US20070225689A1 - Infusion apparatus - 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 substantially constant-force, compressible-expandable wave spring 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 medicament solution to the patient.

Description

• This is a Continuation Application of co-pending U.S. Ser. No. 10/855,425 filed May 26, 2004.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention relates generally to medicament infusion 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 compressible spring energy source, and a novel flow rate control means for precisely 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, continuous 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 the provision of various fluid flow rate control means, including 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 compressible-expandable spring member that provides the force necessary to substantially, uniformly 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 such as insulin, anti-infectives, analgesics, oncolylotics, cardiac drugs biopharmaceuticals, and the like 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 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 compressible-expandable spring member that provides the force necessary to continuously and substantially 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 self-contained medicament dispenser which is of very simple construction and yet extremely reliable in 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 left front view of one embodiment of the medicament infusion apparatus of the present invention for dispensing fluids at a uniform rate.
• FIG. 2 is a generally perspective right front view of the embodiment of the medicament infusion apparatus shown inFIG. 1.
• FIG. 3 is an enlarged, longitudinal cross-sectional view of the apparatus shown inFIG. 1.
• FIG. 4 is an enlarged, cross-sectional view of the area designated as “4” inFIG. 3.
• FIG. 5 is a right end view of the apparatus shown inFIG. 3.
• FIG. 6 is an exploded view of the forward portion of the apparatus shown inFIG. 3.
• FIG. 7 is a cross-sectional view taken along lines7-7 ofFIG. 6.
• FIG. 8 is a view taken along lines8-8 ofFIG. 6.
• FIG. 9 is a cross-sectional view taken along lines9-9 ofFIG. 8.
• FIG. 10 is a view taken along lines10-10 ofFIG. 6.
• FIG. 11 is a greatly enlarged cross-sectional view of one form of the rate control assembly of the invention.
• FIG. 12 is an exploded, cross-sectional view of the rate control assembly shown inFIG. 11.
• FIG. 13 is a generally perspective, exploded front view of the rate control assembly shown inFIG. 11.
• FIG. 14 is a generally perspective, exploded rear view of the rate control assembly shown inFIG. 11.
• FIG. 15 is a cross-sectional view taken along lines15-15 ofFIG. 11.
• FIG. 16 is a view similar toFIG. 15, but showing an alternate form of flow rate control component.
• FIG. 17 is a generally perspective, exploded view of an alternate form of flow rate control assembly.
• FIG. 18 is a generally perspective, exploded view of yet another alternate form of the fluid flow rate assembly of the invention.
• FIG. 19 is a cross sectional view of still another form of the fluid rate control assembly of the invention.
• FIG. 19A is an exploded perspective view of the rate control assembly shown inFIG. 19.
• FIG. 19B is a generally diagrammatic, tabular view illustrating various types of springs that can be used as the stored energy source of the invention.
• FIG. 19C is a generally diagrammatic, tabular view further illustrating various types of springs that can be used as the stored energy source of the invention.
• FIG. 19D is a generally diagrammatic, tabular view further illustrating various types of springs that can be used as the stored energy source of the invention.
• FIG. 19E is a generally diagrammatic, tabular view further illustrating various types of springs that can be used as the stored energy source of the invention.
• FIG. 19F is a generally diagrammatic, tabular view further illustrating various types of springs that can be used as the stored energy source of the invention.
• FIG. 20 is a generally perspective view of an alternate embodiment of the infusion apparatus of the present invention for dispensing fluids at a uniform rate.
• FIG. 21A is an enlarged, longitudinal cross-sectional view of the forward portion of the apparatus shown inFIG. 20.
• FIG. 21B is an enlarged, cross-sectional view of the rear portion of the apparatus.
• FIG. 21C is an enlarged, cross-sectional view of the area designated as21C inFIG. 21A.
• FIG. 21D is an enlarged, cross-sectional view of the area designated as21D inFIG. 21A.
• FIG. 21E is an enlarged, cross-sectional view of the elastomeric sealing band shown in21E inFIG. 21D.
• FIG. 21F is an enlarged, cross-sectional view of the elastomeric sealing band shown inFIG. 21C.
• FIG. 22 is a cross-sectional view similar toFIG. 21, but showing the apparatus in a fluid fill mode.
• FIG. 22A is a cross-sectional view taken alonglines22A-22A ofFIG. 22.
• FIG. 23 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 shown inFIG. 21.
• FIG. 24 is a view taken along lines24-24 ofFIG. 23.
• FIG. 25 is an end view of the apparatus shown inFIG. 21.
• FIG. 26 is a view taken along lines26-26 ofFIG. 25.
• FIG. 27 is a cross-sectional view taken along lines27-27 ofFIG. 21B.
• FIGS. 28 and 28A, when considered together comprise a generally perspective, exploded view of the various internal operating components of this latest form of the apparatus of the invention.
• FIG. 29 is a generally perspective, exploded view of one form of the indexing means of the invention shown inFIG. 21A.
• FIG. 30 is a fragmentary, front view similar to the front view shown inFIG. 25, but better showing the configuration of the indexing means of the invention.
• FIG. 31 is a cross-sectional view taken along lines31-31 ofFIG. 30.
• FIG. 32 is an enlarged, fragmentary, bottom view of the forward portion of the apparatus shown inFIG. 22.
• FIG. 33 is a cross-sectional view taken along lines33-33 ofFIG. 32 but rotated 90° counterclockwise.
• FIG. 34 is a fragmentary, cross-sectional view similar toFIG. 33 but showing the indexing means in a locked position.
• FIG. 35 is a generally perspective, front view of one form of the fluid flow control assembly of the apparatus of the invention.
• FIG. 36 is a generally perspective, exploded front view of the fluid flow control assembly shown inFIG. 35.
• FIG. 37 is a greatly enlarged, fragmentary cross-sectional view of one of the flow control channels formed in the flow control member shown in the central portion ofFIG. 36.
• FIG. 38 is a generally perspective, rear view of the fluid flow control assembly of the apparatus of the invention.
• FIG. 39 is a generally perspective, exploded rear view of the fluid flow control assembly shown inFIG. 38.
• FIG. 40 is a generally perspective view of an alternate form of the flow control member of the invention.
• FIG. 40A is a generally perspective view of yet another form of the flow control member of the invention.
• FIG. 41 is a front view of the assembly shown inFIG. 35.
• FIG. 42 is a cross-sectional view taken along lines42-42 ofFIG. 41.
• FIG. 43 is a view taken along lines43-43 ofFIG. 42.
• FIG. 44 is a cross-sectional view taken along lines44-44 ofFIG. 42.
• FIG. 45 is a cross-sectional view taken along lines45-45 ofFIG. 42.
• FIG. 46 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. 47 is an enlarged, longitudinal cross-sectional view of the embodiment of the invention shown inFIG. 46.
• FIG. 47A is an enlarged, cross-sectional view of the area designated as47A inFIG. 47.
• FIG. 47B is an enlarged, cross-sectional view of the elastomeric sealing band shown inFIG. 47A.
• FIG. 48 is view taken along lines48-48 ofFIG. 47.
• FIG. 49 is a bottom view of the apparatus shown inFIG. 47.
• FIG. 50 is an enlarged view of one of the fill vial assemblies shown inFIG. 47.
• FIG. 50A is a view taken alonglines50A-50A ofFIG. 50.
• FIG. 51 is a generally perspective, exploded view of fluid delivery apparatus shown inFIG. 47
• FIG. 52 is cross-sectional view taken along lines52-52 ofFIG. 47.
• FIG. 53 is a generally perspective view of yet another embodiment of the present invention for dispensing fluids at a uniform rate.
• FIG. 54 is an enlarged, longitudinal cross-sectional view of the embodiment of the invention shown inFIG. 53.
• FIG. 54A is an enlarged, cross-sectional view of the area designated as54A inFIG. 54.
• FIG. 54B is an enlarged, cross-sectional view of the elastomeric sealing band shown inFIG. 54A.
• FIG. 55 is a top view of the apparatus shown inFIG. 54.
• FIG. 56 is cross-sectional view taken along lines56-56 ofFIG. 54.
• FIG. 57 is a left end view of the apparatus shown inFIG. 54.
• FIG. 58 is a side view of the vial cover component of the apparatus.
• FIG. 59 is a view taken along lines59-59 ofFIG. 58.
• FIG. 60 is a generally perspective exploded view of this latest embodiment of the invention.
• FIG. 61 is an enlarged, longitudinal, cross-sectional view of one of the fill vial-assemblies shown inFIG. 54.
• FIG. 62 is a cross-sectional view taken along lines62-62 ofFIG. 61.
• FIG. 63 is an enlarged, longitudinal, cross-sectional view of the other fill vial assembly of the apparatus of the invention.
• FIG. 64 is a cross-sectional view taken along lines64-64 ofFIG. 63.
• FIG. 65 is a cross-sectional view of an alternate form of fill vial assembly of the invention.
• FIG. 66 is a cross-sectional view taken along lines66-66 ofFIG. 65.
• FIG. 67 is a generally perspective view of still another embodiment of the medicament infusion apparatus of the present invention for dispensing fluids at a uniform rate.
• FIG. 68 is a bottom plan view of the embodiment of the apparatus shown inFIG. 67.
• FIG. 69 is a top plan view of the embodiment of the apparatus shown inFIG. 67.
• FIG. 70 is a side elevational view of the vial cover portion of the apparatus shown inFIG. 67.
• FIG. 71 is a view taken along lines71-71 ofFIG. 70.
• FIG. 72 is a cross-sectional view taken along lines72-72 ofFIG. 69.
• FIG. 72A is an enlarged, cross-sectional view of the area designated as72A inFIG. 72.
• FIG. 72B is an enlarged, cross-sectional view of the elastomeric sealing band shown inFIG. 72A.
• FIG. 72C is an enlarged, cross-sectional view of the area designated as72C inFIG. 72.
• FIG. 72D is an enlarged, cross-sectional view of the elastomeric sealing band shown inFIG. 72C.
• FIG. 73 is a right end view of the apparatus shown inFIG. 67.
• FIG. 74 is a left end view of the apparatus shown inFIG. 67.
• FIG. 75 is a cross-sectional view taken along lines75-75 ofFIG. 72.
• FIG. 76 is a cross-sectional view taken along lines76-76 ofFIG. 72.
• FIG. 77 is a cross-sectional view taken along lines77-77 ofFIG. 72.
• FIG. 78 is a generally perspective, front view of the flow rate control means of this latest form of the apparatus of the present invention.
• FIG. 79 is a rear view of the forward most rate control plate of the flow control means shown inFIG. 81.
• FIG. 80 is a cross-sectional view taken along lines80-80 ofFIG. 79.
• FIG. 81 is a generally perspective, rear view of the flow rate control means shown inFIG. 78.
• FIG. 82A is a generally perspective exploded view of the rear half of various flow rate control plates that make up the flow rate control plate assembly of the invention.
• FIG. 82B is a generally perspective exploded view of the front half of various flow rate control plates that make up the flow rate control plate assembly of the invention.
• FIG. 83, when considered in its entirety, comprises a front view of each of the rate control plates of the invention shown inFIGS. 82A and 82B.
• FIG. 84 is a rear view of the first, or leftmost rate control plate of the rate control plate assembly shown inFIG. 81.
• FIG. 84A is a cross-sectional view taken along lines84A-84A ofFIG. 84.
• FIG. 85 is a side elevational view of the rate control plate assembly shown inFIG. 81 as it appears in an assembled configuration.
• FIG. 86 is a rear view of the outlet manifold component of the assembly shown inFIG. 85.
• FIG. 87 is a cross-sectional view taken along lines87-87 ofFIG. 86.
• FIG. 88 is a front view of the assembly shown inFIG. 85.
• FIG. 89 is a front view of the first from the left, rate control plate or inlet manifold shown inFIG. 82.
• FIG. 90 is a front view of the rate control plate shown inFIG. 82.
• FIG. 91 is a cross-sectional view taken along lines91-91 ofFIG. 90.
• FIG. 92 is a front view of the second from the left, rate control plate shown inFIG. 82.
