US20010027294A1 - Fluid delivery apparatus with flow indicator and vial fill - Google Patents
Fluid delivery apparatus with flow indicator and vial fill Download PDFInfo
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- US20010027294A1 US20010027294A1 US09/767,665 US76766501A US2001027294A1 US 20010027294 A1 US20010027294 A1 US 20010027294A1 US 76766501 A US76766501 A US 76766501A US 2001027294 A1 US2001027294 A1 US 2001027294A1
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- Prior art keywords
- fluid
- flow
- rate control
- reservoir
- passageway
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/148—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags
- A61M5/152—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags pressurised by contraction of elastic reservoirs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/141—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor with capillaries for restricting fluid flow
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
- A61M2205/585—Means for facilitating use, e.g. by people with impaired vision by visual feedback having magnification means, e.g. magnifying glasses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/16877—Adjusting flow; Devices for setting a flow rate
Definitions
- the present invention relates generally to fluid delivery devices. More particularly, the invention concerns an improved apparatus for infusing medicinal agents into an ambulatory patient at specific rates over extended periods of time, which apparatus includes fluid flow indicator means and a novel adjustable flow rate control means for precisely adjustably controlling the rate of fluid flow from the reservoir of the device.
- the devices of the aforementioned patents also disclose the use of fluid flow restrictors external of the bladder for regulating the rate of fluid flow from the bladder.
- the prior art bladder type infusion devices are not without drawbacks. Generally, because of the very nature of the bladder or “balloon” configuration, the devices are unwieldy and are difficult and expensive to manufacture and use. Further, the devices are somewhat unreliable and their fluid discharge rates are frequently imprecise.
- the apparatus of the present invention overcomes many of the drawbacks of the prior art by eliminating the bladder and making use of recently developed elastomeric films and similar materials, which, in cooperation with a base define a fluid chamber that contains the fluid which is to be dispensed.
- the elastomeric film membrane controllably forces fluid within the chamber into fluid flow channels provided in the base.
- the apparatus of the present invention can be used with minimal professional assistance in an alternate health care environment, such as the home.
- devices of the invention can be comfortably and conveniently removably affixed to the patient's body and can be used for the continuous infusion of antibiotics, hormones, steroids, blood clotting agents, analgesics, and like medicinal agents.
- the devices can be used for I-V chemotherapy and can accurately deliver fluids to the patient in precisely the correct quantities and at extended microfusion rates over time.
- the apparatus of the present invention comprises a fluid delivery apparatus having a fluid reservoir and an indicator assembly for indicating fluid flow through the apparatus.
- the apparatus of the present invention also 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 novel adjustable fluid flow rate control mechanism of the present invention includes locking means which is operable only by a physician or health care worker who is in possession of a physician operating key. Accordingly, once a particular flow rate is selected, the patient cannot unilaterally change the flow rate.
- Another object of the invention is to provide an apparatus which can be factory prefilled with a wide variety of medicinal fluids or one which can readily be filled in the field shortly prior to use.
- a further object of the invention is to provide a low profile, fluid delivery device of laminate construction which can be manufactured inexpensively in large volume by automated machinery.
- Another object of the invention is to provide a device of the aforementioned character which includes novel adjustable flow rate control means disposed intermediate the fluid reservoir outlet and the outlet port of the device for precisely controlling the rate of fluid flow from the outlet port toward the patient.
- Another object of the invention is to provide a device of the character described which embodies a highly novel fluid flow indicator that provides a readily discernible visual indication of fluid flow status through the device.
- Another object of the invention is to provide an apparatus of the aforementioned character in which the stored energy source is of a novel laminate construction which can be precisely tailored to deliver fluid from the device at precise rates.
- Another object of the invention is to provide unique fill means for use in controllably filling the fluid reservoir of the apparatus.
- Another object of the present invention is to provide an apparatus of the aforementioned character in which the flow rate control means comprises a rotatable flow restrictor support disk that can be rotated by the treating physician to selectively position the flow restrictor between the fluid reservoir and the device outlet port.
- Another object of the present invention is to provide a flow rate control means of the type described in the preceding paragraph in which the flow restrictors comprise porous frits of varying porosity.
- Another object of the present invention is to provide a flow rate control means in which the flow restrictors comprise wafers which have been laser drilled to provide a plurality of micro bores of various sizes.
- Another object of the invention is to provide an apparatus as described in the preceding paragraphs which includes locking means for locking the variable flow rate control disk in a preset position so that the rate control can be set only by the treating physician or an authorized health care worker having an operating key.
- Another object of the invention is to provide a novel fill assembly for use in filling the fluid reservoir of the apparatus of the invention.
- the improved fluid delivery apparatus of the present form of the invention comprises three major cooperating subassemblies, namely a reservoir subassembly, a highly novel adjustable, key-operated fluid flow rate control subassembly and a flow indicator subassembly for visually indicating fluid flow through the device.
- the reservoir subassembly which readily lends itself to automated manufacture, is generally similar to that described in copending U.S. Ser. No. 08/768,663 and includes a base and a stored energy means comprising at least one distendable elastomeric membrane which cooperates with the base to form a fluid reservoir.
- the fluid flow indicator subassembly is also somewhat similar to that described in U.S. Ser. No.
- the apparatus of the invention includes fill means for use in filling the reservoir of the reservoir subassembly this fill means here comprises a fill assembly which can be mated with the base of the reservoir subassembly for use in controllably filling the reservoir thereof.
- FIG. 1 is a generally perspective view of one form of the apparatus of the present invention which includes a flow indicator means for indicating fluid flow as well as a novel adjustable flow rate control means for precisely controlling the rate of fluid flow from the reservoir of the apparatus
- FIG. 1A is an enlarged, fragmentary side-elevational view of the forward portion of the apparatus shown in FIG. 1 showing the adjustable flow rate control means.
- FIGS. 2A and 2B when considered together comprise a generally perspective, exploded view of the apparatus of the invention shown in FIG. 1.
- FIG. 3 is a top plan the view of the apparatus shown in FIG. 1.
- FIG. 4 is an enlarged, side-elevational, cross-sectional view taken along lines 4 - 4 of FIG. 3.
- FIG. 4A is a greatly enlarged, fragmentary, cross-sectional view of the forward portion of the housing of the apparatus shown in FIG. 4.
- FIG. 4B is a diagrammatic front view of the apparatus illustrated in FIG. 4 showing one form of fluid flow indicia of the flow indicator means being displayed.
- FIG. 4C is a diagrammatic front view similar to FIG. 4B, but showing another form of fluid flow indicia.
- FIG. 5 is a bottom plan view of the housing portion of the apparatus of the invention shown in FIG. 1.
- FIG. 5A is an enlarged, fragmentary bottom view of one form of the physician locking means of the invention in a first configuration.
- FIG. 5B is a fragmentary bottom view similar to FIG. 5A, but showing the locking means in a second unlocked configuration.
- FIG. 6 is a greatly enlarged generally perspective rear view of the support means of the apparatus of the invention illustrating the construction of the adjustable flow rate control mechanism of the device and also showing the face of the locking mechanism of the apparatus for locking out the flow rate control means against adjustment.
- FIG. 7 is an enlarged, rear-elevational view of the support means and adjustable flow rate control mechanism of the apparatus shown in FIG. 6.
- FIG. 8 is a cross-sectional view taken along lines 8 - 8 of FIG. 7.
- FIG. 9 is cross-sectional view taken along lines 9 - 9 of FIG. 7
- FIG. 10 is an enlarged front elevational view of the support means of the apparatus.
- FIG. 11 is a cross-sectional view taken along lines 11 - 11 of FIG. 10.
- FIG. 11 A is a generally perspective, fragmentary view of a portion of the adjustable flow rate control mechanism and a portion of the locking mechanism.
- FIG. 12 is a cross-sectional view taken along lines 12 - 12 of FIG. 10.
- FIG. 12A is a cross-sectional view of the locking mechanism of the invention in an unlocked configuration permitting rotation of the control knob of the device.
- FIG. 13 is a cross-sectional view taken along lines 13 - 13 of FIG. 10 and showing the locking mechanism in a locked position preventing rotation of the control knob.
- FIG. 14 is a cross-sectional view taken along lines 14 - 14 of FIG. 10.
- FIGS. 15A and 15B when considered together comprise a greatly enlarged, generally perspective exploded rear view of the support means and the adjustable flow rate control mechanism of the apparatus of the invention showing the construction of the adjustable rate control mechanism and also showing a portion of the lockout means of the apparatus of the invention.
- FIGS. 16A and 16B when considered together comprise a greatly enlarged generally perspective exploded front view of the support means, a portion of the adjustable flow rate control mechanism and another portion of the locking means of the invention as shown in FIGS. 15A and 15B.
- FIGS. 17A and 17B when considered together, comprise a generally perspective, exploded bottom view of a portion of the reservoir assembly of the apparatus, a portion of the support means, a portion of the adjustable flow rate control mechanism and a portion of the flow indicator means with directional arrows illustrating the fluid flow path through the apparatus.
- FIGS. 17C and 17D when considered together, comprise a generally perspective exploded top view similar to FIGS. 17A and 17B further illustrating the operating system and indicating with directional arrows the fluid flow path through the apparatus.
- FIG. 18 is a greatly enlarged, generally perspective exploded rear view of the support means, the flow rate control means and the locking means of the invention, once again indicating with directional arrows the fluid flow path through the forward portion of the apparatus.
- FIG. 19 is a greatly enlarged generally perspective exploded front view of the support means similar to FIG. 18 further illustrating the construction of the various operating systems of the apparatus of the invention and once again using directional arrows to indicate the fluid flow path through the forward portion of the apparatus.
- FIG. 20 is a generally perspective top view of the cover and the forward portion of the housing of an alternate form of the apparatus of the invention in which the adjustable flow rate control mechanism is mounted proximate the top of the housing rather than in the base portion thereof.
- FIG. 21A is a generally perspective exploded view of the forward portion of the alternate form of the apparatus of the invention shown in FIG. 20 illustrating portions of the flow indicating means and of the locking means of this alternate embodiment.
- FIG. 21B is a generally perspective, exploded front view of the support means and a portion of the cover of the alternate form of the invention shown in FIG. 20.
- FIG. 21C is a generally perspective, exploded view of a portion of the adjustable flow rate control mechanism which is mounted proximate the top of the support means.
- FIGS. 22A and 22B when considered together, comprise a generally perspective, exploded view of the support means and of the manifold plate of the alternate form of the apparatus of the invention and depicted by use of directional arrows the fluid flow path there through the forward portion of the alternate embodiment of the invention.
- FIG. 23 is a greatly enlarged, side-elevational, cross-sectional view of a portion of the support means and a portion of the adjustable flow rate control means of this latest form of the invention.
- FIG. 24 is a cross-sectional view taken along lines 24 - 24 of FIG. 23.
- FIG. 25 is a cross-sectional view taken along lines 25 - 25 of FIG. 24.
- FIG. 26 is a generally perspective view of an alternate form of the apparatus of the present invention.
- FIG. 27 is an enlarged, cross-sectional view taken along lines 27 - 27 of FIG. 26.
- FIG. 27A is an enlarged, fragmentary, side-elevational view of the forward portion of the apparatus shown in FIG. 26 showing the adjustable flow rate control means.
- FIG. 27B is an enlarged front view of the support member of the apparatus of the invention.
- FIG. 28 is a view taken along lines 28 - 28 of FIG. 27B.
- FIG. 29 is a view taken along lines 29 - 29 of FIG. 27B.
- FIG. 30 is an enlarged, cross-sectional view taken along lines 30 - 30 of FIG. 27B.
- FIG. 31 is an enlarged, cross-sectional view taken along lines 31 - 31 of FIG. 27B.
- FIG. 32 is a cross-sectional view taken along lines 32 - 32 of FIG. 27B.
- FIG. 33 is a cross-sectional view taken along lines 33 - 33 of FIG. 27B.
- FIG. 34 is an enlarged, cross-sectional view taken along lines 34 - 34 of FIG. 27B.
- FIG. 35 is a generally illustrative front view of one type of flow rate control members of the invention.
- FIG. 36 is an enlarged, cross-sectional view taken along lines 36 - 36 of FIG. 35.
- FIGS. 36A and 36B when considered together, comprise an enlarged, generally perspective exploded front view of the support member and the adjustable flow rate control mechanisms of the apparatus of the invention.
- FIG. 37 is an enlarged, generally perspective exploded front view similar to FIGS. 36A and 36B but showing the fluid flow paths of the fluid flowing from the fluid reservoir toward the outlet of the device
- FIG. 38 is a generally perspective, exploded view of one type of the flow rate control members of the invention.
- FIG. 39 is a generally diagrammatic view illustrating the fluid flow rate control adjustments.
- FIG. 40 is a generally diagrammatic view illustrating the character of the flow rate and indicator bands provided on the control knob.
- the apparatus here comprises four major cooperating subassemblies namely, a reservoir subassembly 32 , an adjustable flow rate control subassembly 34 , a flow indicator subassembly 36 and fill means for filling the fluid reservoir of the reservoir subassembly.
