicatingfinger112athat is visible through avolume indicator window143 that is provided insecond portion38 of the apparatus housing and also comprises a part of the volume indicator means of the invention (FIG. 1).Indicia145, which are provided onindicator window143, function to readily indicate to the caregiver the amount of fluid remaining withinfluid reservoir44.
• A safety disabling means, shown here as a disablingshaft151 that is telescopically movable within apassageway151aformed within the housing functions to disable the device and render it unusable. More particularly,shaft151 has a distal end151bwhich, upon insertion of the shaft, will block fluid flow throughpassageway79. Aretainer151cnormally holdsshaft151 in the retracted position (seeFIG. 3A).
• Turning next toFIGS. 19 through 31, an alternate embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral153. This alternate form of the apparatus of the invention is similar in many respects to that shown inFIGS. 1 through 18 and like numerals are used inFIGS. 19 through 31 to identify like components. As best seen inFIGS. 19, 20 and21, the apparatus of this alternate form of the invention comprises anouter housing154 having first, second andthird portions156,158 and160 respectively. Disposed withinouter housing154 is an inner,expandable housing162 that is quite similar in construction and operation toexpandable housing42.Housing162 includes afluid reservoir164 that is provided with an inlet166 (FIG. 22) for permitting fluid flow into the fluid reservoir.Expandable housing162, likeexpandable housing42, comprises a bellows structure having an expandable and compressible, accordion-like,annular sidewall162aof the character best seen inFIG. 22.
• Disposed withinsecond portion158 ofouter housing154 is the stored energy means of the invention for acting upon innerexpandable housing162 in a manner to cause the fluid contained withinfluid reservoir164 to controllably flow throughoutlet185. In this alternate form of the invention, the important stored energy means is also similar in construction and operation to the earlier described stored energy means and here comprises a compressively deformable,elastomeric member170 that is carried within thesecond portion158 of the outer housing. As before, inoperation member170 is first compressed by fluid flowing intoreservoir164 and then is controllably expanded to cause fluid flow from the fluid reservoir. Storedenergy member170 can be constructed from a wide variety of materials including those materials earlier described herein.
• As in the earlier described embodiment of the invention, the apparatus of this alternate form of the invention comprises fill means carried by thethird portion160 ofouter housing154 for filling thereservoir164 with the fluid to be dispensed. This fill means is also similar to the earlier described fill means, save for the fact that the fill means of this latest embodiment comprises only onefill vial172 which is identical in construction and operation to the earlier describedfill vial62. As before, the fill means also includes an alternate fill means that comprises apierceable septum56 that is disposed within acavity54 formed in thethird portion160 ofouter housing154.Septum56 is pierceable by the needle of the syringe which contains the medicinal fluid to be dispensed and which can be used to fill or partially fillreservoir164 or to recover medicinal fluid therefrom via apassageway171 formed inthird portion160.
• Third portion160 ofhousing154 includes achamber174 for telescopically receiving the medicament containingfill vial172. Anelongated support178, which is mounted withinchamber174, is provided with an internally threadedend portion175 and a longitudinally extending, elongatedhollow needle180 which has a flow passageway180athat communicates with afluid passageway171 via an umbrellatype check valve182 and a stub passageway171a.
• The apparatus of this latest form of the invention also includes flow control means that is quite similar in construction and operation to the flow control means described in connection with the embodiment of the invention shown inFIGS. 1 through 18. This flow control means is connected tofirst portion156 ofouter housing154 and comprises anullage defining member184 having afirst portion184adisposed within inner,expandable housing162 and asecond portion184bhaving afluid passageway185 that is in communication withfluid reservoir164.
• As before, the flow control means includes a flow control subassembly that is substantially identical in construction and operation to the earlier describedflow control subassembly80 and is of the configuration shown inFIGS. 9, 10,12 and13 of the drawings. Accordingly, the details of the construction and operation of the control means of this latest embodiment of the invention will not be here repeated and reference should be made to the earlier description of theflow control subassembly80.
• Turning once again toFIG. 19, also forming a part of the fluid dispensing apparatus of this latest form of the invention is dispensing means for dispensing fluid to the patient. This dispensing means is identical in construction and operation to the previously identified administration set94 and is connected to thefirst portion156 ofhousing154.
• Turning now toFIGS. 23 and 24, it is to be noted that glass orplastic shell vial172 is identical in construction to fillvial66 and includes afluid chamber102 for containing an injectable fluid.Chamber102 is provided with a firstopen end100aand secondclosed end100b. Firstopen end100ais sealably closed by closure means here provided in the form of an externally threadedelastomeric plunger104 which is telescopically movable within the vial from a first location shown inFIG. 24, where the plunger is disposed proximate firstopen end100a, to a second location where the plunger is disposed proximate second,closed end100b.
• After opening ofcover160a(FIG. 22),vial172 can be inserted intochamber174. As the fill vial is so introduced and theplunger104 is threadably interconnected withend175 of the elongated support, the sharp end ofelongated needle180 will pierce thecentral wall104aof the elastomeric plunger. Continuous movement of the vial intochamber174 will cause thestructural support178 to move the elastomeric plunger inwardly of the vial chamber in a direction toward the secondclosed end100bof the vial. As the plunger is moved inwardly of the vial, the fluid contained within the vial chamber will be expelled therefrom into the hollowelongated needle180. As best seen inFIG. 22, the fluid will then flow past umbrellatype check valve182 and intopassageway171 formed inthird portion160 of the apparatus housing.
• As the fluid flows into the bellows reservoir, the bellows will be expanded from the collapsed configuration shown inFIG. 22 into an expanded configuration. As the bellows member expands it will urge a telescopically movablevolume indicator member112 that is carried within second portion of the housing and in engagement with the stored energy source, or compressible-expandable member170 causing it to compress. It is also to be understood that, if desired, the reservoir of the bellows component can also be filled by alternate filling means of the character previously described which comprises a syringe having a needle adapted to pierce thepierceable septum56 which is mounted withinthird portion160 of the apparatus housing. As thereservoir164 fills with fluid either from thefill vial172 or from the filling syringe, any gases trapped within the reservoir will be vented to atmosphere via vent means “V” which comprises the earlier describedgas vent113.
• Upon opening the fluid delivery path to the administration set94 in a manner presently be described, the stored energy means, ormember170, will tend to return to its less compressed starting configuration thereby controllably urging fluid flow outwardly ofreservoir164 viapassageway185 and the flow control means of the invention. As the fluid contained within thebellows reservoir164 is urged outwardly thereof by the stored energy means, the fluid will flow into afluid passageway185 formed in thefirst portion184aofullage member184. The fluid will then flow under pressure through a filter means shown here as afilter116 that is identical to that previously described. After flowing throughfilter116, the fluid will flow, via astub passageway185a(FIG. 22) into the several radially outwardly extendingflow passageways120 formed inflow control member86. The filtered fluid will fillpassageways120 and then will flow into the plurality ofspiral passageways90 formed inmember86 viaoutlets90b, which communicate with passageways120 (seeFIG. 10). The fluid contained withinspiral passageways90 can flow outwardly of the device only when one of thefluid outlets84 formed incasing82 is aligned with apassageway186 formed in the ullage member.
• Selection of thepassageway90 from which the fluid is to be dispensed is accomplished by rotation of theselector knob88 in the manner previously described in connection with the embodiment shown inFIGS. 1 through 18. The construction and operation of the selector knob is identical to that previously described and will not be redescribed at this time.
• As illustrated inFIGS. 22 and 28, as before, the distal portion ofselector knob88 is provided with a plurality of circumferentially spaced apart indexingcavities88cthat closely receive anindexing finger190 which forms a part of the indexing means of this latest form of the invention which is carried withinthird portion160 of the apparatus housing.Indexing finger190 is continuously urged into engagement with a selected one of theindexing cavities88cby acoil spring192 that also forms a part of the indexing means of the invention.Coil spring192 can be compressed by an inward force exerted on anindexing shaft194 that is received withinfront retaining plate196 and is movable from the extended position shown inFIG. 22 to an inward, finger release position whereinspring192 is compressed andfinger190 is retracted from a selectedindexing cavity88c. Withfinger190 in its retracted position it is apparent thatcontrol knob88 can be freely rotated to a position whereinflow rate indicia134 formed on the periphery ofknob88 can be viewed through aviewing window136aformed in the housing.Button197 disables (stops flow) to dispenser line.