• FIG. 93 is a rear view of the rate control plate shown inFIG. 92.
• FIG. 94 is a cross-sectional view taken along lines94-94 ofFIG. 93.
• FIG. 95 is a fragmentary cross-sectional view of the forward portion of the outlet manifold of the flow control means shown sealably mated with the rate control knob of the apparatus of the invention.
• FIG. 95A is an enlarged, fragmentary cross-sectional view of the upper portion ofFIG. 95.
• FIG. 95B is an enlarged fragmentary cross-sectional view of the lower portion ofFIG. 95.
• FIG. 96 is a cross-sectional view taken along lines96-96 ofFIG. 95.
• FIG. 97 is a cross-sectional view similar toFIG. 96, but showing the rate control knob rotated to a second position.
DESCRIPTION OF THE INVENTION
• Referring to the drawings and particularly toFIGS. 1 through 10, one embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral102. As best seen inFIGS. 1 and 2, the apparatus here comprises anouter housing104 having first andsecond portions106 and108 respectively that can be snapped together, adhesively bonded, sonic bonded or otherwise suitably interconnected. Disposed withinouter housing104 is an inner,expandable housing110 having a fluid reservoir112 provided with an inlet114 (FIG. 3) for permitting fluid flow into the fluid reservoir and anoutlet116 for permitting fluid flow from the fluid reservoir.Expandable housing110, which can be constructed from a metal or plastic material, comprises a bellows structure having an expandable and compressible, accordion-like, annular-shapedsidewall110a, the configuration of which is best seen inFIGS. 3 and 4. As best seen inFIG. 4, the inner wall of the bellows is provided with a surface modification orprotective coating118 that is compatible with the fluids contained within reservoir112. Thiscoating118 can be accomplished by several different processes. One process that is extremely clean, fast and effective 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 surface of the bellows. For cases where an inert hydrophobic interface is desired, plasma using fluorine-containing molecules may be employed. That is, the drug interface bellows surface 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. Similar drug interface coatings “C” can be provided on other surfaces, such as fluid passageways, that may be encountered by the drugs that are to be delivered (see, for example,FIG. 37).
• Disposed withinsecond portion108 ofouter housing104 is the novel stored energy means of the invention for acting upon innerexpandable housing110 in a manner to cause the fluid contained within fluid reservoir112 to controllably flow outwardly of the housing. In the present form of the invention, this important stored energy means comprises a resiliently deformable,spring120 that is carried within thesecond portion108 of the outer housing. In a manner presently to be describedspring120 is first more fully compressed by fluid flowing into reservoir112 and then is controllably expanded to cause fluid flow from the outer housing through the dispensing means of the invention. As depicted inFIGS. 19B through 19F and as will be discussed in greater detail hereinafter, storedenergy member120 can be constructed in various configurations and from a wide variety of materials including metals and plastics. Preferably,spring120 takes the form of a wave spring of the type illustrated in configuration F ofFIG. 19C which is readily commercially available from sources, such as the Smalley Company of Lake Zurich, Ill.
• Typically, wave springs operate as load bearing devices. They can also take up play and compensate for dimensional variations within assemblies. A virtually unlimited range of forces can be produced whereby loads build either gradually or abruptly to reach a predetermined working height. This establishes a precise spring rate in which load is proportional to deflection, and can be tuned to a particular load requirement.
• Typically, a wave spring will occupy an extremely small area for the amount of work it performs. The use of this product is demanded, but not limited to tight axial and radial space restraints.
• Forming an important aspect of the apparatus of the present invention is fill means carried byouter housing104 for filling the reservoir112 with the fluid to be dispensed. As best seen inFIG. 3,first portion106 includes afluid passageway122 in communication withinlet114 of fluid reservoir112. Proximate itslower end122a,fluid passageway122 communicates with acavity124 formed withinportion106 of thehousing104. Disposed withincavity124 is an elastomeric,pierceable septum126 that comprises a part of one form of the fill means of the invention.Septum126 is held in position by a bondedretainer126aand 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 fill reservoir112 viapassageway122 and to recover unused medicament. The fill means can also be used to add adjuvant drugs.
• Forming another very important aspect of the apparatus of the present invention is a novel fluid flow control means that is disposed interiorly ofouter housing104. This flow control means functions to precisely control the rate of fluid flow outwardly from reservoir112 and toward the patient. In the form of the invention shown inFIGS. 1 through 19 the flow control means comprises a flow control assembly generally designated in the drawings by the numeral130. As best seen inFIGS. 11 and 12, this novel flow control assembly here comprises aninlet manifold132 having aninlet port134 that is in communication with theoutlet116 of reservoir112 and anoutlet manifold136 that is interconnected withintake manifold132 by means of aseparator plate138. As indicated inFIGS. 11 and 12,outlet manifold136 as anoutlet port139 that is in communication with the outlet of the apparatus and is provided anelongated microchannel140 that is in communication both withinlet port134 and withoutlet port139 of the outlet manifold. Disposedintermediate inlet manifold132 and a generally circular shapedseparator plate138 is filter means here provided as afilter member142 that functions to filter fluid flowing towardoutlet port139 of the outlet manifold. Generally disk shapedfilter member142 can be formed from various porous materials, including porous poly propolene.Filter number142 can be bonded or otherwise suitably fixed in place.
• As best seen inFIG. 13,separator plate138 is provided withstandoff ribs144 for supportingfilter member142 in the manner shown inFIG. 11. The assemblage made up ofinlet manifold132,outlet manifold136,separator plate138 andfilter142 is preferably encapsulated within an outer metal or plastic casing146 (seeFIG. 11).
• As indicated inFIG. 11, the flow rate control means, orassemblage130, has an axial centerline “CL” with which theinlet port134 of theinlet manifold132 is coaxial aligned. However, theoutlet port139 of the outlet manifold is radially spaced from the axial centerline. With this construction, fluid will flow from reservoir112 intoinlet port134, throughfilter member142, through acentral opening138aformed in a separator plate and thence intomicrochannel140. By controlling the length, depth and width of themicrochannel140, the rate of fluid flow flowing outwardly ofoutlet139 can be precisely controlled. In this regard, the microchannel can take several forms as, for example, those illustrated inFIGS. 15 and 16 of the drawings and generally designated therein by thenumerals140aand140b.
• Turning once again toFIGS. 1, 2 and3, also forming a part of the infusion 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 set148 that is connected to thefirst portion106 ofhousing104 in the manner shown in the drawings. Theproximal end150aofadministration line150 of the administration set148 is in communication with anoutlet fluid passageway152 which is formed inhousing portion106 in the manner best seen inFIG. 3. Disposed between theproximal end150aand thedistal end150bof the administration line is a conventional gas vent andparticulate filter156. Provided at thedistal end150bis aluer connector158 and cap158aof conventional construction (FIG. 1).
• To control fluid flow from theoutlet139 of the flow rate control means towardoutlet passageway152, novel operating means are provided. This operating means here comprises acontrol knob assembly160 that includes a finger gripping portion of162 and a generally cylindrically shapedshank portion164 that is rotatably received within abore166 formed in housing portion106 (FIG. 3). O-rings, generally designated as “O”, function to sealably interconnect the various operating components. As indicated inFIG. 5, controlknob assembly160 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 portion106. The control knob assembly is retained in position within ahousing106 by aretainer ring165.Shank portion164 of the control knob assembly includes anaxial flow passageway168 that communicates with the earlier identifiedoutlet flow passageway152 via astub passageway169. Theflow passageway168 also communicates withoutlet139 of flowrate control assembly130 when the control assembly is in the “on” position shown inFIG. 5. In this position, fluid it can flow from reservoir112, throughoutlet116, through flowrate control assembly130, intocentral passageway168 of the control knob assembly and then toward the administration set viapassageway152. As indicated inFIGS. 6 and 8, to guide the travel of the control knob assembly, the control knob assembly is provided with aprotuberance170 that travels within agroove172 provided in thehousing portion106.
• In using the apparatus of the invention, with the control knob assembly in the “off” position, the reservoir112 of thebellows component110 can be filled by filling means which comprises a conventional syringe having a needle adapted to pierce thepierceable septum126 which is mounted withinportion106 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 shown inFIG. 3. As the bellows member expands it will urge a telescopically movablevolume indicator member176 that is carried within asecond portion108 of the housing and in engagement with the stored energy source, orspring member120 causing it to compress. As the reservoir112 fills with fluid from the filling syringe, any gases trapped within the reservoir will be vented to atmosphere via vent means “V” mounted incontrol knob assembly160. A seal ring113 (FIG. 3), prevents leakage of fluid betweenbellows110 andportion106 of the housing.
• With the infusion apparatus interconnected with the patient's clothing by means of aspring clip assembly184, which is affixed to the side of the device housing in the manner shown inFIGS. 2 and 5, and with the administration set148 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, orspring member120, will tend to return to its precompressed or less compressed starting configuration thereby controllably urging fluid flow outwardly of reservoir112 via the flow rate control means of the invention,passageway168 of the control knob assembly anddelivery passageway152 formed inhousing portion106. As the fluid flows outwardly of the apparatus due to the urging of the stored energy means, thebellows structure110 will be collapsed and at thesame time member176 will travel inwardly ofhousing portion108. Couplingmember176, which forms a part of the volume indicator means of the invention, includes a radially outwardly extending indicatingfinger176athat is visible through avolume indicator window177 that is provided in asecond portion108 of the apparatus housing and also comprises a part of the volume indicator means of the invention (FIG. 1 and2).Indicia179, which are provided onindicator window177, function to readily indicate to the caregiver the amount of fluid remaining within bellows fluid reservoir112.Housing portion106 includes an inwardly extendingullage portion180 that functions to ensure that substantially all of the medicinal fluid contained within the bellows reservoir will be expelled therefrom.
