Abstract: A fluid delivery device having a self-contained stored energy membrane for expelling fluids at a precisely controlled rate which is of a compact, laminate construction. The device also includes a novel adapter which is usable to fill the reservoir of the device using a compatable filling syringe apparatus which is mateable with the adapter.

Abstract: An apparatus for accurately infusing fluids into a patient at specific rates over an extended period of time. The apparatus is of a low profile, laminate or layered construction having a stored energy source in the form of a distendable membrane which, in cooperation with the base of the apparatus, defines one or more fluid reservoirs, each having a fluid inlet and a fluid outlet. The apparatus further includes, a novel, conformable ullage made of yieldable materials which uniquely conforms to the shape of the elastomeric membrane as the membrane returns to its less distended configuration. This arrangement will satisfy even the most stringent medicament delivery tolerance requirements and will elegantly overcome the limitations of materials selection encountered in devices embodying solely a rigid ullage construction.

Abstract: A fluid delivery device for infusing medicinal fluids having a self-contained stored energy membrane for expelling fluids at a precisely controlled rate. The device is of a compact, low profile, laminate construction so that it can conveniently be used for the fluids, such as insulin and the like, into an ambulatory patient at controlled rates over extended periods of time. Included within the device are various fluid flow control elements including a unique hydraulic fluid rate control system for ultra low flow delivery. Also included is a highly novel flow indictor for providing a positive indication of fluid flow from the device and for indicating at any given time the amount of fluid remaining in the device.

Abstract: An apparatus for accurately infusing fluids into a patient at specific rates over an extended period of time and the method for making same. The apparatus includes one or more dispensers of a low profile, laminate or layered construction each having a stored energy source in the form of a distendable membrane or an elastomeric cellular mass, which in cooperation with the base, defined a fluid chamber having a fluid inlet and a fluid outlet. The apparatus further includes, in lieu of a rigid ullage, a high novel, conformable ullage made of yieldable materials. The conformable ullage uniquely conforms to the shape of elastomeric membrane as the membrane returns to its less distended configuration. This arrangement will satisfy even the most stringent delivery tolerance requirements and will elegantly overcome the limitations of materials selection encountered in devices embodying the rigid ullage construction.

Abstract: A method and apparatus for the high volume manufacture of fluid infusion devices which embody a self-contained, stored-energy source for expelling fluids from the reservoir of the device into an ambulatory patient at precisely controlled rates over extended periods of time. In accordance with the method of the invention, the base and cover infusion components of the devices of the invention are manufactured in injection molded arrays which comprise a cover array which is superimposed over and connected to a base array with the elastomeric membrane being captured therebetween. The elastomeric membrane material, which forms the stored-energy source of the infusion devices, is continuously unrolled from a large roll of film-backed membrane material which is rotatably mounted on a turret assembly upon which a second back-up roll of elastomeric membrane material is also mounted.

Abstract: An apparatus for accurately infusing fluids into a patient at specific rates over an extended period of time. The apparatus is of a low profile, laminate or layered construction having a stored energy source in the form of a distendable membrane, which, in cooperation with the base of the apparatus, defines one or more fluid reservoirs, each having a fluid inlet and a fluid outlet. The apparatus further includes, a novel conformable ullage made of yieldable materials. The conformable ullage uniquely conforms to the geometry of elastomeric membrane as the membrane returns to its less distended configuration and in so doing can move between a central chamber and a toroidal chamber formed in the cover of the apparatus. This arrangement will satisfy even the most stringent medicament delivery tolerance requirements and will elegantly overcome the limitations of materials selection encountered in devices embodying solely a rigid ullage construction.

Abstract: An injectable medicament dispenser for use in controllably dispensing fluid medicaments such as insulin, antibiotics, oncolytics and the like from a prefilled container at a uniform rate. The dispenser includes a unique stored energy source in the form of a compressively deformable, polymeric elastomeric member that provides the force necessary to controllably discharge the medicament from the prefilled container which is housed within the body of the device. After having been deformed, the polymeric, elastomeric member will return to its starting configuration in a highly predictable manner.

Abstract: An elastomeric bladder stored energy type infusion apparatus which includes a unique fill assembly for use in controllably filling the fluid reservoir of the dispenser portion of the apparatus. The filling assembly includes a prefilled vial which is partially received within a novel adapter assembly that functions to operably couple the prefilled vial with the fluid dispenser subassembly of the apparatus. The body of the prefilled vial is surrounded by a protective covering until immediately prior to mating the assembly with the fluid delivery device.

Abstract: A subcutaneous infusion set for the subdermal infusion of fluids which includes a housing having an internal chamber within which a uniquely configured infusion cannula is dynamically mounted. The cannula, which is generally spiral shaped, has a body portion that is disposed within the internal chamber and a pierceable portion which extends angularly outwardly from the base of the apparatus. With this construction, when the device is interconnected with a patient, normal movement by the patient will permit the cannula to move dynamically within the internal chamber while the base of the device which is removably affixed to the patient 's skin remains completely stationary.

