Abstract: An auto-injector automatically dispenses a predetermined dose of medicament upon activation. The auto-injector includes a needle cover operative to engage an injection site and activate the injector. The needle cover is configured to move from a locked retracted position prior to a medicament dispensing operation to a locked extended position after the medicament dispensing operation. The non-removable needle cover prevents contact with the needle both before and after the medicament dispensing operation.

Abstract: This invention relates to methods, apparatuses and systems for testing the functionality of the pumping mechanism of a medical device, e.g., an implantable infusion pump, while the medical device is contained within a shipping package. The test apparatus enables such functional verification, without opening the shipping package, when the medical device is still contained within the package that has been appropriately sealed to maintain sterility of the medical device.

Abstract: In various embodiments, multiple pumps may be used to deliver substances to multiple respective animals. A computer system may send/receive information to/from the pumps (e.g., to control and monitor various aspects of the pumps and/or store information associated with the pump). In some embodiments, the computer system may determine respective controlled delivery rates for the pumps (e.g., based in part on a weight of an animal receiving the substance from the respective pump) and send the determined controlled delivery rates to the respective pumps. The computer system may also receive user identifications from operators controlling a pump (e.g., in response to a pump alarm) and documentation indicators entered by the operator and/or pump to use in documenting pump activity.

Abstract: In various embodiments, multiple pumps may be used to deliver substances to multiple respective animals. A computer system may send/receive information to/from the pumps (e.g., to control and monitor various aspects of the pumps and/or store information associated with the pump). In some embodiments, the computer system may determine respective controlled delivery rates for the pumps (e.g., based in part on a weight of an animal receiving the substance from the respective pump) and send the determined controlled delivery rates to the respective pumps. The computer system may also receive user identifications from operators controlling a pump (e.g., in response to a pump alarm) and documentation indicators entered by the operator and/or pump to use in documenting pump activity.

Abstract: A single-use indicator is provided and is particularly well suited for use with a surgical catheter device. The indicator includes an absorbent filament or wick which is placed in a transparent or translucent indicator lumen of a multi-lumen catheter. The lumen is provided with at least one side port. When the catheter is inserted into a blood vessel, blood enters the indicator lumen through the side port and is absorbed by the filament, thus turning the filament red or purple in color. When the instrument is removed from the blood vessel, the stained filament is clearly visible as an indicator that the instrument has been used. Because the filament is trapped inside a lumen of a relatively long catheter, it is difficult or impossible to remove it during a remanufacturing process.

Abstract: One embodiment provides an extravasation detection device having an enclosure, an attachment coupled to the enclosure to be removably connected to a patient, and a detection assembly enclosed within the enclosure, in this embodiment, the detection assembly includes a housing and a transducer coupled to the housing to generate a signal representative of a force or pressure applied to the detection device caused by extravasation of medical fluid from the patient. This embodiment of a detection device may be attached to the patient's hand or other injection site. When extravasation occurs, and a swelling or blister presses against the transducer, an alarm can be triggered to warn a clinician, or the device can cause a powered injection system to automatically shut down or halt the injection process.

Abstract: A syringe includes a cylindrical body having a distal end and a proximal end, an injection section at the distal end and an expansion section at the proximal end, the injection section and the expansion section being connected by a cylindrical center section of relatively uniform outer diameter. The injection section includes a conical portion and an injection neck, the conical portion including an alignment flange extending outward from at least a portion of the conical portion. The syringe further includes a plunger movably received in the body and having a coupling end with a pair of flexible coupling members defining a slot therebetween for engaging a drive piston of an injector, the slot being substantially aligned with the alignment flange such that the alignment flange provides an indication of the orientation of the slot, the plunger seated for storage in the expansion section.

Abstract: Implantable infusion apparatus, systems and methods that involve the use of a sensor that is associated with the catheter outlet.

Abstract: A device for administering an injectable product including a housing, a viewing element formed on or in the housing to create a view area, an emptying display movable inside and/or relative to the housing at least partially in or through the view area, and a view release member movable relative to the housing, wherein the visiability of the emptying display can be changed, reduced or eliminated by moving the view release member.