• As previously discussed, a number of beneficial agents can be introduced into reservoir112 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. 17, an alternate form of flow control means of the invention is there shown. This flow control means can be mounted withinhousing104 in place offlow control assembly130 and functions to precisely control the rate of fluid flow from reservoir112 toward the patient. In the form of the invention shown inFIG. 17, the flow control means comprises a flow control assembly generally designated in the drawings by the numeral180.Flow control assembly180 here comprises a first component orinlet manifold180ahaving aninlet port183 that can be placed in communication with theoutlet116 of the fluid reservoir112 and anoutlet manifold180bthat can be interconnected withfirst component180aby means of a pair of separator plates orcomponents181 and182.Outlet manifold component180bhas anoutlet port181 that is in communication with theoutlet182aofseparator plate182 and also in communication with the outlet of the apparatus.Intake manifold180ahas an inner surface that is provided with a plurality of interconnected imbeddedcapillaries184.Capillaries184 have input andoutput channels184athat are in communication both withinlet port183 and with anoutlet port185 formed in the inlet manifold. These input and output channels are typically substantially larger than the intermediate rate control channels. Disposedadjacent manifold180aisseparator plate181.Separator plate181 has an inner surface that is also provided with a plurality of imbeddedcapillaries186 that also have larger input and output channels186athat are in communication withoutlet port185 formed in the inlet manifold. Fluid flowing fromcapillaries184 flows intocapillaries186 via an inlet port181aand then outwardly ofseparator plate181 via an outlet port181b.
• Separator plate182, which is disposedintermediate separator plate181 andoutlet manifold180b, has an inner surface that is provided with a plurality ofinterconnected capillaries187 that receive the fluid flowing outwardly of outlet port181b. After the fluid flow throughcapillaries187, it will flow towardoutlet181 ofoutlet manifold180bviaoutlet port182a.Capillaries187 also have larger input andoutput channels187a. The various components that make up the flow control assembly are preferably adhesively bonded together. It is to be noted that the rear surfaces of the plates are planar and cooperate with the capillaries to form fluid flow passageways.
• By controlling the length and depth ofcapillaries184,186, and187, the rate of fluid flow flowing outwardly ofoutlet181 can be precisely controlled. In this regard, it is to be understood that the capillaries of the flow control assembly can take several forms and be of various sizes depending upon the end use of the fluid delivery device.
• Thermal bonding may be performed by using a channeled plate and an adjacent planar surface plate that are of similar polymeric materials. In this case the two plates are placed in contact with one another confined mechanically and heated 2-5° C. above their glass transition temperatures. Following a holding period sufficient enough for the polymer molecules of the two surface interpenetrate with one another, the temperature is slowly reduced and a stress free bonded interface with imbedded microchannels is yielded. The bonding material or adhesive may be of the thermo-melting variety or of the liquid or light curable variety for thermo-melting adhesives, the adhesive material is melted into the two opposed surfaces, thereby interpenetrating these surfaces and creating a sealed channel structure.
• Liquid curable bonding materials or adhesives and light curable bonding materials or adhesives may be applied to one of the surfaces of one of the plates. Subsequently, the other surface is brought into contact with the coated surface and the adhesive is cured by air exposure or via irradiation with a light source. Liquid curable bonding materials or adhesives may be elastomeric (e.g. thermoplastic elastomers, natural or synthetic rubbers, polyurethanes and silicones). Elastomeric bonding materials may or may not require pressure to seal the channel system. They may also provide closure and sealing to small irregularities in the opposed surface of the channel system.
• A channel system may be formed and sealed in cases where two surfaces are being joined and one of the surfaces has one or more apertures. In order to promote bonding between these two surfaces, a vacuum may be applied to the apertures. Bonding may then be accomplished by thermal methods or after previously having applied a bonding material or adhesive.
• Reference should also be made to U.S. Pat. Nos. 6,182,733; 6,555,067; 6,425,972; 5,882,465; 4,999,069; and 5,376,252 which describe various bonding techniques. Reference should also be made to Publication No. WO99/56954 and WO94/29400. It should also be understood that alternate bonding techniques such as sonic welding and laser thermal bonding techniques can be used.
• Turning now toFIG. 18, still another form of flow control means of the invention is there shown. This flow control means can also be mounted withinhousing104 in place offlow control assembly130 and functions to precisely control the rate of fluid flow from reservoir112 toward the patient. In the form of the invention shown inFIG. 18, the flow control means comprises a bonded-flow, laminate-stack control assembly generally designated in the drawings by the numeral190.Flow control assembly190 here comprises a first component orinlet manifold190ahaving aninlet port191 that can be placed in communication with theoutlet116 of the fluid reservoir112 (FIG. 3) and a second component oroutlet manifold190bthat can be interconnected withintake manifold190aby means of a separator component orplates192 and193.Outlet manifold190bhas anoutlet port194 that is in communication with theoutlet195aofseparator plate193 and also in communication with the outlet of the apparatus.Intake manifold190ahas an inner surface that is provided with a plurality of interconnected imbeddedcapillaries196.Capillaries196 are in communication both withinlet port191 and with anoutlet port197 formed in the inlet manifold. Disposedadjacent manifold190ais theseparator plate192.Separator plate192 has an inner surface that is provided with a plurality of imbeddedcapillaries198 that are in communication withoutlet port197 formed in the inlet manifold. Fluid flowing fromcapillaries196 flows intocapillaries198 via aninlet port197 and then outwardly ofseparator plate192 via anoutlet port200.
• Separator plate195, which is disposedintermediate separator plate192 andoutlet manifold190b, has an inner surface that is provided with a plurality ofinterconnected capillaries201 that receive the fluid flowing outwardly ofoutlet port200. After the fluid flows throughcapillaries201 it will flow towardoutlet194 ofoutlet manifold190bvia anoutlet port195a.
• As before, by controlling the length, depth and width ofcapillaries196,198 and201, the rate of fluid flow flowing outwardly ofoutlet194 can be precisely controlled. It is to be noted that the rear surfaces of the plates are planar and cooperate with the capillaries to form fluid flow passageways.
• Referring next toFIGS. 19 and 19A, yet another form of flow control means of the invention is there shown. This flow control means can also be mounted withinhousing104 in place offlow control assembly130 and functions to precisely control the rate of fluid flow from reservoir112 toward the patient. In the form of the invention shown inFIGS. 19 and 19A, the flow control means comprises a flow control assembly generally designated in the drawings by the numeral200.Flow control assembly200 here comprises a first component orinlet manifold202 having aninlet port202athat can be placed in communication with theoutlet116 of the fluid reservoir112 and a second component oroutlet manifold204 that can be interconnected withintake manifold202 by means of a separator component orplate206.Outlet manifold204 has anoutlet port204athat is in communication with theoutlet206aofseparator plate206 and also in communication with the outlet of the apparatus.Separator plate206 has first and second opposingsurfaces208 and210, each of which is provided with a plurality of interconnected, laser-etchedcapillaries214.Capillaries214 are in communication both withinlet port202aand with anoutlet port204aformed in the outlet manifold. As illustrated inFIG. 19, the inner surfaces of the inlet and outlet manifold cooperate with the capillaries to form fluid flow channels through which the medicinal fluid flows.
• Referring once again toFIGS. 19B through 19F, the various types of springs suitable for use as the stored energy source of the invention are there illustrated and described. By way of background, springs are unlike other machine/structure components in that they undergo significant deformation when loaded and their compliance enables them to store readily recoverable mechanical energy.
• With respect to the specific spring configurations shown in the drawings, the following discussion amplifies the descriptive notations in the drawings.
• Compression Springs:
• Compression springs are open-wound helical springs that exert a load or force when compressed. They may be conical or taper springs, barrel or convex, concave or standard cylindrical in shape. Further, they may be wound in constant or variable pitch. The ends can be closed and ground, closed but unground, open and unground and supplied in alternate lengths. They also can include a configuration where a second compression spring of similar or different performance characteristics which can be installed inside the inside diameter of their first compression spring, i.e., a spring in a spring.
• Many types of materials can be used in the manufacture with compression springs including: Commercial Wire (BS5216 HS3), Music Stainless Steel, Phosphur Bronze, Chrome Vanadium,Monel 400, Inconel 600, Inconel X750, Nimonic 90: Round wire, Square and Rectangular sections are also available. Exotic metals and their alloys with special properties can also be used for special and applications; they include such materials as beryllium copper, beryllium nickel, niobium, tantalum and titanium.
• Compression springs can also be made from plastic including all thermoplastic materials used by custom spring winding service providers. Plastic springs may be used in light-to-medium duty applications for quiet and corrosion-resistant qualities.
• Wave Spring:
• Multiwave compression springs, an example of which is shown as “F” inFIG. 19C are readily commercially available from sources, such as the Smalley Company of Lake Zurich, Ill. As previously discussed, such springs operate as load-bearing devices. They can take up play and compensate for dimensional variations within assemblies. A virtually unlimited range of forces can be produced whereby loads built either gradually or abruptly to reach a predetermined working height. This establishes a precise spring rate in which load is proportional to deflection, and can be turned to a particular load requirement.
• Typically, a wave spring will occupy an extremely small area for the amount of work it performs. The use of this product is demanded, but not limited to tight axial and radial space restraints.
• Disc Springs:
• Disc springs I, J, K, and L ofFIGS. 19C and 19D compare conically shaped annular discs (some with slotted or fingered configuration) which when loaded in the axial direction, change shape. In comparison to other types of springs, disc springs product small spring deflections under high loads.
• Some examples of the disc-shaped compression springs include a single or multiple stacked Belleville washer configuration as shown in G and H ofFIG. 19C, and depending on the requirements of the design (flow rate over time including bolus opportunity) one or more disc springs can be used and also of alternate individual thicknesses. Alternate embodiments of the basic disc spring design in a stacked assembly can be also utilized including specialty disc springs similar to the Belleville configuration called K disc springs manufactured by Adolf Schnorr GM8H of Singelfingen, Germany, as well as others manufactured by Christian Bauer GMBH of Welzheim, Germany.
• Disc springs combine high energy storage capacity with low space requirement and uniform annular loading. They can provide linear or nonlinear spring loadings with their unique ability to combine high or low forces with either high or low deflection rates. They can be preloaded and under partial compression in the design application.
• All these attributes, and more, come from single-component assemblies whose nontangle features (when compared to wirewound, compression springs) make them ideal for automatic assembly procedures.
• With respect to the various springs discussed in the preceding paragraphs, it is to be understood that many alternate materials can be used in the design and application of disc springs and include carbon steel, chrome vanadium steel, stainless steel, heat resistant steels, and other special alloys such as nimonic, inconel, and beryllium copper. In some special applications, plastic disc springs designs can be used.
