Abstract: An exemplary infusion set includes a tubing, a first connector, and a second connector. The first connector connects a first terminus of the tubing to an exit port of an infusion pump, providing fluid communication between fluid being conveyed by the infusion pump and the tubing. The second connector connects a second terminus of the tubing to a delivery module, providing fluid communication between the tubing and the delivery module. Full engagement of the first connector and the exit port of the infusion pump actuates operation of the infusion pump.

Abstract: Embodiments include a system including a sealed prefilled drug-reservoir. The drug-reservoir may include a unit dosage of treprostinil in a sterile fluid composition. The composition may not include an antimicrobial preservative. The treprostinil may be present at a dosage of between 0.1 mg/mL and 25 mg/mL. In addition, the treprostinil may be treprostinil sodium Furthermore, the composition may include sodium chloride. The composition may also include a sodium ion from sodium chloride in a concentration from 3000 to 4500 ppm. The composition may not include metacresol.

Abstract: Embodiments may include a method of delivering a drug. The method may include removing or releasing a structure from a patch-pump assembly. The patch-pump assembly may include a sealed prefilled drug-reservoir, a fluid passageway, a cannula-containing assembly, and a penetrator. The method may also include penetrating the sealed prefilled drug-reservoir containing the drug to establish fluid communication between the sealed prefilled drug-reservoir and a fluid passageway by removing or releasing the structure. The method may further include flowing the drug from the prefilled drug-reservoir to the fluid passageway. In addition, the method may include flowing the drug from the fluid passageway to a cannula-containing assembly. Furthermore, the method may include delivering the drug subcutaneously to a subject using the cannula-containing assembly.

Abstract: This invention provides a prefilled selectively activatable body-worn infusion-pump assembly for rapid delivery of large volumes or highly viscous volume comprising a housing; a pre-filled aseptically-sealed flexible drug reservoir-containing assembly; a conjoined, coordinately controlled and perpendicularly arranged cannulated needle dispensing and needle insertion assembly operationally connected to and in fluid connection with the pre-filled aseptically-sealed drug reservoir-containing assembly, wherein the cannulated needle dispensing assembly projects generally perpendicularly to a generally planar surface of the housing, promotes insertion of the cannulated needle in skin of a subject and promotes retraction of the needle within the cannulated needle dispensing assembly thereafter, and wherein the needle insertion assembly projects generally in a parallel orientation to a generally planar surface of the housing, which projection initiates opening a fluid path with the pre-filled aseptically-sealed drug

Abstract: The present invention provides an infusion-patch comprising; a cannula; a base; at least one adhesive region in said base suitable for skin attachment; at least one skin-access area within said base; and at least one conduit in fluid connection with said at least one skin access area, wherein said at least one conduit in fluid connection with said at least one skin access area facilitates the transfer of an anesthetic substance within at least a first anesthetic-reservoir which may be removably attached and in fluid connection with said at least one contact area, promoting delivery of said anesthetic substance to said at least one skin-access areas, and wherein said anesthetic substance delivered to said skin-access areas may be at least partially replenished without removing said infusion-patch. Embodiments of the present invention include methods of administering a drug using the infusion-patch.

Abstract: The present application provides a self-powered drug-delivery device. The device includes a chamber having a wall. The chamber contains a fluid and is in connection with an administration means. The device also includes a displacement-generating battery cell. The device further includes an electrically-controlled battery unit, which includes the displacement-generating battery cell coupled to the chamber by a coupling means. The displacement-generating battery cell includes an element that changes shape as a result of charge or discharge of the battery cell so as to cause a displacement within the battery unit. The arrangement of the battery unit, the coupling means, the wall, the chamber, and the administration means is such that the displacement derived from the battery unit is conveyed by the coupling means to cause displacement of the wall of the chamber such that the fluid is expelled from the chamber to force a drug towards the administration means.

