WO1995009017A1 - Fluid delivery apparatus - Google Patents
Fluid delivery apparatus Download PDFInfo
- Publication number
- WO1995009017A1 WO1995009017A1 PCT/US1994/010764 US9410764W WO9509017A1 WO 1995009017 A1 WO1995009017 A1 WO 1995009017A1 US 9410764 W US9410764 W US 9410764W WO 9509017 A1 WO9509017 A1 WO 9509017A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- container
- fluid
- casing
- pierceable
- assembly
- Prior art date
Links
- 239000012530 fluid Substances 0.000 title claims abstract description 87
- 239000007788 liquid Substances 0.000 claims description 5
- 239000011521 glass Substances 0.000 claims description 2
- 239000007789 gas Substances 0.000 claims 1
- 238000013022 venting Methods 0.000 claims 1
- 239000012528 membrane Substances 0.000 abstract description 4
- 230000008878 coupling Effects 0.000 abstract description 3
- 238000010168 coupling process Methods 0.000 abstract description 3
- 238000005859 coupling reaction Methods 0.000 abstract description 3
- 230000001413 cellular effect Effects 0.000 abstract description 2
- 239000003795 chemical substances by application Substances 0.000 description 5
- 239000003814 drug Substances 0.000 description 5
- 238000001802 infusion Methods 0.000 description 5
- 230000000712 assembly Effects 0.000 description 3
- 238000000429 assembly Methods 0.000 description 3
- 239000011324 bead Substances 0.000 description 3
- 238000010276 construction Methods 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 230000004888 barrier function Effects 0.000 description 2
- 239000003085 diluting agent Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000006260 foam Substances 0.000 description 2
- 238000001990 intravenous administration Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 239000002831 pharmacologic agent Substances 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- SUBDBMMJDZJVOS-UHFFFAOYSA-N 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole Chemical compound N=1C2=CC(OC)=CC=C2NC=1S(=O)CC1=NC=C(C)C(OC)=C1C SUBDBMMJDZJVOS-UHFFFAOYSA-N 0.000 description 1
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 241000950638 Symphysodon discus Species 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- 229940035676 analgesics Drugs 0.000 description 1
- 239000000730 antalgic agent Substances 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000023555 blood coagulation Effects 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 230000003197 catalytic effect Effects 0.000 description 1
- 150000001768 cations Chemical class 0.000 description 1
- 238000002512 chemotherapy Methods 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 230000001276 controlling effect Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 210000002249 digestive system Anatomy 0.000 description 1
- 229920001971 elastomer Polymers 0.000 description 1
- 239000000806 elastomer Substances 0.000 description 1
- 239000006263 elastomeric foam Substances 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 230000005484 gravity Effects 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 239000005556 hormone Substances 0.000 description 1
- 229940088597 hormone Drugs 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- HOQADATXFBOEGG-UHFFFAOYSA-N isofenphos Chemical compound CCOP(=S)(NC(C)C)OC1=CC=CC=C1C(=O)OC(C)C HOQADATXFBOEGG-UHFFFAOYSA-N 0.000 description 1
- 239000004973 liquid crystal related substance Substances 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 230000007257 malfunction Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000013011 mating Effects 0.000 description 1
- 238000002483 medication Methods 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 230000000737 periodic effect Effects 0.000 description 1
- 235000020030 perry Nutrition 0.000 description 1
- 230000003389 potentiating effect Effects 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 238000005057 refrigeration Methods 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 230000002441 reversible effect Effects 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 150000003431 steroids Chemical class 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
Classifications
-
- 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
- A61M5/1407—Infusion of two or more substances
- A61M5/1409—Infusion of two or more substances in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems
-
- 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
- A61M5/1413—Modular systems comprising interconnecting elements
-
- 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
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/201—Piercing means having one piercing end
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2068—Venting means
- A61J1/2075—Venting means for external venting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2079—Filtering means
- A61J1/2082—Filtering means for gas filtration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
-
- 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
- A61M2205/19—Constructional features of carpules, syringes or blisters
- A61M2205/192—Avoiding coring, e.g. preventing formation of particles during puncture
- A61M2205/197—Avoiding coring, e.g. preventing formation of particles during puncture by the seal material
-
- 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
- A61M2209/00—Ancillary equipment
- A61M2209/04—Tools for specific apparatus
- A61M2209/045—Tools for specific apparatus for filling, e.g. for filling 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
- A61M5/1407—Infusion of two or more substances
-
- 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
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S128/00—Surgery
- Y10S128/12—Pressure infusion
Definitions
- the present invention relates generally to fluid delivery devices. More particularly, the invention concerns an improved apparatus for infusing medicinal agents into an ambu ⁇ latory patient at specific rates over extended periods of time and to a novel fluid containing vial assembly which can be field filled and then used to charge the fluid reservoirs of the fluid delivery apparatus.
