Devices and methods for establishing aseptic connections between a drug container and a fluid pathway connection for a drug pump are provided. A fluid pathway connection includes a connection hub, a piercing member, a piercing member retainer, and a drug container. The drug container includes a cap, a pierceable seal, and a barrel. The piercing member is at least partially disposed in a sterile chamber defined by the connection hub, and the connection hub is configured to be connected to the drug container while maintaining an aseptic condition of a fluid pathway from the sterile chamber to an interior of the drug container.
A61M 5/162 - Needle sets, i.e. connections by puncture between reservoir and tube
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
Handheld drug delivery devices for injection of a medicament into a target location are disclosed herein. The drug delivery devices of the present disclosure include drive mechanisms, needle insertion mechanisms, and fluid pathway connectors. These components may be arranged within a housing. The arrangement of these components may provide an easy to use device that is capable of delivering volumes larger than traditionally injected using syringes. Translation of a drug container of the device may cause connection of a fluid pathway from the drug container for delivery of a medicament to a target location.
An actuating device (100) having integrated plunger is configured to be removably mounted to an automatic mixing device for a syringe. The actuating device includes lower (180) and upper (110) housings, a trigger member (120), a lockout ring (170), a mixing biasing member (150), a delivery plunger (1300), a plunger biasing member, and a mixing plunger (140). The mixing plunger (130) is releasably engaged with the trigger member (120) in an initially locked state and engageable with at least one seal (250) of the mixing device. The trigger member is operable to initiate decompression of the mixing biasing member (150) and engagement of the mixing plunger with the at least one seal (150) of the mixing device. The delivery plunger may also be activated to expand from a first, collapsed configuration (fig 6A) to a second, expanded configuration (fig 6B) by actuation of the trigger member (120).
A controlled delivery drive mechanism includes a drive housing (130); a spring (122) initially retained in an energized state and bearing on a piston (110) configured to translate a plunger seal (60) in a barrel (58) of a drug container (50); and a tether (580) connected between the piston (1 10) and a winch drum (520) to restrain the free expansion of the spring (122). The drive mechanism (100) may include a gear assembly and an escapement regulating mechanism (500) to control the rotation of the gear assembly to release the tether from the winch drum. Escapement regulating mechanism (500) includes a lever (564), escape wheel (562), and balance wheel (566) with hair spring (568) and motor or solenoid actuator (570). Lever has pins (564); and prong (564C) moveably engaging a post (566A) and an impulse pin (566B) of a balance wheel (566).
A fill-finish cartridge includes a carrier, a fluid pathway connection, a needle insertion mechanism, and a drug container. The cartridges enable drug containers to be filled with pharmaceutical treatments using standard filling equipment and process systems, while maintaining the sterility and container integrity of the fluid pathway. The fill-finish cartridges of the present invention can be nested or removably housed in fill-finish trays for batch filling in standard operating processes. As such, the adaptable fill-finish cartridges of the present invention may be flexibly inserted, attached, mounted, or otherwise removably positioned in fill-finish trays. These embodiments, accordingly, may provide novel and cost-efficient assemblies and cartridges which are readily integrated into drug filling processes. Methods of assembly, manufacture, and use are also provided.
Drug delivery devices are provided that are capable of delivering a relatively large dosage form (for example, a 2 mL volume dosage form rather than a 1 mL dosage form) comprising a drug at a controlled rate. Advantageously, these devices deliver the required dose of the drug with a generally acceptable level of pain intensity.
A61M 5/00 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests
A61M 5/14 - Infusion devices, e.g. infusing by gravityBlood infusionAccessories therefor
A61M 5/145 - Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. by means of pistons
A61M 5/20 - Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 31/00 - Devices for introducing or retaining media, e.g. remedies, in cavities of the body
Drug delivery devices are provided that are capable of delivering at a controlled rate a relatively large dosage form (for example, a 2 mL volume dosage form rather than a 1 mL dosage form) comprising a drug. Advantageously, these devices deliver the required dose of the drug with a generally acceptable level of pain intensity.
The present embodiments provide for tralokinumab delivery devices that are capable of delivering a relatively large viscous dosage form (for example, a 2 mL volume dosage form rather than a 1 mL dosage form) at a controlled flow rate. Advantageously, these embodiments deliver the required tralokinumab dose to the subject with a generally acceptable level of pain intensity.