• When theselector knob88 is in the desired position and pressure is released onindexing shaft194,finger190 of the indexing means of the invention will move into locking engagement with one of theindexing cavities88cthereby placing a selected one of the spiral shapedflow control channels90 in communication withoutlet186 of thefluid reservoir164. As the fluid flows outwardly of the apparatus due to the urging of the stored energy means orelastomeric member170, thebellows structure162 will be collapsed and at thesame time member112 will travel inwardly ofhousing portion158 and will provide an indication of the volume of fluid remaining in the fluid reservoir in the same manner as earlier described.
• The apparatus of this latest form of the invention also includes novel safety disabling means for disabling the apparatus. As best seen inFIGS. 19 and 30, the disabling means here comprises a disableshaft197 that is telescopically movable within apassageway198aformed in ahousing198 that forms a part ofportion156 of the outer housing of the apparatus.Shaft197 includes adistal end197a, which, upon insertion ofshaft197 inwardly ofpassageway198a, will block fluid flow throughpassageway186 and outwardly into the fluid dispensing means. Aretainer199 normally holdsshaft197 is the retracted position and an elastomeric O-ring200 carried byshaft197 prevents fluid leakage past the shaft.
• Referring now toFIGS. 32 through 42, still another embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral202. This alternate form of the apparatus of the invention is similar in many respects to that shown inFIGS. 19 through 31 and like numerals are used inFIGS. 32 through 42 to identify like components. The primary difference between this latest form of the invention and the invention shown inFIGS. 19 through 31 resides in the fact that the fill vial used to fill the fluid reservoir is of different construction. As best seen inFIGS. 32 through 36, the apparatus of this alternate form of the invention comprises anouter housing202 having mechanically engaged or suitably bonded together first, second andthird portions206,208 and210 respectively. Disposed withinouter housing206 is an inner,expandable housing162 that is of identical construction and operation to the expandable housing of the last described embodiment of the invention.Housing162 includes afluid reservoir164 that is provided with an inlet166 (FIG. 37) for permitting fluid flow into the fluid reservoir. As before,expandable housing162 comprises a bellows structure having an expandable and compressible, accordion likesidewall162aof the character best seen inFIG. 37.
• Disposed withinsecond portion208 ofouter housing202 is the stored energy means of the invention for acting upon innerexpandable housing162 in a manner to cause the fluid contained withinfluid reservoir164 to controllably flow throughoutlet185. In this alternate form of the invention, the important stored energy means is identical in construction and operation to that earlier described in stored energy means and here comprises a compressively deformable,elastomeric member170 that is carried within thesecond portion208 of the outer housing. As before, inoperation member170 is first compressed by fluid flowing intoreservoir164 and then is controllably expanded to cause fluid flow from the fluid reservoir.
• As in the last described embodiment of the invention, the apparatus of this alternate form of the invention comprises fill means carried by thethird portion210 ofouter housing202 for filling thereservoir164 with the fluid to be dispensed. This fill means is also similar to the earlier described fill means, save for the fact that the fill means of this latest embodiment comprises a singlecartridge fill vial212 which is of a slightly different construction and operation from closed-endshell fill vial172. As before, the fill means also includes an alternate fill and drug recovery means that comprises apierceable septum56 that is disposed within acavity54 formed in thethird portion210 ofouter housing202.Septum56 is pierceable by the needle of the syringe which contains the medicinal fluid to be dispensed and which can be used to fill or partially fillreservoir164 via apassageway171 formed inthird portion210.
• As best seen inFIG. 37,third portion210 ofhousing202 includes achamber214 for telescopically receiving the medicament containingfill cartridge vial212. As shown inFIG. 34, anelongated support218 is mounted within ahollow vial cover220 that removably covers the fill vial in the manner shown inFIG. 37. The purpose ofelongated support218 will presently be described. Fillvial cartridge212, which is of the generally conventional construction shown inFIG. 32A, comprises a hollow glass orplastic body portion219 having aninner surface216 that defines afluid chamber219a. The fill cartridge vial has an openfirst end214aand asecond end214bthat is closed by a pierceable,elastomeric septum221 secured in place by a conventional crimp closure means. Mounted proximate the inboard end ofchamber214 ofhousing202 is a hollow needle215 (FIG. 37) which is adapted to pierceseptum221 when the fill vial is inserted intochamber214 in a manner next to be described.
• Disposed withinfluid reservoir219ais aplunger224 that is moved bysupport218 ofvial cover220 from a first positionproximate end214aofvial212 to a second position shown inFIG. 37. More particularly, as thevial cover220 is mated with the apparatus housing, the inboard218aofelongated support218 engagesplunger224 urging the plunger inwardly offluid chamber219a. As the plunger moves inwardly of the fluid reservoir, the fluid contained in the reservoir will be forced throughhollow needle215, passed anumbrella check valve226 mounted withinthird portion210, into astub passageway228, intopassageway171 and finally intofluid reservoir164. As the fluid flows intoreservoir164 it will compress the stored energy means in the manner previously described.
• The apparatus of this latest form of the invention also includes flow control means that is identical in construction and operation to the flow control means described in connection with the embodiment of the invention shown inFIGS. 18 through 31. This flow control means is connected tofirst portion206 ofouter housing202 and comprises anullage defining member184 having afirst portion184adisposed within inner,expandable housing162 and asecond portion184bhaving afluid passageway186 that is in communication with the outlet of thefluid reservoir164.
• As before, the flow control means includes a flow control subassembly that is substantially identical in construction and operation to the earlier describedflow control subassembly80 and is of the configuration shown inFIGS. 9, 10,12 and13 of the drawings. For this reason, the details of the construction and operation of the control means of this latest embodiment of the invention will not be here repeated and reference should be made to the earlier description of theflow control subassembly80.
• Turning once again toFIG. 32, also forming a part of the fluid dispensing apparatus of this latest form of the invention is dispensing means for dispensing fluid to the patient. This dispensing means is identical in construction and operation to the previously identified administration set94 and is connected to thefirst portion206 ofhousing202.
• Upon opening the fluid delivery path to the administration set94 in a manner presently be described, the stored energy means, ormember170, will tend to return to its less compressed starting configuration thereby controllably urging fluid flow outwardly ofreservoir164 via the flow control means of the invention. As the fluid contained within thebellows reservoir164 is urged outwardly thereof by the stored energy means, the fluid will flow into afluid passageway185 formed in thefirst portion184aofullage member184. The fluid will then flow under pressure through a filter means shown here as afilter116 that is identical to that previously described. After flowing throughfilter116, the fluid will flow, via astub passageway185a(FIG. 37) into the several radially outwardly extendingflow passageways120 formed inflow control member86. The filtered fluid will fillpassageways120 and then will flow into the plurality ofspiral passageways90 formed inmember86 viaoutlets90b, which communicate with passageways120 (seeFIG. 10). The fluid contained withinspiral passageways90 can flow outwardly of the device only when one of thefluid outlets84 formed incasing82 is aligned with passageway186 (FIG. 37).
• Selection of thepassageway90 from which the fluid is to be dispensed is accomplished by rotation of theselector knob88 in the manner previously described in connection with the embodiment shown inFIGS. 19 through 31. The construction and operation of the selector knob, the indexing means and the locking means is identical to that previously described and will not be redescribed at this time.
• As in the earlier described embodiments of the invention, as the fluid flows outwardly of the apparatus due to the urging of the stored energy means orelastomeric member170, thebellows structure162 will be collapsed and at thesame time member112 will travel inwardly ofhousing portion208 and will provide an indication of the volume of fluid remaining in the fluid reservoir in the same manner as earlier described.