- the prior art bladder type infusion devices are not without drawbacks. Generally, because of the very nature of bladder or "balloon" configuration, the devices are unwieldy and are difficult and expensive to manufacture and use. Fur ⁇ ther, 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, expand ⁇ able foams and similar materials, which, in cooperation with a base defines a fluid chamber that contains the fluid which is to be dispensed.
- the elastomeric film membrane or the expand ⁇ able foam member controllably forces fluid within the chamber into fluid flow channels provided in the base.
- the apparatus of the 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 continu ⁇ ous 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 quanti ⁇ ties and at extended microfusion rates over time.
- One of the devices described in Continuation-In-Part application, Serial No. 08/069,937 and illustrated in Figures 34 and 35 thereof includes first, second, and third cooperating fluid chambers which can be selectively filled by individual fluid containers or vials containing various fluids such as diluents and medicaments.
- the novel apparatus shown in Figures 34 and 35 permits two or more liquid components to be stored within the reservoirs of the apparatus and then controllably intermixed at the time of fluid delivery.
- an application filed concurrently with the present application there is de ⁇ scribed a number of inventions which expand on inventions de ⁇ scribed in the 08/069,937 application by providing a novel platform support system to which several fluid dispensers of varying volume can be operably interconnected.
- the present application expands further on the con ⁇ cepts disclosed in the applications identified in the preceding paragraph by providing a novel fluid container or vial that is usable with the apparatus of these inventions and is of a unique design which permits it to be expeditiously filled in the field.
- the novel aseptically field finable vial assembly of the present invention is spe ⁇ cially designed for use with these types of devices so that they can be expeditiously filled in the field shortly before use with a wide variety of medicinal fluids.
- the novel vial con ⁇ struction of the present invention permits field filling of either individual fluid dispensers of the character described in the preceding paragraphs, or alternatively, permits the field filling of multireservoir devices which allow for the controlled delivery therefrom of large volumes of the same or different fluids at controlled rates in accordance with a predetermined delivery protocol.
- the fluid chamber thereof can also be quickly and easily filled in the field using a conventional hypodermic syr ⁇ inge.
- the vial assembly can be coupled with the delivery system in a manner to insure the asceptic transfer of the fluid to be delivered.
- Another object of the invention is to provide field finable vial assemblies of the class described which can be filled and then stored under refrigeration for an extended period.
- a novel temperature indicator is provided as an integral part of the assembly.
- Figure 1 is a generally perspective, exploded view of one form of the field filled vial assembly of the present inven ⁇ tion showing it being filled by means of a conventional hypo ⁇ dermic syringe.
- Figure 2 is an exploded, generally perspective view of one form of the fluid container or vial assembly of the invention.
- Figure 3 is an enlarged, fragmentary, cross-sectional side view of the vial assembly showing the cap removed and the internal plunger thereof being pierced by the syringe needle.
- the apparatus comprises a transparent container, or vial, 14 having a fluid chamber 14a for containing the fluid to be added to the reservoir of a fluid dispenser or other fluid delivery device.
