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WO2015031677A1 - Piston plongeur et soupape de piston plongeur pour l'administration de médicaments - Google Patents

Piston plongeur et soupape de piston plongeur pour l'administration de médicaments Download PDF

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Publication number
WO2015031677A1
WO2015031677A1 PCT/US2014/053262 US2014053262W WO2015031677A1 WO 2015031677 A1 WO2015031677 A1 WO 2015031677A1 US 2014053262 W US2014053262 W US 2014053262W WO 2015031677 A1 WO2015031677 A1 WO 2015031677A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve
plunger
container
opening
chamber
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2014/053262
Other languages
English (en)
Inventor
Rush L. II BARTLETT
Barry Jay DAVIGNON
Peter M. GRECO Jr.
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
GLUCAGO D/B/A LYOGO LLC
Original Assignee
GLUCAGO D/B/A LYOGO LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by GLUCAGO D/B/A LYOGO LLC filed Critical GLUCAGO D/B/A LYOGO LLC
Priority to TW103129912A priority Critical patent/TW201521809A/zh
Publication of WO2015031677A1 publication Critical patent/WO2015031677A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31513—Piston constructions to improve sealing or sliding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31596—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms comprising means for injection of two or more media, e.g. by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3104—Caps for syringes without needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3123—Details having air entrapping or venting means, e.g. purging channels in pistons

Definitions

  • the technological field generally relates to drug delivery devices, such as syringes, cartridges or vials, and more specifically to components of such drug delivery devices, such as plungers and plunger valves BACKGROUND
  • Drugs are commonly stored and/or delivered using a syringe, cartridge, or vial.
  • Syringes especially "pre-filled syringes," cartridges, and vials are commonly referred to as primary containers or “containers.”
  • these containers are long and cylindrical in shape and made of glass or plastic with rubber stoppers or plungers at one or both ends to create a barrier between the internal components from the outside environment.
  • drug containers such as a dual chamber cartridge or syringe
  • dual chamber cartridges or syringes there may also be a bypass channel built into the cylindrical container that allows the materials to mix once the stopper between the two chambers has moved into the bypass area.
  • the plunger is solid with ribs on its circumference to allow it to glide down the barrel of the syringe or cartridge easily, even in the case of bypass cartridges or syringes that facilitate reconstitution. Further, the plunger that moves axially down the barrel of the container may be lubricated or the entire length of the container may be lubricated.
  • the disclosure herein describes a drug delivery device including a container, such as a cartridge or syringe, and a delivery mechanism of one or more plungers or valves which mix and/or administer substances and the filling and manufacturing of those components.
  • the container and/or the valves may be lubricated or frictionally varied in various configurations to allow for appropriate glide force during movement of the plungers in the containers.
  • the container may be or include a cylindrical housing or a cylindrical delivery housing.
  • the valves may comprise one or more regions of a vacuum space, partial pressure or pressurized region, including but not limited to, a gas seal region, where an air pocket, such as a bubble, gas, partial or full vacuum, or pressurized or normal pressure air pocket, helps facilitate a solid, gaseous, or combination solid/gaseous composite barrier between a liquid region and another region of either liquid, solid, or gas.
  • this composite barrier or separating valve will be used with a container having at least two chambers, where one chamber includes a liquid or liquid region separated from a second chamber including a solid or solid region having a dry powder, spray dried, lyophilized, or other powdered material therein.
  • a system for mixing at least two substances to form a mixture for delivery to a human or animal body includes a medicant container having a first chamber for containing a first substance and a second chamber for containing a second substance.
  • the system further comprises a valve disposed between the first and second chambers to isolate the first chamber from the second chamber and prevent the first substance from mixing with the second substance until such mixing is desired.
  • the valve includes an outer portion having at least one opening and an insert portion received in the outer portion when the valve is in an open position and received in the opening when the valve is in a closed position, the outer portion and the insert portion together defining a gas seal region.
  • the system further includes a plunger body disposed in the medicant container and configured to apply a force to the valve to move the valve from a closed position to an open position causing the first and second substances to mix in at least one of the first chamber or the second chamber to form a mixture.
  • the system further includes a needle in fluid communication with the first or second chamber for delivering the mixture into the human or animal body.
  • the medicant container is a syringe or cartridge.
  • the medicant container includes a lubrication or coating to increase and/or decrease a coefficient of friction of at least a portion of the container.
  • the valve is lubricated and/or includes a coating.
  • the gas seal region comprises an air pocket.
  • the second substance is a powder.
  • the first substance is a liquid.
  • an apparatus including a plunger valve configured to fit in a medicant container having at least two chambers and separate the contents of the at least two chambers is disclosed.
  • the plunger valve apparatus includes an outer plunger valve portion having an outer circumferential surface in contact with an inner wall of the medicant container.
  • the outer plunger valve portion includes an open end and a flexible portion opposite the open end and including an opening.
  • the apparatus further includes a plunger valve insert portion received in the outer plunger valve portion.
  • the insert portion includes a tubular pin body extending longitudinally from a bottom surface of the insert portion and a plurality of channels for allowing fluid to flow through the valve insert portion to contact the flexible portion of the outer plunger portion.
  • the outer plunger portion and the plunger valve insert portion together define a gas seal region.
  • the medicant container is a syringe or cartridge.
  • the medicant container includes a lubrication or coating to increase and/or decrease a coefficient of friction of at least a portion of the container.
  • the valve is lubricated and/or includes a coating.
  • the gas seal region comprises an air pocket.
  • the flexible portion is movable from a locked position, in which the tubular pin body substantially fills the opening in the flexible portion to an unlocked position, in which the tubular pin body is separated from the opening to allow fluid flow through the opening.
  • the apparatus further comprises a plurality of protrusions extending longitudinally from a bottom surface of the outer plunger valve portion. In some aspects, the plurality of protrusions guide the valve into the medicant container and define a vent opening for lyophilization.
  • the apparatus further comprises a vent tube positioned in the outer plunger valve portion.
  • the opening in the outer valve portion is a self sealing pinhole opening.
  • a system for reconstitution of two substances includes a medicant container including a first chamber for containing a first substance and a second chamber for containing a second substance.
  • the system further includes a valve disposed between the first and second chambers to isolate the first chamber from the second chamber and prevent the first substance from mixing with the second substance until such mixing is desired.
  • the valve includes an outer portion having at least one opening and an insert portion received in the outer portion when the valve is in an open position and received in the opening when the valve is in a closed position.
  • the medicant container further includes an internal wall having at least one region with a coating to increase a frictional coefficient between the internal wall region of the container and the valve.
  • the medicant container is a syringe or cartridge.
  • the valve includes a frictional coating.
  • the valve further includes the outer valve portion having an outer circumferential surface in contact with an inner wall of the medicant container.
  • the outer valve portion further includes an open end and a flexible portion opposite the open end and including the at least one opening.
  • the insert portion received in the outer valve portion further comprises a tubular pin body extending longitudinally from a bottom surface of the insert portion and a plurality of channels for allowing fluid to flow through the valve insert portion to contact the flexible portion of the outer plunger portion.