Abstract: The present invention relates to a medication delivery device for expelling set doses of medicament, the medication delivery device comprising a position determining assembly for detecting absolute positions of a rotatably mounted member arranged within the device, the position determining assembly comprising a plurality of transmitter electrodes arranged on a first exterior surface part of the rotatably mounted member, a plurality of receiver electrodes arranged on a second exterior surface part of the rotatably mounted member. A number of transmitter electrodes form pairs of interconnected electrodes with a number of receiver electrodes. A reading assembly fixedly arranged relative to for example the housing of the medication delivery device is also provided.

Abstract: Methods and systems of patient treatment are disclosed. The methods and systems include use of medical device informatics to modify and validate therapies and drugs used in those therapies. In certain embodiments, a medical device, such as a medical infusion pump, interfaces with a server to administer the patient treatments. In one aspect, a method of scheduling maintenance of a medical device is disclosed. The method includes storing a medical device maintenance schedule on a computing system remote from the medical device, the medical device maintenance schedule including a reminder to perform maintenance on the medical device. The method further includes transmitting the reminder from the computing system to the medical device.

Abstract: A closure piece (1) for a medical syringe is provided, the syringe having a syringe barrel (3) and a syringe neck (23). The closure piece has an adapter (6) which can be fitted onto the syringe neck (23). A screw-type closure piece (4) can be fitted onto the adapter (6). A twist-off ring (13) is connected to the screw-type closure piece (4). A closure cap (5) can be introduced into the syringe neck (23).

Abstract: Syringe assemblies having a passive disabling system to prevent reuse are provided. In one embodiment, the passive disabling system activates after completion of an injection cycle. An exemplary syringe assembly incorporates a stopper and plunger rod attached in a manner to prevent users from disassembling the syringe prior to completion of the injection cycle. The barrel may also include an annular extension or collar that extends from the proximal end of the barrel. In a specific configuration, the annular extension at least partially envelopes a portion of the thumb press to prevent the user from accessing the thumb press and moving the plunger rod in a proximal direction Syringe assemblies of one or more embodiments also include visual indicators or markers indicating whether a syringe assembly is used or the plunger rod is locked within the barrel.

Abstract: A manual syringe (10) includes a disposable syringe cylinder (12), a disposable piston (14) and a disposable piston rod (16). The piston rod (16) includes a position encoder (18). A piston-position indicator means (22) coupled to the position encoder (18) is fixedly assigned to the syringe cylinder (12). The piston-position indicator means (22) is reusable and is adapted to be detached from the syringe cylinder (12).

Abstract: A medical syringe apparatus includes a syringe unit, a hypodermic needle attached to the syringe unit and at least one interfacing member for mating a labeled medication container to the syringe unit. The medication label is visible. The container remains mated to the syringe when the syringe is in use. Risk of mislabeling the syringe may therefore be substantially reduced or eliminated and patient safety may accordingly be improved.

Abstract: Methods and systems for determining whether an implanted catheter used to deliver fluids to a selected internal delivery site is malfunctioning. The malfunctions may include that the infusion section of the catheter is not located at or has migrated away from the selected internal delivery site, is leaking, is blocked, etc. The determination is made by analyzing the pressure modulation of fluid within the catheter and determining whether the pressure of the fluid in the catheter is modulated by physiologic pressure changes experienced at the selected internal delivery site. The physiologic pressure modulations at the selected internal delivery site may be caused by, e.g., cardiac activity, respiration, changes in patient's posture, etc.

Abstract: A tamperproof retractable non-reusable syringe has a one piece hollow outer body with a barrel for a slidable plunger, a transition zone and a smaller diameter nose portion. An elongated needle holder and spring combination is installable from the rear of the outer body, guided into the nose portion and held by cooperating inwardly and outwardly facing surfaces oriented in the direction of retraction at the most constricted part of the transition zone where the nose begins. The plunger has an opening with a dislodgable stopper for receiving parts of the retraction mechanism. The stopper and the head of the needle holder are of significantly reduced diameter from the injection fluid chamber to resist blowing out prematurely. In one embodiment the head of the needle holder is surrounded by a separable retainer member which is slidingly removed by contact with the tip of the plunger after the stopper is mostly or fully removed to avoid cumulation of force required for retraction after the injection.