- the fluid can be a diluent or any of the medicaments or beneficial agents described in the previously identified U.S. Patent No. 5,205,820.
- Vial 14 has open ends 14b and 14c and closely receives a pierceable piston-like plunger 16 which is movable within vial 14 from a first position, shown in Figure 3, where it is proximate end 14b of the vial to a second position where it is disposed proximate end 14c of the vial.
- Container 14 can be a glass vial or any other suitable sterile container for containing the fluid that is to be used in fill ⁇ ing the reservoirs of the fluid dispensers or fluid delivery devices.
- First portion 18a is provided with threads 20 and is closed by a threaded closure cap 22.
- a socket like construction 24 which is telescopically re ⁇ ceived within the open end portion 26 of second casing portion 18b.
- Outer casing 18 is receivable over vial 14 and portions 18a and 18b are held in mating engagement by an overwrap 30 which functions as an interface sterility barrier and upon which appropriate identifying indicia 32 can be imprinted.
- a novel temperature indicator means, such as indicator "T” is also carried by overwrap 30.
- Indicator "T” may be a reversible liquid crystal temperature bar indicator of a character which is readily commercially available from sources such as Clark Research and Development of Chicago, Illinois, Thermax of Anaheim, California and American Thermo Instruments of Dayton, Ohio. Indicator “T” provides information as to the approximate temperature of the vial assembly during storage and at time of use. As shown in Figure 2, a guide bead 32 is provided on portion 24. Bead 32 is receivable within a corresponding channel 34 provided in portion 18b to insure that portions 18a and 18b of the outer casing are properly aligned.
- penetrable piston 16 is moved within the vial from the first position shown in Figure 3 to a second position wherein it is disposed proximate end 14c.
- Piston 16 is provid ⁇ ed with a plurality of circumferentially extending sealing beads 16a which sealably engage the inner walls 14d of contain ⁇ er 14 as the piston moves rearwardly thereof so as to prevent fluid leakage past the piston.
- a tear away closure cover 37 is removed.
- the needle "N" of the syringe “S” is used to penetrate a pierceable means shown here as an elastomeric plug 38 which closes end 14b of vial 14.
- plug 38 is held in position within vial 14 by an aluminum crimp cap 40, the periphery of which is crimped over into a circumferential groove 42 provided proximate end 14b of the vial.
- cap 22 is reconnected with the outer casing 18 so as to maintain the interior of the vial in a sealed, aseptic condi ⁇ tion.
- casing 18 is provided with an elongated viewing slot 50 that permits viewing of the interior chamber 14c of the vial.
- overwrap 30 has an elon ⁇ gated viewing slot 52 which is indexable with slot 50.
- vial assembly 12 In its sealed, aseptic condition with a sterile fluid path, vial assembly 12 can be stored as may be necessary until it is to be used to fill a fluid dispenser or a reservoir of a delivery apparatus such as that shown in Figures 34 and 35 of USSN 08/069,937
- the vial assembly is there shown being used to fill the fluid chamber of a fluid dispenser of the character having a base 56, a stored energy means for forming, in conjunction with the base, a fluid chamber and a cover means which is receivable over the base for sealably en ⁇ closing the stored energy means.
- the stored energy means is here shown as comprising a distendable membrane 58, of the general character described in U.S. Patent No. 5,205,820 at Column 9, Lines 3-59.
- the cover means here comprises a cover 34 of the general character shown in Figure 61 of U.S. Patent No. 5,205,820.
- the dispenser unit is provided with first flow means for establish ⁇ ing sterile fluid communication between the fluid inlet 66 of the reservoirs of the fluid dispenser and chamber 14c of vial 14, when the filling assemblage is mated with the fluid dis ⁇ an.
- the first flow means comprises a piercing cannula assembly 68 which includes an outwardly protruding hollow cannula 70.
- the cannula assembly 68 also includes a housing 72 which supports hollow needle 70. Housing 72 is connected to the outboard end 84a of an elongated stem 84 which is provided with a central fluid passageway 86 that communicates with the reservoirs of the fluid dispenser.