An insertion mechanism (200, 2200) and methods of assembly and operation of a drag pump (1) may include an insertion mechanism housing (202, 2202); a housing cap (203); a manifold guide (220, 2220); an insertion biasing member (210, 2210) initially held in an energized state; a retraction biasing member (216, 2216) connected to a hub (212, 2212) connected to a proximal end of a needle (214, 2214); and optionally, a clip retainer (219, 2219). The retraction biasing member is held initially in an energized state between the hub and manifold guide. A manifold has a manifold body (240B, 2240B) and one or more septa (230A, 230B, 2230A, 2230B) defining a manifold header (242, 2242). The retraction biasing member may be held initially in an energized state between the hub and the clip retainer. The needle is advanced by the insertion biasing member(s) from the initial configuration to an administration configuration, opening a fluid pathway from the manifold header to the target. The drug delivery pump may include an activation mechanism (14), a dreive mechanism (100), a fluid pathway connection (300), and the insertion mechanism (200).
The present disclosure provides drug containers that allow for the mixing of one or more substances prior to drug injection and drug delivery pumps incorporating such drug containers. The drug delivery pumps may be wearable by a user. Mixing of the two or more substances contained within separate, mutable chambers is initiated by transforming an outer barrel distal seal (524) from a first position in which it covers ports (518) extending through an inner barrel (510) to a second position in which the outer barrel distal seal (524) does not cover the ports. Mixing is induced by forcing the contents of the outer chamber (526) through the ports and into the inner chamber, thereby by mixing with the contents of the inner chamber. After mixing of the substances is complete the mixed contents of the inner chamber are forced out of the inner chamber by distal displacement of an injection seal (512) located within the inner barrel. The contents may be delivered through a sterile pathway connection (300) and sterile fluid conduit (320) into the body of the patient. By providing these drug containers and drug delivery pumps that incorporate them, medicaments may be stored as two or more separate constituents and mixed at or near time of delivery.
The present disclosure provides drug containers that allow for the mixing of one or more substances prior to drug injection and drug delivery pumps incorporating such drug containers. Mixing of the two or more substances contained within separate, mutable chambers (64)(66) is initiated by transforming a seal assembly from a closed position to an open position in which the mutable chambers are in fluid communication with one another. Continued mixing is induced by causing the contents of one of the mutable chambers to be fully displaced. After mixing of the substances is complete one or more of the following steps may be performed by the drug delivery pump (10) : needle insertion, opening of a sterile fluid pathway, drug delivery, and needle retraction. By providing these drug containers and drug delivery pumps medicaments may be stored as two or more separate constituents and mixed at or near time of delivery.
A skin sensing system for a drug delivery device includes a control unit and a skin sensor comprising one or more electrodes. The skin sensor may be configured to store a threshold value associated with skin sensing, receive one or more sensed signal values from the one or more electrodes, compare the one or more sensed signal values with the threshold value, and based on the comparison, transmit a resultant signal to the control unit. The resultant signal is used by the control unit to determine whether a skin surface of a user is substantially proximate to the skin sensor upon receiving the resultant signal. A drug delivery device (50) for sensing contact with the skin includes the skin sensing system. When the skin sensor senses that the drug delivery device is in contact with a patient's skin surface, drug delivery from the device may be permitted.
Systems for drug delivery devices include a temperature control system and an identification system. A temperature control system configured to sense and control temperature of a cartridge containing a drug includes a heater, one or more temperature sensors, and a control unit. An identification system configured to identify a cartridge containing a drug includes a control unit and a tag sensor that is electrically coupled to the control unit, wherein the tag sensor is activated upon detecting a presence of the cartridge. A drug delivery device includes both the temperature control system and the identification system such that the control unit of the device may process the information of the drug that is received from the tag sensor of the identification system, and based on at least a portion of the processed information, determine and control the temperature of the drug within a cartridge.
A61B 90/98 - Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders
A61M 5/20 - Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
A61M 5/315 - PistonsPiston-rodsGuiding, blocking or restricting the movement of the rodAppliances on the rod for facilitating dosing
A61M 5/44 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for cooling or heating the devices or media
A skin sensing system for a drug delivery device includes a control unit and a skin sensor comprising one or more electrodes. The skin sensor may be configured to store a threshold value associated with skin sensing, receive one or more sensed signal values from the one or more electrodes, compare the one or more sensed signal values with the threshold value, and based on the comparison, transmit a resultant signal to the control unit. The resultant signal is used by the control unit to determine whether a skin surface of a user is substantially proximate to the skin sensor upon receiving the resultant signal. A drug delivery device (50) for sensing contact with the skin includes the skin sensing system. When the skin sensor senses that the drug delivery device is in contact with a patient's skin surface, drug delivery from the device may be permitted.