Abstract: According to one exemplary embodiment, a tamper evident cap for placement on a syringe includes a first section for placement about a luer tip of the syringe and a second section for placement above the luer tip when the cap is placed on the syringe. The second section has a slot formed therein that is defined by a ceiling and an opposing floor. The cap also includes a slider received within the slot and being slideable in the slot from at least an open position where the luer tip is accessible through the second section for filling the syringe and a locked position where the luer tip is covered by the slider and access to the luer tip is prevented.

Abstract: The tamper-evident closure is provided for a syringe with a Luer connection or a Luer lock connection, wherein at least the connection end consists of plastic. A cap which is connected to the syringe via at least one frangible web. The cap and the frangible web together with a fixation component are formed as one piece as a plastic injection molded part and are connected to the connection end of the syringe by way of welding.

Abstract: An access device including access site is disclosed for providing access to a medical fluid flow path for the introduction or withdrawal of medical fluids to and from the flow path. The access device includes an indicator for providing a visual indication when the access device has been exposed to an antiseptic agent.

Abstract: An external infusion device comprising a housing, a motor contained within the housing, programmable electronics, a fluid reservoir, and a reservoir sleeve, where the fluid reservoir is encapsulated by the reservoir sleeve. The reservoir sleeve may be made of rubber, neoprene, or the like, and may be supported by a metal mesh-like frame support structure that is infused within the material. Additionally, the fluid reservoir may be made of plastic or glass, and contain insulin or other fluids for administering to humans.

Abstract: A tamper evident tip cap assembly for a prefilled dosage syringe having a tip cap wherein a sleeve is frangibly connected to the tip cap, and is captured within an overcap freely rotatable thereon. The tamper evident tip cap assembly is removed from the syringe tip cap by pulling the overcap to break the frangible connection between the sleeve and syringe tip cap.

Abstract: Applicator for inserting an object such as a tampon into a natural orifice of the human body, comprising the said object inserted in a tubular outer and a plunger intended to expel the said object such as a tampon from the tubular outer. The applicator comprises a flexible sleeve fixed concentrically to the outer, folded initially between the distal end of this outer and the object such as a tampon, the length of the deployed sleeve corresponding substantially to that of the object. The flexible sleeve deploys around the object such as a tampon when the latter leaves the outer under the effect of the plunger.

Abstract: The device comprises a container with a manually displaceable plunger, the container being extended, forming an integral assembly, on a connection piece and a tubular element which has the filling opening at its end, which tubular element has an intermediate membrane filter for preventing the entry of harmful germs, the device also having anti-tamper security means in the portion disposed between the outlet from the container for the infusion liquid and the filter.

Abstract: An access device including access site is disclosed for providing access to a medical fluid flow path for the introduction or withdrawal of medical fluids to and from the flow path. The access device includes an indicator for providing a visual indication when the access device has been exposed to an antiseptic agent.

Abstract: Various present invention devices enable adherence to requirements for medical items. A medical item of the present invention includes a monitoring or data recording device to monitor and/or record medical solution conditions. The device may further include indicators to indicate compliance of the medical solution with prescribed requirements (e.g., manufacturer, medical standard or regulation, etc.). The medical item may alternatively include a barcode or transponder to uniquely identify the medical item to a thermal treatment system measuring and storing conditions in a central database. The present invention further includes various thermal treatment systems that monitor medical items for prescribed requirements and display the monitored parameters to medical personnel. In addition, the present invention may place time stamp information on medical items to enable determination by medical personnel of compliance with prescribed requirements.

Abstract: Valve syringes of the invention include a barrel, a plunger and an applicator valve. The applicator valve, which controls the flow of the fluid material contained within the barrel, can rotate at the end of the barrel between an open position and a closed position. In the open position, slots in the applicator valve align with holes in the barrel and allow the fluid material to flow therethrough. In the closed position, a contact surface seals the holes in the barrel closed to prevent the flow of the fluid material therethrough. The applicator valve includes an applicator tip that is either integrally connected to or detachably connected with the applicator valve. The valve syringe also includes means for releasably securing the applicator valve in the closed position to prevent undesired leaking and evaporation during periods of nonuse.