  • the outer portion and the valve insert portion together define a gas seal region.
  • the gas seal region comprises an air pocket.
  • the flexible portion is movable from a locked position, in which the tubular pin body substantially fills the opening in the flexible portion to an unlocked position, in which the tubular pin body is separated from the opening to allow fluid flow through the opening.
  • the system further includes a plurality of protrusions extending longitudinally from a bottom surface of the outer portion. In some aspects, the plurality of protrusions guide the valve into the medicant container and define a vent opening for lyophilization. In some aspects, the system further includes a vent tube positioned in the outer valve portion. In some aspects, the opening in the outer valve portion is a self sealing pinhole opening. [0010] In one aspect, a method of manufacturing a medicant container with different coefficients of friction is disclosed.
  • the method includes providing a mask to a first internal surface of a medicant container and applying a coating to a second internal surface of a medicant container wherein the coating increases a coefficient of friction of the second internal surface.
  • the method further includes removing the mask from the first internal surface to provide a medicant container having internal surfaces with different coefficients of friction.
  • the coating is selected from the group consisting of salt, sugars, volatile organics, alcohol, water, ice, and C02 vapor, or a combination thereof.
  • the applying step is performed with a spray nozzle.
  • the removing step is performed by applying heat to remove the mask.
  • FIGS. 1 A and B depict a side, cross sectional view of an embodiment of a medicant container of a cartridge with a plunger valve configured to separate two compartments or chambers;
  • FIGS. 2A and B depict a side, cross sectional view of an embodiment of a medicant container of a syringe with a plunger valve configured to separate two compartments or chambers;
  • FIGS. 3A and B depict a side, cross sectional view of an embodiment of a plunger valve for use with the containers of FIGS.1 A-2B, the valve having a region at least partially formed by an air pocket;
  • FIGS. 4A and B depict a side view of embodiments of plunger valve inserts with flow restricting regions designed to at least partially form an air pocket with a shell or outer piece or portion of the plunger valve of FIGS. 3A and 3B;
  • FIGS. 5A and B depict a side view of embodiments of plunger valve inserts with flow restricting regions designed to at least partially form an air pocket with a shell or outer piece or portion of the plunger valve of FIGS. 3A and 3B;
  • FIGS. 6A and B depict a side, cross sectional view of an embodiment of a plunger valve for use with the containers of FIGS.1 A-2B, the valve having a region which is at least partially formed by an air pocket;
  • FIGS. 7A, 7B and 7C depict a side, cross sectional view of an embodiment of a slidably movable plunger valve shown in a container similar to those of FIGS. 1 A-2B, the valve having a region at least a portion of which is formed by an air pocket;
  • FIGS. 8A and 8B depict a side, cross sectional view of an embodiment of aslidably movable plunger valve for use with the containers of FIGS. 1 A-2B, the valve having protrusions or feet that serve as guide members and define a vent opening for lyophilization;
  • FIGS. 9A, 9B, 9C, 9D, 9E, and 9F depict side, cross sectional views of an embodiment of a device with a drug (mixing) container and manufacturing system for lyophilization in the device with an exemplary slidably movable plunger valve with protrusions or guide members that define a vent opening and then activation of that device for delivery of a substance, such as a drug mixed in the container to a patient;
  • FIGS. 10A, 10B, 10C, and 10D depict side, cross sectional views of an embodiment of a device with a drug (mixing) container and manufacturing system for lyophilization in the device with an exemplary slidably movable plunger valve with protrusions or guide members that define a vent opening ;
  • FIGS. 1 1 A-1 1 E depict a side, cross sectional view of an embodiment of a slidably movable plunger valve for use with the containers of FIGS. 1 A-2B that vents pressure in one chamber upon activation;
  • FIG. 12 depicts a side, cross sectional view of an embodiment of a slidably movable plunger valve that defines at least a portion of an air or gas pocket seal for use with the containers of FIGS. 1 A-2B;
  • FIGS. 13A and B depict a side, cross sectional view of an embodiment of a slidably movable plunger valve that defines at least a portion of an air or gas pocket seal for use with the containers of FIGS. 1 A-2B;
  • FIGS. 14A and B depict a side, cross sectional view of an embodiment of a slidably movable plunger valve that defines at least a portion of an air or gas pocket seal for use with the containers of FIGS. 1 A-2B;
  • FIGS. 15A and B depict a side, cross sectional view of an embodiment of a slidably movable plunger valve that contains a vent tube that is plugged by a block during lyophilization for use with the containers of FIGS. 1 A-2B;
  • FIGS. 16A-16C depict a side, cross sectional view of operational steps of an embodiment of a slidably movable plunger valve with a self-sealing pressure activated pinhole valve for use with the containers of FIGS. 1 A-2B;
  • FIGS. 17A-17C depict a side view of a series of operational steps of an embodiment of a slidably movable plunger valve with a self-sealing pressure activated pinhole valve for use with the containers of FIGS. 1 A-2B;
  • FIGS. 18A-18C depict a side, cross sectional view of operational steps of an embodiment of a slidably movable plunger valve with a self-sealing pressure activated pinhole valve;
  • FIG. 19 depicts a side, cross sectional view of an embodiment of expectant container partially lubricated in the front of or distal of two plungers;
  • FIG. 20 depicts a side, cross sectional view of another embodiment of aemisant container partially lubricated in the front of or distal of a single plunger;
  • FIG. 21 depicts a side, cross sectional view of an embodiment of a partially lubricated expectant container where the lubrication is partially between and in front oi or distal of the plungers;
  • FIG. 22 depicts a side, cross sectional view oi an embodiment oi a non-lubricated expectant container with a lubricated plunger and a non-lubricated plunger;
  • FIG. 23 depicts a side, cross sectional view of an embodiment of a partially lubricated necessarilyant container with a lubricated plunger and a non-lubricated plunger;
  • FIG. 24 depicts a side, cross sectional view of an embodiment of a partially lubricated and partially dimpled frictional area of a plunger;
  • FIG. 25 depicts a side, cross sectional view of an embodiment of an internally lubricated needle;
  • FIG. 26 depicts a side, cross sectional view of an embodiment of a friciional system in which the container and plungers are reactive to electrical charge and/or magnetic force such that their friction within the system is adjustable;
  • FIG. 21 depicts a side, cross sectional view of an embodiment of a medicant container with a physical mask insert to facilitate p a rt i a l lubrication of the container;
  • FIGS. 28A-28D depict a method or system of coating a medicant container with a physical mask coating that can be applied and removed under heating, blowing, or wash;
  • FIGS. 29A-29C depict a series of side, cross sectional views of an embodiment of a duckbill or flexing bypass valve disposed in the barrel of a medicant container that has a flow restrictor or filter;
  • FIGS. 30A-30C depict a se ri es of perspective views of an embodiment of a duckbill or flexing bypass valve disposed in the barrel of a medicant container that has a flow restrictor or filter;
  • FIGS. 31 A-31 C depict a series of perspective views of an embodiment of a duckbill or flexing bypass valve disposed in the barrel of a medicant container.
  • Some figures either depict components in isolation or with plungers for use with plungers operable to glide from one end of the medicant container to another position or end of the container.