- casing 18b of the vial subassembly is provided with a multiplicity of outwardly extending, resiliently deformable locking elements 88, which comprise a part of the interlocking means of the invention for interlocking together the vial assem ⁇ bly and the fluid dispenser.
- Elements 88 are adapted to slide past a multiplicity of inwardly extending teeth 90 provided within inlet 62 of the fluid dispenser. These teeth are so constructed and arranged as to engage elements 88 in a manner to permit insertion of the vial assembly into the dispenser inlet but to prevent its removal after it has been fully tele ⁇ scopically inserted into the inlet of the fluid dispenser. To insure proper alignment between the filling subassembly and the inlet of the fluid dispenser, forward and rearward guide rails 92 and 94 are closely receivable within longitudinally extend ⁇ ing tracks 96 provided within the inlet of the fluid dispenser. The coupling of the vial assembly with the fluid dispenser is more fully described in the application filed concurrently herewith.
- indicator means are provided for indicating the volume of fluid remaining within vial 14 as the vial assembly is inserted into the inlet of the fluid dis ⁇ an.
- This indicator means comprises the previously identi ⁇ fied viewing slots 50 and 52 along which are disposed a multi ⁇ plicity of indicating indicia 97. Since vial 14 is transpar ⁇ ent, the amount of fluid remaining within the vial at any point in time can readily be determined by merely aligning one of the indicia markings on the casing with the inboard extremity of piston 16 as it moves toward its innermost position.
- the vial assemblies of the present invention can also be conveniently coupled with connec ⁇ tor means 414a, 414b and 414c of the multireservoir devices il ⁇ lustrated in Figures 34 and 35 of USSN 08/069,937 and can be used to fill the reservoirs of these devices in the manner described in this co-pending application.
Abstract
This invention is a fluid container assembly (12) which can be aseptically filled in the field with selected fluids, and one which is specially designed for sterile coupling and use with fluid dispensing and delivery devices of the character that embody stored energy sources, such as compressible cellular masses and distendable elastomeric membranes (58) that form, in conjunction with a cooperating base (56), fluid chambers for containing the fluid to be dispensed.
Description
FLUID DELIVERY APPARATUS
S P E C I F I C A T I O N
Background of The Invention
This is a Continuation In Part Application of co-pending Appli¬ cation, Serial No. 08/069,937, filed May 28, 1993, which is a Continuation In Part of co-pending Application, Serial No. 08/046,438, which is a Continuation In Part of co-pending Application Serial No. 07/987,021 which is a continuation of co-pending Application 07/870,269 which has now issued into Patent No. 5,205,820 and which is, in turn, a Continuation In Part of Application Serial No. 07/642,208 which has now issued to U.S. Patent No. 5,169,389 which is a Continuation In Part of Application Serial No. 07/367,304 Filed June 16, 1989 which has now issued to U.S. Patent No. 5,019,047
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 ambu¬ latory patient at specific rates over extended periods of time and to a novel fluid containing vial assembly which can be field filled and then used to charge the fluid reservoirs of the fluid delivery apparatus.
Discussion of The Invention
Many medicinal agents require an intravenous route for administration thus bypassing the digestive system and precluding degradation by the catalytic enzymes in the diges-
tive 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 deliv¬ ery device, while not an active pharmacologic agent, may en¬ hance 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 gener¬ ally been accomplished using gravity flow methods, which typi¬ cally 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 rela¬ tively thick-walled bladder by internal stresses within the distended bladder are well-known in the prior art. Such blad¬ der, or "balloon" type, devices are described in U.S. Patent No. 3,469,578, issued to Bierman and in U.S. Patent No. 4,318,400, issued to Perry. The devices of the aforementioned patents also disclose the use of fluid flow restrictors exter¬ nal 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 bladder or "balloon" configuration, the devices are unwieldy and are difficult and expensive to manufacture and use. Fur¬ ther, 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, expand¬ able foams and similar materials, which, in cooperation with a base defines a fluid chamber that contains the fluid which is to be dispensed. The elastomeric film membrane or the expand¬ able foam member 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 con¬ structions of the* apparatus, are described in detail in U. S. Patent No. 5,205,820 issued to the present inventor. There¬ fore, U.S. Patent No. 5,205,820 is hereby incorporated by reference in its entirety as though fully set forth herein. Co-pending USSN 08/046,438 filed by the present inventor on April 13, 1993 also describes various types of expandable cellular elastomers and elastomeric foams used in making the expandable member of various physical embodiments of the inven¬ tion. This co-pending application is also hereby incorporated by reference in its entirety as though fully set forth herein.