• This latest embodiment also includes disabling means, which, as shown inFIG. 42, is substantially identical in construction and operation to that previously described.
• Referring now toFIGS. 43 through 50, yet another embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral230. This alternate form of the apparatus of the invention is similar in many respects to that shown inFIGS. 32 through 34 and like numerals are used inFIGS. 43 through 50 to identify like components. The primary difference between this latest form of the invention and the invention shown inFIGS. 32 through 42 resides in the fact that two fill vials are used to fill the fluid reservoir of the apparatus. As before, the apparatus of this alternate form of the invention comprises anouter housing232 having a first, second andthird portions234,236, and238 respectively. Disposed withinouter housing232 is an inner,expandable housing162 that is of identical construction and operation to the expandable housing of the embodiment of the invention shown inFIGS. 32 through 42. As in the earlier described embodiment,housing162 includes afluid reservoir164 that is provided with an inlet166 (FIG. 44) for permitting fluid flow into the fluid reservoir. As shown inFIG. 44,expandable housing162 comprises a bellows structure having an expandable and compressible, accordion-like side wall162a.
• Disposed withinsecond portion236 ofouter housing232 is the stored energy means of the invention for acting upon innerexpandable housing162 in a manner to cause the fluid contained withinfluid reservoir164 to controllably flow throughoutlet186. In this alternate form of the invention, the important stored energy means is identical in construction and operation to the earlier described stored energy means and here comprises a compressively deformable,elastomeric member170 that is carried within thesecond portion236 of the outer housing. As before, inoperation member170 is first compressed by fluid flowing intoreservoir164 and then is controllably expanded to cause fluid flow from the fluid reservoir.
• As in the last described embodiment of the invention, the apparatus of this alternate form of the invention comprises fill means carried by thethird portion238 ofouter housing232 for filling thereservoir164 with the fluid to be dispensed. This fill means is also similar to the earlier described fill means, save for the fact that the fill means of this latest embodiment comprises a pair of identical fill vials orcartridges212 which are of the same construction and operation as the earlier describedfill vial212. As in the previously described embodiments, the fill means also includes an alternate fill means that comprises apierceable septum56 that is disposed within acavity54 formed in thethird portion238 ofouter housing232.Septum56 is pierceable by the needle of the syringe which contains the medicinal fluid to be dispensed and which can be used to fill or partially fillreservoir164 via apassageway241 formed inthird portion238.
• As best seen inFIGS. 44 and 50,third portion238 ofhousing232 includes a pair of spaced-apartchambers242 for telescopically receiving the medicament containingfill vials212. As shown inFIGS. 34, 44, and50, a pair ofelongated supports244 are mounted within ahollow vial cover246 that forms a part of thethird portion238 of the housing and removably covers the fill vials in the manner shown inFIG. 44. Each of thefill vial cartridges212, has a generally conventional construction shown inFIGS. 49 and 49A, and each comprises a hollow glass orplastic body portion219 that defines afluid chamber220. Each fill vial has an openfirst end214aand a second end that is closed by a pierceable,elastomeric septum221. Mounted proximate the inboard end of each chamber of the housing is ahollow needle215 which is adapted to pierceseptum221 when the fill vials are inserted intochambers242 in a manner next to be described.
• Disposed within eachfluid reservoir220 is aplunger224 that is moved by asupport244 ofvial cover246 from a first positionproximate end214aof the vial to a second position. More particularly, as thevial cover246 is slidably mated with the apparatus housing, the inboard of each of the elongated supports engages aplunger224 urging the plunger inwardly offluid chamber220. As each of the plungers move inwardly of their respective fluid reservoirs, the fluid contained in the reservoir will be forced throughhollow needle215, passed anumbrella check valve226 mounted withinthird housing portion238, into astub passageway248, intopassageway241 and finally intofluid reservoir164 via166. As the fluid flows intoreservoir164, it will compress the stored energy means in the manner previously described.
• The apparatus of this latest form of the invention also includes flow control means that is identical in construction and operation to the flow control means described in connection with the embodiment of the invention shown inFIGS. 32 through 42. This flow control means is connected tofirst portion234 ofouter housing232 and comprises anullage defining member184 having afirst portion184adisposed within inner,expandable housing162 and asecond portion184bhaving afluid passageway186 that is in communication with the outlet of thefluid reservoir164.
• As before, the flow control means includes a flow control subassembly that is substantially identical in construction and operation to the earlier describedflow control subassembly80 and is of the configuration shown inFIGS. 9, 10,12 and13 of the drawings. For this reason, the details of the construction and operation of the control means of this latest embodiment of the invention will not be here repeated and reference should be made to the earlier description of theflow control subassembly80.
• Turning once again toFIG. 43, also forming a part of the fluid dispensing apparatus of this latest form of the invention is dispensing means for dispensing fluid to the patient. This dispensing means is identical in construction and operation to the previously identified administration set94 and is connected to thefirst portion234 ofhousing232.
• Upon opening the fluid delivery path to the administration set94, the stored energy means, ormember170, will tend to return to its less compressed starting configuration thereby controllably urging fluid flow outwardly ofreservoir164 via the flow control means of the invention. As the fluid contained within thebellows reservoir164 is urged outwardly thereof by the stored energy means, the fluid will flow into afluid passageway185 formed in thefirst portion184aofullage member184. The fluid will then flow under pressure through a filter means shown here as afilter116 that is identical to that previously described. After flowing throughfilter116, the fluid will flow, via astub passageway185a(FIG. 44) in the several radially outwardly extendingflow passageways120 formed inflow control member86. The filtered fluid will fillpassageways120 and then will flow into the plurality ofspiral passageways90 formed inmember86 viaoutlets90b, which communicate with passageways120 (seeFIG. 10). The fluid contained withinspiral passageways90 can flow outwardly of the device only when one of thefluid outlets84 formed incasing82 is aligned with passageway186 (FIG. 44).
• Selection of thepassageway90 from which the fluid is to be dispensed is accomplished by rotation of theselector knob88 in the manner previously described in connection with the embodiment shown inFIGS. 19 through 31. The construction and operation of the selector knob, the indexing means and the locking means is identical to that previously described and will not be redescribed at this time.
• As in the earlier described embodiment of the invention, as the fluid flows outwardly of the apparatus due to the urging of the stored energy means orelastomeric member170, thebellows structure162 will be collapsed and at thesame time member112 will travel inwardly ofhousing portion236 and will provide an indication of the volume of fluid remaining in the fluid reservoir in the same manner as earlier described.
• This latest embodiment also includes a safety defeat disabling means, which is substantially identical in construction and operation to that previously described.
• Turning now toFIGS. 51 through 63, another form of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral250. This alternate form of the apparatus of the invention is similar in many respects to that shown inFIGS. 43 through 63 and like numerals are used inFIGS. 51 through 63 to identify like components. The primary difference between this latest form of the invention and the invention shown inFIGS. 43 through 63 resides in the fact that one of the two cartridge fill vials used to fill the fluid reservoir of the apparatus is of a different construction. More particularly, one of the fill vials is specially designed to enable the reconstitution and intermixing of a lypholized drug with a suitable diluent prior to the delivery of the mixture to the fluid reservoir of the device.
• As in the earlier described embodiments, the apparatus of this latest form of the invention comprises anouter housing252 having first, second andthird portions254,256 and258 respectively. Disposed withinouter housing252 is an inner,expandable housing162 that is of identical construction and operation to the expandable housing of the embodiment of the invention shown inFIGS. 32 through 42. As in the earlier described embodiment,housing162 includes afluid reservoir164 that is provided with an inlet166 (FIG. 52) for permitting fluid flow into the fluid reservoir. As shown inFIG. 52,expandable housing162 comprises a bellows structure having an expandable and compressible, accordion likesidewall162a.