  • the components may glide through the medicant container and experience varying degrees of frictional resistance.
  • Components may or may not flex, rotate, bend, or open such that a fluid could flow from one chamber to another of a medicant container upon sufficient application of pressure.
  • a drug delivery device including a container, such as a cartridge or syringe, and a delivery mechanism of one or more plungers or valves which mix and/or administer substances and the filling and manufacturing of those components.
  • the container and/or the valves may be lubricated or frictionally varied in various configurations to allow for appropriate glide force during movement of the plungers in the containers.
  • the container may be or include a cylindrical housing or a cylindrical delivery housing having one or more chambers which house diluents, drugs or other substances as described elsewhere herein.
  • Drugs to be housed and/or delivered within th e cylindrical housings or chambers may include, but are not limited to, diagnostic reagents, atropine, morphine, epinephrine, glucagon, TNF-alpha inhibitors, cytokines, proteins, peptides, vaccines, small molecule drugs, nanoparticles, liposomes, PLGA systems, drug delivery particles, powder medications, lyophilized medications, contrast agents, spray dried materials, sedatives, anti-nausea medications and other drugs.
  • Materials used in the manufacture of the stopper, plunger, and/or medicant container may include, but are not limited to, cyclic polyolefin, polycarbonate, rubber, nylon, silicone, rare earth magnets, glass, plastic, thermosets, poly-anylin, electric conducting polymers, aluminum, iron, steel, an d butyl rubber or other appropriate materials.
  • the valves comprise one or more regions of a vacuum space, partial pressure or pressurized region, including but not limited to, a gas seal region, where an air pocket, such as a bubble, gas, partial or full vacuum, or pressurized or normal pressure air pocket, helps facilitate a solid, gaseous, or combination solid/gaseous composite barrier between a liquid region and another region of either liquid, solid, or gas.
  • this composite barrier or separating valve will be used with a container having at least two chambers, where one chamber includes a liquid or liquid region separated from a second chamber including a solid or solid region having a dry powder, spray dried, lyophilized, or other powdered material therein.
  • the device may also optionally have a retractable needle or a needle safety guard to help improve safety during use, injection, and/or disposal of the delivery device.
  • the device with a separating valve separating two substances until they are mixed and delivered may also be used in an at home setting, emergency setting, hospital setting, intensive care unit, CCU, SICU, NICU, hospital ward, clinical setting, specialty clinic, outdoor emergency care environment, or other area where it is desirable to reconstitute two materials and then inject them from a device that has a flow-through valve.
  • This device may optionally have a safety valve feature that allows for the venting of gas from the cartridge during or after reconstitution.
  • the safety valve feature may be stored under at least a partial vacuum which would at least partially eliminate the need to vent the gas from the container after or during reconstitution.
  • the gas sealing region, or gas seal, of the valve may be at least partially comprised of an air or gas seal bubble that is at least partially captured within the valve to help prevent at least a portion of the liquid from contacting the direct seal portion of the plunger valve.
  • the bubble is prevented or hindered from being entirely removed from the gas sealing region by capillary action of the liquid material such that the flow channels for the liquid to eventually pass through the sealing valve are so small as to prevent, hinder or reduce at least some of the natural flow of the liquid through the air bubble seal region (i.e. gas sealing region) next to the primary direct sealing barrier (direct seal portion) of the plunger valve.
  • This gas sealing region e.g., air or gas or vacuum material at least partially entrapped within a valve disposed inside a cylindrical body, and meant to slide axially within that body, may be composed from any gaseous material, in a vacuum or partial vacuum, including but not limited to, nitrogen, air, alcohol, oxygen, argon or other noble gas, carbon dioxide, water vapor, volatile organic material, and/or any other material which could be advantageous to use in a gas sealing region to provide at least a partial barrier to reduce the passive flow of material from one chamber to another across the valve in the container.
  • Other materials and configurations will be evident to those skilled in the art.
  • the valve which may also be referred to as a reconstitution stopper valve, may include a vent, such that when it is placed inside a container, such as a syringe, cartridge, or vial, it may vent the air/gas seal region and/or other regions within the valve composed of gas, liquid, humidity, partial pressure materials, materials with a vapor pressure, materials being lyophilized, and/or evaporating or subliming materials which may occur or be present during transfer from one chamber out to another chamber.
  • the reconstitution stopper valve with or without an air gas seal region, may have vented notches, feet, guide ports, slits, openings, tunnels, conduits, partially constructed guides between the stopper valve and the container to provide for venting.
  • the valve may include feet for orienting the reconstitution stopper valve such that it can vent material (e.g. gas, liquid, etc. as described above) from a lower chamber from between the openings of the feet or lower plugs on the valve and then use those feet or lower plugs to guide the stopper valve into the cylindrical portion of a cartridge, syringe, or vial.
  • material e.g. gas, liquid, etc. as described above
  • This stopper valve may be used in conjunction with a bypass cartridge but the valve is most prudently used in a standard cartridge, syringe, or vial without a bypass conduit placed in the wall of the container.
  • the stopper or plunger valve includes an internal flow conduit valve that can be activated by pressurizing to a maximum pressure to allow for the valve to open, dislodge, pop, flip, rotate, orient, twist, burst, slide, or move to allow for flow of material from one chamber to another chamber.
  • the stopper valve's feet allow material to evaporate or sublime from a lower chamber out the vent holes and then the stopper valve is compressed into the container via a lyophilizer tray or compression plate or other means such that a seal is formed. Then, either through depression of the valve into the system physically, or with the addition of a pressure gradient, the valve moves to a pre-defined position within the container where the valve is later (subsequently) activated by a user to mix the contents of the at least two chambers.
  • a self-healing or self-sealing material such as silicone, rubber, or an elastomeric compound is configured with an opening, such as a tiny puncture or tiny hole or pinhole, that self-seals and or seals with the compression force on the plunger valve inside a cylindrical drug delivery housing (e.g., cartridge or syringe).
  • a pinhole seals between two chambers separated by this separating plunger valve but the action of the pressure of liquid from the back chamber causes the hole to open and the liquid to squirt, spray, and/or flow from the back chamber to the front chamber.
  • This action may be enhanced by the flipping, squishing, rotation, curving, expanding, contracting, or increase or decrease of surface contact between the valve and the wall of the drug container in a way that facilitates the stationary or slow gliding securing force of the valve in a central position while the liquid is being pushed through a front pinhole.
  • the valve is depressed forward and the pinhole can either (1 ) seal to prevent or limit backflow and/or (2) the pinhole can remain open to allow for total reconstitution of diluent and solid material in the front chamber.
  • the case of prohibiting or limiting backflow into an open cavity is advantageous because it reduces the amount of drug overfill required.
  • the back plunger forces open the pinhole with a pressure or physical effect, such as contact, or the driving of an opening member, such as a flow pin, through the front pinhole upon contact or thereafter.
  • the pinhole or tiny puncture is small enough that the elastomeric property of the rubber, silicone, or other elastomer material allows for the valve material to squish or collapse or otherwise effectively block the pinhole while the valve is in place prior to the compression being applied to expel material (e.g., diluent, drug powder, etc.) from one chamber to another.
