Abstract: A system and method for a patch-like, self-contained multi-component substance infusion device which provides one or more substantially hidden patient needles which can be placed in fluid communication with a fluid reservoir assembly that includes a rigid bladder portion used in conjunction with a non-distensible bladder film, such as a metallized film. The device can be attached to a skin surface via an adhesive contact and a pressurization system provides a pressure to the contents of a fluid reservoir assembly. Improvements to dry powdered formulations for reconstitution for preferred use in the device are also disclosed.

Abstract: A system and method for a patch-like, self-contained multi-component substance infusion device which provides one or more substantially hidden patient needles which can be placed in fluid communication with a fluid reservoir assembly that includes a rigid bladder portion used in conjunction with a non-distensible bladder film, such as a metallized film. The device can be attached to a skin surface via an adhesive contact and a pressurization system provides a pressure to the contents of a fluid reservoir assembly. Improvements to dry powdered formulations for reconstitution for preferred use in the device are also disclosed.

Abstract: An apparatus, a closed-loop system and method for measuring the resistance of inhalation systems and/or devices are disclosed.

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 system and method for a patch-like, self-contained substance infusion device which provides one or more substantially hidden patient needles which can be placed in fluid communication with a fluid reservoir subassembly that includes a rigid bladder portion used in conjunction with a non-distensible bladder film, such as a metallized film. Simple removal of an interlock allows a disk, or Belleville spring assembly to apply an essentially even and constant pressure to the contents of the fluid reservoir assembly, and allows the device to then be attached to a skin surface via an adhesive contact surface. A push button activation assembly is provided which can then be used to release and seat one or more spring-loaded patient needles into the skin surface, and establish a fluid communication path between the patient needles and the pressurized fluid reservoir contents thereby delivering an infusion into the skin.

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: 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 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 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: Dry powder inhaler systems for pulmonary delivery of pharmaceuticals are disclosed. The dry powder inhalation systems comprise a dry powder inhalation device or inhaler and a cartridge containing a pharmaceutical formulation comprising an active ingredient for delivery to the pulmonary circulation. The present devices provide rugged devices which are reusable, use pre-metered unit dose cartridges which deliver a medicament in a liner manner, and can be disassembled for cleaning. The devices also provide a high resistance inhalation system which enables deagglomeration of dry powder particles, have a consistent airflow, are easy to manufacture and are simple and relatively easy to use.

Abstract: A system and method for a patch-like, self-contained substance infusion device which provides one or more substantially hidden patient needles which can be placed in fluid communication with a fluid reservoir subassembly that includes a rigid bladder portion used in conjunction with a non-distensible bladder film, such as a metallized film. Simple removal of an interlock allows a disk, or Belleville spring assembly to apply an essentially even and constant pressure to the contents of the fluid reservoir assembly, and allows the device to then be attached to a skin surface via an adhesive contact surface. A push button activation assembly is provided which can then be used to release and seat one or more spring-loaded patient needles into the skin surface, and establish a fluid communication path between the patient needles and the pressurized fluid reservoir contents thereby delivering an infusion into the skin.

Abstract: Disclosed herein is a blood collection system comprising a blood collection tube, a tube holder, and a self-blunting blood collection needle. A blunting member is deployed upon withdrawal of a blood collection tube from the tube holder, to blunt the needle and so safeguard the patient and the technician from inadvertent needle sticks. The blunting member is retracted to re-sharpen the needle when a subsequent collection tube is inserted into the holder. The mechanism effects blunting and re-sharpening of the needle without requiring that the technician manipulate the mechanism in a manner different from that of conventional, non-blunting blood collection needles. Four types of mechanisms are disclosed: a rack and pinion mechanism; a cylindrical cam mechanism; lever mechanisms and a reversing strap mechanism.

Abstract: A system and method for a patch-like, self-contained substance infusion device which provides one or more substantially hidden patient needles which can be placed in fluid communication with a fluid reservoir subassembly that includes a rigid bladder portion used in conjunction with a non-distensible bladder film, such as a metallized film. Simple removal of an interlock allows a disk, or Belleville spring assembly to apply an essentially even and constant pressure to the contents of the fluid reservoir assembly, and allows the device to then be attached to a skin surface via an adhesive contact surface. A push button activation assembly is provided which can then be used to release and seat one or more spring-loaded patient needles into the skin surface, and establish a fluid communication path between the patient needles and the pressurized fluid reservoir contents thereby delivering an infusion into the skin.