• Disposed withinsecond portion256 ofouter housing252 is the stored energy means of the invention for acting upon innerexpandable housing162 in a manner to cause the fluid contained withinfluid reservoir164 to controllably flow throughoutlet186. In this latest form of the invention, the important stored energy means is identical in construction and operation to the earlier described stored energy means and here comprises a compressively deformable,elastomeric member170 that is carried within thesecond portion256 of the outer housing. As before, in operation,member170 is further compressed by fluid flowing intoreservoir164 and then is controllably expanded to cause fluid flow from the fluid reservoir.
• As previously mentioned, the apparatus of this latest form of the invention comprises fill means of a somewhat different construction that is carried by thethird portion258 ofouter housing252 for filling thereservoir164 with the fluid to be dispensed. This fill means, like the last described fill means, comprises a pair of fill vials or cartridges one of which, namely fillvial212, is of identical construction and operation to the earlier describedfill vial212. The second fill vial or cartridge designated by the numeral262 comprises a container of special design that uniquely contains alyophilized drug264 that is separated from a reconstitutingfluid266 by a barrier stopper268 (FIG. 57).Lyophilized drug264 can, by way of example, comprise anti-infectives, oncolytics, cardiac drugs or various other types of beneficial agents.Cartridge262 is telescopically receivable within avial housing270 that is of the configuration shown inFIGS. 52, 55 and56. As before,vial housing270 includes a pair of spaced apartpusher members272 and274 which, upon mating of the vial housing within the apparatus housing, engage plungers224 (FIG. 59) and276 (FIG. 57) respectively to push them forwardly of their respective container reservoirs.
• Considering in more detail thereconstitution cartridge assembly262, as best seen inFIG. 57, this cartridge assembly includes avial280 that is sealed at one end by aplunger276 and at the other end by a pierceable septum282 (FIGS.5457, and61). Formed intermediate the ends ofvial280 is a raised outer wall portion280awhich permitsfluid266 to bypassbarrier stopper268 as the elastomeric barrier stopper is urged inwardly of the container by pressure exerted thereon by thefluid266.Fluid266 exerts pressure onbarrier member268 as a result ofpusher member274 exerting inward pressure onplunger276, which pressure is, in turn, caused by the inward movement ofplunger276 asvial housing262 is mated with the apparatus housing270 (FIG. 52).
• A continued inward pressure exerted onelastomeric plunger276 will cause thereconstitution agent266 to flow pastbarrier stopper member268 via wall portion280aor the bypass chamber, so as to reconstitutelyophilized drug264. Further pressure exerted onplunger276 will cause the reconstituted drug formed by the fluid266 which has been intermixed withdrug264 to flow through ahollow cannula215,past check valve284, into astub passageway286 then into apassageway290 then intomicrogrooves166aformed inullage184aand finally into reservoir164 (FIG. 52).
• As previously mentioned,plunger224 is disposed withinvial212 and is moved by asupport272 ofvial cover270 as the vial cover is slidably mated with the apparatus housing. Asplunger224 is moved inwardly offluid reservoir219, the diluent contained in the reservoir will be forced throughhollow needle215, passed anumbrella check valve226 mounted withinthird housing portion258, into astub passageway248, intopassageway290, intomicrochannels166aand finally intofluid reservoir164. As the fluid flows intoreservoir164, it will compress the stored energy means in the manner previously described.
• As in the earlier described embodiments, the fill means also includes an alternate fill and recovery means that comprises apierceable septum56 that is disposed within acavity54 formed in thethird portion258 ofouter housing252.Septum56 is pierceable by the needle of the syringe which contains the medicinal fluid to be dispensed and which can be used to fill or partially fillreservoir164 via apassageway290 formed inthird portion258.
• The apparatus of this latest form of the invention also includes flow control means that is identical in construction and operation to the flow control means described in connection with the embodiment of the invention shown inFIGS. 32 through 42. This flow control means is connected tofirst portion254 ofouter housing252 and comprises anullage defining member184 having afirst portion184adisposed within inner,expandable housing162 and asecond portion184bhaving afluid passageway186 that is in communication with outlet168 of thefluid reservoir164.
• As before, the flow control means includes a flow control subassembly that is substantially identical in construction and operation to the earlier describedflow control subassembly80 and is of the configuration shown inFIGS. 9, 10,12 and13 of the drawings. For this reason, the details of the construction and operation of the control means of this latest embodiment of the invention will not be here repeated and reference should be made to the earlier description of theflow control subassembly80.
• Turning once again toFIG. 51, also forming a part of the fluid dispensing apparatus of this latest form of the invention is dispensing means for dispensing fluid to the patient. This dispensing means is identical in construction and operation to the previously identified administration set94 and is connected to thefirst portion254 ofhousing252.
• Upon opening the fluid delivery path to the administration set94 in a manner presently be described, the stored energy means, ormember170, will tend to return to its less compressed starting configuration thereby controllably urging fluid flow outwardly ofreservoir164 via the flow control means of the invention. As the fluid contained within thebellows reservoir164 is urged outwardly thereof by the stored energy means, the fluid will flow into afluid passageway185 formed in thefirst portion184aofullage member184. The fluid will then flow under pressure through a filter means shown here as afilter116 that is identical to that previously described. After flowing throughfilter116, the fluid will flow, via astub passageway185a(FIG. 52) into the several radially outwardly extendingflow passageways120 formed inflow control member86. The filtered fluid will fillpassageways120 and then will flow into the plurality ofspiral passageways90 formed inmember86 viaoutlets90b, which communicate with passageways120 (seeFIG. 10). The fluid contained withinspiral passageways90 can flow outwardly of the device only when one of thefluid outlets84 formed incasing82 is aligned with passageway186 (FIG. 52).
• Selection of thepassageway90 from which the fluid is to be dispensed is accomplished by rotation of theselector knob88 in the manner previously described in connection with the embodiment shown inFIGS. 19 through 31. The construction and operation of the selector knob, the indexing means and the locking means is identical to that previously described and will not be redescribed at this time.
• As in the earlier described embodiments of the invention, as the fluid flows outwardly of the apparatus due to the urging of the stored energy means orelastomeric member170, thebellows structure162 will be collapsed and at thesame time member112 will travel inwardly ofhousing portion256 and will provide an indication of the volume of fluid remaining in the fluid reservoir in the same manner as earlier described.
• This latest embodiment also includes safety defeat disabling means, which, as shown inFIG. 43, is substantially identical in construction and operation to that previously described.
• Considering next the alternate form offill cartridge assembly292, shown inFIGS. 61 and 62, this fill cartridge is similar in some respects to fillcartridge262 and includes avial294 that is sealed at one end by aplunger295 and at the other end by apierceable septum282. Formed intermediate the ends ofvial294 is a plurality of spaced-apart, angularly inclinedfluid flow passageways296 which permit fluid266 to bypass a member orbarrier stopper297 as the barrier stopper is urged inwardly of the container by pressure exerted thereon byfluid266.Fluid266 exerts pressure onbarrier member297 as a result ofpusher member274 of thevial housing270 exerting inward pressure onplunger295, which pressure is, in turn, caused by the inward movement ofplunger295 asvial housing270 is mated with thehousing252.
• A continued inward pressure exerted onelastomeric plunger295 will cause fluid266 to flow pastelastomeric barrier member297 viaflow passageway296 so as to reconstitute lyophilized drug264 (FIG. 61). Further pressure exerted onplunger295 will cause the reconstituted drug formed by the fluid266 which has been intermixed withdrug264 to flow through ahollow cannula283,past check valve284, into astub passageway286, then into apassageway290 into the micro-channels166aand finally into reservoir164 (FIG. 52).
• Referring now toFIGS. 64 through 70, yet another embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral302. This alternate form of the apparatus of the invention is somewhat similar to that shown in the previous figure drawings and like numerals are used inFIG. 64 through70 to identify like components. The primary difference between this latest form of the invention and the invention shown in earlier figure drawings resides in the fact that the only fill means comprises aseptum304 that is disposed within acavity306 in thedevice housing308.Septum304 is pierceable by the needle of a syringe which contains the medicinal fluid to be dispensed and used to fill the fluid reservoir of the device (FIG. 66).