  • the size of the pinhole may be less than approximately 5mm but is preferably less than approximately 0.5mm.
  • the durometer the smaller the hole needs to be, while the lower the durometer, the greater the hole size can be since the compression and or elastomeric squishing of the rubber valve inward can have a greater sealing effect otherwise displacing the opening formed by the pinhole puncture member to create the pinhole during manufacturing.
  • FIGS. 1 A and B depict exemplary cartridges (101 ) with a separating pressure valve (102) that slides axially along the barrel or internal lumen (101 a) of the cartridge (101 ) when pressure is applied to the back or first chamber (105) holding a liquid.
  • the separating pressure valve (102) has a section (104) that is configured to at least partially hold an air pocket that at least partially impedes or hinders the ability of liquid in the upper chamber (105) to move into the lower or second chamber (106) through the activated or opened plunger or pressure valve, shown in FIG. 1 B with opening (103) shown in an open position.
  • FIGS. 2A and B depict exemplary syringes (201 ) with a separating pressure valve (202) that slides axially along the barrel or internal lumen (201 a) of the syringes (201 ) when pressure is applied to the back or first chamber (205) holding a liquid .
  • the separating pressure valve (202) has a section (204) that is configured to at least partially hold an air pocket (204) that at least partially impedes or hinders the ability of liquid in the upper chamber (205) to move into the lower or second chamber (206) through the activated or opened plunger or pressure valve, shown in FIG. 2B with opening (203) shown in an open position.
  • FIGS. 202 depict exemplary syringes (201 ) with a separating pressure valve (202) that slides axially along the barrel or internal lumen (201 a) of the syringes (201 ) when pressure is applied to the back or first chamber (205) holding a liquid .
  • the separating pressure valve (202) has a section (204) that
  • 3A and 3B depict an exemplary cross section of a plunger valve (301 ) and components.
  • the plunger valve (301 ) has an insert or first portion (301 a) that has small slits or openings (302) that partially impede or hinder the flow of material to help form an air pocket or bubble in a section (303) of the valve (301 ).
  • a pin (304) extending from a bottom surface of the first portion (301 a) is configured to fit inside a hole (305) of a second portion (301 b) of the valve (301 ) to create a seal and/or to pop out to open the seal.
  • the outer rubber portion or second portion (301 b) may or may not have varying degrees of protrusions or indentations (306) in order to adjust the air pocket section's (303) volume and or affect the at least partial sealing effect of the slits (302) to keep at least some of the air in the air pocket section (303) and at least some liquid in the liquid chamber.
  • the air pocket (303) comprises part of a flow through region that has pressure driven liquid enter from the slits (302), go through the air pocket region (303) and then exit through a lower opening (305) to facilitate mixing of liquid in an upper chamber (e.g., chambers 105 and 205) and a material in the lower chamber (e.g., chambers 106 and 206).
  • FIGS. 4A and B depict other exemplary embodiments of components or inserts (401 ) of a plunger valve meant to restrict flow inside a valve system .
  • the insert (401 ) has slits or small openings (402) that partially restrict or hinder the free flow of liquid material in an upper chamber from entirely displacing air from an air pocket region (403) which is illustrated to show its location relative to a second portion (not shown), but which can be understood with reference to second portions 201 b and 301 b..
  • FIG. 5A and B depict other exemplary embodiments of inserts (500) meant to at least partially restrict flow inside a valve system disposed to open a flow path and slide axially within a cylindrical container (not shown but see, e.g. Figs. 1 A-2B).
  • the insert 500 may have a ridged wall (501 ) or a flexible wall (503) which interact or form a border with flow through regions 502, 504 meant to at least partially restrict flow between chambers of a container.
  • FIGS. 6A and B illustrate other exemplary embodiments of a plunger valve (602) configured to separate, then allow for flow through, and then slide axially within a cylinder or container.
  • the plunger valve (602) comprises gliding ribs (601 ) and sealing members (603) that comprise formable gas seal regions (604) that can be activated to allow for pressure driven flow through a flow region (605).
  • FIGS. 7A, B, and C illustrate exemplary embodiments of a plunger valve (701 ) with a gas seal component (702) functioning within the barrel (704) of a syringe to seal two chambers (703, 705) open to allow mixing (706) of the contents of the chambers (703,705) and then the valve and chamber with mixed components slides axially forward to allow for injection of the mixed components (707).
  • the plunger valve (701 ) with a gas seal component (702) opens to allow for pressure driven flow from a liquid chamber (703) when a pressure is reached. This flow facilitates mixing of a component in the lower chamber (705) with that of the upper chamber (703).
  • FIGS. 8A-1 1 E illustrate various embodiments of a vented stopper system having a plunger valve that acts as a flow channel and simultaneously acts as a lyophilization vent cap.
  • the disclosed embodiments have a plunger valve that is both a flow channel and a vent cap. As described in more detail below, the disclosed plunger valve is locked before it is put in place in or on top of the medicant container. During lyophilization, venting occurs through the flow channels (or side ports) of the plunger valve.
  • FIGS. 8A & B illustrate an exemplary cross sectional view of an embodiment of a plunger valve (800) with a center vented insert (801 ) whose vent slits are small enough that it defines an air pocket region (802) with surface tension of a fluid material in an upper chamber of a drug delivery housing (not shown but see, e.g., FIGS. 1 A-2B).
  • This exemplary plunger valve (800) also has feet (803) that serve as guide bumps or members (803) extending from a bottom surface of an outer portion (800a) of the valve 800 that allows the valve 800 to fit on top of a medicant container during lyophilization.
  • the feet (803) also define a vent opening (803a) between the feet (803) and a medicant container opening (803a) such that sublimed moisture or vapor can be vented during lyophilization.
  • FIGS. 9A-9F illustrate exemplary cross sectional views of an embodiment of a plunger valve (902) with feet (902a) that define a vent opening (902b) between a medicant container (901 ) and the plunger valve (902).
  • vent opening (902b) allows for vapor, gas, or humidified liquid sublimed or evaporated away (904) from a material, such as a lyophilisate (903), in a medicant container to be vented out of the opening defined by the plunger valve (902) and the medicant container (901 ) (see FIG. 9A).
  • a material such as a lyophilisate (903
  • a shelf, tray, rack, block, plunger, or other means serves to compress the stopper valve (902) such that the vent (902b) defined between the feet opening of the stopper valve (902) and the medicant container (901 ) is closed.
  • addition of an amount of increased external pressure (906) or other force such as a plunger rod (906) serves to push the plunger valve (902) into the appropriate position within the cartridge or syringe (901 ).
  • This pressure gradient may also be accomplished by having the chamber at a vacuum or partial vacuum condition when the vented stopper valve (902) is closed by the tray or shelf device (905).
  • valve (902) When the lyophilizer is returned to atmospheric pressure, the valve (902) will slide down to equalize or at least lessen the gradient of pressure between the two chambers of the medicant container (901 ). As illustrated in FIGS. 9D-9E, upon closure of the lyophilized material (903) in a lower chamber with a movable vented stopper valve (902), an amount of diluent or liquid material (907) can be filled in another chamber and then a sealing stopper (909) placed on that other end.