Abstract: The present invention relates to pre-filled tamper evident syringe assemblies, including a tubular syringe body with a nose portion for receiving a hollow needle communicating with the interior of the syringe body, a needle cap for protecting at least the nose portion and a label bonded to an outer surface of the syringe body. The tamper evident feature of such an assembly is provided by a simple construction. Therefore, at least a portion of the needle cap adjacent to the syringe body is of essentially the same diameter as the syringe body, and the label of the syringe body extends onto the needle cap and is bonded and/or positively engaged thereto, so as to produce evidence of tampering when the needle cap is removed.

Abstract: An injection syringe of the present invention comprises a hollow barrel, a needle seat and a plunger. The top of hollow barrel comprises an axial extension which has an upper channel and a lower channel for forming a positioning spring and a seal spring. The inside of the barrel where it is coupled to the axial extension has at lest one piercer. The needle seat is placed in the hollow barrel, and bottom radius of a body of the needle seat is larger than the top of the body for tightly fastening with the seal spring. The top of needle seat has a needle head seat which includes a plurality of positioning sheets thereon and the needle seat is positioned inside the axial extension by a channel of the needle head seat.

Abstract: Various present invention devices enable adherence to requirements for medical items. A medical item of the present invention includes a monitoring or data recording device to monitor and/or record medical solution conditions. The device may further include indicators to indicate compliance of the medical solution with prescribed requirements (e.g., manufacturer, medical standard or regulation, etc.). The medical item may alternatively include a barcode or transponder to uniquely identify the medical item to a thermal treatment system measuring and storing conditions in a central database. The present invention further includes various thermal treatment systems that monitor medical items for prescribed requirements and display the monitored parameters to medical personnel. In addition, the present invention may place time stamp information on medical items to enable determination by medical personnel of compliance with prescribed requirements.

Abstract: A prefilled syringe of cartridge barrel having a tamper evident closure. Tamper evidence is provided by: a frangible tip seal which is integral with the tapered tip of the barrel; a frangible tip cap covering the tip, the tip seal and a portion of the distal end of the barrel; and an overwrap covering the frangible tip cap and the distal end of the barrel sealed to the distal end of the barrel by a tamper evident seal. The tapered tip is optionally equipped with a luer collar to receive an external luer connector. Alternatively, the tapered tip can be provided with a bore therethrough which can be closed with an elastomeric plug and the external connector can be a tubing conduit.

Abstract: An improved tamper evident end cap assembly for a drug loaded syringe which assembly includes a syringe cap to close the discharge port in the nozzle of the syringe and an indicator ring about the nozzle connected by chads or tabs to a tubular shield which chads or tabs are adapted to break freeing the ring from the shield to loosely wobble on the nozzle indicating tampering if an axial force of separation is applied to the syringe cap to remove it from the syringe and a one way drive mechanism engaging both the shield and syringe cap so the shield may be rotated to advance the assembly onto a syringe nozzle but which is not responsive to counter rotation to withdraw the syringe cap to open the discharge port and gain access to the drug.

Abstract: The present invention provides a device for administering an injectable product in doses, the device including a casing, a container accommodated by the casing, a delivering appliance for delivering the product from the container, a drive for the delivering appliance, and a means for determining a malfunction of the device, wherein a vibrator motor is accommodated by the casing, the vibrator motor being triggered by the means for determining a malfunction such that it generates a vibrating alarm signal when a malfunction is determined.

Abstract: A prefilled syringe of cartridge barrel having a tamper evident closure. Tamper evidence is provided by: a frangible tip seal which is integral with the tapered tip of the barrel; a frangible tip cap covering the tip, the tip seal and a portion of the distal end of the barrel; and an overwrap covering the frangible tip cap and the distal end of the barrel sealed to the distal end of the barrel by a tamper evident seal. The tapered tip is optionally equipped with a luer collar to receive an external luer connector. Alternatively, the tapered tip can be provided with a bore therethrough which can be closed with an elastomeric plug and the external connector can be a tubing conduit.

Abstract: A system for controlling an implantable medical device (e.g., a drug delivery device) susceptible to malfunctioning during exposure to a magnetic field and/or Radio Frequency field (e.g., during a magnetic resonance imaging procedure) and a method for operating the same. Exposure of the implantable device to the magnetic field and/or the Radio Frequency field is detected using the sensing device. When the detected magnetic field and/or Radio Frequency field exceeds a corresponding predetermined threshold level, an input signal is generated at the microcontroller.