• It should be further observed that, in comparison to other types of springs, disc springs produce small spring deflections under high loads. The ability to assemble disc springs into disc spring stacks overcomes this particular limitation. When disc springs are arranged in parallel (or nested), the load increases proportionate to the number of springs in parallel, while when disc springs are arranges in series (alternately) the travel will increase in proportion to the number of springs serially arranged. These assembly methods may be combined in use.
• One special feature of the disc spring is, undoubtedly, the fact that the load/deflection characteristic curve can be designed to produce a wide variety of possibilities. In addition to practically linear load/deflection characteristic curves, regressive characteristics can be achieved and even disc springs which exhibit increasing spring deflection while the corresponding disc spring load is decreasing are readily available.
• Slotted disc springs present a completely different case. Slotting changes the load/deflection characteristic of the single disc spring, providing larger spring deflections for greatly reduced loads. The slotted part is actually functioning as a series of miniature cantilever arms. In some cases the stacked, slotted disc spring, as shown in the clover dome design, will also produce a non-linear, stress strain curve with a noticed flat region (force/deflection). Application and use of this type of spring operating in this region will provide a near constant force between 15% and 75% of compression.
• As before, by controlling the length and depth and width ofcapillaries214, the rate of fluid flow flowing outwardly ofoutlet204acan be precisely controlled.
• Turning next toFIGS. 20 through 45, an alternate embodiment of the infusion device of the present invention is there illustrated and generally designated by the numeral221. As best seen inFIGS. 21A and 21B, the apparatus here comprises anouter housing222 having first, second andthird portions222a,222band222crespectively. Disposed withinouter housing222 is an inner,expandable housing223 having a fluid reservoir224 (FIG. 22) provided with aninlet224a(FIG. 22) for permitting fluid flow into the fluid reservoir and anoutlet224bfor permitting fluid flow from the fluid reservoir.Expandable housing223, which can be constructed from a metal or plastic material and can include a coating of the character previously described, comprises a bellows structure having an expandable and compressible, accordion-like, generally annular-shapedsidewall223a, the configuration of which is best seen inFIGS. 21A and 21B. It is to be understood that the bellows can be constructed in various configurations and, for example, can also be generally rectangular in cross-section.
• Disposed withinsecond portion222bofouter housing222 is the novel stored energy means of the invention for acting upon innerexpandable housing223 in a manner to cause the fluid contained withinfluid reservoir224 to controllably flow outwardly of the housing. In the present form of the invention, this important stored energy means comprises a compressively deformable,spring member225 that is carried within thesecond portion222bof the outer housing. In a manner presently to be describedspring member225 is further compressed from its initial state by fluid flowing intoreservoir224 and then is controllably expanded to cause fluid flow from the outer housing through the dispensing means of the invention. Storedenergy member225 can be constructed from a wide variety of materials including spring steel and plastic.
• Forming an important aspect of the apparatus of this latest form of the invention is fill means carried by thethird portion222cofouter housing222 for filling thereservoir224 with the fluid to be dispensed. As best seen inFIG. 21A,third portion222cincludes afluid passageway226 in communication withinlet224aoffluid reservoir224. Proximate itslower end226a,fluid passageway226 communicates with acavity227 formed within thethird portion222cof the housing. Disposed withincavity227 is an elastomericpierceable septum228 that comprises a part of one form of the fill means of this latest form of the invention.Septum228 can be bonded in place and is held in position by aretainer228aand 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 fillreservoir224 viapassageway226.Septum228 can comprise a conventional or a slip filling septum. Additionally,septum228 can be replaced with a needleless check valve with luer attachments.
• Third portion222cofhousing222 also includes afirst chamber230 for telescopically receiving a first medicament containingfill vial232 and asecond chamber234 for telescopically receiving a secondmedicament containing vial236. Anelongated support238 is mounted withinfirst chamber230 and a secondelongated support240 is mounted withinsecond chamber234. Each of theelongated supports238 and240 has an integrally threadedend portion241 and carries a longitudinally extending, elongatedhollow needle242. Each of thehollow needles242 has aflow passageway242athat communicates withfluid passageway226.First chamber230,second chamber234,elongated support238,elongated support240 andhollow needles242 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 portion222aofouter housing222. This flow control means functions to precisely control the rate of fluid flow outwardly fromreservoir224 and toward the patient. In the form of the invention shown inFIGS. 20 through 45 the flow control means comprises a flow control assembly generally designated in the drawings by the numeral246. This novel flow control assembly here comprises anullage defining member248 having afirst portion248adisposed within inner,expandable housing223 and asecond portion248bthat extends outwardly fromhousing222 in the manner shown inFIG. 21A. For a purpose presently to be described,member248bhas afluid passageway249 that is in communication with an outlet of theflow control subassembly250, the character of which will next be described.
• Referring toFIGS. 35 through 45, it can be seen thatflow control subassembly250, which comprises a part offlow control assembly256, comprises anouter casing252 having a plurality of circumferentially spaced-apartfluid outlets254, aflow control member256 telescopically receivable withincasing252 and aselector knob258 that is interconnected withcontrol member256 in the manner shown inFIGS. 38 and 39. Anelastomeric sealing band253, which has the unique configuration shown inFIGS. 21F and 21E, prevents leakage betweencasing252 andmember248. As best seen inFIGS. 36 and 39,flow control member256 is uniquely provided with a plurality of elongatedflow control channels260, each having aninlet260aand anoutlet260b. Theflow channels260 may be of different sizes, lengths and widths and in alternate configurations as shown byFIGS. 40 and 40A which depict alternate forms of the flow control member. The flow control member shown inFIG. 40 is identified as258a, while the flow control member shown inFIG. 40A is identified as258b.Flow control member258bis provided withflow channels250bthat are formed in spaced-apartflow segments251, each of which has a circuitous microfluidic flow path or micro channel of the configuration shown inFIG. 40A. Further, the flow control channels may be rectangular in cross-section as illustrated inFIG. 37, 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. When the flow control member is properly positioned withinouter casing252, the inner surface of the outer casing wall cooperates withchannels260 to form a plurality of generally spiral-shaped fluid flow passageways each being of different overall length and flow capacity. When the flow control member is positioned within the outer casing, anotch256bformed inmember256 receives atongue252aprovided oncasing252 so as to precisely align theoutlets260bof theflow channels260 withfluid outlets254 formed incasing252. The various components of the flow control assembly are appropriately bonded, or otherwise sealably interconnected.
• Theflow control channels260 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 0.05 mm. 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 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 of 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 by contract, for example, for MicroTEC MbH of Duisburg, Germany.
• A number of materials can be used to fabricateflow control member256. 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 (RMPDO from microTEC). Additionally, theflow control members256 can be constructed from various metals, metal alloys, silicon, silicon dioxide and inorganic oxides.
• Selector knob258, which comprises a part of the selector means of the invention, is rotatably connected tosecond portion248bofullage defining member248 and, in a manner presently to be described, functions to rotate the assembly made up ofouter casing252 and flowcontrol member256. In this way, a selectedoutlet254 incasing252 can be selectively aligned withflow passageway249 provided in the ullage defining member (seeFIGS. 21A and 21B).
• Turning once again toFIG. 20, 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 set264 that is connected to thefirst portion222aofhousing222 in the manner shown in the drawings. The flow channel in theproximal end265aofadministration line265 of the administration set264 is in communication withfluid passageway249 in the manner best seen inFIG. 21A. Disposed between theproximal end265aand thedistal end265bof the administration line is a conventional gas vent andparticulate filter266. Provided at thedistal end265bis aluer connector268 and cap286aof conventional construction.
• Turning now toFIGS. 23 and 24, the details of construction of the vial means orshell vial270 is there shown. As indicated in these figures, each of the glass or plastic vial housings has afluid chamber272 for containing an injectable fluid.Chamber272 is provided with a firstopen end270aand secondclosed end270b. Firstopen end270ais sealably closed by closure means here provided in the form of an externally threaded,elastomeric plunger274 which is telescopically movable within the vial from a first location shown inFIG. 23, where the plunger is disposed proximate firstopen end270a, to a second device-fill location where the plunger is disposed proximate secondclosed end270b.
• After removal of theclosure273, which forms a part of thethird portion222cof housing222 (FIG. 22),vials232 and236 can be inserted intochambers230 and234 respectively. As the fill vials are so introduced and theplungers274 are threadably interconnected withends241 ofsupports238 and240, the sharp ends of the elongatedneedles242 will pierce thecentral walls274aof the elastomeric plungers. Continuous pushing movement of the vials intochambers230 and234 will cause thestructural supports238 and240 to move the elastomeric plungers inwardly of the vial chambers in a direction toward the secondclosed end270bof the vials. As the plunger is moved inwardly of the vial, the fluid contained within the vial chamber will be expelled therefrom into the hollowelongated needles242a. As best seen inFIG. 21A, the fluid will then flow past elastomeric, umbrellatype check valves278 and intopassageways280 formed inthird portion222cof the apparatus housing. Umbrellatype check valves278 function to control fluid flow from the elongatedhollow needles242 towardfluid passageways280. Frompassageways280 the fluid will flow intopassageway226 and then intointernal fluid reservoir224 of thebellows component223 viaullage filling microchannels224a. It is to be understood that thevials232 and236 can contain the same or different medicinal fluids and can be introduced into their respective chambers one at a time as shown inFIG. 22 or simultaneously as shown inFIG. 21.
• As the fluid flows into the bellows reservoir, the bellows will be expanded from the collapsed configuration shown inFIG. 21B into an expanded configuration, such as shown inFIG. 22. As the bellows member expands it will urge a telescopically movable volume indicator orcoupling member282 that is carried within the second portion of the housing in engagement with the stored energy source, orspring member225 causing it to further 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 septum228 which is mounted withinthird portion222cof the apparatus housing. As thereservoir224 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 inportion248bof the ullage member. This vent means here comprises agas vent283 that can be constructed of a suitable hydrophobic porous material such as a porous plastic.Gas vent283 is held in position within the housing by a bondedretainer ring283a(FIG. 21A).