  • a front sealing stopper or sealing mechanism (900) may be on the front or distal end 901 a of the medicant container (901 ) and can be punctured by a needle (910) for delivery of a reconstituted therapy or vaccine (908) upon compression of the plunger rod (909) to deliver the mixture.
  • a drying step could take place for spray dried or powder filled materials under a vacuum, partial vacuum, or temperature induced pressure gradient in addition to lyophilization and the mention of lyophilization by no means limits the use of the invention for powder filled or spray dried filled materials.
  • FIGS. 10A, B, C, and D illustrate an embodiment of a plunger system that comprises a vented section and or guide features 1001 , such as locking pins or grooves that are notched to prevent the valve 1002 from flowing backwards and may also serve to vent the system, and that facilitate the preference to one way movement inside a cartridge, syringe, or vial 1000.
  • This one way movement combined with the utilization of a pressure gradient and/or shelf movement 1005 induced similarly to that of Figure 9, can induce the plunger valve 1002 to move from a partially external vented position (see FIG. 10A), to an internal position (see FIG.
  • FIG. 10B to a placement internal position using pressure gradient where pressure increases greatly above the valve and pressure increases some or a vacuum drives movement of the valve to a center region of the container 1000 (see FIG. 10C), to an activated, locked, or flipped position (see FIG. 10D) such that the pressure gradient between the front chamber and rear chamber urges the plunger valve to rotate, flip, or move such that it locks into place to seal the two compartments or chambers (1004, 1005).
  • FIGS. 1 1 A-1 1 E depict an embodiment of a plunger valve 1 100 inserted into a cartridge 1 102 that allow for venting and or activation with a pressure gradient provided in the two chambers 1 102a,1 102b.
  • the valve 1 100 is inserted into the cartridge 1 102 upside down.
  • the valve may have a trim edge at the front which allows it to pivot around during movement and open if the valve is moved in the forward (downward) direction. If pushed downward in the reverse direction, the pivot edge causes it to want to stay closed.
  • FIG.1 1 B a building of pressure in a lower chamber 1 102b with an advancing force, e.g., compression of a syringe plunger 1 104 to pressurize the system, to then facilitate the forward (see FIG. 1 1 B) and then backward movement of the valve 1 100 (see FIGS. 1 1 C and 1 1 D).
  • the system may be fully siliconized or otherwise lubricated, and the pressure in the two chambers 1 102a, 1 102b is increased but equal.
  • FIGS. 1 1 C and 1 1 D releasing of the plunger 1 104 or otherwise pulling it back to the original position causes the pressure in the back chamber 1 102a to decrease.
  • the pressure in the front chamber 1 102b is increased and causes the valve 1 100 to move backwards (proximally or towards the user) and the valve with a trim edge pivots open or the pressure in the front chamber 1 102b causes the valve to open.
  • This movement occurring in two directions allows guide pegs or ribs that are biased to move in only one direction to rotate, pop, or dislodge the seal of the plunger valve when the valve is moved in the opposite direction of the sealing features normal preferential bias.
  • the plunger 1 104 can be pushed down again to mix the substances in the first and second chambers 1 102a, 1 102b and the mixed substance can then be injected.
  • Loading the valve 1 100 into the container backwards may be advantageous because it aids in valve insertion for manufacturing in a vent tube loader.
  • FIG. 12 illustrates an embodiment of a slidably movable plunger valve 1200 in a container 1202, the valve 1200 defines at least a portion of a pocket seal 1204 such that the flow channels 1206 through the valve 1200 between two chambers 1208, 1210 of a container 1202 are between the inside of an outer plunger component 1200a and the outside of an inner insert component 1200b of the valve 1200.
  • FIGS. 13A and B depict an embodiment of a slidably movable plunger valve 1300 in a container (not shown) that defines at least a portion of a pocket seal 1302 such that there are multiple pockets 1302a, 1302b formed with the compression, inversion, or locking of the outer rubber component 1300a around an insert pin 1304 of an inner portion 1306 of the valve 1300.
  • FIG. 13A illustrates the valve in a non-compressed state
  • FIG. 13B illustrates the valve in a compressed state.
  • FIG. 14A and B depict an embodiment of a slidably movable plunger valve 1400 in a container (not shown) that defines at least a portion of a pocket seal 1402 such that the flow channels 1408 through the valve 1400 between two chambers of the container are between the inside of an outer plunger component 1404 and the outside of an inner insert component 1406 such that the rubber component 1404 has an angular biasing member 1410 at the front 1412 of component 1404 to deflect and seal against a sealing pin 1414 of the inner component 1406.
  • FIG. 14A depicts the valve 1400 where the biasing member 1410 is in an unbiased position.
  • FIG. 14B depicts the valve 1400 where the biasing member 1410 is in a biased position and is sealed against the pin 1414.
  • FIGS. 15A and B depict an embodiment of a slidably movable plunger valve (1501 ) with a vented conduit section (1502) that can be plugged (1503) with a secondary plugging component (1505) that is depressed by the tray (not shown but see, e.g., the tray 905 in FIG. 9B) during lyophilization or by a rod from a manufacturing process when desired.
  • a slidably movable plunger valve 1501
  • a vented conduit section 1502
  • a secondary plugging component 1505
  • FIGS. 15A and 1 5B both depict the valve in a closed position because the opening 1506 is sealed by a pin 1508 of an insert 151 0 of the valve 1501 .
  • FIGS. 16A, B, and C depict an embodiment of a syringe (1601 ) with a needle (1604) but the syringe may not have a needle or it may have another type of front opening such as a cartridge opening or luer connector.
  • This syringe (1601 ) could also be exemplified as other types of cylindrical drug delivery housings or containers such as a cartridge.
  • the diluent is housed in the rear chamber (1602) and the lyophilized, spray dried, or powder filled material is housed in a front chamber (1603).
  • a plunger rod (1605) or other force actuation mechanism drives a plunger (1606) to cause pressure in the diluent chamber (1602) to increase such that a pinhole (1608) in a center valve plunger (1607) would open and cause diluent to be pushed into a front chamber (1603).
  • the front chamber may contain a liquid suspension or other medium.
  • the pinhole 1608 is allowed to self seal once the plunger reaches contact and the pressure is equalized (1609).
  • the pinhole plunger valve (1610) is enabled to move forward upon contact from a rear plunger (1606) to then expel material from the end of the medicant container 1601 .
  • FIGS. 17A, B, and C depict an embodiment of a plunger valve 1700 with a pinhole (1701 ) in a container 1 705 operable to allow liquid in the back chamber 1707 of the container 1705 to be forced forward into a front chamber 1709 through it (see FIG. 17B) and that pinhole plunger valve 1700 is also slidable forward (see FIG. 17C).
  • FIGS. 18A, B, and C depict an embodiment of a dual chamber system 1800 for reconstitution where a plunger valve having a pinhole self-sealing flow channel (1801 ) (see FIG. 18A) is operable by action of a back plunger 1802 pushing diluent through the pinhole (1801 ) (see FIG. 18B) and then or in conjunction to the action of the back plunger 1802 causing the pinhole plunger valve 1801 to slide forward within the container (1800) (see FIG. 18C).