Abstract: A one piece molded vacuum tube holder is fitted with a one piece molded needle hub assembly. A needle protection device is further rotatably mounted to the neck of the one piece vacuum tube holder. One portion of a locking mechanism is provided at the neck of the one piece vacuum tube holder and a second portion of the locking mechanism is provided at the needle hub of the needle hub assembly, so that when the needle hub assembly is press fit to the vacuum tube holder, the two portions of the locking mechanism will coact to fixedly retain the needle hub assembly within the vacuum tube holder. The one piece vacuum tube holder is configured to have an elongate needle cover integrally extending from its neck. A tamper evident notched joint is provided at the junction where the needle cover is connected to the neck.

Abstract: A tamper evident protective cap for a prefilled syringe having a pharmaceutical or biological fluid is provided. The barrel of the container is equipped with a ring. The protective cap consisting of top and bottom portions are connected by a frangible area. The bottom portion contains a flange to engage the ring. Once the flange is engaged to the ring, the engagement prevents the removal of the tamper evident cap unless the top portion is intentionally separated from the bottom portion at the frangible area. If the top portion is intentionally separated, the bottom portion will remain engaged to the ring and the disengaged top portion will indicate tamper evidence.

Abstract: A device for monitoring the service life of injection devices, including needleless injection devices. A method for monitoring the service life of needleless injection devices is also encompassed.

Abstract: The invention provides a safety syringe for extracting blood, with retractable or removable needle that can be retracted into the syringe body or removed after use and safety locks that lock the retractable needle in an extended position during use and in a retracted position after use to ensure that the syringe is not reused or that the needle is not inadvertently extended. When retracted, the needle assembly is cocked at an angle identifying the syringe as used and adding further protection to prevent the needle from being inadvertently extended and exposed from the tube. These safety features work in conjunction to enhance the usability and increase the safety of the syringe. Thereby protecting medical workers from being injured by an exposed needle or contaminated by disease or infection from contact with the patient's blood present on a used needle.

Abstract: In a fluid delivery system for delivering a fluid into an individual's body, a leak detection system indicates that the fluid has leaked outside a normal fluid path of the fluid delivery system, such as near an infusion site or a fluid-filled reservoir. Preferably, the leak detection system includes a chemical positioned near the infusion site that reacts with preservatives in the leaking fluid to generate a highly visible, brightly colored, chemical complex. Alternatively, mechanical, electro-optical, electrochemical, electrical or other chemical systems may be used to detect the presence of fluid that is leaking near the infusion site. Further, the leak detection systems may be used to detect the presence of fluid that is leaking from or near other locations within the fluid delivery system, such as on or near a fluid-filled reservoir, or a flexible tube coupled between the reservoir and the infusion site.

Abstract: The tamper-evident closure is provided for a syringe with a Luer connection or a Luer lock connection, wherein at least the connection end consists of plastic. A cap which is connected to the syringe via at least one frangible web. The cap and the frangible web together with a fixation component are formed as one piece as a plastic injection molded part and are connected to the connection end of the syringe by way of welding.

Abstract: A prefilled syringe of cartridge barrel having a tamper evident closure. Tamper evidence is provided by: a frangible tip seal which is integral with the tapered tip of the barrel; a frangible tip cap covering the tip, the tip seal and a portion of the distal end of the barrel; and an overwrap covering the frangible tip cap and the distal end of the barrel sealed to the distal end of the barrel by a tamper evident seal. The tapered tip is optionally equipped with a luer collar to receive an external luer connector. Alternatively, the tapered tip can be provided with a bore therethrough which can be closed with an elastomeric plug and the external connector can be a tubing conduit.

Abstract: A shielded, sterile, single-use unit dose needle assembly includes a unit dose needle with a hub and two packaging shields sealingly mated to one another encasing the hub and unit dose needle. The unit dose needle has a handle end and a patient end configured to hold a unit dose of a vaccine. The hub is fixedly attached to the unit dose needle between the handle end and the patient end. The first packaging shield extends over the patient end, and the second packaging shield extends over the handle end of the unit dose needle. The first and second packaging shields are removably attached to one another to form an air-tight sterility seal, with the unit dose needle contained within the first packaging shield.

