Abstract: Provided is a plunger including: a plunger body; a first surface configured to come into contact with an inner peripheral surface of the cylindrical member; a second surface disposed on a base end side relative to the first surface, the second surface having an outer diameter that is smaller than that of the first surface; an outer stepped surface disposed between the first surface and the second surface; a first housing disposed in an area at least partly corresponding to the second surface in the recess, the first housing being provided for housing a tip part of the pin; a second housing disposed on the base end side relative to the first housing, the second housing having an inner diameter that is smaller than a largest inner diameter of the first housing; and an inner stepped surface disposed between the first housing and the second housing.

Abstract: Disclosed herein are methods for overfilling primary packaging components, and drug products prepared according to those methods. The methods may include introducing a volume of a formulated drug substance into a primary packaging component having a nominal volume, where the volume of the formulated drug substance is greater than the nominal volume of the primary packaging component. In some cases, the primary packaging component may be a prefillable syringe.

Abstract: A reduced profile syringe assembly is provided that includes an overall profile that is substantially similar to a profile of a syringe barrel. The syringe assembly includes a plunger rod that is significantly disposed within the syringe barrel when filled for use, with the plunger rod adapted to be retracted from the syringe barrel during dispensing of contents of the syringe barrel.

Abstract: A catheter assembly comprising a catheter carried by a catheter adapter, a needle having a sharp distal tip and disposed in the catheter such that in a first needle position, the needle extends beyond the catheter, a damping mechanism fixed adjacent to a proximal end of the needle, and a barrel assembly configured to surround the damping mechanism, the barrel assembly including first and second inner diameters, wherein when the needle is retracted into the barrel assembly away from the first needle position, the needle moves in accordance with a needle retraction speed profile, and the needle retraction speed profile is based on the interaction between the first and second inner diameters of the barrel assembly and the damping mechanism.

Abstract: A container having a barrier layer is provided. The container may be of thermoplastic and the barrier may inhibit materials from leaching from the thermoplastic material or from extraction of compounds from medicants by the thermoplastic. A process is also described that allows for molding thin barrier layers as container lines and for forming thermoplastic containers with barrier liners.

Abstract: Disclosed herein are methods for overfilling primary packaging components, and drug products prepared according to those methods. The methods may include introducing a volume of a formulated drug substance into a primary packaging component having a nominal volume, where the volume of the formulated drug substance is greater than the nominal volume of the primary packaging component. In some cases, the primary packaging component may be a prefillable syringe.

Abstract: Method for coating a glass syringe body for a hypodermic pre-filled glass syringe, wherein at least one emulsion and/or one solution containing at least one layer-forming substance is applied to at least one inner surface of the hypodermic pre-filled glass syringe, which defines an axial direction, wherein at least a partial surface of the inner surface in a syringe cone of the pre-filled glass syringe is subsequently exposed to a plasma, wherein a negative pressure source is arranged in relation to the syringe cone in the axial direction opposite the atmospheric-pressure plasma source, wherein a negative pressure of less than atmospheric pressure is provided by means of the negative pressure source.

Abstract: The invention concerns the field of container closure integrity (CCI) and the testing of CCI and relates to a device and a method for leakage testing of a connection between a rubber stopper and a corresponding drug container which can be used for storing drugs under sterile conditions and which is closed by said rubber stopper.

Abstract: A stable biopolymer-based emulsion lubricant including Agar is provided to reduce the friction between a syringe barrel plunger and the interior surface of the syringe barrel. According to exemplary embodiments the emulsion has a friction of less than 4N, the emulsion is temperature stable in a range of 4-23 degrees Celsius and the emulsion is stable for a period of at least 60 days.

Abstract: A piston for a medical hollow body such as a syringe or a carpule includes at least one sliding surface for contact with the hollow body. The piston has at least one receiving area in which a lubricant can be received, and at least one dispensing mechanism for dispensing the at least one lubricant from the at least one receiving area to the at least one sliding surface.

Abstract: The present invention relates to a syringe, particularly to a small volume syringe such as a syringe suitable for ophthalmic injections.

Abstract: Medical articles with coatings are disclosed herein, as well as methods and systems for depositing these coatings onto medical articles. Surfaces of such articles may be coated. The coating(s) may serve as lubricants for reducing suction between such surfaces or between a coated surface and another surface.