The apparatus of the 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 continu¬ ous 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 quanti¬ ties and at extended microfusion rates over time.
One of the devices described in Continuation-In-Part application, Serial No. 08/069,937 and illustrated in Figures 34 and 35 thereof includes first, second, and third cooperating
fluid chambers which can be selectively filled by individual fluid containers or vials containing various fluids such as diluents and medicaments. The novel apparatus shown in Figures 34 and 35 permits two or more liquid components to be stored within the reservoirs of the apparatus and then controllably intermixed at the time of fluid delivery. In an application filed concurrently with the present application there is de¬ scribed a number of inventions which expand on inventions de¬ scribed in the 08/069,937 application by providing a novel platform support system to which several fluid dispensers of varying volume can be operably interconnected. Both this last mentioned application filed on even date herewith and Applica¬ tion Serial No. 08/069,937 are incorporated herein by reference as though fully set forth herein.
The present application expands further on the con¬ cepts disclosed in the applications identified in the preceding paragraph by providing a novel fluid container or vial that is usable with the apparatus of these inventions and is of a unique design which permits it to be expeditiously filled in the field.
Summary of The Invention
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 specifically, 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 a particular object of the invention to provide a device of the aforementioned character which embodies stored energy sources such as distendable elastomeric membranes, that form in conjunction with a cooperating base, fluid chambers for
containing the fluids to be dispensed. The novel aseptically field finable vial assembly of the present invention is spe¬ cially designed for use with these types of devices so that they can be expeditiously filled in the field shortly before use with a wide variety of medicinal fluids.
By way of summary description, the novel vial con¬ struction of the present invention permits field filling of either individual fluid dispensers of the character described in the preceding paragraphs, or alternatively, permits the field filling of multireservoir devices which allow for the controlled delivery therefrom of large volumes of the same or different fluids at controlled rates in accordance with a predetermined delivery protocol.
In one form of the fluid container of the present invention, the fluid chamber thereof can also be quickly and easily filled in the field using a conventional hypodermic syr¬ inge. After filling, the vial assembly can be coupled with the delivery system in a manner to insure the asceptic transfer of the fluid to be delivered.
Another object of the invention is to provide field finable vial assemblies of the class described which can be filled and then stored under refrigeration for an extended period. For those types of assemblies, a novel temperature indicator is provided as an integral part of the assembly.
Other objects of the invention are set forth in U. S. Patent No. 5,205,820 and Serial No. 08/069,937 which are incor¬ porated herein and will become more apparent from the discus¬ sion which follows.
Brief Description of The Drawings
Figure 1 is a generally perspective, exploded view of
one form of the field filled vial assembly of the present inven¬ tion showing it being filled by means of a conventional hypo¬ dermic syringe.
Figure 2 is an exploded, generally perspective view of one form of the fluid container or vial assembly of the invention.
Figure 3 is an enlarged, fragmentary, cross-sectional side view of the vial assembly showing the cap removed and the internal plunger thereof being pierced by the syringe needle.
Figure 4 is a fragmentary, perspective view of one form of the fluid dispenser with which the vial assembly of the present invention can be used.