- a reservoir subassembly 32 an adjustable flow rate control subassembly 34
- a flow indicator subassembly 36 and fill means for filling the fluid reservoir of the reservoir subassembly.
- this subassembly includes a base assembly 38 , a stored energy source, shown here as a distendable membrane 40 , and a cover 41 for enclosing the stored energy source.
- the base assembly includes an ullage substrate 42 and a membrane capture housing 44 having a bottom opening 46 which receives the distendable membrane engaging element or protuberance 48 of ullage substrate 42 .
- the ullage substrate, or base, 42 also includes a fill assembly 49 , which forms a part of the fill means of the invention.
- the stored energy means can be in the form of a single prestressed or unstressed isotropic, elastomeric, distendable membrane, or it can comprise a laminate assemblage made up of a plurality of initially generally planar distendable elements or films.
- the distendable membrane 40 is distended by fluid pressure exerted on the membrane by fluid flowing into the reservoir 50 under pressure. As membrane 40 is distended, additional internal stresses are formed therein which continuously urge the membrane in a direction toward engagement with protuberance 48 .
- reservoir 50 will be uniformly and controllably forced outwardly through reservoir outlet 52 , through passageway 54 and finally through longitudinally extending passageway 56 which is formed in ullage substrate 42 .
- An upstanding tongue 58 formed on ullage substrate 42 extends completely about the perimeter of member 42 and is closely receivable within a groove 64 formed in capture housing 44 .
- capture housing 44 is bonded to member 42 by any suitable means such as adhesive or sonic bonding. This done, cover 41 is mated with capture housing 44 and bonded in place. This assembly and bonding step is discussed more fully in incorporated by reference U.S. application Ser. No. 08/768,663.
- this means for controlling the rate of fluid flow of fluid from the device, this means here comprises an adjustable rate control mechanism which is carried by a support means shown here as comprising a deck-like support 68 which includes first and second faces 68 a and 68 b .
- Support 68 is connected to base assembly 38 and cover 41 in the manner best seen in FIGS. 2B and 4.
- wing-like protuberances 70 are formed on support 68 , which protuberances are received within spaced-apart, arcuate-shaped cavities 72 formed in base assembly 38 (FIG. 2B).
- Located proximate the upper edge of support 68 are arcuately, spaced, apart connector members 74 (FIG. 6) which mate with arcuately spaced connectors 76 provided on cover 41 (FIG. 2B) to enable secure interconnection of support 68 with the base assembly to form the hollow housing of the device generally designated by the numeral 77 (FIG. 2B).
- support 68 of the support means includes an outwardly extending, generally frustoconically shaped fluid inlet protuberance 80 which is closely receivable within a socket like cavity 81 formed in base member 42 .
- a fluid inlet passageway 82 formed in protuberance 80 is placed in fluid communication with reservoir 50 via passageways 54 and 56 .
- boot 88 is of similar construction to boot 266 shown in FIG. 13A of incorporated by reference U.S. Ser. No. 08/768,663 and reference should be made to this application for a more complete discussion of the construction and operation of the flow indicator boots.
- boot 88 includes a yieldably distendable fluid flow blocking body portion 88 a which is circumscribed by a marginal portion 88 b .
- Marginal portion 88 b is clamped between a manifold plate 90 and a uniquely configured boot-supporting indicator base 92 so that the boot extends through an opening 92 a formed in the indicator base 92 . It is to be understood that, when the fluid flowing from reservoir 50 in the direction of arrow 83 fills passageways 56 and 82 and impinges upon boot 88 , flow will be diverted in the direction of arrows 93 of FIGS. 17C and 17A rearwardly toward plate 90 and into a passageway 96 which is formed in plate 90 . When plate 90 is abutted against support 68 , passageway 96 will cooperate with a passageway 97 formed in support 68 (FIG.
- Control member 100 and the flow restrictors carried thereby form an important aspect of the previously mentioned fluid rate control means of the invention for controlling the rate of fluid outwardly from the device.
- control member 100 this member is here provided in the form of a generally disk shaped component having teeth 100 a formed about its periphery (FIGS. 6 and 15A).
- control member 100 also has a central bore 101 which receives a spindle 104 so that the member can be controllably rotated relative to face 68 a of support 68 (FIG. 6).
- Circumferentially spaced about central bore 101 is a plurality of apertures 106 , each of which is adapted to carry one of the previously mentioned flow restrictors, which here take the form of a porous rate control frit 107 (FIG. 11A).
- Member 100 is controllably rotated about spindle 104 by a driving member shown here as a toothed wheel 110 .
- a driving member shown here as a toothed wheel 110 .
- wheel 110 Connected to wheel 110 is a coaxially aligned, toothed wheel 112 which is driven by a finger engaging control knob 114 which, as shown in FIGS. 1, 10, and 11 includes a peripheral portion 114 a , a portion of which extends through an opening 114 c formed in the forward portion of the device (FIG. 2A).
- Knob 114 includes a lower toothed portion 114 b which meshes with toothed wheel 112 so that rotation of knob 114 about spindle 115 (FIG. 15B) will impart rotation to wheels 110 and 112 about a spindle 117 and will also impart rotation to control member 100 .
- FIG. 17A the fluid will flow forwardly in the direction of arrow 125 through a passageway 129 formed in support 68 and through a passageway 127 formed in plate 90 (FIG. 17A).
- the fluid will impinge on a second elastomeric, distendable boot 130 (FIG. 17A) which also forms a part of the indicator means of the invention.
- the periphery 130 a of indicator boot 130 which is of identical construction to boot 88 , (see also FIG. 13A of U.S. Ser. No. 08/768,663) is clamped within an opening 92 b formed in indicator base 92 .
- the fluid will next flow back toward support 68 in the direction of arrow 133 (FIGS.
- the flow indicator means also comprises the boot clamping plate 90 , a support or lens plate 150 , and a hollow forward housing 152 within which the platform and the support plate are enclosed (FIG. 4).
- a viewing lens 154 is viewable through an aperture 152 a provided in forward housing 152 .
- first and second indicia-carrying means 155 shown here as a pair of closely adjacent, thin films. These films are virtually identical in construction and operation to films 306 and 308 of the embodiment described in incorporated by reference U.S. Ser.
- the films are in intimate contact and are preferably constructed from a substantially transparent, flexible polymer material such as mylar.
- the downstream surface of the inferior or first film 306 is printed with three integrated symbols (see FIG. 12 of U.S. Ser. No. 08/768,663), which may comprise, by way of example, a blue circle, a green arrow, and a red X, each consisting of diagonal strips of color printed in an alternating pattern (blue, green, red, blue, green, red, and so on (see also FIGS. 1, 4B and 4 C).
- the second film 308 serves as a “mask” over film 306 and is printed with a pattern of diagonal alternating clear and opaque strips that occur in approximately a 1:2 ratio.
- the printed ratio of the “mask” allows only one colored symbol to appear at a time when viewed through viewing lens 154 .
- the inferior and superior films are provided at their opposite ends with apertures 160 which receive retention pins 162 provided on platform 92 (FIG. 17C) which permit attachment of the films to platform 92 in a manner such that the non-patterned portions of each film covers boot openings 92 a and 92 b provided proximate each end of platform 92 with the patterned portions of both the superior and inferior films being maintained in index.
- each thin film is able to move in response to pressure exerted thereon by the elastomeric boots 88 and 130 in opposing directions parallel to the film plane with its range of motion limited to one axis in the film plane by edge guides 163 provided on platform 92 (FIG. 17C).
- edge guides 163 provided on platform 92 (FIG. 17C).
- both the first and second elastomeric actuator elements or boots 88 and 130 will be deflected outwardly toward plate 92 when the device is filled and primed, but not in a state of delivery or when there is a build up of fluid pressure during delivery that is caused by blockage of the delivery line downstream from boot 130 . While boot 88 can be deflected by normal line pressure, boot 130 is deflected only by pressure buildup resulting from the downstream blockage.
- both the superior and inferior films are displaced transversely to a second position revealing a second symbol, as for example, an X as viewed through the viewing aperture of the support plate (FIG. 4B).
- a second symbol as for example, an X as viewed through the viewing aperture of the support plate (FIG. 4B).
- an indicia such as an arrow (FIG. 4C) is visible through the viewing window.
- a third alignment of symbol patterns is visible when the device is in an unfilled state or when the delivery line is open, the reservoir is empty and fluid delivery to the patient has been completed.
- the inferior and superior films are not transversely displaced and thus exhibit a third combination of patterns resulting in a third symbol as, for example, a circle being visible through the viewing aperture of the support plate.
- Boots 88 and 130 can be precisely tailored to deflect under various pressures thereby permitting great apparatus versatility.
- the fill means here includes a fill subassembly 49 and also includes a fill line assembly 170 which comprises an elongated fill line 172 having at one end a luer connector 174 of the character adapted to be readily interconnected with a luer connector 176 which extends from a bottom of ullage substrate 42 and comprises a part of the fill assembly 49 (FIG. 4). Also forming a part of fill assembly 49 is valve means for controlling fluid flow from fill line 172 toward reservoir 50 .
- this valve means comprises a conventional type of umbrella valve 180 having a resiliently deformable skirt portion 182 .
- fill line 172 When fill line 172 is appropriately interconnected with a source of the fluid to be infused into the patient, fluid will flow through line 172 into luer connector 176 and then into an internal chamber 184 within which umbrella valve 180 is disposed. Fluid flowing into chamber 184 under pressure will resiliently deform skirt portion 182 permitting fluid to flow into reservoir 50 via reservoir inlet port 186 . As the fluid flows under pressure into reservoir 50 , yieldably deformable membrane 40 will be deformed outwardly into the configuration shown in FIG. 4.
- This locking means which is generally designated in FIG. 1 by the numeral 190 , comprises a generally cylindrically shaped hollow housing 192 which is closely received within an opening 193 formed in forward housing 152 and is also received within an opening 194 formed in support 68 (see FIGS. 2A and 15B).
- latch member 196 having a first end 196 a and a second and 196 b (FIG. 15A).
- latch member 196 is pivotally connected to support 68 by opposed hubs 197 for movement between first and second positions. Hubs 197 are pivotally mounted in cradles 197 a formed on support 68 (FIG. 15B).
- end 196 a is spaced apart from driver wheel 112 so as to permit free rotation thereof.
- first end 196 a operably engages drive wheel 112 so as to prevent its rotation and also the rotation of control member 100 . More particularly, as shown in FIGS. 13 and 14, when latch member 196 is moved into a first locking position, an outwardly extending tongue 196 c provided on the locking member is received within a pair of oppositely disposed, circumferentially spaced slots 112 a formed in driven wheel 112 (FIG. 15A).
- latch operating assembly 195 which includes a latch operating member 198 is provided.
- Latch operating assembly 193 is telescopically received within hollow housing 192 and is movable against the urging of an operating member biasing means between a first extended position and a second depressed position.
- latch operating member 198 includes a generally spherically shaped inboard extremity 198 a which is in snug engagement with a cavity formed in second end 196 b of latch 196 .
- an outwardly extending push button 200 is telescopically movable within hollow housing 192 .
- the previously mentioned operating member biasing means is here provided in the form of a spring 199 which is carried by the shank portion of member 198 and functions to normally urge the latch member into the disengaged or rate selection position shown and FIG. 12A and, at the same time, to urge the push button 200 outwardly in the direction of arrow 201 into the extended position as shown in FIG. 12A.
- a key operated assembly 204 which is received within an opening 192 a of hollow housing 192 (FIG. 15B). Assembly 204 is rotatable between a first locked position, shown in FIG. 5A, and a second unlocked position, shown in FIG. 5B (see also FIGS. 12A and 13).
- a pusher member 205 which is disposed between push button 200 and member 198 is provided with a longitudinally extending slot 205 a which terminates proximate one end in a transversely extending segment 205 b .
- key operated assembly 204 comprises a key operated member 206 which includes an apertured key receiving head 206 a and a stem portion 206 b which is closely receivable within slot 205 a .
- Stem portion 206 b terminates in a foot portion 207 which is receivable in segment 205 b when the device is in the locked position shown in FIG. 14.
- the physician or caregiver can insert the tines 210 a formed on the physician's key 210 (see FIG. 1) into the openings 209 provided in head portion 206 a of the key operated member 206 .
- tines 210 a are provided at the extremity of a stem-like portion 210 b of the physician's key so that upon rotation of the physician's key, operated member 206 can be rotated from the locked position shown in FIG. 14 to the unlocked position shown in FIG. 12 a where the latch biasing means move it in the direction of the arrow 211 of FIG. 12A. This, in turn, will move push button 200 outwardly in the direction of the arrow 201 .
- the delivery line 146 of the delivery means of the invention is interconnected with the outlet 144 of the device.
- the delivery means of the invention also includes a line clamp 214 which is of conventional construction and a gas vent and filter unit 216 which is also of a conventional construction well known to those skilled in the art.
- attachment means are affixed to the lower surface of the base unit 38 .