Abstract: An improved tamper evident end cap assembly for a drug loaded syringe which assembly includes a syringe cap to close the discharge port in the nozzle of the syringe and an indicator ring about the nozzle connected by chads or tabs to a tubular shield which chads or tabs are adapted to break freeing the ring from the shield to loosely wobble on the nozzle indicating tampering if an axial force of separation is applied to the syringe cap to remove it from the syringe and a one way drive mechanism engaging both the shield and syringe cap so the shield may be rotated to advance the assembly onto a syringe nozzle but which is not responsive to counter rotation to withdraw the syringe cap to open the discharge port and gain access to the drug.

Abstract: A safety syringe employs a mechanical logic arrangement to control the movement of a spring-biased protective shield that covers the needle except during an injection, and which limits the number of injection cycles. The mechanical logic arrangement can include a series of parallel gated tracks, and a track follower pin disposed on the slide portion of the protective shield. There are one-way gates and redirection gates, which can be formed as flaps with a radial hinge in respect to the barrel axis. An alternative arrangement can employ a rotary cam. The number of injection cycles can be two or more, and the penetration depth for a given injection cycle can be controlled.

Abstract: An injection device is disposable, and is designed to have a reusable firing mechanism fitted to its rear end. A syringe carrier within the barrel of the device is initially locked in a position with the needle of the syringe retracted by a locking element inserted laterally through the barrel. This element also holds an axially movable connector to which the firing mechanism connects. The device is made operable by removal of the locking element, and after use a return spring ensures that neither the syringe carrier nor the connector assume positions where the locking element can be reinserted. An adaptor may be provided to facilitate preparing a syringe with a two-component dose, and for disposal after use the adaptor with an empty vial still attached can be fitted to the rear end of the injection device in place of the firing mechanism.

Abstract: A simple mechanism that provides the manipulations required to deliver a correct injection and also incorporates the safety modifications that are needed to prevent needlestick injury and ensure self destruct capability. A surprisingly simple and cheap modification to a sterile package for the standard syringe and needle can successfully be used to automate the medical skills needed to deliver a safe injection and dispose of the hazardous needle afterwards. The sterile package consists of a housing for the syringe barrel, which can telescope into a larger diameter hollow cap covering the syringe plunger. The syringe and needle are located fully inside this two-part packaging sheath, which completely encloses and protects them.

Abstract: A single-use syringe has a barrel which can constitute a one-piece extrusion, and a shank which is reciprocably guided in the barrel and the distal end of which carries a plunger movable in the barrel toward and away from the needle-carrying front end portion of the barrel. The coupling between the plunger and the shank includes a set of circumferentially spaced-apart breakable spokes which can be of one piece with the distal end of the shank as well as with the plunger. The spokes break not later than when the shank completes a forward stroke during which the plunger expels a flowable substance, such as a medicine, from a chamber located in the barrel between the needle-carrying front end portion and the plunger. The plunger, the spokes and the shank can constitute a one-piece extrusion.

Abstract: A safety syringe with a hollow barrel housing and a retraction trunk coaxially formed within the housing to forming an annular chamber between the inner surfaces of said outer elongated hollow barrel and the outer surface of said retraction trunk. A needle cannula carriage is held within the distal end of the retraction trunk by a latching means and a biasing means. A needle cannula module is suitably fixed to the distal end of the needle cannula carriage wherein a cannula or passage provides fluid communication from the needle cannula module, through the needle cannula carriage, through the retraction trunk and into the annular chamber. An annular plunger is provided between the inner surfaces of the outer elongated hollow barrel and the outer surface of the retraction trunk, wherein said annular plunger forces fluid through said annulus and into a body.

Abstract: An improved tamper evident end cap assembly for a drug loaded syringe which assembly includes a syringe cap to close the discharge port in the nozzle of the syringe and an indicator ring about the nozzle connected by chads or tabs to a tubular shield which chads or tabs are adapted to break freeing the ring from the shield to loosely wobble on the nozzle indicating tampering if an axial force of separation is applied to the syringe cap to remove it from the syringe and a one way drive mechanism engaging both the shield and syringe cap so the shield may be rotated to advance the assembly onto a syringe nozzle but which is not responsive to counter rotation to withdraw the syringe cap to open the discharge port and gain access to the drug.