Abstract: A safety shield system for a needle cannula of a pen needle injector or similar device, wherein the safety shield may be retracted from a first position enclosing the needle to a second position exposing the needle for injection. The safety shield system permits retraction of the safety shield during use, but extends the shield enclosing the needle in a locked position following use. The shield system is utilized with a pen needle injector having a double ended needle cannula mounted in a hub received on the open end of the pen needle injector. The assembly is disposed of by removing the assembly and needle cannula hub and storing the assembly in the cup-shaped cap enclosing the exposed end of the needle cannula within the cap. The cap includes internal radial ribs preventing retraction of the shield prior to removing the cap preventing inadvertently piercing the cap during assembly.

Abstract: A system and method for identifying a biological sample associated with a container is disclosed. A universally unique identifier is associated with each container. In one or more embodiments, the identifier comprises one or more markings having a specular reflectance which differs from the specular reflectance of the outer surface of the container adjacent the markings. A detection apparatus detects the differences in specular reflectance light to identify the identifier associated with the container. The identifier is associated with certain information regarding the container and biological sample. From that point forward, any information about the contents of the container may be retrieved by searching on its container ID. Because the container ID is assured by its manufacturer to be universally unique, the container and sample may move from one organization to another under the same identifier, and information about the contents of the container may be shared by querying on its container ID.

Abstract: A closed loop therapy system for controlling a concentration of a substance, such as blood glucose concentration, in the body of a user. The system and method employ a sensor system that measures a glucose level in the body, a controller that uses the measured glucose levels to generate an output that can be used to automatically or manually control an intradermal insulin infusion system to set a constant or time-varying profile of target blood glucose concentrations in a user, and then infuse an appropriate amount of insulin into the body of the user so as to reach and maintain the target values of the blood glucose concentration.

Abstract: The present device and method includes a handle, a blade connected to the handle, and a guard slidably mounted partially within the handle for sliding movement between a retracted position in which the blade is exposed for use, and an extended position for covering the sharp cutting edge of the blade. In the retracted position, an exposed guard radius is provided at the distal end of the handle to allow improved handle control and blade orientation. The exposed guard radius is positioned to allow the user to firmly grip a large distal handle portion which is molded as a single piece with the blade holder, preventing unwanted blade or handle movement due to guard mechanism tolerances. A leaf spring and detent is provided to fix the guard in the extended and retracted position, and provide slight resistance during movement between each position. Additionally, an antitravel mechanism is incorporated in the guard to prevent accidental retraction from the fully extended position.

Abstract: The present invention is a mechanical contrivance integrated into the closure of a sharps collector. It is intended to allow for the safe removal and disposal of a used pen needle from a pen syringe device. The pen syringe, with the used pen needle attached, is inserted into the specially designed port of the present invention. The pen syringe is then rotated counterclockwise about its longitudinal axis. The pen needle itself is constrained by at least one tooth, which only allows the pen needle one degree of freedom (linear displacement along its longitudinal axis). These conditions cause the pen needle to be unthreaded from the pen syringe, such that when the pen syringe is withdrawn from the port, a tang then blocks the pen needle from being withdrawn with the pen syringe, and the used pen needle falls into the sharps collector without the use of a secondary operation.

Abstract: A medication delivery pen having a magnifier, a spring biased leadscrew and a mechanism to allow the user to easily reset the dose on the medication delivery pen if the user requires a smaller dose than has been set.

Abstract: A system and method for identifying a biological sample associated with a container is disclosed. A universally unique-identifier is associated with each container. In one or more embodiments, the identifier comprises one or more markings having a specular reflectance which differs from the specular reflectance of the outer surface of the container adjacent the markings. A detection apparatus detects the differences in specularly reflected light to identify the identifier associated with the container. The identifier is associated with certain information regarding the container and biological sample. From that point forward, any information about the contents of the container may be retrieved by searching on its container ID. Because the container ID is assured by its manufacturer to be universally-unique, the container and sample may move from one organization to another under the same identifier, and information about the contents of the container may be shared by querying on its container ID.