Description of the Invention
Referring to the drawings and particularly to Figures 1 through 3, one form of the vial assembly of the invention is there illustrated and generally identified by the numeral 12. The apparatus comprises a transparent container, or vial, 14 having a fluid chamber 14a for containing the fluid to be added to the reservoir of a fluid dispenser or other fluid delivery device. The fluid can be a diluent or any of the medicaments or beneficial agents described in the previously identified U.S. Patent No. 5,205,820. Vial 14 has open ends 14b and 14c and closely receives a pierceable piston-like plunger 16 which is movable within vial 14 from a first position, shown in Figure 3, where it is proximate end 14b of the vial to a second position where it is disposed proximate end 14c of the vial. Container 14 can be a glass vial or any other suitable sterile container for containing the fluid that is to be used in fill¬ ing the reservoirs of the fluid dispensers or fluid delivery devices.
Also forming a part of the vial assembly of the present embodiment of the invention is an outer safety casing 18, shown here as comprising cooperating first and second portions 18a and 18b which are joined to form a sterile barrier system. First portion 18a is provided with threads 20 and is closed by a threaded closure cap 22. Provided at its open end is a socket like construction 24 which is telescopically re¬ ceived within the open end portion 26 of second casing portion 18b. Outer casing 18 is receivable over vial 14 and portions 18a and 18b are held in mating engagement by an overwrap 30 which functions as an interface sterility barrier and upon which appropriate identifying indicia 32 can be imprinted. A novel temperature indicator means, such as indicator "T", is also carried by overwrap 30. Indicator "T" may be a reversible liquid crystal temperature bar indicator of a character which is readily commercially available from sources such as Clark Research and Development of Chicago, Illinois, Thermax of Anaheim, California and American Thermo Instruments of Dayton, Ohio. Indicator "T" provides information as to the approximate temperature of the vial assembly during storage and at time of use. As shown in Figure 2, a guide bead 32 is provided on portion 24. Bead 32 is receivable within a corresponding channel 34 provided in portion 18b to insure that portions 18a and 18b of the outer casing are properly aligned.
In a manner presently to be described, as the fluid chamber of the vial is filled with fluid using syringe "S" (Figure 1) , penetrable piston 16 is moved within the vial from the first position shown in Figure 3 to a second position wherein it is disposed proximate end 14c. Piston 16 is provid¬ ed with a plurality of circumferentially extending sealing beads 16a which sealably engage the inner walls 14d of contain¬ er 14 as the piston moves rearwardly thereof so as to prevent fluid leakage past the piston.
Referring now to Figure 3, after the vial assembly
has been assembled in the manner shown in Figure 1 and with cap 22 removed, a tear away closure cover 37 is removed. Next the needle "N" of the syringe "S" is used to penetrate a pierceable means shown here as an elastomeric plug 38 which closes end 14b of vial 14. As shown in Figure 3, plug 38 is held in position within vial 14 by an aluminum crimp cap 40, the periphery of which is crimped over into a circumferential groove 42 provided proximate end 14b of the vial. As fluid is forced from the syringe into an interior chamber 16b of plunger 16, the plunger will be forced to the left until it moves into close proximity with end 14c of the vial where it engages a retainer ring 44 (Figure 2) that is closely received within end 14c of the vial. During the vial filling step, air disposed within chamber 14c will be expelled through a sterile vent patch 45 which is bonded to a closure cap 46 that is provided with vent apertures 46a.
After the vial has been filled with the selected fluid, cap 22 is reconnected with the outer casing 18 so as to maintain the interior of the vial in a sealed, aseptic condi¬ tion. As best seen in Figure 2, casing 18 is provided with an elongated viewing slot 50 that permits viewing of the interior chamber 14c of the vial. Similarly, overwrap 30 has an elon¬ gated viewing slot 52 which is indexable with slot 50. With this construction, the user can tell at a glance whether the vial is full or empty.