• Upon opening the fluid delivery path to the administration set264 in a manner presently be described, the stored energy means, ormember225, will tend to return to its initial starting, less compressed configuration thereby controllably urging fluid flow outwardly ofreservoir224 via the flow control means of the invention.
• As previously discussed a number of beneficial agents can be contained withinvials232 and236 and can be controllably dispensed to the patient including, by way of example, liquid injectable 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.
• Considering next the operation of the flow rate control means of the invention, as the fluid contained within thebellows reservoir224 is urged outwardly thereof by the stored energy means, the fluid will flow into afluid passageway284 formed in thefirst portion248aofullage member248. The fluid will then flow under pressure through a filter means shown here as afilter286 that is peripherally bonded within a cavity provided in theflow control member256 of theflow control subassembly250.Filter286, which functions to filter particulate matter from the fluid flowing outwardly fromreservoir224 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 throughfilter286, the fluid will flow, via a stub passageway288 (FIG. 21A) into the distribution means of the invention for distributing fluid from the fluid reservoir to each of the plurality ofspiral passageways260. This distribution means here comprises several radially outwardly extendingflow passageways290 formed inflow control member256. The filtered fluid will fillpassageways290 and then will flow into the plurality ofspiral passageways260 formed inmember256 viaoutlets260b, which communicate with passageways260 (seeFIG. 39). The fluid contained withinspiral passageways260 can flow outwardly of the device viaoutlets260bonly when one of thefluid outlets254 formed incasing252 is aligned with reservoir outlet passageway249 (FIG. 21A).
• Selection of thepassageway260 from which the fluid is to be dispensed is accomplished by rotation of theselector knob258 which, as best seen inFIG. 39, includes a reduceddiameter portion258ahaving aslot258bformed therein. As illustrated inFIG. 36,slot258bis adapted to receive aspline256a(FIG. 36) formed anteriorly ofmember256. With this construction, rotation ofselector member258 by gripping a transversally extendingfinger gripping member258gwill impart rotation tomember256. As seen inFIG. 39, casing252 is also provided with an inwardly extendingspline segment252athat is received within aslot256bformed in the rearward periphery of member256 (FIG. 38). Accordingly, rotation ofmember256 will also impart concomitant rotation to casingmember252.
• As illustrated inFIGS. 35 and 39,selector knob258 is provided with a plurality of circumferentially spaced apart indexingcavities258cthat closely receive anindexing finger294 which forms a part of the indexing means of the invention, which means comprises a lockingshaft cover296 that is connected tothird portion222cof the apparatus housing (seeFIGS. 20 and 21A).Indexing finger294 is continuously urged into engagement with a selected one of theindexing cavities258cby acoil spring298 that also forms a part of the indexing means of the invention.Coil spring298 can be compressed by an inward force exerted on anindexing shaft300 that is mounted in lockingshaft cover296 and is movable from the extended position shown inFIG. 21A to an inward, finger release position whereinspring298 is compressed andfinger294 is retracted from a selectedindexing cavity258c(see alsoFIGS. 30, 31 and32). Withfinger294 in its retracted position it is apparent thatcontrol knob258 can be freely rotated to a position whereinflow rate indicia304 formed on the periphery of knob258 (FIG. 35) can be viewed through aviewing window305 formed in thefirst portion206 of the apparatus housing. Locking means, here provided in the form of a locking member310 (seeFIG. 29), is also carried by the locking shaft cover and, when moved from the release position shown inFIG. 33 into the locking position shown inFIG. 34, prevents inward movement of theindexing shaft300 against the urging ofspring298. A spring biased retainer pin311 (FIG. 31) functions to retain the selector knob in position withinhousing222a.
• When the selector knob is in the desired position and pressure is released onindexing shaft300,spring298 will urgefinger294 of the indexing means of the invention into locking engagement with one of theindexing cavities258cthereby placing a selected one of the spiral shapedflow control channels260 in communication with thefluid reservoir224 viapassageways290,288 and284. As the fluid flows outwardly of the apparatus due to the urging of the stored energy means orspring member225, thebellows structure223 will be collapsed and at thesame time member282 will travel inwardly ofhousing portion222b. Couplingmember282, which forms a part of the volume indicator means of the invention, includes a radially outwardly extending indicatingfinger282athat is visible through avolume indicator window313 that is provided in asecond portion222bof the apparatus housing and also comprises a part of the volume indicator means of the invention (FIG. 20).Indicia315, which are provided onindicator window313, function to readily indicate to the caregiver the amount of fluid remaining withinfluid reservoir224.
• Safety disabling means, shown here as a disablingshaft318 that is telescopically movable within apassageway320 formed withinhousing portion222afunctions to disable the device (FIG. 22A, 28A), by occluding theoutput passageway249. More particularly,shaft318 has adistal end318a, which, upon insertion of the shaft, will block fluid flow throughpassageway249. Aretainer318bnormally holdsshaft318 in the retracted position (seeFIG. 22A).
• Referring now toFIGS. 46 through 52, yet another embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral330. This alternate form of the apparatus of the invention is similar in many respects to that shown inFIGS. 20 through 45 and like numerals are used inFIGS. 46 through 52 to identify like components. The primary difference between this latest form of the invention and the invention shown inFIGS. 20 through 45 resides in the fact that two cartridge fill vials of a different construction are used to fill the fluid reservoir of the apparatus. As before, the apparatus of this alternate form of the invention comprises anouter housing332 having first, second andthird portions334,336, and338 respectively. Disposed withinouter housing332 is an inner,expandable housing223 that is of identical construction and operation to the expandable housing of the embodiment of the invention shown inFIGS. 21A and 21B. As in the earlier described embodiment,housing223 includes a fluid reservoir that is provided with aninlet224a(FIG. 47) for permitting fluid flow into the fluid reservoir. As shown inFIG. 47,expandable housing223 comprises a bellows structure having an expandable and compressible, accordion-like side wall223a, which is suitably bonded at its open end223btomember370b.
• Disposed withinsecond portion336 ofouter housing332 is the stored energy means of the invention for acting upon innerexpandable housing223 in a manner to cause the fluid contained within the fluid reservoir to controllably flow throughoutlet376. 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,wave spring member225 that is carried within thesecond portion336 of the outer housing. As before, inoperation member225 is first more fully compressed by fluid flowing into the reservoir and then is controllably unloaded or expanded to cause fluid flow from the 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 portion338 ofouter housing332 for filling the reservoir 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 glass or plastic fill vials orcartridges342 which each are of identical construction. As in the earlier described embodiments, the fill means also includes an alternate fill means that comprises apierceable septum344 that is disposed within acavity346 formed in thethird portion338 ofouter housing332.Elastomeric septum344 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 fill the fluid reservoir via apassageway348 formed inthird portion338.
• As best seen inFIG. 47,third portion338 ofhousing332 includes a pair of spaced-apartchambers350 for telescopically receiving the medicament containingfill vials342. As shown inFIGS. 47 and 51 a pair ofelongated supports354 are mounted within ahollow vial cover356 that forms a part of thethird portion338 of the housing and removably covers the fill vials in the manner shown inFIG. 47. Each of thefill vial cartridges342, is of the generally conventional pharmaceutical industry construction shown inFIGS. 50 and 50A, and each comprises a hollow glass orplastic body portion358 that defines afluid chamber360. Each fill vial has an openfirst end342aand a second end that is closed by a pierceable,elastomeric septum362 that is held in place by a mechanical clamping ring. Mounted proximate the inboard end of eachchamber350 is ahollow needle364 which is adapted to pierceseptum362 when the fill vials are inserted intochambers350 in a manner next to be described.
• Disposed within eachvial reservoir360 is aplunger366 that is moved by asupport354 ofvial cover356 from a first positionproximate end342aof the vial to a second position. More particularly, as thevial cover356 is mated with the apparatus housing, the inboard end of each of theelongated supports354 engages aplunger366 urging the plunger inwardly of thevial chamber360. As each of the plungers move inwardly of their respective vial reservoirs, the fluid contained in the reservoir will be forced throughhollow needle364, passed anumbrella check valve368 mounted withinthird housing portion338, into astub passageway370, into a passageway and finally into fluid reservoir viainlet224a. As the fluid flows into the reservoir, it will more fully 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 quite similar in construction and operation to the flow control means described in connection with the embodiment of the invention shown inFIGS. 20 through 45. This flow control means is connected tofirst portion334 ofouter housing332 and comprises anullage defining member370 having afirst portion370adisposed within inner,expandable housing223 and asecond portion370bhaving afluid passageway372 that is in communication withoutlet376 of the fluid reservoir.
• As before, the flow control means includes a flow control subassembly that is substantially identical in construction and operation to the earlier describedflow control subassembly250 and is of the configuration shown inFIGS. 35 through 45 of the drawings. For this reason, the details of the construction and operation of the flow 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 subassembly250.
• Turning once again toFIG. 46, 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 set264 and is connected to thefirst portion334 ofhousing332.
• Upon opening the fluid delivery path to the administration set264, the stored energy means, ormember225, will tend to return to its less compressed starting configuration thereby controllably urging fluid flow outwardly of the device reservoir via the flow control means of the invention. As the fluid contained within the bellows reservoir is urged outwardly thereof by the stored energy means, the fluid will flow into afluid passageway376 formed in thefirst portion370aofullage member370. The fluid will then flow under pressure through a filter means shown here as afilter286 that is identical to that previously described. After flow throughfilter286, the fluid will flow, via a stub passageway378 (FIG. 47) into the several radially outwardly extendingflow passageways290 formed inflow control member256. The filtered fluid will fillpassageways290 and then will flow into the plurality ofspiral passageways260 formed inmember256 viaoutlets254, which communicate with passageways260 (seeFIG. 36). The fluid contained withinspiral passageways260 can flow outwardly to the patient via the administration line only when one of thefluid outlets254 formed incasing252 is aligned with passageway372 (FIG. 47).