- This attachment means here comprises a generally rectangularly shaped foam pad 220 which includes lower adhesive covered surface 220 a that enables the device to be removably affixed to a portion of the patient's body such as the patient's abdomen or the like.
- the device can be affixed to the patient's clothing or can be connected to a belt or the like.
- the infusion cannula 221 of the cannula assembly 220 of the invention can be invasively interconnected with the patient.
- the cannula assembly 221 of the present form of the invention is of a conventional construction and is attached proximate the outboard end of delivery line 146 .
- the assembly includes a butterfly assembly 222 which provides a convenient means for taping the assembly securely in position.
- line clamp 214 can be open to permit fluid flow outwardly of the device through delivery line 146 and toward the patient.
- Fluid will flow toward the patient at the rate of flow selected by the physician at the time of setting the fluid flow rate control means of the invention.
- the fluid status of the device can be continuously monitored by observing the various flow symbols of the indicator means that appear through viewing window 154 of the apparatus.
- FIGS. 20 through 25 an alternate form of the invention is there illustrated and generally designated by the numeral 250 .
- the apparatus of this latest form of the invention is quite similar to that shown in FIGS. 1 through 19 and also comprises four major cooperating subassemblies namely, a reservoir subassembly, an adjustable flow rate control subassembly, a flow indicator subassembly and fill means for filing the fluid reservoir of the reservoir subassembly.
- the reservoir subassembly, the flow indicator subassembly and the fill means are substantially identical in construction and operation to those earlier described and, accordingly, like numbers are used in FIGS. 20 through 25 to identify like components.
- this subassembly includes a base assembly which is identical to base assembly 38 and operates in precisely the same way. Therefore, this assembly is not shown in FIGS. 20 through 25.
- this means also here comprises an adjustable rate control mechanism which is carried by a support means 252 which is similar to support 68 but, in this instance, carries the flow rate control mechanism at a location proximate the upper portion of the support.
- support 252 also includes wing-like protuberances 70 which are received within spaced-apart, arcuate-shaped cavities formed in base assembly 38 .
- wing-like protuberances 70 which are received within spaced-apart, arcuate-shaped cavities formed in base assembly 38 .
- Located proximate the upper edge of support 252 are arcuately, spaced-apart connector members 74 (FIG. 22B) which mate with arcuately spaced connectors 76 provided on cover 254 (FIG. 21 B) to enable secure interconnection of support 252 with the base assembly to form the hollow housing of the device.
- support 252 of the support means also includes an outwardly extending, generally frustoconically shaped fluid inlet protuberance 80 which is closely receivable within a socket like cavity 81 formed in base member 42 .
- a fluid inlet passageway 82 formed in protuberance 80 is placed in fluid communication with reservoir 50 of the base assembly.
- the fluid will flow through protuberance 80 in the direction of arrow 255 (FIG. 22B).
- the fluid will then flow into a passageway 258 formed in manifold plate 260 (FIGS.
- the adjustable flow rate control means of this latest embodiment of the invention comprises a control assembly 270 which is mounted within a vertically extending chamber 252 a formed proximate the top support 252 .
- control assembly 270 includes knob-like selector member 272 which includes a head portion 272 a and a shank portion 272 b .
- Head portion 272 a extends upwardly from the forward housing 273 of this latest form of the invention.
- Shank portion 272 b of control selector 272 is receivable within the hollow stem portion 274 a of a flow control assemblage 274 which is rotatably mounted within chamber 253 .
- Control assemblage 274 also includes a cup like head portion 274 b within which a portion of head portion 272 a of selector member 272 is closely received.
- a flange 274 c which is disposed between stem portion 274 a and cup like portion 274 b , is closely receivable within notch-like openings 252 b and 260 a formed in support 252 and in manifold 260 (FIGS. 22A and 22B).
- the flow restrictor means can take several forms such as orifices of various sizes or, as here shown, can comprise a plurality of porous rate control frits 277 of various porosity.
- Shank portion 272 b of selector member 272 is provided with driving splines 272 c which drivably engage control assemblage 274 to cause it to rotate within chamber 252 a upon rotation of the knob-like head portion 272 a which extends upwardly from the forward device housing in the manner shown in FIG. 20.
- frits 277 can be sequentially moved into index with control passageway 266 .
- a plurality of O-rings 278 are carried by stem 274 a in a manner to sealably engage mating grooves 253 in the wall of chamber 252 a .
- a selected one of the plurality of rate control frits 277 can be moved into alignment with central passageway 266 of support 252 so that fluid from reservoir 50 will flow therethrough at a selected rate.
- Rate indicating indicia 274 d are provided on flange 274 c and are viewable through a viewing window 279 formed in the forward housing 273 (FIGS. 20 and 25).
- the fluid will then flow forwardly in the direction of arrow 283 through an orifice 286 formed in plate 260 where it will impinge in a second elastomeric, distendable boot which is also identical to boot 130 of the earlier described embodiment.
- the fluid will next flow back toward support 252 in the direction of arrow 289 (FIGS. 22A and 22B) through orifice 290 formed in plate 260 and then, via an orifice formed in support 252 , into a passageway 292 formed by cover 292 a and support 252 .
- the fluid Upon entering passageway 292 , the fluid will flow downwardly of the passageway and then into a tubular extension 144 formed on support 252 and finally into the delivery line 146 of the apparatus via the outlet port.
- FIGS. 26 through 37 still another form of the apparatus of the present form of the invention is there illustrated and generally designated by the numeral 300 .
- the apparatus of this latest embodiment is similar to that shown in FIGS. 1 through 19 and also comprises four major cooperating subassemblies namely, a reservoir subassembly, an adjustable flow rate control subassembly, a flow indicator subassembly and fill means for filling the fluid reservoir of the reservoir subassembly. Because of the similarities between this latest form of the invention and those earlier described, like numerals are used in FIGS. 26 through 37 to identify like components.
- this subassembly is virtually identical in construction and operation to that shown in FIG. 4 and includes a base assembly 38 , a stored energy source, shown here as a distendable membrane 40 , and a cover 41 for enclosing the stored energy source.
- the base assembly includes an ullage substrate 42 and a membrane capture housing 44 having a bottom opening 46 which receives the distendable membrane engaging element or protuberance 48 of ullage substrate 42 .
- the ullage substrate, or base, 42 also includes a fill assembly 49 , which is substantially identical in construction and operation to that previously described herein and illustrated in FIG. 3.
- the assembly of the ullage substrate, capture housing and cover is the same as previously described in connection with FIGS. 1 through 8.
- FIGS. 1 through 8 The major difference between this latest embodiment of the invention and that shown in FIGS. 1 through 8 is the differently configured flow rate control means of the invention, for controlling the rate of fluid flow of fluid from the device.
- This means here comprises a pair of cooperating, adjustable rate control mechanisms which are carried by a support means shown here as comprising a deck-like support 302 which includes first and second faces 302 a and 302 b .
- Support 302 is connected to base assembly 38 and cover 41 in the manner best seen in FIG. 27.
- Located proximate the upper edge of support 302 are arcuately, spaced, apart connector members 303 (FIG. 36B) which mate with arcuately spaced connectors provided on cover 41 to enable secure interconnection of support 302 with the base assembly to form the hollow housing of the device.
- support 302 of the support means includes an outwardly extending, generally frustoconically shaped fluid inlet protuberance 304 which is closely receivable within a socket like cavity 81 formed in base member 42 .
- a fluid inlet passageway 306 formed in protuberance 304 is placed in fluid communication with reservoir 50 via passageways 54 and 56 .
- the fluid will flow into passageway 54 , into passageway 56 and then into passageway 306 formed in protuberance 304 .
- the fluid will flow into a passageway 308 formed in face 302 b of support 302 (FIG.
- the flow indicator means of this latest form of the invention is generally similar to that previously described and reference should be made to FIGS. 1 through 19 and the earlier discussion thereof for a more complete understanding of the construction and operation of the flow indicator means of this latest form of the invention.
- flow will be diverted in the direction of arrows 310 of FIG. 37 rearwardly toward the novel flow rate control means, the character of which will presently be described.
- the fluid After flowing through the rate control means, the fluid will flow through a passageway 312 provided in a first cover 314 which overlays a first rate control housing 316 . Next, the fluid will flow in the direction of the arrow 318 (FIG. 37), and into passageway 320 . The fluid will then flow forwardly in the direction of arrow 324 through a passageway 326 formed in support 302 . Next the fluid will impinge on a second elastomeric, distendable boot which also forms a part of the indicator means of the invention.
- the fluid After impinging on the second boot, the fluid will flow back toward cover 316 in the direction of arrows 330 through passageway 332 formed in cover 316 and then in the direction of arrow 332 into a delivery line 146 via the outlet port of the device (FIG. 27).
- this means here comprises a pair of rate control members 336 and 338 each of which has teeth formed about its periphery (FIGS. 36A, 36B and 37 ).
- Each control member also has a central bore which receives a spindle 340 so that the member can be controllably rotated relative to face 302 a of support 302 (FIG. 30).
- Circumferentially spaced about the central bore of each member is a plurality of apertures 342 , each of which is adapted to carry a flow restrictor of the general character previously described.
- the flow restrictors take the form of a porous rate control frit 344 (FIG. 11A).
- Member 336 is controllably rotated about spindle 340 by a driving member shown here as a toothed wheel 346 .
- a driving member shown here as a toothed wheel 346 .
- wheel 346 Connected to wheel 346 is a coaxially aligned, toothed wheel 348 which is driven by a finger engaging control knob 350 which, as shown in FIGS. 26 and 28 includes a peripheral portion 350 a , a portion of which extends through an opening 352 formed in the forward portion of the device (FIG. 26).
- Knob 350 includes a lower toothed portion 350 b which meshes with toothed wheel 348 so that rotation of knob 350 about spindle 354 (FIG. 37) will impart rotation to wheels 346 and 348 about a spindle 357 and will also impart rotation to control member 336 .
- a selected one of the plurality of rate control frits 344 carried thereby can be moved into alignment with a first passageway 360 of support 302 so that fluid from reservoir 50 will flow therethrough.
- fluid will flow from reservoir 50 through a second passageway 362 provided in support 302 .
- Second passageway 362 is aligned with an open, non-frit carrying aperture 363 provided in member 336 so that a portion of the fluid will flow toward second control member 338 in the direction of arrow 365 .
- Two pairs of elastomeric O-rings 367 and 367 a sealably engage either the side of member 336 to prevent leakage about the periphery of the openings aligned with the fluid flow paths.
- O-rings 367 a are carried by a generally “L” shaped member which is disposed between members 336 and 338 in the manner shown in FIG. 37.
- member 338 is separately rotatable by a second driving mechanism which includes a toothed drive wheel 370 .
- Drive wheel 370 is driven by a second finger engaging control knob 372 which also includes a peripheral portion 372 a , a portion of which extends through opening 352 formed in the forward portion of the device (FIG. 26).
- Second knob 372 includes a toothed portion 372 b which meshes with drive wheel 370 so that rotation of knob 372 about spindle 354 will impart rotation to a pair of coaxially aligned gear wheels 374 and 376 and will also impart rotation to second control member 338 which is operably associated with gear wheel 376 .
- finger engaging wheel 350 can be provided with indicia such as 8, 10, 12, 14, 16 and 18 milliliter per hour bands. Rotation of knobs 350 will, therefore, accomplish the coarse rate control for fluid flowing along the flow control path indicated by the arrow 310 in FIG. 37.
- rate control knob 372 can be provided with indicia in tenths of milliliter per hour such as 0.2, 0.4, 0.6, 0.8, and 1.0.
- aperture 342 designated by the letter “B” is provided with a porous flow control frit 344 which is represented in FIG. 39 by the resistance symbol R-1.
- This flow control frit would permit fluid flow toward the fluid delivery outlet of the device in coarse milliliter per hour increments such as 8, 10, 12, 14, 16, 18 and so forth. It is to be observed by referring to FIG. 37 that fluid flowing through rate control frit 344 will continue in the direction of the arrow 310 through an open aperture in control member 338 which is designated in FIG. 37 by the letter “D”. Therefore, the coarsely controlled fluid will flow forwardly of the device into cover 314 in the manner shown in FIG. 37.
- fluid flowing into chamber 375 which is formed in support 302 , will also flow through an open aperture provided in control member 336 which aperture is designated by the letter “A” in FIG. 37.
- the fluid flowing freely through open aperture “A” will flow onwardly toward control member 338 where it will flow through a porous rate control frit “C” which will limit fluid flow in one-tenth milliliter per hour increments as for example 0.2, 0.4, 0.6, 0.8 and so on. as indicated in FIG. 40.
- the fluid After the fluid flow through fine rate control frit “C”, the fluid will flow toward cover 314 where it will mix with the fluid flowing along fluid flow path 310 .
- the mixture of fluid then flowing toward the outlet of the device will be the sum of the fluids flowing along fluid flow paths 310 and 365 .
- rate control frit “B” will permit a fluid flow rate along fluid path 310 at 14 milliliters per hour.
- control wheel 372 is rotated so that the indicia 06 aligns with the viewing window, fluid flowing along flow path 365 will flow at a rate of 0.6 milliliters per hour in the direction toward cover 314 . As is indicated by FIG.