Abstract: The present invention relates to a blood collection system comprising a blood collection tube, a tube holder, and a self-blunting blood collection needle. A blunting member is deployed upon withdrawal of a blood collection tube from the tube holder, to blunt the needle and so safeguard the patient and the technician from inadvertent needle sticks. The blunting member is retracted to re-sharpen the needle when a subsequent collection tube is inserted into the holder. The mechanism effects blunting and re-sharpening of the needle with requiring that the technician manipulate the mechanism in a manner different from that of conventional, non-blunting blood collection needles. Four types of mechanisms are disclosed: a rack and pinion mechanism; a cylindrical cam mechanism; lever mechanisms and a reversing strap mechanism.

Abstract: A novel self-blunting needle apparatus (10d) employs a blunting member (70) and a needle (12). The blunting member (70) may be disposed within the needle (12) and may be adapted for fluid flow therethrough. The needle (12) may then be inserted into a patient's tissue and the blunting member (70) may be extended to blunt the apparatus. In other embodiments, e.g., apparatus (10), a driver (76) may be employed to move the blunting member (70) without obstructing fluid flow. There may be a locking spline (58) and cam channel (30) configuration to prevent backward motion of the blunting member (70) in various embodiments. A hollow body (22) is configured to facilitate assembly.

Abstract: A novel self-blunting needle apparatus (10d) employs a blunting member (70) and a needle (12). The blunting member (70) may be disposed within the needle (12) and may be adapted for fluid flow therethrough. The needle (12) may then be inserted into a patient's tissue and the blunting member (70) may be extended to blunt the apparatus. In other embodiments, e.g., apparatus (10), a driver (76) may be employed to move the blunting member (70) without obstructing fluid flow. There may be a locking spline (58) and cam channel (30) configuration to prevent backward motion of the blunting member (70) in various embodiments. A hollow body (22) is configured to facilitate assembly.

Abstract: A self-blunting needle medical device comprises a needle cannula (18) fixed to a hub (20) having a receiving structure therein such as ferrule (22) and a movable blunting member (14) movably received within the cannula (18). Ferrule (22) defines a passage (38) extending therethrough, within which both the cannula (18) and the movable member (14) can be received and which establishes a coaxial relationship between them. The ferrule (22) defines a first guide surface (40) for directing the blunting end (14a) of the movable member (14) into the central bore of the cannula (18) during assembly. A second guide surface (42) performs the function of guiding the mounting end (18b) of the cannula (18) into ferrule (22) for mounting therein. Typically, the cannula (18) has a tissue puncture tip (18a). When the movable member (14) is retracted into the cannula (18), the puncture tip (18a) is exposed for use, e.g., injection into tissue.

Abstract: The present invention relates to a self-blunting blood collection needle (55) in which a blunting member (26a) is deployed upon withdrawal of a blood collection tube (56a) from the tube holder (e.g., 136), to blunt the needle (22) and so safeguard the patient and the technician from inadvertent needle sticks. The blunting member (26a) is retracted to re-sharpen the needle (22) when a subsequent collection tube is inserted into the holder (136). The deployment and retraction of the blunting member (26a) is accomplished with a mechanism (142) that is responsive to the insertion and withdrawal of the blood collection tube (56a) to retract and deploy the blunting member (26a) accordingly. One feature of the present invention is that the mechanism (142) effects blunting and re-sharpening of the needle without requiring that the technician manipulate the mechanism in a manner different from that of conventional, non-blunting collection needles.

Abstract: A self-blunting needle medical device comprises a needle cannula (18) fixed to a hub (20) having a receiving structure therein such as ferrule (22) and a movable blunting member (14) movably received within the cannula (18). Ferrule (22) defines a sleeve bore (38) extending therethrough, within which both the cannula (18) and the movable member (14) can be received and which establishes a coaxial relationship between them. The ferrule (22) defines a first guide surface (40) for directing the blunting end (14a) of the movable member (14) into the central bore of the cannula (18) during assembly. A second guide surface (42) performs the function of guiding the proximal end (18b) of the cannula (18) into ferrule (22) for mounting therein. Typically, the cannula (18) has a tissue puncture tip (18a). When the movable member (14) is retracted into the cannula (18), the puncture tip (18a) is exposed for use, e.g., injection into tissue.

Abstract: A self-blunting needle assembly (10) for use with a catheter (40), and a catheter assembly (50) attained by mounting the self-blunting needle assembly into a catheter are disclosed. The needle (12) includes a needle shaft (14) having a connector (18) thereon and a blunting device (28) including an elongate probe (30) having a retainer (32) thereon. The connector (18) engages the retainer (32) to provide a lost motion connection between the blunting device (28) and the needle (12). The needle assembly (10) is mounted within a catheter (40) by a force fit of the retainer into the hub chamber (42a) of the catheter, with the needle puncture tip (16) protruding beyond the catheter tube tip (46).