Systems for drug delivery devices include a temperature control system and an identification system. A temperature control system configured to sense and control temperature of a cartridge containing a drug includes a heater, one or more temperature sensors, and a control unit. An identification system configured to identify a cartridge containing a drug includes a control unit and a tag sensor that is electrically coupled to the control unit, wherein the tag sensor is activated upon detecting a presence of the cartridge. A drug delivery device includes both the temperature control system and the identification system such that the control unit of the device may process the information of the drug that is received from the tag sensor of the identification system, and based on at least a portion of the processed information, determine and control the temperature of the drug within a cartridge.
A61M 5/20 - Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
A61M 5/44 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for cooling or heating the devices or media
A61B 90/98 - Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders
A61M 5/315 - PistonsPiston-rodsGuiding, blocking or restricting the movement of the rodAppliances on the rod for facilitating dosing
18.
SPRAY CONFIGURATIONS FOR DUAL CHAMBER MIXING DEVICES
A treatment apparatus (200, 300, 400) for a mixing device (100) having a concentric barrel configuration. The treatment apparatus comprises a manifold (202, 302, 402) including an input end (210, 310, 410) and an output end (213, 313, 413). The treatment apparatus also comprises a conduit body (206, 306, 406) having a manifold end (209, 309, 409) and a nozzle end (211, 311, 411). The manifold end is connected to the output end of the manifold, and the conduit body includes at least one nozzle (204, 314, 414) at the nozzle end of the conduit body opposite the manifold. At least one fluid pathway (332, 334) is formed between the input end of the manifold, the conduit body, and the at least one nozzle.
C10M 107/50 - Lubricating compositions characterised by the base-material being a macromolecular compound containing silicon
B05D 1/00 - Processes for applying liquids or other fluent materials
B05D 7/22 - Processes, other than flocking, specially adapted for applying liquids or other fluent materials to particular surfaces or for applying particular liquids or other fluent materials to internal surfaces, e.g. of tubes
B05B 7/04 - Spray pistolsApparatus for discharge with arrangements for mixing liquids or other fluent materials before discharge
B05B 13/06 - Machines or plants for applying liquids or other fluent materials to surfaces of objects or other work by spraying, not covered by groups specially designed for treating the inside of hollow bodies
B05B 1/00 - Nozzles, spray heads or other outlets, with or without auxiliary devices such as valves, heating means
An expanding plunger rod (100) for a syringe (50). The expanding plunger rod is configured to transition from a packaged configuration for packaging to an expanded configuration for operation. The expanding plunger rod comprises a substantially cylindrical outer sleeve (110) having a closed-off bottom end (108) and an open upper end (111). The expanding plunger includes an inner rod (114) having a lower end (138) and an upper end (140). The inner rod is slidably disposed coaxially within the outer sleeve. In the packaged configuration, the inner rod is nested within the outer sleeve. In the expanded configuration, the inner rod is disposed substantially axially above the outer sleeve, and the inner rod is configured to lock axially in place so as to prevent transition from the expanded configuration to the packaged configuration.
The present embodiments provide for a syringe and a retraction plunger assembly configured to accept various retractable needle assemblies, which are capable of cooperating to provide a retraction safety syringe. In particular, the syringe includes a barrel and a retraction plunger assembly comprising a control unit attached to a plunger and releasably engaged to a housing, and at least one biasing means disposed within the plunger assembly. Upon completion of dose delivery via a retractable needle, the control unit disengages from housing and the biasing member retracts the plunger and a connected needle into the barrel. Various elements are configured to prevent further use of the syringe. The control unit can be used to control a rate of needle retraction.
A drive mechanism 2100, 3100 includes a housing 2130, a piston 2110 adapted to impart movement to a plunger seal 2060 within a drug container 2050, a plurality of biasing members 2106, 2122 disposed in parallel, and a retainer 2115. The biasing members 2106, 2122 are disposed to release energy to cause movement of the piston 2110 from a retracted first position to the extended second position, the piston 2110 bearing against the plunger seal 2060 to dispense medicine. The retainer 2115 is disposed to maintain the biasing members 2106, 2122 in the energized position and to release the biasing members 2106, 2122 to permit the piston 2110 to dispense the medicine. The drive mechanism 2100, 3100 may also include an end-of-dose indicator 2133, 3133 to identify at least one of when the sleeve assembly 2120, 3120 is disposed subjacent a window 2131, 3131 in the housing 2130, 3130 the relative motion of the sleeve assembly 2120, 3120 with reference to the window 2131, 3131 or another reference component, the stoppage of such motion, and the rated or change of rate of motion.