Abstract: A plunger head moveable in an axial direction within a reservoir having an interior volume for containing fluidic media may have a first portion in contact with fluidic media when fluidic media is in the interior volume of the reservoir, the first portion comprising a first material compatible with fluidic media in the interior volume of the reservoir, a second portion located on an opposite side of the plunger head from the interior volume of the reservoir, the second portion connectable to a plunger arm, and a third portion located between the first portion and the second portion of the plunger head, at least one of the first portion, second portion, and the third portion is made of a material that comprises one of a cyclic olefin copolymer and a cyclic olefin polymer.

Abstract: A method for providing a saccharide based lubricating or protective coating or layer on a substrate surface is provided. In particular, a lubricity and/or protective coating or layer made by said method is provided. Pharmaceutical packages or other vessels coated by said method and the use of such pharmaceutical packages or other vessels protecting a compound or composition contained or received in said vessel with a protective coating against mechanical and/or chemical effects of the surface of the vessel without a protective coating material are also provided.

Abstract: A gasket for use in a syringe so formed as to liquid-tightly and slidably contact an inner surface of an outer cylinder of the syringe, the gasket including a gasket body made of an elastic body and a coating layer formed on a portion thereof which contacts at least the syringe, wherein the coating layer includes a composition containing a silicone resin which comprises a condensate of a reactive silicone resin having a terminal silanol group and which has a siloxane bond derived from the silanol group, and does not contain solid fine particles.

Abstract: Pre-loaded syringes for delivering an embolic agent are disclosed herein. Methods related to syringes pre-loaded with an embolic agent are also disclosed.

Abstract: An object of the present invention is to provide a syringe for prefilled syringe in which the adsorption of a low-molecular medical agent or a protein for a long term is precluded. In accordance with the present invention, the above-described object is achieved by a syringe for prefilled syringe including: a plunger in which a gasket is attached to a top; and a syringe barrel in which the plunger is slidably accommodated, wherein the surface of the gasket and the inner wall of the syringe barrel are subjected to surface modification with a polymer containing zwitterion.

Abstract: The present invention relates to a medicament delivery device comprising a housing (12); a medicament container (14) arranged within said housing; medicament delivery drive means (22, 24); manually operable release means (38); and a movement speed control mechanism (44, 46, 48) comprising at least one fixed, flexible and elongated compartment (48) containing a liquid, and at least one flexible speed control member (44, 46) connected to the medicament delivery drive means; wherein said at least speed control member is arranged to be pressing on said at least one compartment for forcing said liquid past said member and thereby creating a movement speed control of said medicament delivery drive means when moved.

Abstract: The present invention relates to a medicament delivery device (10) comprising a front housing (12) and a rear housing (14) connected to each other; a medicament container (18) disposed within the front housing (12), wherein the container (18) has a front opening with or for a delivery member for delivering the medicament therethrough and at least one movable stopper (25); and a compression spring (26) having a predetermined compressed length and a predetermined outer diameter, wherein the compressed length is the length of the spring when it is in a pre-tensioned state; wherein the device further comprises a first guide means comprising a front part (28) having a predetermined first length (61), a middle part (42) having a predetermined second length (62), and a rear part (34) having a predetermined third length (63), wherein said predetermined third length corresponds to the predetermined compressed length of the compression spring, wherein the front part (28) is arranged to be in contact with the movable st

Abstract: An article is described including an article surface, a primer coating or layer of SiOx, SiOxCy or SiNxCy applied to the article surface, and a deposit of lubricant applied to the primer coating or layer. The primer coating or layer of SiOx, SiOxCy or SiNxCy is applied by chemical vapor deposition of a polysiloxane or polysilazane precursor in the presence of oxygen. A first deposit of lubricant is applied to the primer coating or layer. The primer coating or layer improves the adhesion or wetting of the lubricant on the surface to be lubricated. Examples of such an article are a prefilled syringe having a barrel with a lubricated interior portion and a plunger tip that slides along it. Another example of such an article is a vial having a lubricated opening to receive a septum. Another aspect of the invention is a method of making such an article.

Abstract: In a pre-filled syringe having an intermediate gasket, a liquid drug is enclosed in the second chamber located on the base end side with respect to the intermediate gasket while a powdered drug is enclosed in the first chamber located on the front end side with respect to the intermediate gasket. The intermediate gasket has at least two layers including a front end layer corresponding to a wall of the first chamber and a base end layer corresponding to a wall of the second chamber, and also has a low water-absorptive layer in the layer on the base end side with respect to the front end layer. The base end layer is formed of a material having low water-absorptivity and not lowering a pH of the liquid drug.