• As best seen inFIGS. 64 and 68, theouter housing308 comprises first andsecond portions310 and312 respectively. Disposed withinouter housing308 is an inner,expandable housing162 that is of identical construction and operation to the expandable housing of the earlier described embodiments of the invention.Housing162 includes afluid reservoir164 that is provided with an inlet314 (FIG.66) for permitting fluid flow into the fluid reservoir. As before,expandable housing162 comprises a bellows structure having an expandable and compressible, accordion likesidewall162aof the character best seen inFIG. 66.
• Disposed withinsecond portion312 ofouter housing308 is the stored energy means of the invention for acting upon innerexpandable housing162 in a manner to cause the fluid contained withinfluid reservoir164 to controllably flow through an outlet, the character of which will presently be described. Any gases contained within the expandable housing will be substantially vented to atmosphere through a vent “V” via apassageway316 and afilter317.
• In this alternate form of the invention, the important stored energy means is identical in construction and operation to the earlier described stored energy means and here comprises a compressively deformable,elastomeric member170 that is carried within thesecond portion312 of the outer housing. As before, in operation,member170 is first compressed by fluid flowing intoreservoir164 and then is controllably expanded to cause fluid flow from the fluid reservoir.
• As previously mentioned, in the last described embodiment of the invention, the fill means which is carried by thesecond portion312 ofouter housing308 for filling thereservoir164 with the fluid to be dispensed comprises theseptum304.Septum304 is pierceable by the needle of the syringe which contains the medicinal fluid that can be used to fill or partially fillreservoir164 viapassageway314 formed insecond portion312 of the housing.
• Turning once again toFIG. 64, also forming a part of the fluid dispensing apparatus of this latest form of the invention is dispensing means for dispensing fluid to the patient. This dispensing means is identical in construction and operation to the previously identified administration set94 and is connected to the ullage defining means of the invention that comprises a part of thehousing308. This ullage means is provided in the form of anullage defining member315 that includes afirst portion315athat is disposed within innerexpandable housing162 and asecond portion315bhaving apassageway316 that is in communication withfluid reservoir164.
• Upon opening the fluid delivery path to the administration set94, the stored energy means, ormember170, will tend to return to its uncompressed starting configuration thereby controllably urging fluid flow outwardly ofreservoir164. As the fluid contained within thebellows reservoir164 is urged outwardly thereof by the stored energy means, the fluid will flow under pressure through a filter means shown here asfilter116 that is identical to that previously described. After flowing throughfilter116, the fluid will flow, via a stub passageway318 (FIG. 66) and into afluid passageway320, which comprises a fine bore capillary line portion of the administration set94. The capillary line portion can be of various diameters and lengths to thereby enable precise fluid flow rate control.
• As in the earlier described embodiments of the invention, as the fluid flows outwardly of the apparatus due to the urging of the stored energy means orelastomeric member170, thebellows structure162 will be collapsed and at the same time amember112 will travel inwardly of housing portion and will provide an indication of the volume of fluid remaining in the load reservoir in the same manner as earlier described.
• This latest embodiment also uniquely includes fastening means for releasably fastening the device to the clothing of the patient, such as a shirt pocket or a belt. This fastening means is here provided in the form of aspring clip322 that is affixed to one side of thehousing308.
• Referring next toFIGS. 71 through 85, yet another embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral442. As best seen inFIGS. 71 and 72, the apparatus here comprises anouter housing444 having first andsecond portions446 and448 respectively and a bondedend plate449. Disposed withinouter housing444 is an inner,expandable housing450 having afluid reservoir452 provided with an inlet454 (FIG. 73) for permitting fluid flow into the fluid reservoir and anoutlet456 for permitting fluid flow from the fluid reservoir.Expandable housing450, which can be constructed from a metal or plastic material, comprises a bellows structure having an expandable and compressible, accordion-like, annular-shapedsidewall450a, the configuration of which is best seen inFIGS. 73 and 74. As best seen inFIG. 74, the inner wall of the bellows is provided, in the manner previously described herein, with one or more layers of aprotective coating458 that is compatible with the fluids contained withinreservoir452.
• Disposed withinsecond portion448 ofouter housing444 is the novel stored energy means of the invention for acting upon innerexpandable housing450 in a manner to cause the fluid contained withinfluid reservoir452 to controllably flow outwardly of the housing. In the present form of the invention, this important stored energy means comprises a compressively deformable,elastomeric member460 that is carried within thesecond portion448 of the outer housing. In a manner presently to be described,member460 is first compressed by fluid flowing intoreservoir452 and then is controllably expanded to cause fluid flow from the outer housing through the dispensing means of the invention. Storedenergy member460 can be constructed from a wide variety of materials including metals and plastics. By way of example, storedenergy member460 can be constructed from a wide variety of foam-like, solid and cellular materials including rubbers, molded or extruded plastics and other thermoplastic elastomers (TPE) and thermoplastic urethane (TPU) and polyethylene. By way of example, suitable materials include latex rubber, rubber polyolefins, polyisoprene (natural rubber), butyl rubber, nitrile rubber, polyurethane, vinyls, vinyl-end-blocked polydimethylsiloxanes, other homopolymer, copolymers (random alternating, block, graft, cross-link and star block), silicones and other flouropolymers, mechanical poly-blends, polymer alloys and other thermoplastic elastomers (TPE) and thermoplastic urethane (TPU) and polyethylene.
• Forming an important aspect of the apparatus of the present invention is fill means carried byouter housing444 for filling thereservoir452 with the fluid to be dispensed. As best seen inFIG. 73,first portion446 includes afluid passageway462 in communication withinlet454 offluid reservoir452. Proximate itslower end462a,fluid passageway462 communicates with acavity464 formed withinportion446 of thehousing444. Disposed withincavity464 is apierceable septum466 that comprises a part of one form of the fill means of the invention.Septum466 is held in position by aretainer466aand is pierceable by the needle of the syringe which contains the medicinal fluid to be dispensed and which can be used in a conventional manner to fill or partially fillreservoir452 viapassageway462.
• Forming another very important aspect of the apparatus of the present invention is a novel flow control means that is disposed interiorly ofouter housing444. This flow control means functions to precisely control the outwardly rate of fluid flow fromreservoir452 and toward the patient. In the form of the invention shown inFIGS. 71 through 88 the flow control means comprises a flow control assembly generally designated in the drawings by the numeral470. As best seen inFIGS. 81 and 82, this novel flow control assembly here comprises aninlet manifold472 having aninlet port474 that is in communication with theoutlet456 of thefluid reservoir452 and anoutlet manifold476 that is interconnected withintake manifold472 by means of aseparator plate478. As indicated inFIGS. 81 and 82,outlet manifold476 as anoutlet port479 that is in communication with the outlet of the apparatus and is provided with anelongated microchannel480 that is coated with a coating C-1 (FIG. 86A) and is in communication both withinlet port474 and with theoutlet port479 of the outlet manifold. Disposedintermediate inlet manifold472 and a generally circular shapedseparator plate478 is filter means, here provided as afilter member482 that functions to filter fluid flowing towardoutlet port478 of the outlet manifold. Generally disk shapedfilter member482 can be formed from various porous materials, including porous metals, plastics and porous ceramics.
• As best seen inFIG. 82,separator plate478 is provided withstandoff ribs484 for supportingfilter member482 in the manner shown inFIG. 81. The assemblage made up ofinlet manifold472,outlet manifold476,separator plate478 andfilter482 is preferably encapsulated within an outer metal or plastic casing486 (seeFIG. 81).
• As indicated inFIG. 81, the flow rate control means, orassemblage470, has an axial centerline “C” with which theinlet port474 of theinlet manifold472 is coaxial aligned. However, theoutlet port479 of the outlet manifold is radially spaced from the axial centerline. With this construction, fluid will flow fromreservoir452 intoinlet port474, throughfilter member482, through acentral opening478aformed inseparator plate478 and thence into microchannel480 (see alsoFIG. 85). By controlling the length, depth and width of themicrochannel480, the rate of fluid flow flowing outwardly ofoutlet479 can be precisely controlled. In this regard, the microchannel can take several forms as for example that illustrated inFIG. 86 of the drawings and generally designated therein by the numeral480a. Where required for drug compatibility purposes, themicro channel480acan be coated with a compatibility coating “C-1” of the character previously described. This coating can be accomplished in several ways, including the plasma coating process earlier described herein.