In its sealed, aseptic condition with a sterile fluid path, vial assembly 12 can be stored as may be necessary until it is to be used to fill a fluid dispenser or a reservoir of a delivery apparatus such as that shown in Figures 34 and 35 of USSN 08/069,937
Turning now to Figure 4, the vial assembly is there shown being used to fill the fluid chamber of a fluid dispenser of the character having a base 56, a stored energy means for
forming, in conjunction with the base, a fluid chamber and a cover means which is receivable over the base for sealably en¬ closing the stored energy means. The stored energy means is here shown as comprising a distendable membrane 58, of the general character described in U.S. Patent No. 5,205,820 at Column 9, Lines 3-59. The cover means here comprises a cover 34 of the general character shown in Figure 61 of U.S. Patent No. 5,205,820.
After tear-away cover 46 has been removed from the vial assembly (Figure 2) , the outboard end 60 of the vial assembly, which presents a sterile interface, is inserted into the likewise sterile inlet opening 62 of the dispenser unit to accomplish a sterile coupling. As indicated in Figure 4, the dispenser unit is provided with first flow means for establish¬ ing sterile fluid communication between the fluid inlet 66 of the reservoirs of the fluid dispenser and chamber 14c of vial 14, when the filling assemblage is mated with the fluid dis¬ penser. In the embodiment of the invention, shown in Figure 4, the first flow means comprises a piercing cannula assembly 68 which includes an outwardly protruding hollow cannula 70. The cannula assembly 68 also includes a housing 72 which supports hollow needle 70. Housing 72 is connected to the outboard end 84a of an elongated stem 84 which is provided with a central fluid passageway 86 that communicates with the reservoirs of the fluid dispenser.
After end 60 of the vial assembly is inserted into inlet port 62 of the fluid dispenser, an inward pressure exert¬ ed against the vial assembly will cause hollow cannula 70 to penetrate penetrable piston 16 of the vial assembly opening a fluid flow passageway between passageway 86 of the fluid dis¬ penser and chamber 14c of the vial assembly. As shown in Figure 4, casing 18b of the vial subassembly is provided with a multiplicity of outwardly extending, resiliently deformable locking elements 88, which comprise a part of the interlocking
means of the invention for interlocking together the vial assem¬ bly and the fluid dispenser. Elements 88 are adapted to slide past a multiplicity of inwardly extending teeth 90 provided within inlet 62 of the fluid dispenser. These teeth are so constructed and arranged as to engage elements 88 in a manner to permit insertion of the vial assembly into the dispenser inlet but to prevent its removal after it has been fully tele¬ scopically inserted into the inlet of the fluid dispenser. To insure proper alignment between the filling subassembly and the inlet of the fluid dispenser, forward and rearward guide rails 92 and 94 are closely receivable within longitudinally extend¬ ing tracks 96 provided within the inlet of the fluid dispenser. The coupling of the vial assembly with the fluid dispenser is more fully described in the application filed concurrently herewith.
As previously mentioned, indicator means are provided for indicating the volume of fluid remaining within vial 14 as the vial assembly is inserted into the inlet of the fluid dis¬ penser. This indicator means comprises the previously identi¬ fied viewing slots 50 and 52 along which are disposed a multi¬ plicity of indicating indicia 97. Since vial 14 is transpar¬ ent, the amount of fluid remaining within the vial at any point in time can readily be determined by merely aligning one of the indicia markings on the casing with the inboard extremity of piston 16 as it moves toward its innermost position.
As previously mentioned, the vial assemblies of the present invention can also be conveniently coupled with connec¬ tor means 414a, 414b and 414c of the multireservoir devices il¬ lustrated in Figures 34 and 35 of USSN 08/069,937 and can be used to fill the reservoirs of these devices in the manner described in this co-pending application.
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
1. A fluid container assembly for use with a fluid delivery apparatus of the character having a base and a stored energy means for forming in conjunction with the base a fluid reservoir having an inlet and an outlet, said stored energy means being adapted to expel fluid from the fluid chamber, said fluid container assembly comprising:
(a) a container having a fluid chamber with first and second open ends;
(b) pierceable means for sealably closing one of said first and second open ends of said container, said pierceable means being pierceable by a cannula; and
(c) a plunger telescopically movable within said container by fluid pressure from a first location prox¬ imate said pierceable means to a second, spaced-apart location; and
(d) an outer casing surrounding said container, said casing having first and second ends, one of said first and second ends being closed by a removable closure cap and the other of said first and second ends being closed by closure assembly including vent means for venting gases within said container to atmosphere.