Abstract: A stopper adapted for attachment with a plunger rod for use within a syringe barrel is disclosed. The stopper includes a main body defining an open rearward end and a closed front end. The open rearward end is adapted to receive a front forward end attachment portion of the plunger rod. The stopper also includes a core member integrally formed with the main body adjacent the closed front end. The core member includes a nose portion having a conical tip configured for entering an outlet opening of the syringe barrel. The closed front end of the stopper has a profile configured to cooperate with an internal surface of the syringe barrel wall to prevent reflux and reduce dead space within the barrel.

Abstract: Medical articles with coatings are disclosed herein, as well as methods and systems for depositing these coatings onto medical articles. Surfaces of such articles may be coated. The coating(s) may serve as lubricants for reducing stiction between such surfaces or between a coated surface and another surface.

Abstract: The present invention provides rubber sealing members having an exterior surface adapted to sealingly engage an inner surface of a chamber of a medical device, the exterior surface of the sealing member having a coating thereon prepared from a curable composition including: (a) a first organopolysiloxane having at least two alkenyl groups; and (b) a second organopolysiloxane having at least two pendant hydrogen groups, the second organopolysiloxane being different from the first organopolysiloxane, wherein at least one of the first organopolysiloxane, the second organopolysiloxane or an optional third organopolysiloxane of the curable composition comprises a fluoro group.

Abstract: A pressurized injection device comprises a mechanical loading mechanism comprising a double set of rackets (17,18) and ball bearings/pins running in a curved track (20) which enables a resilient element (7) to be pre-stressed by—twisting the two outer house parts of the device relative to each other back and forth. When twisted in one direction one set of rackets (17) engages the teeth of the piston rod (9) connected to the resilient element and when twisted in the opposite direction, the other set of rackets (18) engages same piston rod. The resilient element is set off to engage a plunger of a container holding a drug to be injected by pressing the release button (1), which can be secured by a safety switch.

Abstract: In one aspect, a self-lubricating component is provided for a pharmaceutical packaging assembly. The self-lubricating component comprises a polymer composition and an effective amount of a lubricating additive such as, for example, boron nitride. In another aspect, a pharmaceutical packaging assembly may be provided having a surface thereof coated with a lubricating composition comprising boron nitride. The pharmaceutical packaging composition may be, for example, a pre-filled syringe comprising a body (barrel) and a plunger assembly.

Abstract: The present invention relates to damper for a medicament delivery device, which device comprises a container containing medicament, a stopper arranged in said container and movable for expelling said medicament through a dose delivery means, a plunger rod having opposing proximal and distal ends and capable of acting on said stopper, and force means capable of exerting a force on said plunger rod, wherein said damper comprises a tubular sleeve having opposing proximal and distal ends; said sleeve comprises a compartment formed by a closed end wall at the proximal end of the sleeve and the proximal end of the plunger rod which is positioned in an open end at the distal end of the sleeve; and wherein said compartment comprises a sealable and resilient pad, a fluid, and at least one passage for expelling said fluid in an annular space between said sleeve and an inner wall of said container, thereby creating a dampening force, upon movement of said plunger rod.

Abstract: A syringe device and injector system including a vent for relieving a vacuum within a syringe is provided. Embodiments provide a syringe device including a reservoir having a sidewall. The reservoir includes a dispensing distal end a proximal end. The syringe device also includes a piston in movable sealing engagement with the sidewall. Furthermore, the sidewall defines a vent extending from the proximal end of the reservoir. The vent is configured to interrupt the sealing engagement between the piston and the sidewall so as to allow a gas to enter the reservoir through the proximal aperture and past the piston member as the piston member is moved from the distal end to the proximal end of the tubular aperture.

Abstract: A dispenser assembly for liquid products is disclosed. Such an assembly may include an elongated barrel, and an elongated plunger having a flexible sealing lip disposed at an end thereof. The sealing lip may have an outer diameter in a relaxed state that is greater than an internal cross-sectional diameter of the barrel. When the plunger and barrel are actuated axially relative to one another, the sealing lip flexes inwardly and provides the sole contact between the plunger and the barrel.

Abstract: This invention relates to components useful for medical articles, such as a syringe assemblies, having sliding contact surface (s) coated with at least one coating layer, wherein the contact surface has an average surface roughness (Ra) ranging from about 10 nm to about 1700 nm and/or the coating layer has crystalline domains, the mass of the crystalline domains being at least about 20% of the total mass of the coating layer, and methods of making the same.