• Turning once again toFIGS. 71, 72 and73, also forming a part of the fluid dispensing apparatus of the present invention is dispensing means for dispensing fluid to the patient. In the present form of the invention this dispensing means comprises an administration set488 that is connected to thefirst portion446 ofhousing444 in the manner shown in the drawings. Theproximal end490aofadministration line490 of the administration set488 is in communication with anoutlet fluid passageway492 which is formed inhousing portion446 in the manner best seen inFIG. 73. Disposed between the proximal and490aand thedistal end490bof the administration line is a conventional gas vent andfilter496. Provided at thedistal end490bof the administration line is aluer connector498 of conventional construction (FIG. 71).
• To control fluid flow from theoutlet479 of the flow rate control means towardoutlet passageway492, novel operating means are provided. This operating means here comprises acontrol knob assembly500 that includes a finger gripping portion of502 and a generally cylindrically shapedshank portion504 that is rotatably received within abore506 formed in housing portion446 (FIG. 73). As indicated inFIG. 75,control knob assembly500 is rotatable from a first “on”, or fluid flow position, to a second “off” position as indicated by indicia provided on the forward face ofhousing portion446. The control knob assembly is retained in position with ahousing446 by aretainer ring505.Shank portion504 of the control knob assembly includes anaxial flow passageway508 that communicates with the earlier identifiedoutlet flow passageway492 via astub passageway509. Theflow passageway508 also communicates withoutlet479 of flowrate control assembly470 when the control assembly is in the “on” position shown inFIG. 75. In this position, fluid it can flow fromreservoir452, throughoutlet456, through flowrate control assembly470, intocentral passageway508 of the control knob assembly and then toward the administration set viapassageway492. As indicated inFIGS. 76 and 78, to guide the travel of the control knob assembly, the control knob assembly is provided with aprotuberance502athat travels within agroove511 provided in thehousing portion446.
• In using the apparatus of the invention, with the control knob assembly in the “off” position, thereservoir452 of thebellows component450 can be filled by filling means which comprises a conventional syringe having a needle adapted to pierce thepierceable septum466 which is mounted withinportion446 of the apparatus housing. As the fluid flows into the bellows reservoir, the bellows will be expanded from a collapsed into an expanded configuration, such as is shown inFIG. 73. As the bellows member expands it will urge a telescopically movablevolume indicator member512 that is carried within asecond portion448 of the housing into engagement with the stored energy source causing it to compress. As thereservoir452 fills with fluid from the filling syringe, any gases trapped within the reservoir will be vented to atmosphere via vent means “V” mounted inknob502.
• With the infusion apparatus interconnected with the patient's clothing by means of aspring clip assembly518, which is affixed to the side of the device housing in the manner shown inFIGS. 72 and 75, and with the administration set488 interconnected with the patient, opening the fluid delivery path to the administration set can be accomplished by rotating the control knob from the “off” position to the “on” position. Upon opening the fluid delivery path, the stored energy means, ormember460, will tend to return to its starting configuration thereby controllably urging fluid flow outwardly ofreservoir452 via the flow rate control means of the invention,passageway508 of the control knob assembly anddelivery passageway492 formed inhousing portion446. As the fluid flows outwardly of the apparatus due to the urging of the stored energy means, thebellows structure450 will be collapsed and at thesame time member512 will travel inwardly ofhousing portion448.Member512, which forms a part of the volume indicator means of the invention, includes a radially outwardly extending indicating finger512athat is visible through avolume indicator window514 that is provided in asecond portion448 of the apparatus housing and also comprises a part of the volume indicator means of the invention (FIGS. 71 and 72).Indicia516, which are provided onindicator window514, function to readily indicate to the caregiver the amount of fluid remaining withinfluid reservoir452.
• As previously discussed, a number of beneficial agents can be introduced intoreservoir452 and can be controllably dispensed to the patient including, by way of example, medicaments of various types, drugs, pharmaceuticals, hormones, antibodies, biologically active materials, elements, chemical compounds, or any other suitable material useful in diagnostic cure, medication, treatment or preventing of diseases or the maintenance of the good health of the patient.
• Referring next toFIG. 87, an alternate form of flow control means of the invention is there shown. This flow control means can be mounted within a modifiedhousing444 that will accommodate off-set, in-line input and output ports of the diameter shown inFIGS. 27 and 28. This latter flow control means functions to precisely control the rate of fluid flow fromreservoir452 toward the patient. In the form of the invention shown inFIG. 87, the flow control means comprises a flow control assembly generally designated in the drawings by the numeral520.Flow control assembly520 here comprises a first component orinlet manifold522 having aninlet port524 that can be placed in communication of theoutlet456 of thefluid reservoir452 and anoutlet manifold526 that can be interconnected withfirst component522 by means of a pair of separator plates orcomponents528 and529.Outlet manifold component526 has anoutlet port528 that is in communication with theoutlet542 ofseparator plate529 and also in communication with the outlet of the apparatus.Intake manifold522 has aninner surface522athat is provided with a plurality of interconnected, imbeddedcapillaries532.Capillaries532 are in communication both withinlet port524 and with anoutlet port534 formed in the inlet manifold. Disposedadjacent manifold522 isseparator plate528.Separator plate528 has an inner,uninterrupted surface528athat is also provided with a plurality of imbeddedcapillaries536 that are in communication withoutlet port534 formed in the inlet manifold. Fluid flowing fromcapillaries532 flows intocapillaries536 via aninlet port537 and then outwardly ofseparator plate528 via anoutlet port536a.
• Separator plate529, which is disposedintermediate separator plate528 andoutlet manifold526, has an inner,uninterrupted surface529athat is provided with a plurality ofinterconnected capillaries540 that receive the fluid flowing outwardly ofoutlet port536a. After the fluid flow throughcapillaries540, it will flow towardoutlet543 ofoutlet manifold526 via anoutlet port542.
• By controlling the length, width and depth ofcapillaries532,536, and540, the rate of fluid flow flowing outwardly ofoutlet543 can be precisely controlled. In this regard, it is to be understood that the capillaries of the flow control assembly can take several forms depending upon the end use of the fluid delivery device.
• Turning now toFIG. 88, still another form of flow control means of the invention is there shown. This flow control means can also be mounted withinhousing444 in place offlow control assembly470 and functions to precisely control the rate of fluid flow fromreservoir452 and toward the patient. In the form of the invention shown inFIG. 88, the flow control means comprises a flow control assembly generally designated in the drawings by the numeral550.Flow control assembly550 here comprises a first component orinlet manifold552 having aninlet port554 that can be placed in communication with theoutlet456 of thefluid reservoir452 and a second component oroutlet manifold556 that can be interconnected withintake manifold552 by means of a separator component orplates558 and559.Outlet manifold556 has anoutlet port558 that is in communication with theoutlet560 ofseparator plate559 and also in communication with the outlet of the apparatus.Intake manifold552 has an inner surface552athat is provided with a plurality of interconnected imbeddedcapillaries562.Capillaries562 are in communication both withinlet port554 and with an outlet port564 formed in the inlet manifold. Disposedadjacent manifold552 is aseparator plate558.Separator plate558 has aninner surface558athat is provided with a plurality of imbeddedcapillaries566 that are in communication withoutlet port554 formed in the inlet manifold. Fluid flowing fromcapillaries562 flows intocapillaries566 via aninlet port567 and then outwardly ofseparator plate558 via anoutlet port569.
• Separator plate559, which is disposedintermediate separator plate558 andoutlet manifold556, has aninner surface559athat is provided with a plurality ofinterconnected capillaries570 that receive the fluid flowing outwardly ofoutlet port569. After the fluid flows throughcapillaries570, it will flow towardoutlet558 ofoutlet manifold556 via anoutlet port560.
• As before, by controlling the length, width and depth ofcapillaries562,566, and570 the rate of fluid flow flowing outwardly ofoutlet558 can be precisely controlled.
• Having now described the invention in detail in accordance with the requirements of the patent statutes, those skilled in this art will have no difficulty in making changes and modifications in the individual parts or their relative assembly in order to meet specific requirements or conditions. Such changes and modifications may be made without departing from the scope and spirit of the invention, as set forth in the following claims.