- This locking means which is generally similar to that previously described, comprises a generally cylindrically shaped hollow housing 380 which is closely received within an opening 382 formed in a forward housing 384 (FIG. 26). Also forming a part of the rate control locking means of the invention is a latch member 386 having a first end 386 a and a second end 386 b (FIG. 36A).
- latch member 386 is pivotally connected to support 302 for movement between first and second position.
- end 386 a permits rotation of driver wheel 370 and also permits free rotation of driver wheels 346 and 348 .
- a tab 387 provided on first end 386 a moves into a selected slot 370 a provided in wheel 370 so as to prevent rotation of the wheel.
- locking tabs 389 provided on latch 386 move into one of the circumferentially spaced slots 391 formed in wheels 346 and 348 thereby preventing rotation of these wheels.
- a latch operating assembly 400 which includes a latch operating member 402 is provided (FIG. 37).
- Latch operating assembly 400 is telescopically received within hollow housing 380 and is movable against the urging of an operating member biasing means between a first extended position and a second depressed position.
- Latch operating member 402 includes an inboard extremity 402 a (FIG. 33) which is in snug engagement with a cavity formed in second end 386 b of latch 386 .
- an outwardly extending push button 404 is telescopically movable within hollow housing 380 .
- the previously mentioned operating member biasing means is here provided in the form of a spring 407 which is carried by the shank portion of member 402 and functions to normally urge the latch member into the disengaged or rate selection position (FIG. 33).
- Spring 407 functions to continuously urge the push button 404 outward of housing 380 into an extended position to permit operation of the flow rate control means.
- a key operated assembly 204 which is of similar construction and operation to that described in the embodiment shown in FIGS. 1 through 19.
- a pusher member 408 which is disposed between push button 404 and member 402 is provided with a longitudinally extending slot 408 a which terminates proximate one end in a transversely extending segment 408 b .
- key operated assembly 204 comprises a key operated member 206 which is of identical construction and operation to that previously described.
- member 206 can be rotated from the locked position to the unlocked position where the latch biasing means will move the latch member 386 into the unlocked position to permit rotation of knobs 350 and 372 which will, in turn, impart rotation to control members 336 and 338 .
- the various rate control frits can be sequentially move into index with the fluid passageways indicated by the arrows 310 and 365 of FIG. 37. In this way, the precise fluid flow outwardly of the device can be selected and the device can be interconnected with the patient in the manner previously described.
Abstract
Description
- This is a Continuation of copending U.S. application Ser. No. 09/165,706 filed Oct. 2, 1998 which is a Continuation-In-Part of copending U.S. application Ser. No. 08/768,663 filed Dec. 18, 1996.
- 1. Field of the Invention
- The present invention relates generally to fluid delivery devices. More particularly, the invention concerns an improved apparatus for infusing medicinal agents into an ambulatory patient at specific rates over extended periods of time, which apparatus includes fluid flow indicator means and a novel adjustable flow rate control means for precisely adjustably controlling the rate of fluid flow from the reservoir of the device.
- 2. Discussion of the Prior Art
- 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 results in toxic reaction.
- In the past, prolonged infusion of fluids has generally been accomplished using gravity flow methods, which typically involve the use of intravenous administration sets and the familiar bottle suspended above the patient. Such 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. Devices from which liquid is expelled from a relatively thick-walled bladder by internal stresses within the distended bladder are well-known in the prior art. Such bladder, or “balloon” type, devices are described in U.S. Pat. No. 3,469,578, issued to Bierman and in U.S. Pat. No. 4,318,400, issued to Perry. The devices of the aforementioned patents also disclose the use of fluid flow restrictors external of the bladder for regulating the rate of fluid flow from the bladder. The prior art bladder type infusion devices are not without drawbacks. Generally, because of the very nature of the bladder or “balloon” configuration, the devices are unwieldy and are difficult and expensive to manufacture and use. Further, the devices are somewhat unreliable and their fluid discharge rates are frequently imprecise.
- The apparatus of the present invention overcomes many of the drawbacks of the prior art by eliminating the bladder and making use of recently developed elastomeric films and similar materials, which, in cooperation with a base define a fluid chamber that contains the fluid which is to be dispensed. The elastomeric film membrane controllably forces fluid within the chamber into fluid flow channels provided in the base.
- The elastomeric film materials used in the apparatus of the present invention, as well as various alternate constructions of the apparatus, are described in detail in U.S. Pat. No. 5,205,820 issued to the present inventor. Therefore, U.S. Pat. No. 5,205,820 is hereby incorporated by reference in its entirety as though fully set forth herein. Co-pending U.S. Ser. No. 08/768,663 filed by the present inventors on Dec. 18, 1996 also describes various alternate constructions and modified physical embodiments of the invention. Because the present application discloses improvements to the apparatus described in U.S. Ser. No. 08/768,663, this co-pending application is also hereby incorporated by reference in its entirety as though fully set forth herein. U.S. Pat. No. 5,721,382 issued to the present inventor on Feb. 24, 1998 discloses an apparatus for indicating fluid pressure within a conduit. The present invention comprises an improvement to the devices disclosed in this latter patent and, therefore, U.S. Pat. No. 5,721,383 is also incorporated by reference as though fully set forth herein.
- 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 and can be used for the continuous infusion of antibiotics, hormones, steroids, blood clotting agents, analgesics, and like medicinal agents. Similarly, the devices can be used for I-V chemotherapy and can accurately deliver fluids to the patient in precisely the correct quantities and at extended microfusion rates over time.
- The embodiments of the invention described in U.S. Ser. No. 08/768,663, which application is incorporated herein by reference, comprises a fluid delivery apparatus having a fluid reservoir and an indicator assembly for indicating fluid flow through the apparatus. However, the apparatus of the present invention, also 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. As will be better understood from the description which follows, the novel adjustable fluid flow rate control mechanism of the present invention includes locking means which is operable only by a physician or health care worker who is in possession of a physician operating key. Accordingly, once a particular flow rate is selected, the patient cannot unilaterally change the flow rate.
- It is an object of the present invention to provide an apparatus for expelling fluids at a precisely controlled rate which is of a compact, low profile, laminate construction. More particularly, it is an object of the invention to provide such an apparatus which can be used for the precise infusion of pharmaceutical fluids to an ambulatory patient at controlled rates over extended periods of time.
- It is another object of the invention to provide an apparatus of the aforementioned character which is highly reliable and easy-to-use by lay persons in a non-hospital environment.
- Another object of the invention is to provide an apparatus which can be factory prefilled with a wide variety of medicinal fluids or one which can readily be filled in the field shortly prior to use.
- A further object of the invention is to provide a low profile, fluid delivery device of laminate construction which can be manufactured inexpensively in large volume by automated machinery.
- Another object of the invention is to provide a device of the aforementioned character which includes novel adjustable flow rate control means disposed intermediate the fluid reservoir outlet and the outlet port of the device for precisely controlling the rate of fluid flow from the outlet port toward the patient.
- Another object of the invention is to provide a device of the character described which embodies a highly novel fluid flow indicator that provides a readily discernible visual indication of fluid flow status through the device.
- Another object of the invention is to provide an apparatus of the aforementioned character in which the stored energy source is of a novel laminate construction which can be precisely tailored to deliver fluid from the device at precise rates.
- Another object of the invention is to provide unique fill means for use in controllably filling the fluid reservoir of the apparatus.
- Another object of the present invention is to provide an apparatus of the aforementioned character in which the flow rate control means comprises a rotatable flow restrictor support disk that can be rotated by the treating physician to selectively position the flow restrictor between the fluid reservoir and the device outlet port.
- Another object of the present invention is to provide a flow rate control means of the type described in the preceding paragraph in which the flow restrictors comprise porous frits of varying porosity.
- Another object of the present invention is to provide a flow rate control means in which the flow restrictors comprise wafers which have been laser drilled to provide a plurality of micro bores of various sizes.
- Another object of the invention is to provide an apparatus as described in the preceding paragraphs which includes locking means for locking the variable flow rate control disk in a preset position so that the rate control can be set only by the treating physician or an authorized health care worker having an operating key.
- Another object of the invention is to provide a novel fill assembly for use in filling the fluid reservoir of the apparatus of the invention.
- By way of summary, the improved fluid delivery apparatus of the present form of the invention comprises three major cooperating subassemblies, namely a reservoir subassembly, a highly novel adjustable, key-operated fluid flow rate control subassembly and a flow indicator subassembly for visually indicating fluid flow through the device. The reservoir subassembly, which readily lends itself to automated manufacture, is generally similar to that described in copending U.S. Ser. No. 08/768,663 and includes a base and a stored energy means comprising at least one distendable elastomeric membrane which cooperates with the base to form a fluid reservoir. The fluid flow indicator subassembly is also somewhat similar to that described in U.S. Ser. No. 08/768,663 and comprises a mechanical fluid flow indicator that provides a clear visual indication of normal fluid flow and absence of fluid flow either because the reservoir is empty or because the flow lines are occluded. Additionally, the apparatus of the invention includes fill means for use in filling the reservoir of the reservoir subassembly this fill means here comprises a fill assembly which can be mated with the base of the reservoir subassembly for use in controllably filling the reservoir thereof.
- FIG. 1 is a generally perspective view of one form of the apparatus of the present invention which includes a flow indicator means for indicating fluid flow as well as a novel adjustable flow rate control means for precisely controlling the rate of fluid flow from the reservoir of the apparatus
- FIG. 1A is an enlarged, fragmentary side-elevational view of the forward portion of the apparatus shown in FIG. 1 showing the adjustable flow rate control means.
- FIGS. 2A and 2B when considered together comprise a generally perspective, exploded view of the apparatus of the invention shown in FIG. 1.
- FIG. 3 is a top plan the view of the apparatus shown in FIG. 1.
- FIG. 4 is an enlarged, side-elevational, cross-sectional view taken along lines4-4 of FIG. 3.
- FIG. 4A is a greatly enlarged, fragmentary, cross-sectional view of the forward portion of the housing of the apparatus shown in FIG. 4.
- FIG. 4B is a diagrammatic front view of the apparatus illustrated in FIG. 4 showing one form of fluid flow indicia of the flow indicator means being displayed.
- FIG. 4C is a diagrammatic front view similar to FIG. 4B, but showing another form of fluid flow indicia.
- FIG. 5 is a bottom plan view of the housing portion of the apparatus of the invention shown in FIG. 1.
- FIG. 5A is an enlarged, fragmentary bottom view of one form of the physician locking means of the invention in a first configuration.
- FIG. 5B is a fragmentary bottom view similar to FIG. 5A, but showing the locking means in a second unlocked configuration.
- FIG. 6 is a greatly enlarged generally perspective rear view of the support means of the apparatus of the invention illustrating the construction of the adjustable flow rate control mechanism of the device and also showing the face of the locking mechanism of the apparatus for locking out the flow rate control means against adjustment.
- FIG. 7 is an enlarged, rear-elevational view of the support means and adjustable flow rate control mechanism of the apparatus shown in FIG. 6.
- FIG. 8 is a cross-sectional view taken along lines8-8 of FIG. 7.
- FIG. 9 is cross-sectional view taken along lines9-9 of FIG. 7
- FIG. 10 is an enlarged front elevational view of the support means of the apparatus.
- FIG. 11 is a cross-sectional view taken along lines11-11 of FIG. 10.
- FIG. 11 A is a generally perspective, fragmentary view of a portion of the adjustable flow rate control mechanism and a portion of the locking mechanism.
- FIG. 12 is a cross-sectional view taken along lines12-12 of FIG. 10.
- FIG. 12A is a cross-sectional view of the locking mechanism of the invention in an unlocked configuration permitting rotation of the control knob of the device.
- FIG. 13 is a cross-sectional view taken along lines13-13 of FIG. 10 and showing the locking mechanism in a locked position preventing rotation of the control knob.
- FIG. 14 is a cross-sectional view taken along lines14-14 of FIG. 10.
- FIGS. 15A and 15B when considered together comprise a greatly enlarged, generally perspective exploded rear view of the support means and the adjustable flow rate control mechanism of the apparatus of the invention showing the construction of the adjustable rate control mechanism and also showing a portion of the lockout means of the apparatus of the invention.
- FIGS. 16A and 16B when considered together comprise a greatly enlarged generally perspective exploded front view of the support means, a portion of the adjustable flow rate control mechanism and another portion of the locking means of the invention as shown in FIGS. 15A and 15B.
- FIGS. 17A and 17B, when considered together, comprise a generally perspective, exploded bottom view of a portion of the reservoir assembly of the apparatus, a portion of the support means, a portion of the adjustable flow rate control mechanism and a portion of the flow indicator means with directional arrows illustrating the fluid flow path through the apparatus.
- FIGS. 17C and 17D, when considered together, comprise a generally perspective exploded top view similar to FIGS. 17A and 17B further illustrating the operating system and indicating with directional arrows the fluid flow path through the apparatus.