  • the container and/ or the valves are lubricated or frictionally varied in various aspects. As shown i n F I GS . 1 9-31 , in som e em bodim ents , the container and/ or the valves are lubricated or frictionally varied in various aspects.
  • plungers and/or stoppers may optionally have differences in friction against the wall of the medicant container in addition to or in the absence of the differences in the wall of the medicant container itself. This allows the contact surface of a plunger or stopper to be rough or smooth in one region so that its frictional force against the medicant container is different from another plunger or stopper within the barrel of the medicant container.
  • the plunger or stopper may be lubricated or coated to achieve a difference in frictional effect between two plungers or stoppers within the barrel of the medicant container.
  • the container and/ or the valves are lubricated or frictionally varied in various configurations to allow for appropriate glide force during movement of the plungers in the containers.
  • the frictional force will be different in different regions of the medicant container and in different configurations of the plungers and/or valves depending on the step in the process of use.
  • a portion of the medicant container may include a difference in friction between at least two sections of its internal surface.
  • plungers and/or stoppers may or may not have differences in friction against the wall of the medicant container in addition to or in the absence of the differences in the wall of the medicant container itself. This allows the contact surface of a plunger or stopper to be rough or smooth in one region so that its frictional force against the medicant container is different from another plunger or stopper within the barrel of the medicant container. Similarly, the plunger or stopper may be lubricated or coated to achieve a difference in frictional effect between two plungers or stoppers within the barrel of the medicant container. [0081] In other aspects, a system for reconstitution of two substances using moving plunger systems is disclosed herein.
  • the system includes a plunger inside a medicant container with a bypass which is placed into a section of the medicant container that has a higher frictional coefficient with the wall to improve the seal.
  • a second plunger or stopper moving into contact with the first stopper e ng ag es and dislodges t h e first stopper.
  • the second stopper may have a higher frictional coefficient.
  • Either stopper may have a different coefficient of friction from the other and/or a different frictional coefficient in different sections of the medicant container.
  • other exemplary versions include a system to facilitate movement during administration, or the lack thereof when sealed, of a locking plunger or stopper that is allowed to adjust or change its compression force against the wall of a medicant container.
  • the locking plunger or stopper is lubricated and the barrel of the medicant container non- lubricated or the reverse scenario of that.
  • a partially lubricated plunger or stopper includes unlocking th e p l u ng e r/stoppe r by a n adjustment to the compression to release a portion of the plunger selectively that had a higher frictional coefficient against the wall of the medicant container. This enables another section that releases compression with less magnitude to glide with easy movement with a lubricated or smoothed section.
  • Another technique for affecting the frictional surface of a medicant container in different regions is the use of electrostatic charge and or charge neutralization.
  • magnetic force may be used to affect the friction
  • a surface of the medicant container and/or the surrounding area and/or the stopper and/or the plunger may be charged and or charge neutralized in order to affect the seal and/or friction of the materials against each other. This feature may be utilized during shipping in order to maintain a stronger sea! while in transit. Then, the charge and or magnetic force is affected in order to facilitate an easier glide force for an injection.
  • a magnetic or electrostatic device may be used as a companion system external to the delivery system to help facilitate the delivery by reducing the frictional forces of the plunger against the wall of the medicant housing.
  • the system of differential frictional surfaces for medicant containers in addition to a vial, cartridge, syringe, inhaler cartridge, or other drug housing, includes a needle that is used to administer and or store materials prior to use.
  • the needle may be used for intravenous, intramuscular, subcutaneous, intradermal, or other type of injection by which material (e.g., a drig substance) is either stored in the needle itself and/or pushed out of the needle from another housing compartment or chamber.
  • material e.g., a drig substance
  • the lubricant or a coating on the inside surface of the needle may be used to prevent inappropriate contact of stored or injected drug materials and/or it may facilitate easier injection by reducing the frictional force against the wall.
  • the coating and/or abrasive force may be used to slow the speed of injection or keep the fluid material from slipping out of the needle prematurely.
  • a method and system for lubricating a portion of the medicant container that facilitates the appropriate glide force is disclosed.
  • the combination of a proportion of a medicant container being lubricated and one or more plungers with or without lubricant on their entirety or on sections of the plungers is also an exemplary feature shown.
  • Changes in frictional coefficient may be achieved with, but are not limited to, coatings or lubricants such as silicone, tribiglide, nanofilms, emulsions, oils, greases, hydrophobic materials, hydrophilic materials, nano-composite structures, smoothed surfaces, rough surfaces, sand grains, roughed surface, machined surfaces, lithographic materials, different regions of hydrophilic and hydrophobic areas, frictional properties of a materials surface after manufacturing, different materials configured in the wall of a medicant container in composite arrangements, electrostatic charge, an d charge neutralization or other appropriate coatings or lubricants.
  • coatings or lubricants such as silicone, tribiglide, nanofilms, emulsions, oils, greases, hydrophobic materials, hydrophilic materials, nano-composite structures, smoothed surfaces, rough surfaces, sand grains, roughed surface, machined surfaces, lithographic materials, different regions of hydrophilic and hydrophobic areas, frictional properties of a materials surface after manufacturing, different materials
  • Drugs to be housed and/or delivered within th e cylindrical housings or chambers may include, but are not limited to, diagnostic reagents, atropine, morphine, epinephrine, glucagon, TNF-alpha inhibitors, cytokines, proteins, peptides, vaccines, small molecule drugs, nanoparticles, liposomes, PLGA systems, drug delivery particles, powder medications, lyophilized medications, contrast agents, spray dried materials, sedatives, anti-nausea medications and other drugs.
  • Materials used in the manufacture of the stopper, plunger, and/or medicant container may include, but are not limited to, cyclic polyolefin, polycarbonate, rubber, nylon, silicone, rare earth magnets, glass, plastic, thermosets, poly-anylin, electric conducting polymers, aluminum, iron, steel, an d butyl rubber or other appropriate materials.
  • a method for adding different amounts of lubricant and/or a coating for friction reduction or friction increase includes partially spraying materials into the barrel of a medicant container body. This partial spray may be done in separate sections of the body of the medicant container.
  • the spray may be supplied as a pattern such as a striation, checkerboard, segmented, banded, hemisphere and/or other pattern to achieve the desired frictional profile across the surface of the container body. That frictional profile may be operable to interact with the plunger, delivery mechanism, and/or the medicant itself to achieve the desired movement characteristic, stationary characteristic, and/or sealing characteristic of the materials when they contact each other.
  • the spray m may be performed intermittently or continuously through a spray nozzle.
  • the components of the system may be coated by dip coating with full or partial emersion of the medicant container, plunger, stopper, or other components of the system.
  • the desired areas for the spray may be pre-treated with a material in certain sections to affect the frictional properties of those sections.
  • an area of the material desired not to have an effect from a dip coat or spray could be coated or masked with a physical barrier material to prevent a significant portion of the lubricant and/or coating from contacting or adhering to the masked or blocked area.