2. An apparatus as defined in Claim 1 in which said casing is provided with indicator means for indicating the volume of fluid within said chamber of said container.
3. An apparatus as defined in Claim 2 in which said indicator means comprises an elongated viewing slot formed in said casing and indicating indicia marked on said casing prox- imate said slot.
4. An apparatus as defined in Claim 2 further including temperature indicating means provided on said casing for indi¬ cating the temperature of the apparatus.
5. A fluid container assembly for use with a hypodermic syringe having a piercing cannula, said container assembly com¬ prising:
(a) a container having a fluid chamber with first and second open ends;
(b) pierceable means for sealably closing one of said first and second open ends of said container, said pierceable means being pierceable by the piercing cannula of the syringe;
(c) a plunger telescopically movable within said container by fluid pressure from a first location prox¬ imate said pierceable means to a second, spaced-apart location; and
(d) an outer casing surrounding said container, said casing having first and second ends, one of said first and second ends being closed by a closure cap and the other of said first and second ends being closed by closure assem¬ bly comprising a vent patch and a tear-away closure cap.
6. An apparatus as defined in Claim 5 in which said casing is provided with temperature indicating means for indi¬ cating the temperature of the apparatus.
7. A vial assembly for containing an infusible liquid, said vial assembly being usable with a syringe having a pierc¬ ing cannula and comprising: (a) a container having a liquid chamber with first and second open ends;
(b) pierceable means for sealably closing one of said first and second open ends of said container, said pierceable means being pierceable by the piercing cannula;
(c) a plunger telescopically movable within said container by liquid pressure from a first location prox¬ imate said pierceable means to a second, spaced-apart location; and
(d) an outer casing surrounding said container, said casing having first and second ends, one of said first and second ends being closed by a closure cap and the other of said first and second ends being closed by a closure assembly comprising a vent patch and tear away closure cap.
8. A vial assembly as defined in Claim 7 in which said container is transparent and in which said casing is provided with indicator means for indicating the volume of fluid within said chamber of said container and with temperature indicating means for indicating the temperature of the vial assembly.
9. A vial assembly as defined in Claim 8 in which said indicator means comprises an elongated viewing window formed in said casing and indicating indicia marked on said casing prox¬ imate said window.
10. A vial assembly as defined in Claim 9 in which said container comprises a glass vial and in which said casing com¬ prises first and second interconnectable portions.
11. A vial assembly as defined in Claim 9 in which said plunger is pierceable by a cannula.
12. A vial assembly as defined in Claim 9 further includ¬ ing an overwrap surrounding said casing.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU78411/94A AU7841194A (en) | 1993-09-29 | 1994-09-23 | Fluid delivery apparatus |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/129,470 US5374256A (en) | 1989-06-16 | 1993-09-29 | Fluid container for use with a fluid delivery apparatus |
US08/129,470 | 1993-09-29 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1995009017A1 true WO1995009017A1 (en) | 1995-04-06 |
Family
ID=22440114
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1994/010764 WO1995009017A1 (en) | 1993-09-29 | 1994-09-23 | Fluid delivery apparatus |
Country Status (3)
Country | Link |
---|---|
US (2) | US5374256A (en) |
AU (1) | AU7841194A (en) |
WO (1) | WO1995009017A1 (en) |
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- 1994-09-23 WO PCT/US1994/010764 patent/WO1995009017A1/en active Application Filing
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Also Published As
Publication number | Publication date |
---|---|
US5374256A (en) | 1994-12-20 |
US5545139A (en) | 1996-08-13 |
AU7841194A (en) | 1995-04-18 |
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