A drive mechanism 2100, 3100 includes a housing 2130, a piston 2110 adapted to impart movement to a plunger seal 2060 within a drug container 2050, a plurality of biasing members 2106, 2122 disposed in parallel, and a retainer 2115. The biasing members 2106, 2122 are disposed to release energy to cause movement of the piston 2110 from a retracted first position to the extended second position, the piston 2110 bearing against the plunger seal 2060 to dispense medicine. The retainer 2115 is disposed to maintain the biasing members 2106, 2122 in the energized position and to release the biasing members 2106, 2122 to permit the piston 2110 to dispense the medicine. The drive mechanism 2100, 3100 may also include an end-of-dose indicator 2133, 3133 to identify at least one of when the sleeve assembly 2120, 3120 is disposed subjacent a window 2131, 3131 in the housing 2130, 3130 the relative motion of the sleeve assembly 2120, 3120 with reference to the window 2131, 3131 or another reference component, the stoppage of such motion, and the rated or change of rate of motion.
An automatic accurate dose syringe includes a barrel, a plunger seal, a barrel adapter assembly having a barrel tip and a needle, and a dose control mechanism having a plunger having a coarse pitch screw on its exterior surface, a housing having a corresponding coarse pitch guide along the interior surface of the housing, a screw having a fine pitch screw which interfaces with a fine pitch nut of an adapter, wherein the plunger has an internal annular space within which screw at least partially resides. The syringe further includes a locking mechanism, an activation button, and a biasing member such as a compression and/or a torsional spring. The components are configured such that actuation of the activation button by the user manipulates the locking mechanism to permit the biasing member to move from an initial energized state to a lower energy state, thereby automating drug delivery from the syringe.
A sterile fluid pathway connector includes a piercing member, a connector hub, and a pierceable seal; wherein at least a portion of the pierceable seal is configured to move from a first position in which the piercing member is retained within a sterile cavity between the pierceable seal and the connector hub, to a second position in which the pierceable seal has been penetrated by the piercing member. A filter may be utilized to enclose the sterile cavity from the outside environment. Such fluid pathway connections may be integrated into a fluid container having a barrel and a plunger seal. The components of the fluid pathway connector may further be capable of transmitting a signal to the user upon completion of fluid delivery, for example, upon contact between the plunger seal and the pierceable seal. A fluid delivery pump includes such integrated fluid pathway connectors and fluid containers.
A sterile fluid pathway connector includes a piercing member, a connector hub, and a pierceable seal; wherein at least a portion of the pierceable seal is configured to move from a first position in which the piercing member is retained within a sterile cavity between the pierceable seal and the connector hub, to a second position in which the pierceable seal has been penetrated by the piercing member. A filter may be utilized to enclose the sterile cavity from the outside environment. Such fluid pathway connections may be integrated into a fluid container having a barrel and a plunger seal. The components of the fluid pathway connector may further be capable of transmitting a signal to the user upon completion of fluid delivery, for example, upon contact between the plunger seal and the pierceable seal. A fluid delivery pump includes such integrated fluid pathway connectors and fluid containers.
A sterile fluid pathway connector includes a piercing member, a connector hub, and a pierceable seal; wherein at least a portion of the pierceable seal is configured to move from a first position in which the piercing member is retained within a sterile cavity between the pierceable seal and the connector hub, to a second position in which the pierceable seal has been penetrated by the piercing member. A filter may be utilized to enclose the sterile cavity from the outside environment. Such fluid pathway connections may be integrated into a fluid container having a barrel and a plunger seal. The components of the fluid pathway connector may further be capable of transmitting a signal to the user upon completion of fluid delivery, for example, upon contact between the plunger seal and the pierceable seal. A fluid delivery pump includes such integrated fluid pathway connectors and fluid containers.