  • the mask may be a physical barrier or a tube placed in front of the spray nozzle or it may be another coating applied before the lubricant.
  • This m ask coating may then be removed with heat to evaporate or melt the mask coating, or the mask coating may be eliminated during washing if it is highly water soluble.
  • a coating that is water soluble or heat sensitive may include, but is not limited to, salt, sugars, volatile organics, alcohol, water, ice, C02 vapor, or other approp r i ate materials or substances.
  • FIG. 19 depicts an embodiment of a medicant container (1 901 ) positioned with a forward plunger (1902) and a rear plunger (1903).
  • the forward plunger (1902) may be operable to pass through a bypass region or It may be configured to include a valve such that material from the rear chamber (1904) may flow nto the forward chamber (1905).
  • the rear chamber (1904) does not have lubricant or a frictionai coating applied to it.
  • the forward chamber (1905) has lubricant or a frictionai coating applied to it.
  • FIG. 20 depicts another embodiment of a medicant container (2001 ) with a lubricated or frictionally coated section (2002) in front of a plunger (2003) positioned in the rear of the medicant container (2001 ) such that the plunger (2003) will experience different frictionai forces when it travels along the length of the medicant container (2001 ) to expel the contents of the container.
  • FIG. 20 depicts another embodiment of a medicant container (2001 ) with a lubricated or frictionally coated section (2002) in front of a plunger (2003) positioned in the rear of the medicant container (2001 ) such that the plunger (2003) will experience different frictionai forces when it travels along the length of the medicant container (2001 ) to expel the contents of the container.
  • FIG. 21 depicts another embodiment of a medicant container (2101 ) with a rear section (2106) and a forward section (2107) on either side of a separating plunger (2102) which may be configured with a bypass system or flow through valve.
  • the back plunger (2103) is configured to slide forward to activate the separating plunger (2102).
  • FIG. 22 depicts another exemplary embodiment of a dual chamber medicant container (2201 ) which may have a bypass (2205) or it may have a valve plunger (2202) separating the chambers such that the valve plunger (2202) would allow for flow or the bypass (2205) would.
  • the wall of the medicant container (2204) is not coated with a second material but may have native frictionai properties to increase or decrease the friction between the plungers (2203 and 2202) and the wall as they move through the length of the med cant container.
  • the rear plunger (2203) is lubricated and the separating stopper (2202) Is not lubricated.
  • FIG. 23 depicts another exemplary embodiment of a partially lubricated or fictionally coated medicant container (2301 ).
  • the front chamber (2305) contains a lubricant coating or a frictional coating and the back chamber (2304) does not.
  • the separating plunger (2302 ⁇ may include a plunger valve to open the flow between chambers or function to open a path between the two chambers through a bypass.
  • the rear plunger (2303) has a lubricant and/or frictional coating to facilitate its movement through the region without a coating (2304) with a lower glide force than if it was bare.
  • the rear plunger (2303) may not be coated but instead made out of a material with appropriate frictional glide or resistance as desired to glide through the two regions (2304) and (2305).
  • the rear plunger (2303) has a lubricant
  • the rear chamber (2304) has no lubricant
  • the front chamber (2305) h as a lubricant
  • the separating stopper is a pressure activated valve (2302) and has no lubricant on it to help keep it frictiona!!y in place until it opens to allow flow between the two chambers. After its opening, it (2302) advances with further force from the rear plunger (2303) to expel mixed materials from the medicant container (2301 ).
  • FIG. 24 depicts an exemplary embodiment of a plunger 2400 that has different regions of lubrication and frictional areas.
  • the plunger 2400 has ribs (2401 and 2402) that facilitate gliding of the system in a medicant container (not shown).
  • the ribs (2401 and 2402) are frictionaiiy lubricated and/or made of a low frictional coefficient material.
  • a front section of the stopper (2403) is made with pits or indentations 2403a to frictionaiiy grab a smooth surface such as a glass or plastic medicant container.
  • An open segment (2404) may communicate with a pressure relief valve pin or other mechanism in order to constrict to alleviate the frictional drag of the high friction region of the stopper (2403) when it is desired that the stopper advance through the medicant container,
  • FIG. 25 illustrates another embodiment of a lubricated needle (2501 ).
  • the needle (2501 ) is lubricated on at least the inside wail 2502 of the needle (2501 ) in order for medicant stored in the needle (2501 ) or medicant flowing through the needle (2501 ) to be less or more frictionaiiy impacted by the materials of the wail 2502 of the needle (2501 ).
  • the needle has an opening at the front (2503) to deliver the medicant to a patient.
  • FIG. 26 depicts an exemplary embodiment of a medicant container (2601 ) with frictionaiiy bound plungers or stoppers (2602 and 2603).
  • These plungers (2602 and 2603) are frictionaiiy impacted by the magnetic (2605) or electric field, charge, or current (2606) of an external unit.
  • the plungers (2602 and 2603) may be frictionai!y impacted by the materials that form the wall (2604) of the medicant container, such as, but not limited to, an electrically conducting or magnetically charged material.
  • the electric and/or magnetic fields may be modulated such that the static charge, magnetic field, electrical charge, or other electromagnetic force holds the plungers (2802 and 2603) in place or allows them to more easily move throughout the barrel of the cartridge 2601 .
  • the devices applying external energy (2606 and 2605) may be used in shipping to prevent leaking or may be used prior to use of the container in order to unlock the plungers from a tight frictional grip on the wall. I n som e em bod im ents , a de-static device that removes static charge may also be used.
  • FIG. 27 depicts an embodiment of a system for masking a medicant container
  • the masking element (2702) is physically inserted into the barrel of the medicant container (2701 ).
  • the masking element may have pores, holes, or other cutout shapes (2705) which will allow for variability of the spray to reach past the masking element (2702) to the wall of the medicant container (2701 ).
  • FIGS. 28A-28D depict an embodiment of a system for masking a medicant container 2800 by dip coating with a masking element (2801 ) (see FIG. 28A). Then after dip coating a masking coating 2801 that is removable, the medicant container is submerged in a bath of lubricant or frictional material (2802) (see FiG. 28B). The masking element 2801 and attached or associated lubricant or frictional material 2802 are removed by the addition of heat to melt or evaporate it, airflow to blow it off, or liquid to wash it off (2803) (see FiG. 28C).
  • the masking element 280 1 may include wax, oil, ice, or other material. Once the masking element is removed, the medicant container 2800 has two or more regions, one or more regions 2805 with coating 2802 and one or more regions without coating (2806) (see FIG. 28D).
  • FIGS. 29A-29G depicts an embodiment of a system for mixing two components within a medicant container (2901 ) and delivering them from said medicant container (2901 ).
  • the duckbill, pressure relief valve, of rubber stopper (2902) with a flow through area flexibly blocked under low pressure with two or more flexible flaps or pins (2904) has a ring region (2905) that provides frictional force against the wall of the medicant container that is larger than the force to open the valve (2904) and provide flow through.
  • the exemplary system may also have a third rubber stopper (2903) or a filter or flow restrictor (2903) to help prevent medicant from being expelled during the mixing of the two chambers in the medicant container (2902).