- FIG. 18 is a greatly enlarged, generally perspective exploded rear view of the support means, the flow rate control means and the locking means of the invention, once again indicating with directional arrows the fluid flow path through the forward portion of the apparatus.
- FIG. 19 is a greatly enlarged generally perspective exploded front view of the support means similar to FIG. 18 further illustrating the construction of the various operating systems of the apparatus of the invention and once again using directional arrows to indicate the fluid flow path through the forward portion of the apparatus.
- FIG. 20 is a generally perspective top view of the cover and the forward portion of the housing of an alternate form of the apparatus of the invention in which the adjustable flow rate control mechanism is mounted proximate the top of the housing rather than in the base portion thereof.
- FIG. 21A is a generally perspective exploded view of the forward portion of the alternate form of the apparatus of the invention shown in FIG. 20 illustrating portions of the flow indicating means and of the locking means of this alternate embodiment.
- FIG. 21B is a generally perspective, exploded front view of the support means and a portion of the cover of the alternate form of the invention shown in FIG. 20.
- FIG. 21C is a generally perspective, exploded view of a portion of the adjustable flow rate control mechanism which is mounted proximate the top of the support means.
- FIGS. 22A and 22B, when considered together, comprise a generally perspective, exploded view of the support means and of the manifold plate of the alternate form of the apparatus of the invention and depicted by use of directional arrows the fluid flow path there through the forward portion of the alternate embodiment of the invention.
- FIG. 23 is a greatly enlarged, side-elevational, cross-sectional view of a portion of the support means and a portion of the adjustable flow rate control means of this latest form of the invention.
- FIG. 24 is a cross-sectional view taken along lines24-24 of FIG. 23.
- FIG. 25 is a cross-sectional view taken along lines25-25 of FIG. 24.
- FIG. 26 is a generally perspective view of an alternate form of the apparatus of the present invention.
- FIG. 27 is an enlarged, cross-sectional view taken along lines27-27 of FIG. 26.
- FIG. 27A is an enlarged, fragmentary, side-elevational view of the forward portion of the apparatus shown in FIG. 26 showing the adjustable flow rate control means.
- FIG. 27B is an enlarged front view of the support member of the apparatus of the invention.
- FIG. 28 is a view taken along lines28-28 of FIG. 27B.
- FIG. 29 is a view taken along lines29-29 of FIG. 27B.
- FIG. 30 is an enlarged, cross-sectional view taken along lines30-30 of FIG. 27B.
- FIG. 31 is an enlarged, cross-sectional view taken along lines31-31 of FIG. 27B.
- FIG. 32 is a cross-sectional view taken along lines32-32 of FIG. 27B.
- FIG. 33 is a cross-sectional view taken along lines33-33 of FIG. 27B.
- FIG. 34 is an enlarged, cross-sectional view taken along lines34-34 of FIG. 27B.
- FIG. 35 is a generally illustrative front view of one type of flow rate control members of the invention.
- FIG. 36 is an enlarged, cross-sectional view taken along lines36-36 of FIG. 35.
- FIGS. 36A and 36B, when considered together, comprise an enlarged, generally perspective exploded front view of the support member and the adjustable flow rate control mechanisms of the apparatus of the invention.
- FIG. 37 is an enlarged, generally perspective exploded front view similar to FIGS. 36A and 36B but showing the fluid flow paths of the fluid flowing from the fluid reservoir toward the outlet of the device FIG. 38 is a generally perspective, exploded view of one type of the flow rate control members of the invention.
- FIG. 39 is a generally diagrammatic view illustrating the fluid flow rate control adjustments.
- FIG. 40 is a generally diagrammatic view illustrating the character of the flow rate and indicator bands provided on the control knob.
- Referring to the drawings and particularly to FIGS. 1 through 5, one form of the apparatus of the present form of the invention is there illustrated and generally designated by the numeral30. As best seen in FIGS. 1 and 4, the apparatus here comprises four major cooperating subassemblies namely, a
reservoir subassembly 32, an adjustable flowrate control subassembly 34, aflow indicator subassembly 36 and fill means for filling the fluid reservoir of the reservoir subassembly. The construction and operation of each of these cooperating subassemblies will be discussed in greater detail in the paragraphs which follow. - Considering first the reservoir subassembly shown in FIG. 4, this subassembly includes a
base assembly 38, a stored energy source, shown here as adistendable membrane 40, and acover 41 for enclosing the stored energy source. The base assembly includes anullage substrate 42 and amembrane capture housing 44 having abottom opening 46 which receives the distendable membrane engaging element orprotuberance 48 ofullage substrate 42. Referring particularly to FIGS. 4 and 5, the ullage substrate, or base, 42 also includes afill assembly 49, which forms a part of the fill means of the invention. - The stored energy means can be in the form of a single prestressed or unstressed isotropic, elastomeric, distendable membrane, or it can comprise a laminate assemblage made up of a plurality of initially generally planar distendable elements or films. The
distendable membrane 40 is distended by fluid pressure exerted on the membrane by fluid flowing into thereservoir 50 under pressure. Asmembrane 40 is distended, additional internal stresses are formed therein which continuously urge the membrane in a direction toward engagement withprotuberance 48. During the delivery operation, as the membrane moves towardprotuberance 48, fluid withinreservoir 50 will be uniformly and controllably forced outwardly throughreservoir outlet 52, throughpassageway 54 and finally through longitudinally extendingpassageway 56 which is formed inullage substrate 42. - An
upstanding tongue 58 formed onullage substrate 42 extends completely about the perimeter ofmember 42 and is closely receivable within agroove 64 formed incapture housing 44. When the ullage substrate and the membrane capture housing are assembled in the manner shown in FIG. 4, the periphery ofdistendable membrane 40 will be securely clamped withingroove 64 bytongue 58. After the parts are thus assembled, capturehousing 44 is bonded tomember 42 by any suitable means such as adhesive or sonic bonding. This done, cover 41 is mated withcapture housing 44 and bonded in place. This assembly and bonding step is discussed more fully in incorporated by reference U.S. application Ser. No. 08/768,663. - Reference should be made to U.S. Pat. No. 5,205,820 for the various materials that can be used to construct
base assembly 38,membrane 40,cover 41, and themembrane capture housing 44 as identified in the preceding paragraph. - Turning now to a consideration of the important flow rate control means of the invention, for controlling the rate of fluid flow of fluid from the device, this means here comprises an adjustable rate control mechanism which is carried by a support means shown here as comprising a deck-
like support 68 which includes first and second faces 68 a and 68 b.Support 68 is connected tobase assembly 38 and cover 41 in the manner best seen in FIGS. 2B and 4. For this purpose wing-like protuberances 70 (FIG. 6) are formed onsupport 68, which protuberances are received within spaced-apart, arcuate-shapedcavities 72 formed in base assembly 38 (FIG. 2B). Located proximate the upper edge ofsupport 68 are arcuately, spaced, apart connector members 74 (FIG. 6) which mate with arcuately spacedconnectors 76 provided on cover 41 (FIG. 2B) to enable secure interconnection ofsupport 68 with the base assembly to form the hollow housing of the device generally designated by the numeral 77 (FIG. 2B). - As shown in FIG. 4,
support 68 of the support means includes an outwardly extending, generally frustoconically shapedfluid inlet protuberance 80 which is closely receivable within a socket likecavity 81 formed inbase member 42. Whensupport 68 is mated withbase assembly 38, afluid inlet passageway 82 formed inprotuberance 80 and is placed in fluid communication withreservoir 50 viapassageways reservoir outlet 52 by the stored energy means, the fluid will flow intopassageway 54, intopassageway 56 and then intopassageway 82 formed inprotuberance 80. Next, the fluid will flow in the direction of arrow 83 (FIG. 17B) into apassageway 84 formed inface 68 b of support 68 (FIGS. 16B and 17D) and finally into achamber 86 formed in a distendable, elastomericfirst boot 88 of the flow indicator means of the invention (FIG. 17A).Boot 88 is of similar construction to boot 266 shown in FIG. 13A of incorporated by reference U.S. Ser. No. 08/768,663 and reference should be made to this application for a more complete discussion of the construction and operation of the flow indicator boots. As best seen in FIGS. 17A and 17B,boot 88 includes a yieldably distendable fluid flow blockingbody portion 88 a which is circumscribed by amarginal portion 88 b.Marginal portion 88 b is clamped between amanifold plate 90 and a uniquely configured boot-supportingindicator base 92 so that the boot extends through anopening 92 a formed in theindicator base 92. It is to be understood that, when the fluid flowing fromreservoir 50 in the direction ofarrow 83fills passageways boot 88, flow will be diverted in the direction ofarrows 93 of FIGS. 17C and 17A rearwardly towardplate 90 and into apassageway 96 which is formed inplate 90. Whenplate 90 is abutted againstsupport 68,passageway 96 will cooperate with apassageway 97 formed in support 68 (FIG. 17D) to form a closed fluid flow chamber likepassageway 98 which is in communication with acontrol passageway 99 which extends through support 68 (FIGS. 16B and 17B) so that fluid will flow fromchamber 98 toward a novel rate control flow passageway formed in acontrol member 100.Control member 100 and the flow restrictors carried thereby form an important aspect of the previously mentioned fluid rate control means of the invention for controlling the rate of fluid outwardly from the device. - Considering further the
novel control member 100, this member is here provided in the form of a generally disk shapedcomponent having teeth 100 a formed about its periphery (FIGS. 6 and 15A). As best seen in FIGS. 15A and 15B,control member 100 also has acentral bore 101 which receives aspindle 104 so that the member can be controllably rotated relative to face 68 a of support 68 (FIG. 6). Circumferentially spaced aboutcentral bore 101 is a plurality ofapertures 106, each of which is adapted to carry one of the previously mentioned flow restrictors, which here take the form of a porous rate control frit 107 (FIG. 11A).Member 100 is controllably rotated aboutspindle 104 by a driving member shown here as atoothed wheel 110. Connected towheel 110 is a coaxially aligned,toothed wheel 112 which is driven by a finger engagingcontrol knob 114 which, as shown in FIGS. 1, 10, and 11 includes aperipheral portion 114 a, a portion of which extends through anopening 114 c formed in the forward portion of the device (FIG. 2A).Knob 114 includes a lowertoothed portion 114 b which meshes withtoothed wheel 112 so that rotation ofknob 114 about spindle 115 (FIG. 15B) will impart rotation towheels spindle 117 and will also impart rotation to controlmember 100. With this construction, by rotatingknob 114 a selected one of the plurality of rate control frits 107 can be moved into alignment withcentral passageway 99 ofsupport 68 so that fluid fromreservoir 50 will flow therethrough. A pair of elastomeric O-rings 107 a sealably engagefrits 107 to prevent leakage about the periphery of the frit. - Considering once again the flow indicator means of the invention, it is to be observed that the fluid which is diverted back from
boot 88 towardsupport 68 will flow in the direction of thearrow 93 of FIGS. 17C and 17D, throughpassageway 99 insupport 68 and then through a selectedrate control frit 107. After flowing through the selectedrate control frit 107, the fluid will flow through apassageway 116 provided in acover 120 which overlayscontrol member 68. Next, the fluid will flow in the direction of the arrow 125 (FIGS. 17B, 17D, and 18), intopassageway 122 formed in asecond cover 124 which is connected to cover 120. Next the fluid will flow forwardly in the direction ofarrow 125 through apassageway 129 formed insupport 68 and through apassageway 127 formed in plate 90 (FIG. 17A). Next the fluid will impinge on a second elastomeric, distendable boot 130 (FIG. 17A) which also forms a part of the indicator means of the invention. The periphery 130 a ofindicator boot 130, which is of identical construction to boot 88, (see also FIG. 13A of U.S. Ser. No. 08/768,663) is clamped within anopening 92 b formed inindicator base 92. After impinging onboot 130, the fluid will next flow back towardsupport 68 in the direction of arrow 133 (FIGS. 17A, 17B, and 17D), throughorifice 131 formed inplate 90 and then, via anorifice 134 formed insupport 68, into apassageway 140 which is formed bysupport 68 andplate 120. Upon enteringpassageway 140, the fluid will flow downwardly of the passageway and then into atubular extension 144 formed onsupport 68 and finally in the direction ofarrow 145 into adelivery line 146 via outlet port 76 (FIG. 17A). - It is to be observed that fluid flowing from
reservoir 50 intopassageways passageway 82 and then on towardboot 88 is under a higher pressure than fluid flowing towardboot 130. This is because the pressure of the fluid flowing towardboot 130 has been reduced as a result of the fluid flowing throughrate control frit 107. As will be discussed more fully in the paragraphs which follow, this result enables a determination of the various fluid flow operating conditions of the device namely normal fluid flow, fluid flow blockage or occlusion, and reservoir empty. - Turning particularly to FIGS. 17A, 17B,17C and 17D, in addition to
platform 92 andboots boot clamping plate 90, a support orlens plate 150, and a hollowforward housing 152 within which the platform and the support plate are enclosed (FIG. 4). As seen in FIG. 4, aviewing lens 154 is viewable through anaperture 152 a provided inforward housing 152. Disposed betweenplatform 92 andlens plate 150 are first and second indicia-carrying means 155 shown here as a pair of closely adjacent, thin films. These films are virtually identical in construction and operation tofilms first film 306 is printed with three integrated symbols (see FIG. 12 of U.S. Ser. No. 08/768,663), which may comprise, by way of example, a blue circle, a green arrow, and a red X, each consisting of diagonal strips of color printed in an alternating pattern (blue, green, red, blue, green, red, and so on (see also FIGS. 1, 4B and 4C). Thesecond film 308 serves as a “mask” overfilm 306 and is printed with a pattern of diagonal alternating clear and opaque strips that occur in approximately a 1:2 ratio. The printed ratio of the “mask” allows only one colored symbol to appear at a time when viewed throughviewing lens 154. As in the embodiments described in U.S. Ser. No. 08/768,663, the inferior and superior films are provided at their opposite ends withapertures 160 which receiveretention pins 162 provided on platform 92 (FIG. 17C) which permit attachment of the films toplatform 92 in a manner such that the non-patterned portions of each film coversboot openings platform 92 with the patterned portions of both the superior and inferior films being maintained in index. With this construction, each thin film is able to move in response to pressure exerted thereon by theelastomeric boots - As is apparent from a study of FIGS. 13 and 13A of incorporated by reference U.S. Ser. No. 08/768,663, the central portions of both the first and second elastomeric actuator elements or
boots plate 92 when the device is filled and primed, but not in a state of delivery or when there is a build up of fluid pressure during delivery that is caused by blockage of the delivery line downstream fromboot 130. Whileboot 88 can be deflected by normal line pressure,boot 130 is deflected only by pressure buildup resulting from the downstream blockage. When bothelastomeric boots - A third alignment of symbol patterns is visible when the device is in an unfilled state or when the delivery line is open, the reservoir is empty and fluid delivery to the patient has been completed. In this case, there is no fluid pressure in the line on either the upstream or the downstream side of the flow control means and thus both the first and second boots are in a non-deflected position. In this condition, the inferior and superior films are not transversely displaced and thus exhibit a third combination of patterns resulting in a third symbol as, for example, a circle being visible through the viewing aperture of the support plate.