A retainer 220 for a needle assembly 200 of a retractable syringe 1000 that includes a plunger assembly 400 and a barrel 100 having a mounting member 110. The needle assembly 200 includes a retractable needle 210, a needle hub 230, and a retainer 220. The retractable needle 210 is engageable by the plunger assembly 400 to facilitate retraction thereof. The needle hub 230 is mountable to the mounting member 110 of the barrel 100. The retainer 220 includes a body 225 and at least one retaining member 221 that extends distally from the body 225. The retaining member 221 includes an inwardly projecting lateral projection 224 to engage the retractable needle 210 and thereby prevent inadvertent proximal movement of said retractable needle 210 prior to retraction. A retractable needle assembly 200 includes the retainer 220, and a retractable syringe includes the retractable needle assembly 200 including the retainer 220. A syringe kit 90 includes a retractable syringe, a plurality of retractable needle assemblies 200, and a vial adapter 2000.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A connector mountable to a syringe barrel has a proximal barrel-engaging portion, a distal luer fitment portion, and a fluid aperture therethrough. The barrel-engaging portion of the connector includes an axial ledge configured to abut the axial distal edge of a glass syringe barrel. The connector facilitates mounting a luer assembly to the barrel. The luer assembly may be a tip cap, a luer needle assembly, or a luer needle-less assembly, having a complementary luer fitment for connection to the luer fitment portion of the connector. The connector and syringe may further include an immobile, compressible needle seal. The needle seal is adjacent to or engageable with the barrel-engaging portion of the connector.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
29.
LUER CONNECTION ADAPTERS FOR RETRACTABLE NEEDLE SYRINGES
A connector mountable to a syringe barrel has a proximal barrel-engaging portion, a distal luer fitment portion, and a fluid aperture therethrough. The barrel-engaging portion of the connector includes an axial ledge configured to abut the axial distal edge of a glass syringe barrel. The connector facilitates mounting a luer assembly to the barrel. The luer assembly may be a tip cap having a complementary luer fitment for connection to the luer fitment portion of the connector. The luer assembly may be a luer needle assembly having a complementary luer fitment for connection to the luer fitment portion of the connector. The connector and syringe may further include an immobile, compressible needle seal. The needle seal is adjacent to or engageable with the barrel-engaging portion of the connector. The syringe may be configured with a plunger capable of engaging a retractable needle.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
Sequential delivery syringes including a valve mechanism are configured and configurable to enable one or more substances to be prefilled into the syringe. The valve mechanism may be an aspect of a distal seal assembly. Actuation of the valve mechanism permits opening of a fluid passage for the mixing of one or more substances, and the resulting mixed substance can be delivered by the syringe, for example, for administration of a pharmaceutical to a subject. The sequential delivery of substances contained in a distal and proximal chamber is also provided, where a second substance from the distal chamber is delivered followed by the delivery of a first substance from the distal chamber after the first substance from the proximal chamber is transferred into the distal chamber involving the actuation of the valve mechanism.
Mixing syringes including a valve mechanism are configured and configurable to enable one or more substances to be prefilled into the syringe. The valve mechanism may be an aspect of a distal seal assembly. Actuation of the valve mechanism permits opening of a fluid passage for the mixing of one or more substances, and the resulting mixed substance can be delivered by the syringe, for example, for administration of a pharmaceutical to a subject. The repetitive mixing of substances contained in a distal and proximal chamber is also provided, where the plunger rod is configured to releasably engage a locking mechanism to actuate the valve, and can axially displace the distal seal assembly while the fluid passage is open.
Mixing syringes including a valve mechanism are configured and configurable to enable one or more substances to be prefilled into the syringe. The valve mechanism may be an aspect of a distal seal assembly. Actuation of the valve mechanism permits opening of a fluid passage for the mixing of one or more substances, and the resulting mixed substance can be delivered by the syringe, for example, for administration of a pharmaceutical to a subject.
An automatic mixing device (200), an actuating device (100) having an integrated plunger (130) and configured to be removably mounted to the automatic mixing device (200), and a retractable syringe (10) having the automatic mixing device (200) are provided. The actuating device (100) has an initially compressed spring (150) and a trigger member (120) that is rotatable to initiate spring (150) decompression to drive depression of a mixing plunger (140) that bears against a seal (250) of the automatic mixing device (200). Another seal (260) also located in an outer chamber (240) of the mixing device (200) is capable of axial movement upon depression of the mixing plunger (140), from a first position in sealing engagement with one or more apertures (211A, B) in an inner barrel (211A, B) to a second position intermediate the apertures and vents (271, A, B, C, D) in an outer barrel (220). This allows depression of the mixing plunger (140) to force a first substance from the outer chamber (240) through the apertures (211A, B) to mix with a second substance in an inner chamber (230) of the inner barrel (210). The mixed substance in the inner chamber (230) is then delivered by the syringe (10) with subsequent needle (310) retraction.