  • a third rubber stopper (2903) or a filter or flow restrictor (2903) to help prevent medicant from being expelled during the mixing of the two chambers in the medicant container (2902).
  • the rear plunger is slid forward to activate the valve (2902 ⁇ to open a flow path between the two chambers. Then, when the rear plunger contacts the valve (2905), the further compression of the fear plunger in tandem with the vaive expe!s the mixed materials from the front of the medicant container (2906) through or around the flow restrictor, rubber pressure equalizer, or filter (2903).
  • FIG. 30A-30C depicts another exemplary embodiment of a delivery- system with a medicant container and a flow through vaive (3003), As i n d ic ated i n F I G . 3 OA , this system may be lubricated in differential areas to ensure that the rear plunger slides forward to open the flow through vaive with pressure before the flow through vaive is physically contacted by the rear plunger (3004).
  • the two chambers may have a liquid in a rear chamber 3001 and a powder or iyophiiized material in the front c h am be r 3002.
  • St may also be desirable to have multiple flow through valves dispersed throughout the length of the medicant container to reconstitute or mix more than two materials in more than two separated chambers. Subsequent compression from the rear plunger and flow through vaive (3003) will cause them both to be compressibly siid through the medicant container to expel the mixed materials out the needle or otherwise exit from the medicant container (see FIGS. 30B-30C ⁇ .
  • FIGS. 31 A-31 C depict another exemplary embodiment of a delivery housing or medicant container 3 1 00 with a flexing or duckbill pressure relief vaive with a side rib 3102 configured to slide along the length of the medicant container 3100.
  • This system does not have a filter, pressure equalizing stopper, or flow restrictor mechanism at the front (3101 ) of the container 3100.
  • FIG. 31 A shows the system prior to compression by a plunger 3105
  • FIG, 31 B shows the system as it is being compressed
  • FIG. 31 C shows the system in a fully compressed state such that drug components mixed in the container 3100 as described elsewhere herein may be inserted info a patient.
  • All directional references e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise
  • Connection references e.g., attached, coupled, connected, and joined
  • connection references are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other.
  • delivery sheath and delivery catheter may be used interchangeably for purposes of this description.
  • the exemplary drawings are for purposes of illustration only and the dimensions, positions, order and relative sizes reflected in the drawings attached hereto may vary.

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Abstract

Cette invention concerne un dispositif d'administration de médicaments, comprenant un contenant tel qu'une cartouche ou une seringue, et un mécanisme de distribution comprenant un ou plusieurs pistons plongeurs ou soupapes qui mélangent et/ou administrent des substances. Selon un mode de réalisation, ledit contenant et/ou lesdites soupapes est/sont lubrifié(s) ou présente(nt) diverses configurations entraînant une diversification du frottement afin d'assurer une force de glissement appropriée au cours du déplacement des pistons plongeurs dans les contenants. Selon un mode de réalisation, lesdites soupapes comprennent une région formant joint étanche aux gaz ou un trou d'aiguille auto-obturateur.
PCT/US2014/053262 2013-08-30 2014-08-28 Piston plongeur et soupape de piston plongeur pour l'administration de médicaments Ceased WO2015031677A1 (fr)

Priority Applications (1)

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TW103129912A TW201521809A (zh) 2013-08-30 2014-08-29 用於藥物輸送的柱塞及柱塞閥

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US10543315B2 (en) 2015-02-19 2020-01-28 Cube Pharmaceuticals N. Kalofolias & Co. Oe Multi-chambered vessels
CN111479603A (zh) * 2017-12-18 2020-07-31 赛诺菲 制造两件式弹性柱塞
CN115315283A (zh) * 2020-03-17 2022-11-08 贝克顿迪金森法国公司 用于医用注射装置的塞子
WO2023196178A1 (fr) * 2022-04-04 2023-10-12 Becton, Dickinson And Company Seringue à chambres multiples pour distribution séquentielle de fluides et procédés d'utilisation
EP4342509A1 (fr) * 2022-09-20 2024-03-27 Dali Medical Devices Ltd. Traitement d'une seringue à double chambre et ses procédés d'utilisation
WO2024163642A1 (fr) * 2023-01-31 2024-08-08 Credence Medsystems, Inc. Système et procédé d'injection

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US11701472B2 (en) * 2018-03-20 2023-07-18 Becton, Dickinson And Company Syringe stopper and plunger rod arrangement for a syringe assembly
TWI736329B (zh) * 2020-06-22 2021-08-11 慈濟學校財團法人慈濟科技大學 可承載溶液之藥劑混合針具
CN111840763A (zh) * 2020-08-18 2020-10-30 上海微创医疗器械（集团）有限公司 一种液体输送装置及治疗装置

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US20020168530A1 (en) * 2001-01-24 2002-11-14 Kevin Tingey Lubricious coating for a medical device
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WO2010139793A1 (fr) * 2009-06-04 2010-12-09 Novo Nordisk A/S Dispositif mélangeur à accouplement de pistons
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US3380451A (en) * 1965-06-14 1968-04-30 Robert E. Porter Two compartment syringe
US4031892A (en) * 1974-07-18 1977-06-28 Ampoules Corporation Two-chamber mixing syringe
US5817055A (en) * 1992-07-07 1998-10-06 Pharmacia & Upjohn Aktiebolag Dual-chamber injection cartridge
US5752940A (en) * 1994-01-25 1998-05-19 Becton Dickinson And Company Syringe and method for lyophilizing and reconstituting injectable medication
US20020168530A1 (en) * 2001-01-24 2002-11-14 Kevin Tingey Lubricious coating for a medical device
US20090062740A1 (en) * 2007-09-05 2009-03-05 Thorne Jr Gale H Multi-chamber, sequentially dispensing syringe
US20120209171A1 (en) * 2007-09-27 2012-08-16 Becton, Dickinson And Company Cartridge for powder and liquid drug
WO2010139793A1 (fr) * 2009-06-04 2010-12-09 Novo Nordisk A/S Dispositif mélangeur à accouplement de pistons

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10543315B2 (en) 2015-02-19 2020-01-28 Cube Pharmaceuticals N. Kalofolias & Co. Oe Multi-chambered vessels
CN111479603A (zh) * 2017-12-18 2020-07-31 赛诺菲 制造两件式弹性柱塞
CN115315283A (zh) * 2020-03-17 2022-11-08 贝克顿迪金森法国公司 用于医用注射装置的塞子
CN115315283B (zh) * 2020-03-17 2024-07-30 贝克顿迪金森法国公司 用于医用注射装置的塞子
US12458756B2 (en) 2020-03-17 2025-11-04 Becton Dickinson France Stopper for a medical injection device
WO2023196178A1 (fr) * 2022-04-04 2023-10-12 Becton, Dickinson And Company Seringue à chambres multiples pour distribution séquentielle de fluides et procédés d'utilisation
EP4342509A1 (fr) * 2022-09-20 2024-03-27 Dali Medical Devices Ltd. Traitement d'une seringue à double chambre et ses procédés d'utilisation
WO2024163642A1 (fr) * 2023-01-31 2024-08-08 Credence Medsystems, Inc. Système et procédé d'injection

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