• Selection of thepassageway260 from which the fluid is to be dispensed is accomplished by rotation of theselector knob258 in the manner previously described in connection with the embodiment shown inFIGS. 20 through 45. 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 orspring member225, thebellows structure223 will be collapsed and at the sametime coupler member282 will travel inwardly ofhousing portion336 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 disabling means318, which is substantially identical in construction and operation to that previously described.
• Turning now toFIGS. 53 through 66, still another form of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral380. This alternate form of the apparatus of the invention is similar in some respects to that shown inFIGS. 46 through 52 and like numerals are used inFIGS. 53 through 66 to identify like components. The primary difference between this latest form of the invention and the invention shown inFIGS. 46 through 52 resides in the fact that one of the two fill vials used to fill the fluid reservoir of the apparatus is of totally different construction. More particularly, one of the fill vials is specially designed to enable the reconstitution and intermixing of a contained lypholized drug with a suitable reconstitution agent prior to the delivery of the mixture to the fluid reservoir of the device. The second cartridge will typically carry a diluent to add to the first now injectable drug in residence in the reservoir.
• As in the earlier described embodiments, the apparatus of this latest form of the invention comprises anouter housing382 having first, second andthird portions384,386 and388 respectively. Disposed withinouter housing382 is an inner,expandable housing223 that is of identical construction and operation to the expandable housing of the embodiment of the invention shown inFIGS. 46 through 52. As in the earlier described embodiment,housing382 includes a fluid reservoir that is provided with an inlet216 (FIG. 54) for permitting fluid flow into the fluid reservoir. As shown inFIG. 54,expandable housing223 comprises a bellows structure having an expandable and compressible, accordion likesidewall223a.
• Disposed withinsecond portion386 ofouter housing382 is the stored energy means of the invention for acting upon innerexpandable housing223ain a manner to cause the fluid contained within the fluid reservoir of the device to controllably flow through outlet374. 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,spring member225 that is carried within thesecond portion386 of the outer housing. As before, inoperation member225 is first more fully compressed by fluid flowing into the device reservoir and then is controllably unloaded or expanded to cause fluid flow from the 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 portion388 ofouter housing382 for filling the device reservoir 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 fillvial342, is of identical construction and operation to the earlier describedfill vial342. The second fill vial or cartridge designated by the numeral392 comprises a container of special design that uniquely contains alyophilized drug394 that is separated from a reconstitutingfluid396 by a barrier stopper398 (FIG. 61).Lyophilized drug394 can, by way of example, comprise an anti-infective, an oncolytics agent, a cardiac drug or various other types of beneficial agents.Cartridge392 is telescopically receivable within avial housing400 that is of the configuration shown inFIGS. 54, 58 and60. As before,vial housing400 includes a pair of spaced apartpusher members402 and404 which engage plungers366 (FIG. 63) and406 (FIG. 61) respectively to push the plungers forwardly of their respective container reservoirs.
• Considering in more detail thenovel cartridge assembly392, as best seen inFIG. 61, this cartridge assembly includes avial408 that is sealed at one end by aplunger406 and at the other end by a pierceable septum410 (FIG. 61) that is held in place by a suitable crimp ring. Formed intermediate the ends ofvial408 is a raisedouter wall portion408awhich permitsfluid396 to bypasselastomeric barrier stopper398 as the barrier stopper is urged inwardly of the container by pressure exerted thereon by thefluid396.Fluid396 exerts pressure onbarrier member398 as a result ofpusher member404 exerting inward pressure onplunger406, which pressure is, in turn, caused by the inward movement ofplunger406 as the vial housing is mated with and advanced within theapparatus housing382.
• A continued inward pressure exerted onplunger406 will cause fluid396 to flowpast barrier member398 viawall portion408aso as to reconstitutelyophilized drug394 with an internally containedreconstitution agent396. Further pressure exerted onplunger406 will cause the reconstituted drug formed by the fluid396 which has been intermixed withdrug394 to flow through ahollow cannula412,past check valve414, into astub passageway416 and then into apassageway418 and finally into the device reservoir viaullage microchannels420.
• As previously mentioned,plunger406 is disposed withinvial392 and is moved by asupport404 ofvial closure400 as the vial cover is mated with the apparatus housing. Asplunger366 is moved inwardly ofvial reservoir360, the fluid contained in the reservoir will be forced throughhollow needle412a, passed an umbrella check valve414amounted withinthird housing portion388, into astub passageway416, into apassageway418 and finally into the device reservoir via ullagereservoir filling channel420. As the fluid flows into the device reservoir, it will more fully compress the stored energy means in the manner previously described.
• As in the earlier described embodiments, the fill means also includes an alternate fill means that comprises a mechanical check valve (not shown) or an elastomericpierceable septum344 that is disposed within acavity346 formed in thethird portion388 ofouter housing382.Septum344 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 fill the device reservoir viapassageway418 formed inthird portion388.
• 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. 36 through 45. This flow control means is connected tofirst portion384 ofouter housing382 and comprises anullage defining member370 having afirst portion370adisposed within inner,expandable housing223 with which the bellows slidably cooperates and asecond portion370bhaving afluid passageway372 that is in communication with outlet374 of the device reservoir. Once again, the ullage defining member functions to ensure that substantially all of the medicament is dispensed from the fluid reservoir.
• As before, the flow control means includes a flow control subassembly that is substantially identical in construction and operation to the earlier describedflow control subassembly250 and is of the configuration shown inFIGS. 36 and 38 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 subassembly250.
• Turning once again toFIG. 53, 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 set264 and is connected to thefirst portion384 ofhousing382.
• Upon opening the fluid delivery path to the administration set264 in the manner previously described, the stored energy means, ormember225, will tend to return to its less compressed starting configuration thereby controllably urging fluid flow outwardly of the device reservoir via the flow control means of the invention. As the fluid contained within the reservoir is urged outwardly thereof by the stored energy means, the fluid will flow into a fluid passageway374 formed in thefirst portion370aof ullage member370 (FIG. 54). The fluid will then flow under pressure through a filter means shown here as afilter286 that is identical to that previously described. After flowing throughfilter286, the fluid will flow, via a stub passageway288 (FIG. 54) into the several radially outwardly extendingflow passageways290 formed in flow control member256 (FIG. 44). The filtered fluid will fillpassageways290 and then will flow into the plurality ofspiral passageways260 formed inmember256 viaoutlets260b, which communicate with passageways260 (seeFIG. 36). The fluid contained withinspiral passageways260 can flow outwardly of the device only when one of thefluid outlets254 formed incasing252 is aligned with passageway372 (FIG. 54).
• Selection of thepassageway260 from which the fluid is to be dispensed is accomplished by rotation of theselector knob258 in the manner previously discussed in connection with the earlier described embodiments. 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 toward the patient via the administration set264 due to the urging of the stored energy means orspring member225, thebellows structure223 will be generally collapsed and at thesame time member282 will travel inwardly ofhousing portion386 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 safetydefeat disabling means318, which is substantially identical in construction and operation to that previously described.
• Considering next the alternate form offill cartridge assembly422, shown inFIG. 65. This fill cartridge is similar in some respects to fillcartridge392 and includes avial424 that is sealed at one end by aplunger425 and at the other end by an elastomericpierceable septum428. Formed intermediate the ends ofvial424 is a plurality of internalfluid flow passageways430 which permit fluid432 to bypass a strategically positionbarrier stopper434 as the barrier stopper is urged inwardly of the container by pressure exerted thereon byfluid432.Fluid432 exerts pressure onbarrier member434 as a result ofpusher member404 of thevial housing400 exerting inward pressure onplunger425, which pressure is, in turn, caused by the inward movement ofplunger434 asvial housing400 is mated with thehousing382 as is advanced therewithin.
• A continued inward pressure exerted onplunger425 will cause fluid432 to flow pastelastomeric barrier member434 via internalbypass flow channels430 so as to reconstitute lyophilized drug433 (FIG. 65). Further pressure exerted onplunger425 will advanceplunger434 to a more and subsequently fully distal location which will cause the reconstituted drug formed by the fluid432 which has been intermixed withdrug433 to flow through ahollow cannula412 pastelastomeric check valve414, into astub passageway416 and then into apassageway418 and finally into the device reservoir via filling channel420 (FIG. 54).
• Referring now toFIGS. 67 through 97, yet another embodiment of the dispensing apparatus of the present invention is there illustrated and generally designated by the numeral442. This alternate form of the apparatus of the invention is similar in some respects to the previously described embodiments of the invention and like numerals are used inFIGS. 67 through 97 to identify like components. The primary difference between this latest form of the invention and those previously discussed concerns the provision of a differently configured stored energy means and of a differently configured flow rate control means. Further, the reservoir fill means of this latest form of the invention includes only a single, cartridge type fill vial.
• As best seen inFIG. 67, the apparatus here comprises anouter housing442 having first, second andthird portions446,448 and449 respectively. Disposed withinouter housing442 is an inner,expandable housing450, which is generally similar in construction and operation toexpandable housing223, which housing was described in connection with the embodiment ofFIG. 21.
• Also disposed withinouter housing442 is the novel stored energy means of the invention for acting upon innerexpandable housing450 in a manner to cause the fluid contained within the fluid reservoir thereof to controllably flow outwardly of the housing (FIG. 72). In this latest form of the invention, this stored energy means comprises a plurality of cooperatively associated disk springs453. These disk springs, exhibit superior load/deflection curves and are ideally suited for use in the present application.Springs453 are readily commercially available from a number of sources including the Schnorr Co. of Sindelfingen, Germany.
• As in the earlier described embodiments of the invention, the present invention includes fill means, which are here carried by thethird portion449 of the outer housing. As before, the fill means functions to fill the device reservoir that is defined bybellows member450 with the fluid to be dispensed. As best seen inFIGS. 67, 68 and72third housing portion449 includes afluid passageway454 that is in communication with the inlet orpassageway456 of fluid reservoir. Proximate itslower end454afluid passageway454 communicates with acavity457 formed within the third portion of the housing. Disposed withincavity457 is apierceable septum458 that comprises a part of the fill means of this latest form of the invention.Septum458 is held in position by aretainer458aand 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 fill the device reservoir viapassageway454. As the reservoir fills, and gases trapped within the reservoir will be vented via vents “V”.