Abstract: A system and method are provided for estimating the initial level of an analyte in a sample based on an actual level observed, a time of storage of the sample, a storage temperature, and a type of container in which said sample is stored. Equations are generated for a particular analyte based on observations of actual analyte levels initially after a sample is drawn, as well as at various times thereafter. The time of storage, the temperature of storage, and the type of container are observed along with actual analyte level in each observation. The equations generated are considered useful if the estimated initial values are more accurate than the actual observed final values.

Abstract: The present invention is a label system and method for label alignment and placement on a container. The label system includes a first label or a container whereby the first label includes alignment symbology and a second label having an alignment area corresponding to the alignment symbology of the first label. The second label is positioned on the container whereby the alignment area of the second label is aligned with the alignment symbology of the first label. The method for label alignment and placement comprises the steps of (i) providing a container with identification information and a label bearing area; (ii) scanning the identification information; (iii) processing the identification information; (iv) printing indicia on a label at a position defined by the identification information; and (v) placing the label on the container with the indicia positioned at the desired predetermined location.

Abstract: An apparatus and method of providing a flexible needle assembly for use with a medication delivery pen. The flexible needle assembly includes a needle cannula having proximal and distal points and a hub coupled to the needle cannula. The hub includes a flexible roof, or ball-and-socket arrangement, that permits the needle cannula to move about the centerline of the hub. The flexible roof can include one or more concentric ribs to enhance flexibility of the needle cannula about the centerline of the hub.

Abstract: The present invention provides systems and methods for simulating certain regions of the anatomy involved in ophthalmological surgery. In particular, the present invention provides a practice cornea simulating dimensional, geometric and mechanical properties of a human cornea. In one embodiment, the practice cornea is seated in tight apposition to a simulated iris that is characterized by dimensional and geometric properties similar to a human iris. The practice cornea seated upon the simulated iris may be inserted into an aperture in a simulated sclera, forming therewith a smooth surface similar to that found in the anterior part of the human eye. The simulated sclera may be provided with dimensional and geometric characteristics resembling the human sclera. The combination of these elements provides an anatomic replica of the anterior part of the human eye upon which surgeons may realistically practice surgical techniques, in particular corneal incisions.

Abstract: A wearable, self contained drug infusion device is disclosed that is capable of achieving the precise flow rate control needed for dose-critical drugs such as insulin. In preferred embodiments of the device, piezoelectrically-actuated valve or pump structures are used in combination with thermal flow sensors and closed-loop control circuits for providing the desired flow rate control. The device has a two-part construction in which the more expensive electronic components are housed in a reusable portion and the fluid delivery components are housed in a separable disposable portion. The invention may also utilize a wireless unit for controlling the operation of the drug infusion device.

Abstract: A medication delivery pen includes a housing having opposing proximal and distal ends. An actuator is disposed in the proximal end of the housing for setting and administering a dosage of medication. The pen also includes a medication-containing cartridge assembly having a cartridge with a pierceably sealed distal end, an open proximal end removably attachable to the distal end of the housing, and a piston in sliding fluid tight engagement within the cartridge. A drive mechanism is coupled between the actuator and the cartridge to exert an axial force on the piston to inject the set dosage of medication. The actuator triggers the drive mechanism to administer the injection of medication held in the cartridge. A processor is coupled to the actuator to determine a value equal to the dosage set by the actuator. A memory device is coupled to the processor to store at least the dosage value determined by the processor.

Abstract: A lancer device that enables a user to draw blood from a patient and discard the used lancet without touching it. The device also has an adjustable tip for selecting the depth of stylet penetration into the patient and a triggering mechanism that utilizes a yoke latch and a leaf spring to discharge the lancet. The lancer also has a dampening feature to reduce vibrations when the lancet is moving.