Abstract: A modular inserter assembly for use in inserting an interbody fusion cage into the disc space between opposing vertebrae comprises a depth stop and a modular inserter tip releasably attached thereto. The modular inserter assembly includes a cage attachment surface for releasable attachment to an interbody fusion cage, the depth stop including a movable stop axially movable relative to the inserter tip and being sized and configured to engage an exterior surface of one of the vertebrae to establish the depth to which the interbody fusion cage is to be inserted in the disc space. A plurality of modular inserter tips, each being configured for selective releasable attachment to differently sized interbody fusion cages are provided in a kit with the depth stop.

Abstract: A disc preparation instrument for use in fusing spinal vertebrae comprises a modular scoring trial and a depth stop releasably attached to the scoring trial. The trial includes an elongate stem supporting a trial device at its distal tip. The trial device is insertable into a disc space and includes a rotatable rasp for scoring opposing vertebral endplates at a scored location. A stop, sized to engage an exterior surface of the vertebrae, is movable on the depth stop stem by rotation of an adjustment knob to a plurality of selectable distances between the proximal end of the trial device and the movable stop. An actuator releasably attached to the trial is operable to rotate the rasp. A plurality of modular trials, each having a trial device of different heights may be provided in a kit. Each scoring trial is selectively releasably attachable to a single depth stop.

Abstract: A breath-powered, dry powder inhaler, a cartridge, and a pulmonary drug delivery system are provided.

Abstract: A pulmonary drug delivery system is disclosed, including a breath-powered, dry powder inhaler, with or without a cartridge for delivering a dry powder formulation. The inhaler and cartridge can be provided with a drug delivery formulation comprising, for example, a diketopiperazine and an active ingredient, including, small organic molecules, peptides and proteins, including, hormones such as insulin and glucagon-like peptide 1 for the treatment of disease and disorders, for example, diseases and disorders, including endocrine disease such as diabetes and/or obesity.

Abstract: A breath-powered, dry powder inhaler, a cartridge, and a pulmonary drug delivery system are provided. The dry powder inhaler can be provided with or without a unit dose cartridge for using with the inhaler. The inhaler and/or cartridge can be provided with a drug delivery formulation comprising, for example, a diketopiperazine and an active ingredient, including, peptides and proteins such as insulin and glucagon-like peptide 1 for the treatment of diabetes and/or obesity. The dry powder inhaler is compact; can be provided in various shapes and sizes, colors, and comprises a housing, a mouthpiece, a cartridge placement area, and a mechanism for opening and closing the medicament cartridge. The device is easy to manufacture, provides a pre-metered single unit dose, it is relatively easy to use, and can be reusable or disposable.

Abstract: A pulmonary drug delivery system is disclosed, including a breath-powered, dry powder inhaler, with or without a cartridge for delivering a dry powder formulation. The inhaler and cartridge can be provided with a drug delivery formulation comprising, for example, a diketopiperazine and an active ingredient, including, small organic molecules, peptides and proteins, including, hormones such as insulin and glucagon-like peptide 1 for the treatment of disease and disorders, for example, diseases and disorders, including endocrine disease such as diabetes and/or obesity.

Abstract: Described herein are interactive apparatus and methods for sensing and measuring real-time characteristic patterns of a subject's use of a dry powder inhalation system. The devices can be used in a wired or wireless communication mode to communicate with a display to assess the subject's usage of the inhalation system, to evaluate the performance of the inhalation system and/or to detect the characteristics profile of a dry powder formulation emitted from the inhalation system in use.

Abstract: Described herein are interactive apparatus and methods for sensing and measuring real-time characteristic patterns of a subject's use of a dry powder inhalation system. The devices can be used in a wired or wireless communication mode to communicate with a display to assess the subject's usage of the inhalation system, to evaluate the performance of the inhalation system and/or to detect the characteristics profile of a dry powder formulation emitted from the inhalation system in use.

Abstract: Dry powder inhaler systems for pulmonary delivery of pharmaceuticals are disclosed.

Abstract: A dry powder inhaler including replaceable cartridges containing a dry powder for local or systemic delivery through the pulmonary tract and lungs is disclosed. The inhalers are used with inhalable dry powders, including medicament formulations comprising active agents for local or systemic delivery and for the treatment of diseases such as, pulmonary hypertension, cardiovascular disease, anaphylaxis, diabetes, obesity, cancer, and other diseases, or symptoms associated with these and other diseases, such as nausea, vomiting, pain and inflammation.