Boots - Operation
- Considering now the method of using the apparatus of the invention for delivering medicinal fluid to a patient. Presuming that
reservoir 50 was not filled at the factory, the first step in using the apparatus of the invention is to fill the reservoir using the fill means of the invention. As previously mentioned, the fill means here includes afill subassembly 49 and also includes afill line assembly 170 which comprises anelongated fill line 172 having at one end aluer connector 174 of the character adapted to be readily interconnected with aluer connector 176 which extends from a bottom ofullage substrate 42 and comprises a part of the fill assembly 49 (FIG. 4). Also forming a part offill assembly 49 is valve means for controlling fluid flow fromfill line 172 towardreservoir 50. In the present form of the invention, this valve means comprises a conventional type ofumbrella valve 180 having a resilientlydeformable skirt portion 182. Whenfill line 172 is appropriately interconnected with a source of the fluid to be infused into the patient, fluid will flow throughline 172 intoluer connector 176 and then into aninternal chamber 184 within whichumbrella valve 180 is disposed. Fluid flowing intochamber 184 under pressure will resiliently deformskirt portion 182 permitting fluid to flow intoreservoir 50 viareservoir inlet port 186. As the fluid flows under pressure intoreservoir 50, yieldablydeformable membrane 40 will be deformed outwardly into the configuration shown in FIG. 4. - After
reservoir 50 is appropriately filled, the next step in using the apparatus of the invention is for the physician or caregiver to set the adjustable fluid rate control mechanism of the invention to establish the desired rate of fluid flow from the apparatus toward the patient. However, before the adjustable flow rate control mechanisms can be operated, the physician must use the physicians key to unlock the novel rate control locking means of the invention. This locking means, which is generally designated in FIG. 1 by the numeral 190, comprises a generally cylindrically shapedhollow housing 192 which is closely received within anopening 193 formed inforward housing 152 and is also received within anopening 194 formed in support 68 (see FIGS. 2A and 15B). Also forming a part of the rate control locking means of the invention is alatch member 196 having afirst end 196 a and a second and 196 b (FIG. 15A). As best seen by referring to FIG. 12A,latch member 196 is pivotally connected to support 68 byopposed hubs 197 for movement between first and second positions.Hubs 197 are pivotally mounted incradles 197 a formed on support 68 (FIG. 15B). Whenlatch member 196 is in its flow rate selection position as shown in FIG. 6, end 196 a is spaced apart fromdriver wheel 112 so as to permit free rotation thereof. However, whenlatch member 196 is in its locking, or first position,first end 196 a operably engagesdrive wheel 112 so as to prevent its rotation and also the rotation ofcontrol member 100. More particularly, as shown in FIGS. 13 and 14, whenlatch member 196 is moved into a first locking position, an outwardly extendingtongue 196 c provided on the locking member is received within a pair of oppositely disposed, circumferentially spaced slots 112 a formed in driven wheel 112 (FIG. 15A). - In order to move
latch member 196 between its first and second positions, a latch operating assembly 195 which includes alatch operating member 198 is provided.Latch operating assembly 193 is telescopically received withinhollow housing 192 and is movable against the urging of an operating member biasing means between a first extended position and a second depressed position. As best seen in FIG. 12A,latch operating member 198 includes a generally spherically shapedinboard extremity 198 a which is in snug engagement with a cavity formed insecond end 196 b oflatch 196. To move operatingmember 198 into its second, depressed position, an outwardly extendingpush button 200 is telescopically movable withinhollow housing 192. The previously mentioned operating member biasing means is here provided in the form of aspring 199 which is carried by the shank portion ofmember 198 and functions to normally urge the latch member into the disengaged or rate selection position shown and FIG. 12A and, at the same time, to urge thepush button 200 outwardly in the direction ofarrow 201 into the extended position as shown in FIG. 12A. - Also forming a part of the rate control locking means of the invention is a key operated
assembly 204 which is received within anopening 192 a of hollow housing 192 (FIG. 15B).Assembly 204 is rotatable between a first locked position, shown in FIG. 5A, and a second unlocked position, shown in FIG. 5B (see also FIGS. 12A and 13). Referring particularly to FIGS. 15B and 16B it is to be noted apusher member 205 which is disposed betweenpush button 200 andmember 198 is provided with alongitudinally extending slot 205 a which terminates proximate one end in a transversely extendingsegment 205 b. As best seen in FIG. 16B, key operatedassembly 204 comprises a key operatedmember 206 which includes an aperturedkey receiving head 206 a and a stem portion 206 b which is closely receivable withinslot 205 a. Stem portion 206 b terminates in afoot portion 207 which is receivable insegment 205 b when the device is in the locked position shown in FIG. 14. - With the locking means of the invention in the locked configuration shown in FIG. 13, the physician or caregiver can insert the
tines 210 a formed on the physician's key 210 (see FIG. 1) into theopenings 209 provided inhead portion 206 a of the key operatedmember 206. As illustrated in FIG. 1,tines 210 a are provided at the extremity of a stem-like portion 210 b of the physician's key so that upon rotation of the physician's key, operatedmember 206 can be rotated from the locked position shown in FIG. 14 to the unlocked position shown in FIG. 12a where the latch biasing means move it in the direction of thearrow 211 of FIG. 12A. This, in turn, will movepush button 200 outwardly in the direction of thearrow 201. With thelatch member 196 in the unlocked position shown in FIG. 12A, rotation ofknob 114 will impart rotation to controlmember 100 viadrive wheel 110. As thecontrol member 100 is rotated, the various rate control frits 107 will sequentially move into index withfluid passageway 99. In this way, the particular control frit which will provide the desired rate of fluid flow outwardly of the device can be selected. Once the selection has been madebutton 200 can once again be depressed which will causelatch operating member 198 to pivotlatch member 196 into the locked position shown in FIG. 13. Withlatch member 196 in this locked position, rotation ofwheel 112 as well asdrive wheel 110 is blocked thereby preventing further adjustment of the flow rate control. By turning the physician's key to the locked position shown in FIG. 5A the flow rate control mechanism will remain in its locking position until the physician's key is once again used to place the rate control mechanism in the rate selection configuration shown in FIG. 12A (see also FIGS. 5A and 5B). - Once the adjustable flow rate control mechanism has been set in the manner described in the preceding paragraphs, the
delivery line 146 of the delivery means of the invention is interconnected with theoutlet 144 of the device. In addition to thedelivery line 146, the delivery means of the invention also includes aline clamp 214 which is of conventional construction and a gas vent andfilter unit 216 which is also of a conventional construction well known to those skilled in the art. - Referring to FIG. 2B, it is to be noted that attachment means, generally designated by the numeral218, are affixed to the lower surface of the
base unit 38. This attachment means here comprises a generally rectangularly shapedfoam pad 220 which includes lower adhesive coveredsurface 220 a that enables the device to be removably affixed to a portion of the patient's body such as the patient's abdomen or the like. Alternatively, the device can be affixed to the patient's clothing or can be connected to a belt or the like. - Once the device is suitably affixed to the patient, the
infusion cannula 221 of thecannula assembly 220 of the invention (FIG. 3) can be invasively interconnected with the patient. As best seen in FIG. 3, thecannula assembly 221 of the present form of the invention is of a conventional construction and is attached proximate the outboard end ofdelivery line 146. In addition to the infusion cannula, the assembly includes abutterfly assembly 222 which provides a convenient means for taping the assembly securely in position. With the cannula invasively interconnected with the patient,line clamp 214 can be open to permit fluid flow outwardly of the device throughdelivery line 146 and toward the patient. Fluid will flow toward the patient at the rate of flow selected by the physician at the time of setting the fluid flow rate control means of the invention. In the manner previously described, the fluid status of the device can be continuously monitored by observing the various flow symbols of the indicator means that appear throughviewing window 154 of the apparatus. - Referring next to FIGS. 20 through 25, an alternate form of the invention is there illustrated and generally designated by the numeral250. The apparatus of this latest form of the invention is quite similar to that shown in FIGS. 1 through 19 and also comprises four major cooperating subassemblies namely, a reservoir subassembly, an adjustable flow rate control subassembly, a flow indicator subassembly and fill means for filing the fluid reservoir of the reservoir subassembly. The reservoir subassembly, the flow indicator subassembly and the fill means are substantially identical in construction and operation to those earlier described and, accordingly, like numbers are used in FIGS. 20 through 25 to identify like components.