Abstract: A method for coating a substrate surface by PECVD is provided, the method comprising generating a plasma from a gaseous reactant comprising an organosilicon precursor and optionally O2. The lubricity, hydrophobicity and/or barrier properties of the coating are set by setting the ratio of the O2 to the organo silicon precursor in the gaseous reactant, and/or by setting the electric power used for generating the plasma. In particular, a lubricity coating made by said method is provided. Vessels coated by said method and the use of such vessels protecting a compound or composition contained or received in said coated vessel against mechanical and/or chemical effects of the surface of the uncoated vessel material are also provided.

Abstract: The present invention relates to a drive mechanism for a drug delivery device, comprising a number of mechanically interacting functional components among which at least a piston rod is adapted to transfer thrust to a piston of a cartridge that contains a medicinal product to be dispensed, wherein at least one of the functional components at least in sections comprises a friction-reducing slide coating. In this way, a force level required for dispensing and/or setting of a dose can be effectively reduced.

Abstract: A plunger for a syringe used to inject gas and liquid chromatography samples has an end portion surrounded by a flexible sleeve. The sleeve forms a seal in the bore of a barrel traversed by the plunger, the bore being in fluid communication with a cannula attached to the end of the barrel. The plunger has an end surface that is exposed and is flush with an annular end surface of the sleeve. The plunger end surface, and not the sleeve, contacts the cannula upon injection and avoids imposing cyclical hoop stresses on the barrel which tend to crack the barrel after a finite number of cycles. In a further embodiment, a thin layer of sleeve material covers the end surface of the plunger. The thin layer avoids inducing significant barrel stress.

Abstract: A system to minimize fluid turbulence inside a tissue cavity during endoscopic procedures. A body tissue cavity of a subject is distended by continuous flow irrigation using a solenoid operated pump on the inflow side and a positive displacement pump, such as a peristaltic pump, on the outflow side, such that the amplitude of the pressure pulsations created by the outflow positive displacement pump inside the said tissue cavity is substantially dampened to almost negligible levels. The present invention also provides a method for accurately determining the rate of fluid loss into the subject's body system during any endoscopic procedure without utilizing any deficit weight or fluid volume calculation, the same being accomplished by using two fluid flow rate sensors. The present invention also provides a system of creating and maintaining any desired pressure in a body tissue cavity for any desired cavity outflow rate.

Abstract: A first movable element (4) and a second movable element (7) of a mechanism in a medical device are arranged in such a manner that, during an operation of the mechanism, a surface of the first element slides on a surface of the second element. The first element and the second element are formed from materials providing a coefficient of sliding friction of said surfaces on one another of less than 0.14 at a relative velocity of 2 mm per second.

Abstract: The present invention provides rubber sealing members having an exterior surface adapted to sealingly engage an inner surface of a chamber of the medical device, the exterior surface of the sealing member having a coating thereon prepared from a curable composition including: (a) a first organopolysiloxane having at least two alkenyl groups; and (b) a second organopolysiloxane having at least two pendant hydrogen groups, the second organopolysiloxane being different from the first organopolysiloxane, wherein at least one of the first organopolysiloxane, the second organopolysiloxane or an optional third organopolysiloxane of the curable composition comprises a fluoro group.

Abstract: A piston for a medical hollow body such as a syringe or a carpule includes at least one sliding surface for contact with the hollow body. The piston has at least one receiving area in which a lubricant can be received, and at least one dispensing mechanism for dispensing the at least one lubricant from the at least one receiving area to the at least one sliding surface.

Abstract: In one aspect, a self-lubricating component is provided for a pharmaceutical packaging assembly. The self-lubricating component comprises a polymer composition and an effective amount of a lubricating additive such as, for example, boron nitride. In another aspect, a pharmaceutical packaging assembly may be provided having a surface thereof coated with a lubricating composition comprising boron nitride. The pharmaceutical packaging composition may be, for example, a pre-filled syringe comprising a body (barrel) and a plunger assembly.

Abstract: The invention comprises a disposable hypodermic syringe with means for passive aspiration. The syringe comprises a barrel (10) of clear synthetic plastics material and a plunger (12) comprising an elastic bung (28) slideable in the barrel (10). Pressure on the plunger elastically deforms the bung (28). If this pressure is released the bung (28) resiles to effect aspiration. This aspiration is passive, requiring no active withdrawal of the plunger by the user. After use the syringe may be disposed of as a whole, with no disassembly, using one hand only. The syringe may be made by adapting cartridges conventionally used for dental local anaesthetic.