Claims (39)

1. A dispensing apparatus for dispensing fluids to a patient comprising:

(a) an outer housing;

(b) an inner, expandable housing disposed within said outer housing, said inner expandable housing having a fluid reservoir provided with an inlet for permitting fluid flow into said fluid reservoir and an outlet for permitting fluid flow from said fluid reservoir;

(c) stored energy means disposed within said outer housing for acting upon said inner expandable housing to cause the fluid contained within said fluid reservoir to controllably flow through said outlet, said stored energy means comprising a compressively deformable, cellular member carried within said outer housing, said cellular member being expandable to cause fluid flow from said fluid reservoir;

(d) fill means carried by said outer housing for filling said reservoir with the fluid to be dispensed;

(e) flow control means connected to said outer housing for controlling fluid flow from said reservoir; and

(f) dispensing means operably associated with said flow control means for dispensing fluid to the patient.

2. The apparatus as defined inclaim 1 in which said cellular member comprises a flexible polymeric foam member.

3. The apparatus as defined inclaim 1 in which said cellular member comprises a metalized foam.

4. The apparatus as defined inclaim 1 in which said inner expandable housing comprises a bellows structure having an accordion-like side wall movable from a substantially collapsed configuration to a substantially expanded configuration by fluid flowing into said fluid reservoir.

5. The apparatus as defined inclaim 1 further including flow control means connected to said first portion of said outer housing for controlling fluid flow between said reservoir and said dispensing means, said flow control means comprising a flow control member rotatable within said reservoir and having a plurality of elongated flow control channels.

6. The apparatus as defined inclaim 1 in which said fill means comprises a first fill vial receivable within said outer housing.

7. The apparatus as defined inclaim 6 in which said outer housing includes:

(a) a fluid passageway;

(b) a first chamber for telescopically receiving said first fill vial; and

(c) an elongated support mounted within said first chamber, said elongated support having an elongated hollow needle, said hollow needle defining a flow passageway in communication with said fluid passageway.

8. The apparatus as defined inclaim 7 in which said first fill vial has a first open end, a closed second end and includes

(a) a fluid reservoir disposed between said first and second ends; and

(b) a pierceable plunger disposed within said fluid reservoir for movement between first and second positions.

9. The apparatus as defined inclaim 8 in which said fill means comprises a second fill vial receivable within said outer housing and in which said outer housing includes:

(a) a second chamber for telescopically receiving said second fill vial; and

(b) an elongated support mounted within said second chamber, said elongated support having an elongated hollow needle, said hollow needle defining a flow passageway in communication with said fluid passageway.

10. The apparatus as defined inclaim 9 in which said second fill vial has a first open end, a closed second end and includes;

(a) a fluid reservoir disposed between said first and second ends of said second fill vial; and

(b) a pierceable plunger disposed within said fluid reservoir of said second fill vial for movement between first and second positions.

11. A dispensing apparatus for dispensing fluids to a patient comprising:

(a) an outer housing having a first, second and third portions;

(b) an inner, expandable housing disposed within said outer housing, said inner expandable housing having a fluid reservoir provided with an inlet for permitting fluid flow into said fluid reservoir;

(c) stored energy means disposed within said second portion of said outer housing for acting upon said inner expandable housing to cause the fluid contained within said fluid reservoir to controllably flow outwardly toward the patient, said stored energy means comprising a compressively deformable, substantially continuous, semisolid member carried within said second portion of said outer housing, said elastomeric member being expandable to cause fluid flow from said fluid reservoir;

(d) fill means carried by said outer housing for filling said reservoir with the fluid to be dispensed;

(e) flow control means connected to said first portion of said outer housing for controlling fluid flow from said reservoir, said flow control means comprising a flow control assembly including:

(i) an ullage defining member having a first portion disposed within said inner, expandable housing and a second portion having a fluid passageway in communication with said outlet of said fluid reservoir;

(ii) a fluid flow control member rotatably mounted within said first portion of said ullage defining member, said flow control member having a plurality of elongated fluid flow control channels, each of said plurality of elongated fluid flow control channels having an inlet and all outlet; and

(iii) selector means rotatably connected to said second portion of said ullage defining member for rotating said fluid flow control member to selectively align an outlet of one of said elongated fluid flow control channels with said with fluid passageway in said second portion of said ullage defining member; and

(iv) dispensing means for dispensing fluid to the patient, said dispensing means being connected to said second portion of said ullage defining member, and being in communication with said fluid passageway of said second portion of said ullage defining member.

12. The apparatus as defined inclaim 11 in which said flow control assembly further comprises:

(a) an outer casing circumscribing said flow control member; and

(b) distribution means formed in said flow control member for distributing fluid from said fluid reservoir to each of said plurality of elongated flow control channels.