Abstract: Embodiments of the present invention provide drug-delivery devices comprising a drug reservoir chamber containing a substance to be delivered, in fluid connection with a drug administration means, and at least one displacement-generating battery cell coupled to said drug reservoir chamber by a coupling means, the at least one displacement-generating battery cell comprising an element that changes shape as a result of discharge of the battery cell so as to cause a displacement within the battery unit, the arrangement being such that the displacement derived from said battery unit is conveyed by said coupling means to cause displacement of at least a portion of a wall of said drug reservoir chamber reducing the volume of said drug reservoir chamber such that said substance is expelled from said drug reservoir chamber towards said drug administration means upon discharge, thereby being a self-powered drug delivery device.

Abstract: The present application provides a self-powered drug-delivery device. The device includes a chamber having a wall. The chamber contains a fluid and is in connection with an administration means. The device also includes a displacement-generating battery cell. The device further includes an electrically-controlled battery unit, which includes the displacement-generating battery cell coupled to the chamber by a coupling means. The displacement-generating battery cell includes an element that changes shape as a result of charge or discharge of the battery cell so as to cause a displacement within the battery unit. The arrangement of the battery unit, the coupling means, the wall, the chamber, and the administration means is such that the displacement derived from the battery unit is conveyed by the coupling means to cause displacement of the wall of the chamber such that the fluid is expelled from the chamber to force a drug towards the administration means.

Abstract: This invention provides for a unit dosage form of treprostinil at a dosage of between 0.1 mg/mL and 25 mg/mL in a sterile fluid composition formulated for subcutaneous or intravenous injection, which composition does not comprise an antimicrobial preservative, and methods of reducing irritation, inflammation or a combination thereof at a site of subcutaneous or intravenous infusion of treprostinil in a subject in need thereof.

Abstract: An exemplary infusion set includes a tubing, a first connector, and a second connector. The first connector connects a first terminus of the tubing to an exit port of an infusion pump, providing fluid communication between fluid being conveyed by the infusion pump and the tubing. The second connector connects a second terminus of the tubing to a delivery module, providing fluid communication between the tubing and the delivery module. Full engagement of the first connector and the exit port of the infusion pump actuates operation of the infusion pump.

Abstract: Embodiments may include a method of delivering a drug. The method may include removing or releasing a structure from a patch-pump assembly. The patch-pump assembly may include a sealed prefilled drug-reservoir, a fluid passageway, a cannula-containing assembly, and a penetrator. The method may also include penetrating the sealed prefilled drug-reservoir containing the drug to establish fluid communication between the sealed prefilled drug-reservoir and a fluid passageway by removing or releasing the structure. The method may further include flowing the drug from the prefilled drug-reservoir to the fluid passageway. In addition, the method may include flowing the drug from the fluid passageway to a cannula-containing assembly. Furthermore, the method may include delivering the drug subcutaneously to a subject using the cannula-containing assembly.

Abstract: Embodiments may include a method of delivering a drug. The method may include removing or releasing a structure from a patch-pump assembly. The patch-pump assembly may include a sealed prefilled drug-reservoir, a fluid passageway, a cannula-containing assembly, and a penetrator. The method may also include penetrating the sealed prefilled drug-reservoir containing the drug to establish fluid communication between the sealed prefilled drug-reservoir and a fluid passageway by removing or releasing the structure. The method may further include flowing the drug from the prefilled drug-reservoir to the fluid passageway. In addition, the method may include flowing the drug from the fluid passageway to a cannula-containing assembly. Furthermore, the method may include delivering the drug subcutaneously to a subject using the cannula-containing assembly.

Abstract: A drug-delivery device comprising a drug-reservoir assembly, displacement-generating actuator, and drug administration unit is described, wherein the drug-reservoir assembly comprises at least one flexible wall and a constraining ring, such that the displacement generated by the actuator collapses a flexible wall of the assembly expelling the drug contents of the drug-reservoir towards said drug administration means.

Abstract: A drug-delivery device comprising a drug-reservoir assembly, displacement-generating actuator, and drug administration unit is described, wherein the drug-reservoir assembly comprises at least one flexible wall and a constraining ring, such that the displacement generated by the actuator collapses a flexible wall of the assembly expelling the drug contents of the drug-reservoir towards said drug administration means.