Abstract: Methods for processing a vessel, for example to provide a gas barrier or lubricity, are disclosed. First and second PECVD or other vessel processing stations or devices and a vessel holder comprising a vessel port are provided. An opening of the vessel can be seated on the vessel port. The interior surface of the seated vessel can be processed via the vessel port by the first and second processing stations or devices. Vessel barrier, lubricity and hydrophobic coatings and coated vessels, for example syringes and medical sample collection tubes are disclosed. A vessel processing system and vessel inspection apparatus and methods are also disclosed, for example using material outgassed from a surface to inspect the properties of a surface coating.

Abstract: Methods are provided for surface modifying a hydrophobic polymer substrate to increase wettability comprising the steps of pre-treating the hydrophobic polymer substrate with a radio frequency (RF)-generated first plasma and a RF-generated second plasma wherein the first plasma and the second plasma are applied sequentially, coating the hydrophobic polymer substrate with a hydrophilic coating; and polymerizing the hydrophilic coating on the hydrophobic polymer substrate by exposure to a RF-generated third plasma.

Abstract: A syringe stopper that is suitable for use in syringes without silicone oil or other liquid lubricants. The invention provides a low friction barrier between an elastomeric stopper material and a therapeutic in the syringe. The barrier may inhibit materials from leaching from the elastomer material or from extraction of compounds from medicants by the elastomer. A process is also described that allows for molding thin barrier layers while allowing adequate bonding with the elastomer.

Abstract: Methods are provided for surface modifying a hydrophobic polymer substrate to increase wettability comprising the steps of pre-treating the hydrophobic polymer substrate with a radio frequency (RF)-generated first plasma and a RF-generated second plasma wherein the first plasma and the second plasma are applied sequentially, coating the hydrophobic polymer substrate with a hydrophilic coating; and polymerizing the hydrophilic coating on the hydrophobic polymer substrate by exposure to a RF-generated third plasma.

Abstract: In one aspect, a self-lubriating component is provided for a pharmaceutical packaging assembly. The self-lubricating component comprises a polymer composition and an effective amount of a lubricating additive such as, for example, boron nitride. In another aspect, a pharmaceutical packaging assembly may be provided having a surface thereof coated with a lubricating composition comprising boron nitride. The pharmaceutical packaging composition may be, for example, a pre-filled syringe comprising a body (barrel) and a plunger assembly.

Abstract: Methods for processing a vessel, for example to provide a gas barrier or lubricity, are disclosed. First and second PECVD or other vessel processing stations or devices and a vessel holder comprising a vessel port are provided. An opening of the vessel can be seated on the vessel port. The interior surface of the seated vessel can be processed via the vessel port by the first and second processing stations or devices. Vessel barrier, lubricity and hydrophobic coatings and coated vessels, for example syringes and medical sample collection tubes are disclosed. A vessel processing system and vessel inspection apparatus and methods are also disclosed.

Abstract: A rubber-made syringe piston with a film laminated on it includes a plurality of annular ridges of different outer diameters formed continuously and integrally on a sliding surface of a liquid-contacting, leading end portion of the piston. The annular ridges may preferably be different by from 0.01 to 0.2 mm from one to another in outer diameter.

Abstract: Medical articles with coatings are disclosed herein, as well as methods and systems for depositing these coatings onto medical articles. Surfaces of such articles may be coated. The coating(s) may serve as lubricants for reducing stiction between such surfaces or between a coated surface and another surface.

Abstract: A syringe coated with a lubricant containing a silicone oil and a fine silica powder on the inner surface of the barrel of the syringe can be used for injection of a surface-active drug solution without oil droplet formation on the inner surface while preventing an increase of the gasket sliding friction.

Abstract: The present invention relates to a device comprising a piston sliding in a body like, for example, a syringe.

Abstract: A sample handling tool includes a body having at least one plunger associated with a channel and arranged for axial movement within the channel. A seal is provided in the channel and sealingly engaged with a contact surface. The contact surface may include a surface feature, such that when contact surface moves, the seal and surface feature come into at least partial contact with one another. The seal may include an elastomeric member, such as an O-ring or X-ring, and the contact surface may be formed from any suitable material, including ceramic. The surface feature may take on a variety of forms including any suitable texture, surface porosity or include one or more grooves, holes, recesses, indentations, bumps, protrusions, etc., or a combination thereof.