Abstract: A flexible pouch and valve assembly is provided for aseptically storing a substance, dispensing multiple portions of the stored substance therefrom, and maintaining substance remaining in the pouch in an aseptic condition sealed with respect to ambient atmosphere. The flexible pouch and valve assembly are receivable within a relatively rigid housing, and are adapted to cooperate with a pump for pumping discrete portions of substance from the pouch and through the one-way valve to dispense the substance therefrom. The assembly comprises a flexible pouch defining therein a variable-volume storage chamber sealed with respect to the ambient atmosphere for aseptically storing therein multiple portions of the substance. A one-way valve of the assembly includes a valve body defining an axially-extending valve seat and at least one flow aperture extending through the valve body and/or the valve seat.

Abstract: A dispenser has a body with a variable-volume storage chamber for storing substance, and a dispensing portion defining a dosage chamber in fluid communication with the storage chamber. A first valve includes a valve seat and a flexible valve cover seated thereon defining a normally-closed fluid-tight seam therebetween. The valve cover relative to moves from the valve seat to allow substance through the seam and out of the dispenser. A second valve allows substance from the storage chamber into the dosage chamber and substantially prevents flow from the dosage chamber into the storage chamber. An actuator is manually movable between (i) a first non-actuated position, and (ii) a second actuated position extending into the dosage chamber for compressing a dose of substance therein, dispensing substance through the first valve. The elasticity of the actuator causes it to return to the first non-actuated position upon manually releasing the actuator.

Abstract: A pulmonary drug delivery system is disclosed, including a breath-powered, dry powder inhaler, and a cartridge for delivering a dry powder formulation. The inhaler and cartridge can be provided with a drug delivery formulation comprising, for example, a diketopiperazine and an active ingredient, including, peptides and proteins such as insulin and glucagon-like peptide 1 for the treatment of endocrine disease, for example, diabetes and/or obesity.

Abstract: A pulmonary drug delivery system is disclosed, including a breath-powered, dry powder inhaler, and a cartridge for delivering a dry powder formulation. The inhaler and cartridge can be provided with a drug delivery formulation comprising, for example, a diketopiperazine and an active ingredient, including, peptides and proteins such as insulin and glucagon-like peptide 1 for the treatment of endocrine disease, for example, diabetes and/or obesity.

Abstract: A breath-powered, dry powder inhaler, a cartridge, and a pulmonary drug delivery system are provided. The dry powder inhaler can be provided with or without a unit dose cartridge for using with the inhaler. The inhaler and/or cartridge can be provided with a drug delivery formulation comprising, for example, a diketopiperazine and an active ingredient, including, peptides and proteins such as insulin, oxyntomodulin and glucagon-like peptide.

Abstract: Described herein are an interactive apparatus and methods for sensing and measuring real-time characteristic patterns of a subject's use of a dry powder inhalation system. The inhaler device can be used in a wireless communication mode to communicate with a display to assess the subject's usage of the inhalation system concurrently as the inhalation is performed and thus the subject's inhalation can be evaluated as well as the performance of the inhalation system. The system can also detect the identity of the medicament, its dosage, lot, expiration, etc. and the characteristics profile of a dry powder formulation emitted from the inhalation system in use.

Abstract: A modular inserter assembly for use in inserting an interbody fusion cage into the disc space between opposing vertebrae comprises a depth stop and a modular inserter tip releasably attached thereto. The modular inserter assembly includes a cage attachment surface for releasable attachment to an interbody fusion cage, the depth stop including a movable stop axially movable relative to the inserter tip and being sized and configured to engage an exterior surface of one of the vertebrae to establish the depth to which the interbody fusion cage is to be inserted in the disc space. A plurality of modular inserter tips, each being configured for selective releasable attachment to differently sized interbody fusion cages are provided in a kit with the depth stop.

Abstract: A disc preparation instrument for use in fusing spinal vertebrae comprises a modular scoring trial and a depth stop releasably attached to the scoring trial. The trial includes an elongate stem supporting a trial device at its distal tip. The trial device is insertable into a disc space and includes a rotatable rasp for scoring opposing vertebral endplates at a scored location. A stop, sized to engage an exterior surface of the vertebrae, is movable on the depth stop stem by rotation of an adjustment knob to a plurality of selectable distances between the proximal end of the trial device and the movable stop. An actuator releasably attached to the trial is operable to rotate the rasp. A plurality of modular trials, each having a trial device of different heights may be provided in a kit. Each scoring trial is selectively releasably attachable to a single depth stop.

Abstract: A breath-powered, dry powder inhaler, a cartridge, and a pulmonary drug delivery system are provided. The dry powder inhaler can be provided with or without a unit dose cartridge for using with the inhaler. The inhaler and/or cartridge can be provided with a drug delivery formulation comprising, for example, a diketopiperazine and an active ingredient, including, peptides and proteins such as insulin, oxyntomodulin and glucagon-like peptide.