Abstract: An apparatus for accurately infusing medicinal agents into an ambulatory patient at specific rates over extended periods of time. The apparatus is of a compact, low profile, laminate construction and includes an elastic distendable membrane, chamber having a fluid outlet. Disposed within the fluid chamber is a thin fluid permeable member which precisely controls the rate of fluid flow through the fluid outlet. The apparatus also includes a highly novel fluid flow indicator that provides a readily discernible visible indication of fluid flow through the apparatus. Additionally, the apparatus includes a fill assembly comprising a prefilled vial that can be used to fill the fluid reservoir of the device with a selected medicinal fluid.

Abstract: A fluid delivery apparatus for continuous basal infusion, together with controlled bolus infusion of injectable medicaments, which embodies a stored energy source such as distendable elastomeric membrane which cooperates with a base and a conformable ullage to define a fluid reservoir and one which includes a unique fill assembly for use in controllably filling the fluid reservoir. The novel fill assembly of the invention enables the fluid reservoir of the fluid delivery portion of the apparatus to be aseptically filled in the field with a wide variety of selected medicinal fluids.

Abstract: A fluid delivery apparatus which embodies a stored energy source such as distendable elastomeric membrane which cooperates with a base and a conformable ullage to define a fluid reservoir and one which includes a unique fill assembly for use in controllably filling the fluid reservoir. The novel fill assembly of the invention enables the fluid reservoir of the fluid delivery portion of the apparatus to be aseptically filled in the field with a wide variety of selected medicinal fluids.

Abstract: A syringe type apparatus which includes a unique fill assembly for use in controllably injecting medicinal fluids into a patient. The filling assembly includes a prefilled vial which is partially received within a novel adapter assembly that functions to operably couple the prefilled vial with the syringe assembly of the apparatus. The body of the prefilled vial is surrounded by a protective covering until immediately prior to mating the assembly with the syringe assembly.

Abstract: An apparatus for accurately infusing fluids into a patient at specific rates over an extended period of time. The apparatus is of a low profile, laminate or layered construction having a stored energy source in the form of a distendable membrane, which in cooperation with the base of the apparatus, defines one or more fluid reservoirs, each having a fluid inlet and a fluid outlet. The apparatus further includes, a novel, conformable ullage made of yieldable materials which uniquely conform to the shape of the elastomeric membrane as the membrane returns to its less distended configuration. This arrangement will satisfy even the most stringent medicament delivery tolerance requirements and will elegantly overcome the limitations of materials selection encountered in devices embodying solely a rigid ullage construction. Additionally, in one form of the invention, the apparatus includes a novel fill assembly for controllably filling the reservoirs of the device in the field.

Abstract: An apparatus for accurately infusing fluids into a patient at specific rates over an extended period of time. The apparatus is of a low profile, laminate or layered construction having a stored energy source in the form of a distendable membrane, which, in cooperation with the base of the apparatus, defines one or more fluid reservoirs, each having a fluid inlet and a fluid outlet. The apparatus further includes, a novel, conformable ullage made of yieldable materials which uniquely conforms to the shape of the elastomeric membrane as the membrane returns to its less distended configuration. This arrangement will satisfy even the most stringent medicament delivery tolerance requirements and will elegantly overcome the limitations of materials selection encountered in devices embodying solely a rigid ullage construction.

Abstract: An apparatus for separately storing a medicament component, such as a drug and for mixing this component with a liquid component, such as a sterilized diluent, to form a beneficial agent which can be delivered to a patient from the container containing the liquid component. The device includes a novel collapsible vial structure which can be used for controllably introducing a support structure carrying the medicament component into the liquid container whereby the medicament and liquid components will thoroughly mix under sterile conditions.

Abstract: An injectable medicament dispenser for use in controllably dispensing fluid medicaments such as insulin, antibiotics, oncolytics and the like from a prefilled container at a uniform rate. The dispenser includes a unique stored energy source in the form of a compressively deformable, polymeric elastomeric member that provides the force necessary to controllably discharge the medicament from the prefilled container which is housed within the body of the device. After having been deformed, the polymeric, elastomeric member will return to its starting configuration in a highly predictable manner.

Abstract: A fluid delivery apparatus which includes a fluid delivery assembly and a unique fill assembly that can be used to controllably fill the fluid reservoir of the fluid delivery assembly in the field. The fill assembly includes a fluid containing vial assembly mounted within a unique adapter assembly which functions to conveniently mate the vial assembly with several different types of fluid delivery assemblies of the character that embody self-contained stored energy means.

Abstract: An apparatus for accurately infusing fluids into a patient at specific rates over an extended period of time. The apparatus is of a low profile, laminate or layered construction having a stored energy source in the form of a distendable membrane, which, in cooperation with the base of the apparatus, defines one or more fluid reservoirs, each having a fluid inlet and a fluid outlet. The apparatus further includes, a novel conformable ullage made of yieldable materials. The conformable ullage uniquely conforms to the geometry of elastomeric membrane as the membrane returns to its less distended configuration and in so doing can move between a central chamber and a toroidal chamber formed in the cover of the apparatus. This arrangement will satisfy even the most stringent medicament delivery tolerance requirements and will elegantly overcome the limitations of materials selection encountered in devices embodying solely a rigid ullage construction.

Abstract: A fluid container assembly 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 distendible elastomeric membranes that form, in conjunction with a cooperating base, fluid chambers for containing the fluid to be dispensed.