Abstract: The present invention provides an infusion-patch comprising; a cannula; a base; at least one adhesive region in said base suitable for skin attachment; at least one skin-access area within said base; and at least one conduit in fluid connection with said at least one skin access area, wherein said at least one conduit in fluid connection with said at least one skin access area facilitates the transfer of an anesthetic substance within at least a first anesthetic-reservoir which may be removably attached and in fluid connection with said at least one contact area, promoting delivery of said anesthetic substance to said at least one skin-access areas, and wherein said anesthetic substance delivered to said skin-access areas may be at least partially replenished without removing said infusion-patch.

Abstract: The present application provides a self-powered drug-delivery device. The device includes a chamber having a wall. The chamber contains a fluid and is in connection with an administration means. The device also includes a displacement-generating battery cell. The device further includes an electrically-controlled battery unit, which includes the displacement-generating battery cell coupled to the chamber by a coupling means. The displacement-generating battery cell includes an element that changes shape as a result of charge or discharge of the battery cell so as to cause a displacement within the battery unit. The arrangement of the battery unit, the coupling means, the wall, the chamber, and the administration means is such that the displacement derived from the battery unit is conveyed by the coupling means to cause displacement of the wall of the chamber such that the fluid is expelled from the chamber to force a drug towards the administration means.

Abstract: The invention provides a unit dosage form of Ketorolac providing for a reduced dosage than typically provided to a subject in need of same, wherein said dosage form of Ketorolac is in a sterile fluid composition formulated for continuous subcutaneous delivery via body-worn infusion pump assembly, and wherein said Ketorolac is present at a concentration of between 40 mg/mL and 240 mg/mL formulated for single use delivery in a volume not to exceed 1-10 mL. Methods of use of same, body-worn infusion pump assemblies containing same and containers containing same for incorporation within a body-worn infusion pump assembly for a dose-sparing formulation comprising Ketorolac are also provided.

Abstract: Embodiments provide a more efficacious and/or more comfortable, consistent and reliable Ketorolac treatment for patients in need of same, which in some aspects yields a formulation that is much more stable over time. In some aspects, there is provided a Ketorolac-containing formulation adapted to contain specific stabilizers in an ethanol free setting and/or sodium chloride free setting, which provides for enhanced formulation stability. In some aspects, such formulation is characterized by enhanced stability even when the formulation is stored at room temperature, or in some embodiments, when the formulation is stored at higher temperatures, such as, for example, that experienced in the United States in various states, in various seasons outdoors, etc. In some aspects, such enhanced stability is in addition to other advantages as described herein, for example, for example, in terms of a dose sparing effect, and others, as described herein.

Abstract: Embodiments include a displacement-generating battery cell for driving a drug-delivery device. The cell includes at least one volume-changing element. The cell also includes a housing formed according to a concertina-shaped design with folds in the walls thereof and containing an internal chemical reaction system. The arrangement of the chemical reaction system is such that as the cell is discharged, the volume-changing element expands, thereby lengthening the battery and thus reducing the extent of said folds, such that the cell becomes taller to reflect the expansion of the volume-changing component.

Abstract: This invention provides for a unit dosage form of treprostinil at a dosage of between 0.1 mg/mL and 25 mg/mL in a sterile fluid composition formulated for subcutaneous or intravenous injection, which composition does not comprise an antimicrobial preservative. Selectively activatable patch-pump assemblies comprising a sealed prefilled drug-reservoir containing the unit dosage form is described as are methods for reducing pain at a site of subcutaneous or intravenous infusion of treprostinil in a subject in need thereof, and methods of reducing irritation, inflammation or a combination thereof at a site of subcutaneous or intravenous infusion of treprostinil in a subject in need thereof. The invention also provides a method of treating pulmonary hypertension, and methods for treating, or reducing the severity or reducing the pathogenesis of Pulmonary arterial hypertension (PAH) in a subject making use of the compositions as herein described.