- Considering first the reservoir subassembly shown in FIG. 4, this subassembly includes a base assembly which is identical to
base assembly 38 and operates in precisely the same way. Therefore, this assembly is not shown in FIGS. 20 through 25. - With respect to the flow rate control means of this latest form of the invention, this means also here comprises an adjustable rate control mechanism which is carried by a support means252 which is similar to support 68 but, in this instance, carries the flow rate control mechanism at a location proximate the upper portion of the support. As shown in FIG. 22B,
support 252 also includes wing-like protuberances 70 which are received within spaced-apart, arcuate-shaped cavities formed inbase assembly 38. Located proximate the upper edge ofsupport 252 are arcuately, spaced-apart connector members 74 (FIG. 22B) which mate with arcuately spacedconnectors 76 provided on cover 254 (FIG. 21 B) to enable secure interconnection ofsupport 252 with the base assembly to form the hollow housing of the device. - Turning to FIG. 22B it can be seen that
support 252 of the support means also includes an outwardly extending, generally frustoconically shapedfluid inlet protuberance 80 which is closely receivable within a socket likecavity 81 formed inbase member 42. Whensupport 252 is mated withbase assembly 38 andcover 254, afluid inlet passageway 82 formed inprotuberance 80 and is placed in fluid communication withreservoir 50 of the base assembly. As before, when fluid is forced throughreservoir outlet 52 by the stored energy means, the fluid will flow throughprotuberance 80 in the direction of arrow 255 (FIG. 22B). The fluid will then flow into apassageway 258 formed in manifold plate 260 (FIGS. 22A and 22B) and finally in the direction ofarrow 261 into a chamber formed in a distendable, elastomeric first boot of the flow indicator means of the invention which is identical in construction and operation to boot 88 of the earlier described embodiment. As before, when the fluid flowing fromreservoir 50 impinges uponboot 88, flow will be diverted back in the direction ofarrows 263 of FIG. 22A towardplate 260 and into apassageway 264 formed therein. Whenplate 260 is abutted againstsupport 252,passageway 264 will cooperate with an aligned passageway formed insupport 252 to form a closed flow passageway which is in communication with acontrol passageway 266 which extends through support 252 (FIGS. 22A and 22B) so that fluid will flow toward a flow rate control means mounted insupport 252. This control means, which is of a different construction from the previously described control means, functions to control the rate of fluid flowing outwardly from the device. - The adjustable flow rate control means of this latest embodiment of the invention, comprises a
control assembly 270 which is mounted within a vertically extendingchamber 252 a formed proximate thetop support 252. As illustrated in FIGS. 20, 21C, 22B and 23,control assembly 270 includes knob-like selector member 272 which includes ahead portion 272 a and ashank portion 272 b.Head portion 272 a extends upwardly from theforward housing 273 of this latest form of the invention.Shank portion 272 b ofcontrol selector 272 is receivable within thehollow stem portion 274 a of aflow control assemblage 274 which is rotatably mounted withinchamber 253.Control assemblage 274 also includes a cup likehead portion 274 b within which a portion ofhead portion 272 a ofselector member 272 is closely received. Aflange 274 c, which is disposed betweenstem portion 274 a and cup likeportion 274 b, is closely receivable within notch-like openings support 252 and in manifold 260 (FIGS. 22A and 22B). - Circumferentially spaced about the lower extremity of
stem portion 274 a are the flow restrictor means of this latest embodiment. The flow restrictor means can take several forms such as orifices of various sizes or, as here shown, can comprise a plurality of porous rate control frits 277 of various porosity.Shank portion 272 b ofselector member 272 is provided with drivingsplines 272 c which drivably engagecontrol assemblage 274 to cause it to rotate withinchamber 252 a upon rotation of the knob-like head portion 272 a which extends upwardly from the forward device housing in the manner shown in FIG. 20. Asstem 274 a rotates, frits 277 can be sequentially moved into index withcontrol passageway 266. To prevent leakage betweenstem 274 a and the wall ofchamber 252 a, a plurality of O-rings 278 are carried bystem 274 a in a manner to sealably engagemating grooves 253 in the wall ofchamber 252 a. With this construction, by rotatingknob 272 a, a selected one of the plurality of rate control frits 277 can be moved into alignment withcentral passageway 266 ofsupport 252 so that fluid fromreservoir 50 will flow therethrough at a selected rate.Rate indicating indicia 274 d are provided onflange 274 c and are viewable through aviewing window 279 formed in the forward housing 273 (FIGS. 20 and 25). - Considering once again the flow indicator means of the invention, it is to be observed that fluid which is diverted back from
boot 88 towardsupport 252, will flow in the direction of thearrow 263 of FIG. 22A throughcentral passageway 266 and then through a selectedrate control frit 277. After flowing through the selectedrate control frit 277, the fluid will flow upwardly ofhollow stem 274 a and outwardly thereof through apassageway 280 provided therein (FIG. 22B). Next, the fluid will flow in the direction of thearrow 281, intopassageway 282 formed insupport 252. The fluid will then flow forwardly in the direction ofarrow 283 through anorifice 286 formed inplate 260 where it will impinge in a second elastomeric, distendable boot which is also identical to boot 130 of the earlier described embodiment. After impinging on the boot, the fluid will next flow back towardsupport 252 in the direction of arrow 289 (FIGS. 22A and 22B) through orifice 290 formed inplate 260 and then, via an orifice formed insupport 252, into apassageway 292 formed by cover 292 a andsupport 252. Upon enteringpassageway 292, the fluid will flow downwardly of the passageway and then into atubular extension 144 formed onsupport 252 and finally into thedelivery line 146 of the apparatus via the outlet port. - As previously discussed, fluid flowing from
reservoir 50 towardboot 88 is under a higher pressure than fluid flowing towardboot 130. This is because the pressure of the fluid flowing towardboot 130 has been reduced as a result of the fluid flowing throughrate control frit 277. As before, this result enables determination by the substantially identical indicator assembly of the various fluid flow operating conditions of the device of this latest form of the invention, namely normal fluid flow, fluid flow blockage or occlusion, and reservoir empty. - Turning to FIGS. 26 through 37, still another form of the apparatus of the present form of the invention is there illustrated and generally designated by the numeral300. The apparatus of this latest embodiment is similar to that shown in FIGS. 1 through 19 and also comprises four major cooperating subassemblies namely, a reservoir subassembly, an adjustable flow rate control subassembly, a flow indicator subassembly and fill means for filling the fluid reservoir of the reservoir subassembly. Because of the similarities between this latest form of the invention and those earlier described, like numerals are used in FIGS. 26 through 37 to identify like components.
- Considering first the reservoir subassembly shown in FIG. 27, this subassembly is virtually identical in construction and operation to that shown in FIG. 4 and includes a
base assembly 38, a stored energy source, shown here as adistendable membrane 40, and acover 41 for enclosing the stored energy source. The base assembly includes anullage substrate 42 and amembrane capture housing 44 having abottom opening 46 which receives the distendable membrane engaging element orprotuberance 48 ofullage substrate 42. As shown in FIG. 27 the ullage substrate, or base, 42 also includes afill assembly 49, which is substantially identical in construction and operation to that previously described herein and illustrated in FIG. 3. The assembly of the ullage substrate, capture housing and cover is the same as previously described in connection with FIGS. 1 through 8. - The major difference between this latest embodiment of the invention and that shown in FIGS. 1 through 8 is the differently configured flow rate control means of the invention, for controlling the rate of fluid flow of fluid from the device. This means here comprises a pair of cooperating, adjustable rate control mechanisms which are carried by a support means shown here as comprising a deck-
like support 302 which includes first andsecond faces Support 302 is connected tobase assembly 38 and cover 41 in the manner best seen in FIG. 27. Located proximate the upper edge ofsupport 302 are arcuately, spaced, apart connector members 303 (FIG. 36B) which mate with arcuately spaced connectors provided oncover 41 to enable secure interconnection ofsupport 302 with the base assembly to form the hollow housing of the device. - As shown in FIG. 27,
support 302 of the support means includes an outwardly extending, generally frustoconically shapedfluid inlet protuberance 304 which is closely receivable within a socket likecavity 81 formed inbase member 42. Whensupport 302 is mated withbase assembly 38, afluid inlet passageway 306 formed inprotuberance 304 and is placed in fluid communication withreservoir 50 viapassageways reservoir outlet 52 by the stored energy means, the fluid will flow intopassageway 54, intopassageway 56 and then intopassageway 306 formed inprotuberance 304. Next, the fluid will flow into apassageway 308 formed inface 302 b of support 302 (FIG. 37) and finally into a chamber formed in a distendable, elastomeric first boot of the flow indicator means of the invention. The flow indicator means of this latest form of the invention is generally similar to that previously described and reference should be made to FIGS. 1 through 19 and the earlier discussion thereof for a more complete understanding of the construction and operation of the flow indicator means of this latest form of the invention. However, by way of summary, when the fluid flowing fromreservoir 50 fillspassageways arrows 310 of FIG. 37 rearwardly toward the novel flow rate control means, the character of which will presently be described. After flowing through the rate control means, the fluid will flow through apassageway 312 provided in afirst cover 314 which overlays a firstrate control housing 316. Next, the fluid will flow in the direction of the arrow 318 (FIG. 37), and intopassageway 320. The fluid will then flow forwardly in the direction ofarrow 324 through apassageway 326 formed insupport 302. Next the fluid will impinge on a second elastomeric, distendable boot which also forms a part of the indicator means of the invention. After impinging on the second boot, the fluid will flow back towardcover 316 in the direction ofarrows 330 throughpassageway 332 formed incover 316 and then in the direction ofarrow 332 into adelivery line 146 via the outlet port of the device (FIG. 27). - As before, the fluid flowing from
reservoir 50 intopassageway 56, intopassageway 306 and then on toward the first boot is under a higher pressure than fluid flowing toward the second boot. This is because the pressure of the fluid flowing toward the second boot has been reduced as a result of the fluid flowing through the novel rate control means of the invention. As previously described, this enables a determination of the various fluid flow operating conditions of the device namely normal fluid flow, fluid flow blockage or occlusion, and reservoir empty (see the discussion on pages 21 through 34). - Considering now the details of the novel flow rate control means of the invention, this means here comprises a pair of
rate control members spindle 340 so that the member can be controllably rotated relative to face 302 a of support 302 (FIG. 30). Circumferentially spaced about the central bore of each member is a plurality ofapertures 342, each of which is adapted to carry a flow restrictor of the general character previously described. Once again the flow restrictors take the form of a porous rate control frit 344 (FIG. 11A).Member 336 is controllably rotated aboutspindle 340 by a driving member shown here as atoothed wheel 346. Connected towheel 346 is a coaxially aligned,toothed wheel 348 which is driven by a finger engagingcontrol knob 350 which, as shown in FIGS. 26 and 28 includes aperipheral portion 350 a, a portion of which extends through anopening 352 formed in the forward portion of the device (FIG. 26).Knob 350 includes a lowertoothed portion 350 b which meshes withtoothed wheel 348 so that rotation ofknob 350 about spindle 354 (FIG. 37) will impart rotation towheels spindle 357 and will also impart rotation to controlmember 336. With this construction, by rotatingknob 350 a selected one of the plurality of rate control frits 344 carried thereby can be moved into alignment with afirst passageway 360 ofsupport 302 so that fluid fromreservoir 50 will flow therethrough. At the same time, fluid will flow fromreservoir 50 through asecond passageway 362 provided insupport 302.Second passageway 362 is aligned with an open, non-frit carryingaperture 363 provided inmember 336 so that a portion of the fluid will flow towardsecond control member 338 in the direction ofarrow 365. Two pairs of elastomeric O-rings member 336 to prevent leakage about the periphery of the openings aligned with the fluid flow paths. O-rings 367 a are carried by a generally “L” shaped member which is disposed betweenmembers - As indicated in the drawings,
member 338 is separately rotatable by a second driving mechanism which includes atoothed drive wheel 370.Drive wheel 370 is driven by a second finger engagingcontrol knob 372 which also includes aperipheral portion 372 a, a portion of which extends throughopening 352 formed in the forward portion of the device (FIG. 26).Second knob 372 includes atoothed portion 372 b which meshes withdrive wheel 370 so that rotation ofknob 372 aboutspindle 354 will impart rotation to a pair of coaxially alignedgear wheels second control member 338 which is operably associated withgear wheel 376. With this construction, by rotatingknob 372 a selected one of the plurality of rate control frits carried bycontrol member 338 can be moved into alignment with the fluid flow paths of fluid flowing fromreservoir 50 in the direction ofarrows rings 373 sealably engagemember 338 to prevent leakage about the periphery of theapertures 342 formed therein. - Referring particularly to FIGS. 37, 39 and40, with the construction there shown, it is apparent that through the use of the
dual control members finger engaging wheel 350 can be provided with indicia such as 8, 10, 12, 14, 16 and 18 milliliter per hour bands. Rotation ofknobs 350 will, therefore, accomplish the coarse rate control for fluid flowing along the flow control path indicated by thearrow 310 in FIG. 37. Similarly,rate control knob 372 can be provided with indicia in tenths of milliliter per hour such as 0.2, 0.4, 0.6, 0.8, and 1.0. These indicia indicate flow rate through the control members along the fluid flow path indicated by thearrow 365. As indicated in FIG. 37,aperture 342 designated by the letter “B” is provided with a porousflow control frit 344 which is represented in FIG. 39 by the resistance symbol R-1. This flow control frit would permit fluid flow toward the fluid delivery outlet of the device in coarse milliliter per hour increments such as 8, 10, 12, 14, 16, 18 and so forth. It is to be observed by referring to FIG. 37 that fluid flowing throughrate control frit 344 will continue in the direction of thearrow 310 through an open aperture incontrol member 338 which is designated in FIG. 37 by the letter “D”. Therefore, the coarsely controlled fluid will flow forwardly of the device intocover 314 in the manner shown in FIG. 37. On the other hand, fluid flowing intochamber 375, which is formed insupport 302, will also flow through an open aperture provided incontrol member 336 which aperture is designated by the letter “A” in FIG. 37. The fluid flowing freely through open aperture “A” will flow onwardly towardcontrol member 338 where it will flow through a porous rate control frit “C” which will limit fluid flow in one-tenth milliliter per hour increments as for example 0.2, 0.4, 0.6, 0.8 and so on. as indicated in FIG. 40. After the fluid flow through fine rate control frit “C”, the fluid will flow towardcover 314 where it will mix with the fluid flowing alongfluid flow path 310. The mixture of fluid then flowing toward the outlet of the device will be the sum of the fluids flowing alongfluid flow paths finger wheel 350 is rotated so that the numeral 14 appears in the window, rate control frit “B” will permit a fluid flow rate alongfluid path 310 at 14 milliliters per hour. Similarly, ifcontrol wheel 372 is rotated so that the indicia 06 aligns with the viewing window, fluid flowing alongflow path 365 will flow at a rate of 0.6 milliliters per hour in the direction towardcover 314. As is indicated by FIG. 40, the summation of these two fluid flows will move on to the delivery outlet port of the device at a rate of 14.6 milliliters per hour. With this novel arrangement, precise fluid flow rates to the tenth of a milliliter per hour flow rate can be achieved using the dual flow rate control mechanism of the invention shown in FIGS. 26 through 40. - In using the apparatus of the latest form of the invention, after
reservoir 50 is appropriately filled, the physician or caregiver will set the course and fine adjustable rate control mechanisms of the invention in the manner just described. However, as before, in order to operate the adjustable flow rate control mechanisms, the physician must use the physicians key to unlock the novel rate control locking means of the invention. This locking means, which is generally similar to that previously described, comprises a generally cylindrically shapedhollow housing 380 which is closely received within anopening 382 formed in a forward housing 384 (FIG. 26). Also forming a part of the rate control locking means of the invention is alatch member 386 having a first end 386 a and asecond end 386 b (FIG. 36A). As beforelatch member 386 is pivotally connected to support 302 for movement between first and second position. Whenlatch member 386 is in its flow rate selection position, end 386 a permits rotation ofdriver wheel 370 and also permits free rotation ofdriver wheels latch member 386 is in its locking, or first position, atab 387 provided on first end 386 a moves into a selectedslot 370 a provided inwheel 370 so as to prevent rotation of the wheel. Similarly, lockingtabs 389 provided onlatch 386 move into one of the circumferentially spacedslots 391 formed inwheels - In order to move
latch member 386 between its first and second positions, a latch operating assembly 400 which includes alatch operating member 402 is provided (FIG. 37).Latch operating assembly 400 is telescopically received withinhollow housing 380 and is movable against the urging of an operating member biasing means between a first extended position and a second depressed position.Latch operating member 402 includes aninboard extremity 402 a (FIG. 33) which is in snug engagement with a cavity formed insecond end 386 b oflatch 386. To move operatingmember 386 into its second, depressed position, an outwardly extendingpush button 404 is telescopically movable withinhollow housing 380. The previously mentioned operating member biasing means is here provided in the form of aspring 407 which is carried by the shank portion ofmember 402 and functions to normally urge the latch member into the disengaged or rate selection position (FIG. 33).Spring 407 functions to continuously urge thepush button 404 outward ofhousing 380 into an extended position to permit operation of the flow rate control means. - Also forming a part of the rate control locking means of this latest form of the invention is a key operated
assembly 204 which is of similar construction and operation to that described in the embodiment shown in FIGS. 1 through 19. In this regard, apusher member 408 which is disposed betweenpush button 404 andmember 402 is provided with alongitudinally extending slot 408 a which terminates proximate one end in a transversely extendingsegment 408 b. As before, key operatedassembly 204 comprises a key operatedmember 206 which is of identical construction and operation to that previously described. Using the physician's key,member 206 can be rotated from the locked position to the unlocked position where the latch biasing means will move thelatch member 386 into the unlocked position to permit rotation ofknobs members arrows - Having now described the invention in detail in accordance with the requirements of the patent statutes, those skilled in this art will have no difficulty in making changes and modifications in the individual parts or their relative assembly in order to meet specific requirements or conditions. Such changes and modifications may be made without departing from the scope and spirit of the invention, as set forth in the following claims.