• The fill means also here comprises a cartridge type fillvial460 which is of the construction shown inFIG. 72. As shown inFIG. 72, thethird portion449 of the housing includes achamber462 for telescopically receivingcartridge fill vial460. Ahollow needle464 is mounted withinthird portion449 of the device housing and is located proximate the inboard end ofchamber462. When thecartridge fill vial460 is inserted intochamber462 and pushed forwardly into the position shown inFIG. 72,hollow needle464 will pierce aseptum466 that sealably closes the open end of the cartridge fill vial.
• As illustrated inFIGS. 70, 71 and72, thevial cover469 ofportion449 of the device housing includes apusher member471 which engages aplunger474 ofvial460 when the vial cover is mated with the device housing.Pusher member471 functions to push the plunger forwardly ofcontainer reservoir476 as thevial cover469 is moved into the fully mated position shown inFIG. 72. Asplunger474 is moved forwardly ofreservoir476, the fluid contained in the vial reservoir will be forced throughhollow needle464, passed a conventionalumbrella check valve480 that is mounted withinthird housing portion449, into astub passageway482, intopassageways454 and456 and finally into the device reservoir. As the fluid flows into the device reservoir, it will controllably compress the stored energy means, or disc springs453.
• Turning particularly toFIGS. 78 through 97, the novel flow control means of the apparatus of this latest form of the invention is there shown. This important flow control means functions to precisely control the outwardly rate of fluid flow from the device reservoir toward the patient. In this latest form of the invention, the flow control means comprises a flow rate control assembly generally designated in the drawings by the numeral484. This flow rate control assembly is non-rotatably mounted withinhousing portion446 and includes anelongated spline485 that functions to align the assembly within the outer housing. As best seen inFIGS. 72 and 81, this novel flow rate control assembly here comprises aninlet manifold486 having an inlet port488 (FIG. 72) that is in communication with theoutlet489 of the fluid reservoir and anoutlet manifold490 that is interconnected withinlet manifold486 by means of a plurality of interconnected flowrate control plates492,494,496,498,500,502,504,506,508 and510 (see alsoFIGS. 82A and 82B).
• As indicated inFIGS. 79, 80 and85,outlet manifold490 has a plurality of circumferentially spaced outlet ports, each of which is in communication with an outlet port of a selected one of the rate control plates. In a manner presently to be described, by using the selector means of the apparatus these circumferentially spaced outlet ports can be selectively brought into communication withoutlet passageway514 of the apparatus and with theadministration line150 of the administration set148 (FIG. 72).
• As best seen by referring toFIGS. 82A and 82B, each of the flow rate control plates is provided with an elongated micro channel of a particular configuration. These micro-flow channels can be formed in various ways known to those skilled in the art. For example, U.S. Pat. No. 6,176,962 issued to Soane et al. describes methods for constructing micro channel structures for use in micro fluidic manipulations. Similarly, International Publication WO 99/5694A1 describes such methods. When the rate control plates are assembled in the manner shown inFIGS. 82A and 82B, it is apparent that the micro channel formed in each of the rate control plates will cooperate with the adjacent planar surface of the next adjacent rate control plate to form a fluid flow control channel through which the fluid flowing intoinlet488 can controllably flow. As indicated in the drawings, one end of each of the micro channels is in communication with theinlet port488 of theinlet manifold486 via acenter port489 and the other end of each of the micro channels is in communication with a selected one of the circumferentially spaced outlet ports provided in theoutlet manifold490. More particularly, as can be seen by referring toFIGS. 82A, 82B,83 and88 of the drawings,outlet492aofrate control plate492 is in communication withoutlet521 ofoutlet manifold490;outlet494aofrate control plate494 is in communication withoutlet522 ofoutlet manifold490;outlet496aofcontrol plate496 is in communication withoutlet523 ofmanifold490;outlet498aofcontrol plate498 is in communication withoutlet524 ofoutlet manifold490 andoutlet500aofrate control500 is in communication withoutlet525 ofoutlet manifold490, andoutlet502aofrate control plate502 is in communication withoutlet526 ofoutlet manifold490. In similar fashion,outlet504aofrate control plate504 is in communication withoutlet527 ofoutlet manifold490;outlet506aofrate control plate506 is in communication withoutlet528 ofmanifold490;outlet508aofcontrol plate508 is in communication withoutlet529 ofoutlet manifold490 andoutlet510aofrate control plate510 is in communication withoutlet530 ofoutlet manifold490.
• With the construction of the flow control means shown in the drawings, fluid will flow from the device reservoir intoinlet port488 ofinlet manifold486, through a filter member533 (FIG. 85) and thence intomicro channel534 formed inplate492. By controlling the length, width and depth of themicro channel534, the rate of fluid flow flowing outwardly ofoutlet492acan be precisely controlled. In a manner presently to be described, the fluid will then flow onwardly toward the administration set via the flow regulation means of the invention. It is to be understood thatmicro channel534 can take various forms and can be of varying length, width and depth to precisely control the rate of fluid flow their through.
• Fluid flowing throughinlet port488 will also flow intomicro channel536 formed inrate control plate494. Once again, depending upon the length, width and depth ofmicro channel536, the rate of fluid flowing outwardly ofoutlet494acan be precisely controlled. In similar manner, fluid flowing throughinlet port488 will fillmicro channel538 formed inrate control plate496, will fillmicro channel540 formed inplate498, will fillmicro channel542 formed inrate control plate500, will fill rate controlmicro channel544 formed inrate control plate502, will fill rate controlmicro channel546 formed inrate control plate504, will fill rate controlmicro channel548 formed inrate control plate506, will fill flow controlmicro channel550 formed inrate control plate508 and will fill rate controlmicro channel552 formed inrate control plate510. After flowing through the rate control micro channels formed in the various indexedly aligned rate control plates, the fluid will flow onwardly towardoutlet manifold490 and will fill each of thestub passageways555 formed therein (FIG. 87). The rate of flow of fluid flowing outwardly of each of the outlet ports of the various rate control plates will, of course depend upon the configuration of the individual rate control micro channels formed in the rate control plates.
• As shown inFIGS. 72 and 76, aselector knob558 which is sealably rotatably connected tofirst portion446 of the outer housing, is provided with a plurality of circumferentially spaced apart indexingcavities559.Elastomeric sealing bands558cand558d, which are of the unique configuration shown inFIGS. 72B and 72D, prevent leakage between the cooperatively mated components. These indexing cavities closely receive anindexing finger560, which forms a part of the indexing means of the invention, which means comprises afront bezel562 that is connected to the apparatus housing (seeFIG. 67).Indexing finger560 is continuously urged into engagement with a selected one of theindexing cavities559 by acoil spring564 that also forms a part of the indexing means of the invention.Coil spring564 can be compressed by an inward force exerted on anindexing shaft566 that is movable from an extended position to an inward, finger release position whereinspring564 is compressed andfinger560 is retracted from a selectedindexing cavity559. Withfinger560 in its retracted position, it is apparent thatcontrol knob558 can be freely rotated to a position wherein a grippingmember558acan be aligned with selectedflow rate indicia568 formed on thefront bezel562 of the apparatus housing.
• When the selector knob is in the desired position and pressure is released onindexing shaft566,spring564 will urgefinger560 of the indexing means of the invention into locking engagement with one of theindexing cavities559 thereby placing a selected one of flow control channels of a flow rate control plate in communication withflow passageway558bof the flow control knob (FIG. 81). As the fluid flows outwardly of the apparatus due to the urging of the stored energy means orspring members453, thebellows structure450 will be collapsed and at the same time andindicator member569 will travel inwardly of the housing.Member569, which forms a part of the volume indicator means of the invention, includes a radially outwardly extending indicatingfinger569athat is visible through avolume indicator window570 that is provided in asecond portion448 of the apparatus housing and also comprises a part of the volume indicator means of the invention.Indicia571, which are provided on indicator window570 (FIG. 69), function to readily indicate to the caregiver the amount of fluid remaining within fluid reservoir of the device at any point in time.
• Referring toFIGS. 67 and 77, disabling means, shown here as a disablingshaft574 that is telescopically movable within a passageway formed within housing portion, functions in the manner previously described to disable the device (see discussion concerningFIG. 22A).
• Referring particularly toFIG. 95, selector knob558 (see alsoFIGS. 78 and 81), which comprises a part of the selector means of the invention, is sealably connected tooutlet manifold490 by means of O-Rings “O” and is rotatable with respect thereto. As previously mentioned, this novel selector means of the invention functions to control the flow of fluid fromoutlet manifold490 toward the administration set150. More particularly, as illustrated inFIGS. 95, 95A and95B,selector knob558 is provided with a circumferentially extendingflow channel578 which is selectively in communication withpassageways555 ofoutlet manifold490 depending upon the position of the selector knob. As illustrated inFIGS. 95A and 95B, the rearwardly-extending, generally-cylindrical, reduced-diameter portion558dof the control knob, which circumscribes theoutlet manifold490, is provided with a circumferentially extending,elastomeric band582 which prevents fluid leakage between the outlet manifold and theflange558d.Outlet manifold490 is also provided with a similarly configured, circumferentially extending,elastomeric band584. As indicated inFIG. 95A,elastomeric band584 has anopening584athat is in alignment withfluid outlet passageway514 formed in thefirst portion446 of the outer housing (see alsoFIG. 72).Elastomeric band582 also has anopening582awhich is aligned with a radially extendingflow passageway578bformed onportion558dof the control knob, which, in turn, is in communication with circumferentially extending flow channel578 (FIG. 95A). With this construction, when thecontrol knob558 is rotated to a position such as that illustrated inFIG. 95A, wherein one of the outlets of the outlet manifold is in alignment with the opening582aformed in theelastomeric band582, fluid can flow from that outlet and into circumferentially extendingflow channel578. Fromflow channel578, the fluid can flow into radially extendingpassageway578b, through opening584aand intopassageway514. Frompassageway514, the fluid can flow onwardly into the dispensing means or administration set148. The rate at which the fluid flows toward the administration set depends, of course, upon which rate control plate outlet is in communication withradial passageway578bformed in the control knob. By way of example, with thecontrol knob558 in the position shown inFIG. 95A, it is to be observed that the fluid flowing toward the administration set is flowing fromoutlet492aofrate control plate492 and will flow at a rate determined by the configuration of rate controlmicro channel534. (seeFIGS. 82 and 96).
• 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 of 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 (10)