13. The apparatus as defined inclaim 12, in which said flow control member is provided with an inlet passageway in communication with said fluid reservoir and in which said fluid flow control assembly further includes filter means carried by said fluid flow control member for filtering fluid flowing toward said distribution means.

14. The apparatus as defined inclaim 13 in which said distribution means comprises a plurality of radially extending flow passageways formed in said fluid flow control member.

15. The apparatus as defined inclaim 13 in which said selector means comprises a selector knob connected to said fluid flow control member, said selector knob having finger gripping means for imparting rotation to said selector knob to align said outlet of a selected one of said elongated fluid flow control channels with said outlet of said fluid passageway in said second portion of said ullage defining member.

16. The apparatus as defined inclaim 13, further including volume indicator means carried by said outer housing for indicating the volume of fluid remaining in said fluid reservoir.

17. The apparatus as defined inclaim 13 further including disabling means carried by said outer housing for preventing fluid flow toward said dispensing means.

18. The apparatus as defined inclaim 13 in which said housing includes a cavity in communication with said inlet of said fluid reservoir and in which said fill means comprises a pierceable septum disposed within said cavity.

19. The apparatus as defined inclaim 18 in which said fill means comprises a first fill vial receivable within said third portion of said outer housing.

20. The apparatus as defined inclaim 19 in which said fill means comprises a second fill vial receivable within said third portion of said outer housing.

21. The apparatus as defined inclaim 20 in which said third portion of said outer housing includes:

(a) a fluid passageway in communication with said inlet of said fluid reservoir;

(b) a first chamber for telescopically receiving said first fill vial;

(c) an elongated support mounted within said first chamber, said elongated support having an elongated hollow needle, said hollow needle defining a flow passageway in communication with said fluid passageway;

(d) a second chamber for telescopically receiving said second fill vial; and

(e) an elongated support mounted within said second chamber, said elongated support having an elongated hollow needle, said hollow needle defining a flow passageway in communication with said fluid passageway.

22. The apparatus as defined inclaim 21 in which each of said first and second fill vials has a first open end, a closed second end and each includes;

(a) a fluid reservoir disposed between said first and second ends; and

(b) a pierceable plunger disposed within said fluid reservoir for movement between first and second positions.

23. A dispensing apparatus for dispensing fluids to a patient comprising:

(a) an outer housing having a first, second and third portions;

(b) an inner, expandable housing disposed within said outer housing, said inner expandable housing having a fluid reservoir provided with an inlet for permitting fluid flow into said fluid reservoir;

(c) stored energy means disposed within said second portion of said outer housing for acting upon said inner expandable housing to cause the fluid contained within said fluid reservoir to controllably flow outwardly toward the patient, said stored energy means comprising a compressively deformable, elastomeric member carried within said second portion of said outer housing said, said elastomeric member being expandable to cause fluid flow from said fluid reservoir;

(d) fill means carried by said outer housing for filling said reservoir with the fluid to be dispensed;

(e) flow control means connected to said first portion of said outer housing for controlling fluid flow from said reservoir, said flow control means comprising a flow control assembly including:

(i) an ullage defining member having a first portion disposed within said inner, expandable housing and a second portion having a fluid passageway in communication with said outlet of said fluid reservoir;

(ii) a flow control member rotatably mounted within said first portion of said ullage defining member, said flow control member having a plurality of elongated micro fluidic flow control channels, each of said plurality of elongated micro fluidic flow control channels having an inlet and an outlet;

(iii) an outer casing circumscribing said flow control member;

(iv) distribution means formed in said flow control member for distributing fluid from said fluid reservoir to each of said plurality of elongated micro fluidic flow control channels, said distribution means comprising a plurality of radially extending flow passageways formed in said flow control member;

(v) selector means rotatably connected to said second portion of said ullage defining member for rotating said flow control member to selective align an outlet of one of said elongated flow control channels with said fluid passageway of said second portion of said ullage defining member, said selector means comprising a selector knob connected to said flow control member, said selector knob having finger gripping means for imparting rotation to said selector knob to align said outlet of a selected one of said elongated micro fluidic flow control channels with said outlet of said fluid passageway in said second portion of said ullage defining member;

(vi) dispensing means for dispensing fluid to the patient, said dispensing means being connected to said second portion of said ullage defining member, and being in communication with said fluid passageway of said second portion of said ullage defining member; and

(f) volume indicator means for indicating the volume of fluid remaining in said fluid reservoir.

24. The apparatus as defined inclaim 23 further including disabling means carried by said outer housing for preventing fluid flow toward said dispensing means.

25. The apparatus as defined inclaim 23 in which said outer housing includes a cavity in communication with said inlet of said fluid reservoir and in which said fill means comprises a pierceable septum disposed within said cavity.

26. The apparatus as defined inclaim 23 further including locking means carried by said outer housing for blocking rotation of said selector knob.

27. The apparatus as defined inclaim 23 in which said fill means comprises a cartridge fill vial receivable within said third portion of said outer housing.

28. The apparatus as defined inclaim 26 in which said third portion of said outer housing includes;

(a) a removable vial cover;

(b) a fluid passageway in communication with said inlet of said fluid reservoir;

(c) a chamber for telescopically receiving said cartridge fill vial; and

(d) an elongated support mounted within said removable vial cover.

29. The apparatus as defined inclaim 28 in which said cartridge fill vial has first and second ends and includes:

(a) a pierceable septum closing one of said first and second ends;

(b) a fluid reservoir disposed between said first and second ends; and

(c) a plunger disposed within said fluid reservoir for movement between first and second positions.

30. A dispensing apparatus for dispensing fluids to a patient comprising:

(a) an outer housing having a first, second and third portions;

(b) an inner, expandable housing disposed within said outer housing, said inner expandable housing having a fluid reservoir provided with an inlet for permitting fluid flow into said fluid reservoir and an outlet for permitting fluid flow from said fluid reservoir, said inner expandable housing comprising a flexible bellows structure having an accordion-like side wall movable from a substantially collapsed configuration to an expanded configuration by fluid flowing into said fluid reservoir;

(c) stored energy means disposed within said second portion of said outer housing for acting upon said inner expandable housing to cause the fluid contained within said fluid reservoir to controllably flow through said outlet, said stored energy means comprising a compressively deformable, spring member carried within said second portion of said outer housing, said spring member being expandable to cause fluid flow from said fluid reservoir;

(d) fill means carried by said third portion of said outer housing for filling said reservoir with the fluid to be dispensed;

(e) flow control means carried by said outer housing for controlling fluid flow from said reservoir; and

(f) dispensing means operably associated with said flow control means for dispensing fluid to the patient.

31. The apparatus as defined inclaim 30 in which said spring member comprises a metal spring.

32. The apparatus as defined inclaim 30 in which said spring member comprises a plastic spring.

33. The apparatus as defined inclaim 30 in which said spring member comprises a wave spring.

34. The apparatus as defined inclaim 30 in which said side wall of said bellows structure is coated with a drug compatible coating.

35. The apparatus as defined inclaim 30 in which said coating on said side wall of said bellows structure comprises a plasma containing fluorine molecules.

36. The apparatus as defined inclaim 30 in which said flow control means comprises a flow control assembly, including at least one component having a plurality of embedded capillaries.

37. The apparatus as defined inclaim 30 in which said flow control assembly includes a plurality of components having embedded capillaries.

38. The apparatus as defined inclaim 37 in which said embedded capillaries comprise a micro fluidic flow channels.

39. The apparatus as defined inclaim 38 in which said microfluidic flow channels are coated.

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