Claims (6)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/767,665 US6394980B2 (en) | 1996-12-18 | 2001-01-22 | Fluid delivery apparatus with flow indicator and vial fill |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/768,663 US5840071A (en) | 1996-12-18 | 1996-12-18 | Fluid delivery apparatus with flow indicator and vial fill |
US09/165,706 US6176845B1 (en) | 1996-12-18 | 1998-10-02 | Fluid delivery apparatus with flow indicator and vial fill |
US09/767,665 US6394980B2 (en) | 1996-12-18 | 2001-01-22 | Fluid delivery apparatus with flow indicator and vial fill |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/165,706 Continuation US6176845B1 (en) | 1996-12-18 | 1998-10-02 | Fluid delivery apparatus with flow indicator and vial fill |
Publications (2)
Publication Number | Publication Date |
---|---|
US20010027294A1 true US20010027294A1 (en) | 2001-10-04 |
US6394980B2 US6394980B2 (en) | 2002-05-28 |
Family
ID=22600094
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/165,706 Expired - Fee Related US6176845B1 (en) | 1996-12-18 | 1998-10-02 | Fluid delivery apparatus with flow indicator and vial fill |
US09/767,665 Expired - Fee Related US6394980B2 (en) | 1996-12-18 | 2001-01-22 | Fluid delivery apparatus with flow indicator and vial fill |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/165,706 Expired - Fee Related US6176845B1 (en) | 1996-12-18 | 1998-10-02 | Fluid delivery apparatus with flow indicator and vial fill |
Country Status (4)
Country | Link |
---|---|
US (2) | US6176845B1 (en) |
EP (1) | EP1117459A4 (en) |
AU (1) | AU6278799A (en) |
WO (1) | WO2000020068A1 (en) |
Cited By (6)
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US20090159083A1 (en) * | 2007-12-21 | 2009-06-25 | Zettergren Linda J | Color-coding system for breathing bags |
US20110077614A1 (en) * | 2006-10-19 | 2011-03-31 | Ofer Shay | Device and method for patient activated bolus administration |
US20140228758A1 (en) * | 2011-06-24 | 2014-08-14 | Combativ Inc. | Elastomeric infusion pump |
US10765801B2 (en) | 2014-12-19 | 2020-09-08 | Amgen Inc. | Drug delivery device with proximity sensor |
US11213624B2 (en) | 2014-06-03 | 2022-01-04 | Amgen Inc. | Controllable drug delivery system and method of use |
US11357916B2 (en) | 2014-12-19 | 2022-06-14 | Amgen Inc. | Drug delivery device with live button or user interface field |
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US6176845B1 (en) * | 1996-12-18 | 2001-01-23 | Science Incorporated | Fluid delivery apparatus with flow indicator and vial fill |
US6679865B2 (en) * | 2001-12-07 | 2004-01-20 | Nedrip Ltd. | Fluid flow meter for gravity fed intravenous fluid delivery systems |
EP1386634B1 (en) | 2002-08-02 | 2005-10-19 | Medos SA | Cerebrospinal fluid shunt system incorporating an adjustable resistance valve |
JP3915742B2 (en) * | 2003-06-20 | 2007-05-16 | 株式会社デンソー | Vehicle object recognition device |
US7169128B2 (en) * | 2003-08-04 | 2007-01-30 | Bioquiddity, Inc. | Multichannel fluid delivery device |
US7220244B2 (en) * | 2003-08-04 | 2007-05-22 | Bioquiddity, Inc. | Infusion apparatus with constant force spring energy source |
US20050033232A1 (en) * | 2003-08-05 | 2005-02-10 | Kriesel Marshall S. | Infusion apparatus with modulated flow control |
US20050277884A1 (en) * | 2004-05-26 | 2005-12-15 | Kriesel Marshall S | Fluid delivery apparatus with bellows reservoir |
US20070156090A1 (en) * | 2004-05-26 | 2007-07-05 | Kriesel Marshall S | Fluid delivery apparatus |
US20050277883A1 (en) * | 2004-05-26 | 2005-12-15 | Kriesel Marshall S | Fluid delivery device |
US7220245B2 (en) * | 2004-05-26 | 2007-05-22 | Kriesel Marshall S | Infusion apparatus |
US7470253B2 (en) * | 2004-05-26 | 2008-12-30 | Bioquiddity, Inc. | Fluid delivery apparatus with adjustable flow rate control |
US8029468B2 (en) * | 2005-02-15 | 2011-10-04 | Bioquiddity, Inc. | Fluid delivery and mixing apparatus with flow rate control |
US7694938B2 (en) * | 2005-02-17 | 2010-04-13 | Bioquiddity, Inc. | Distal rate control device |
US20080009835A1 (en) * | 2005-02-17 | 2008-01-10 | Kriesel Marshall S | Fluid dispensing apparatus with flow rate control |
US7837653B2 (en) * | 2005-02-18 | 2010-11-23 | Bioquiddity, Inc. | Fluid delivery apparatus with vial fill |
PL1745812T3 (en) | 2005-07-22 | 2009-06-30 | Rowemed Ag Medical 4 Life | Valve for a fluid, in particular for being used in a mechanically actuated liquid pump |
US8113244B2 (en) * | 2006-02-09 | 2012-02-14 | Deka Products Limited Partnership | Adhesive and peripheral systems and methods for medical devices |
US7993304B2 (en) * | 2006-03-15 | 2011-08-09 | Bioquiddity, Inc. | Fluid dispensing apparatus |
US7828772B2 (en) | 2006-03-15 | 2010-11-09 | Bioquiddity, Inc. | Fluid dispensing device |
US7975721B2 (en) * | 2006-03-30 | 2011-07-12 | John Hiebert | Fluid valve systems |
US8292848B2 (en) * | 2006-07-31 | 2012-10-23 | Bio Quiddity, Inc. | Fluid dispensing device with additive |
US8057435B2 (en) | 2006-07-31 | 2011-11-15 | Kriesel Joshua W | Fluid dispenser |
US20080243077A1 (en) * | 2007-04-02 | 2008-10-02 | Bivin Donald B | Fluid dispenser with uniformly collapsible reservoir |
US8211059B2 (en) * | 2007-06-25 | 2012-07-03 | Kriesel Marshall S | Fluid dispenser with additive sub-system |
US20080319385A1 (en) * | 2007-06-25 | 2008-12-25 | Kriesel Marshall S | Fluid dispenser with additive sub-system |
US9987416B2 (en) * | 2015-01-09 | 2018-06-05 | BioQuiddity Inc. | Sterile assembled liquid medicament dosage control and delivery device |
USD770034S1 (en) * | 2015-01-09 | 2016-10-25 | BioQ Pharma, Inc. | Liquid medicament dosage control and delivery device |
US11338082B2 (en) | 2019-09-04 | 2022-05-24 | BloQ Pharma, Inc. | Variable rate dispenser with aseptic spike connector assembly |
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US3469578A (en) * | 1965-10-12 | 1969-09-30 | Howard R Bierman | Infusion device for ambulatory patients with flow control means |
US4058123A (en) * | 1975-10-01 | 1977-11-15 | International Paper Company | Combined irrigator and evacuator for closed wounds |
US5005604A (en) * | 1984-07-13 | 1991-04-09 | Aslanian Jerry L | Flow control device for administration of intravenous fluids |
US5009251A (en) * | 1988-11-15 | 1991-04-23 | Baxter International, Inc. | Fluid flow control |
JPH05506163A (en) * | 1990-03-08 | 1993-09-16 | マクノート・プロプライアタリー・リミテッド | Flow regulator for fluid injector |
US5267957A (en) * | 1990-04-24 | 1993-12-07 | Science Incorporated | Closed drug delivery system |
US5354278A (en) * | 1992-04-17 | 1994-10-11 | Science Incorporated | Fluid dispenser |
US6176845B1 (en) * | 1996-12-18 | 2001-01-23 | Science Incorporated | Fluid delivery apparatus with flow indicator and vial fill |
AU5803698A (en) * | 1996-12-18 | 1998-07-15 | Science Incorporated | Fluid delivery apparatus |
US5840071A (en) * | 1996-12-18 | 1998-11-24 | Science Incorporated | Fluid delivery apparatus with flow indicator and vial fill |
-
1998
- 1998-10-02 US US09/165,706 patent/US6176845B1/en not_active Expired - Fee Related
-
1999
- 1999-10-01 EP EP99950049A patent/EP1117459A4/en not_active Withdrawn
- 1999-10-01 WO PCT/US1999/022730 patent/WO2000020068A1/en not_active Application Discontinuation
- 1999-10-01 AU AU62787/99A patent/AU6278799A/en not_active Abandoned
-
2001
- 2001-01-22 US US09/767,665 patent/US6394980B2/en not_active Expired - Fee Related
Cited By (10)
Publication number | Priority date | Publication date | Assignee | Title |
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US20110077614A1 (en) * | 2006-10-19 | 2011-03-31 | Ofer Shay | Device and method for patient activated bolus administration |
US20090159083A1 (en) * | 2007-12-21 | 2009-06-25 | Zettergren Linda J | Color-coding system for breathing bags |
US20140228758A1 (en) * | 2011-06-24 | 2014-08-14 | Combativ Inc. | Elastomeric infusion pump |
US9511188B2 (en) * | 2011-06-24 | 2016-12-06 | Combat Iv, Inc. | Elastomeric infusion pump |
US11213624B2 (en) | 2014-06-03 | 2022-01-04 | Amgen Inc. | Controllable drug delivery system and method of use |
US11738146B2 (en) | 2014-06-03 | 2023-08-29 | Amgen Inc. | Drug delivery system and method of use |
US10765801B2 (en) | 2014-12-19 | 2020-09-08 | Amgen Inc. | Drug delivery device with proximity sensor |
US10799630B2 (en) | 2014-12-19 | 2020-10-13 | Amgen Inc. | Drug delivery device with proximity sensor |
US11357916B2 (en) | 2014-12-19 | 2022-06-14 | Amgen Inc. | Drug delivery device with live button or user interface field |
US11944794B2 (en) | 2014-12-19 | 2024-04-02 | Amgen Inc. | Drug delivery device with proximity sensor |
Also Published As
Publication number | Publication date |
---|---|
AU6278799A (en) | 2000-04-26 |
US6176845B1 (en) | 2001-01-23 |
US6394980B2 (en) | 2002-05-28 |
EP1117459A1 (en) | 2001-07-25 |
EP1117459A4 (en) | 2002-10-23 |
WO2000020068A1 (en) | 2000-04-13 |
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