1. 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, 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 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) a flow control member disposed within said inner expandable housing, said flow control member having a plurality of elongated flow control channels;

(ii) selector means operably associated with said flow control member for rotating said flow control member; and

(iii) dispensing means connected to said flow control member for dispensing fluid to the patient.

2. The apparatus as defined inclaim 1 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.

3. The apparatus as defined inclaim 2 in which said flow control member is provided with an inlet passageway in communication with said fluid reservoir and in which said flow control assembly further includes filter means carried by said flow control member for filtering fluid flowing toward said distribution means.

4. The apparatus as defined inclaim 3 in which said distribution means comprises a plurality of radially extending flow passageways formed in said flow control member.

5. The apparatus as defined inclaim 3, further including volume indicator means carried by said outer housing for indicating the volume of fluid remaining in said fluid reservoir.

6. The apparatus as defined inclaim 3 further including disabling means carried by said outer housing for preventing fluid flow toward said dispensing means.

7. The apparatus as defined inclaim 3 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.

8. The apparatus as defined inclaim 7 in which said fill means comprises a first fill vial receivable within said third portion of said outer housing.

9. The apparatus as defined inclaim 8 in which said fill means comprises a second fill vial receivable within said third portion of said outer housing.

10. The apparatus as defined inclaim 9 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.

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