A61M 5/28 - Syringe ampoules or cartridges, i.e. ampoules or cartridges provided with a needle
A61M 5/315 - PistonsPiston-rodsGuiding, blocking or restricting the movement of the rodAppliances on the rod for facilitating dosing
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
Plunger sub-assemblies 10 for automatic injectors 100 include a plunger outer 104 having one or more engagement prongs 104A, B, a plunger inner 110 having one or more engagement slots 110A, B which correspond with the engagement prongs 104A,B of the plunger outer 104, and a retraction biasing member 106. The retraction biasing member 106 is retained in a first energized state between the plunger outer 104 and plunger inner 110 when the engagement prongs 104A, B of the plunger outer 104 are releasably engaged with the engagement slots 110A, B of the plunger inner 110. The one or more engagement prongs 104A, B are capable of flexing substantially radially to release from engagement with the engagement slots 110A, B of the plunger inner 110 to permit the retraction biasing member 106 to expand from the first energized state to a second expanded state. An automatic injector 100 having a plunger sub-assembly 10 includes a housing 11, an activation mechanism 30, and a plunger sub-assembly 10 at least partially mounted within a syringe cartridge 20 having a needle assembly 40.
A61M 5/20 - Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
Barrel adapters 100, 200 for safety syringes 10 include a barrel 20 and a plunger assembly 8 adapted to move within the barrel 20, a barrel tip 130, 230 adapted to be sealingly engaged with a distal end of the barrel 20 and a needle retraction mechanism 111, 211 having a needle subassembly 120, 220 and an actuator subassembly 110, 210. The needle subassembly 120, 220 includes a needle 101, 201, and a needle-over-mold 122, 222 (NOM) through which the needle 101, 201 extends. The needle subassembly 120, 220 is disposed at least partially within the barrel tip 130, 230, and adapted to move from an injection position in which the needle 101, 201 extends from a distal end of the barrel tip 130, 230 to a retracted position in which the needle 101, 201 is disposed within at least one of the barrel tip 130, 230 or the barrel 20. The actuator subassembly 110, 210 includes a needle seal 116, 216, a push-bar, and an actuator 114 surface. The needle retraction mechanism 111, 211 includes a biasing member 140, 240 and an actuable locking arrangement. A syringe 10 includes such barrel adapters 100, 200.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 5/34 - Constructions for connecting the needle
Needle assemblies for retractable needle syringes include a needle, a needle seal, and a needle retainer, wherein the needle includes one or more barbs substantially at its proximal end. The needle retainer engages an optional needle-over-mold component that is fixedly attached to the needle. The needle-over-mould may be connected to the distal surface of the needle seal and may travel, such as by being a couple component, with the needle during the operation of the syringe. A safety syringe includes a barrel having a needle assembly mounted at a distal end and a plunger assembly mounted at a proximal end. A drug may be contained in a drug chamber of barrel, between the plunger assembly and needle assembly, proximally of the needle seal for drug delivery to a user. The plunger assembly includes a plunger seal having a needle-engaging portion to capture the needle at the barb for retraction.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
37.
INTEGRATED SLIDING SEAL FLUID PATHWAY CONNECTION AND DRUG CONTAINERS FOR DRUG DELIVERY PUMPS
A fluid pathway connection (300) includes a piercing member (330), a connection hub (310), and a sliding pierceable seal (56), wherein the sliding pierceable seal (56) is configured to move from a first position, where the piercing member (330) is initially retained within a sterile cavity (311) between the connection hub (310) and the sliding pierceable seal (56), to a second position, where the pierceable seal (56) has been penetrated by the piercing member (330). A filter (309) may be utilized to enclose the sterile cavity (311) from the outside environment. The fluid pathway connection (300) may further be configured to move to a third position where one or more interconnects (61, 102) and/or one or more corresponding contacts (62, 104) are permitted to transmit a signal to the user. Such fluid pathway connections (300) may be integrated into a drug container (50) having a barrel (58) and a plunger seal (60). A drug delivery pump (10) includes such integrated fluid pathway connections (300) and drug containers (50).
A drive mechanism 2100 includes a housing 2130, a piston 2110 adapted to impart movement to a plunger seal 2060 within a drug container 2050, a plurality of biasing members 2106, 2122 disposed in parallel, and a retainer 2115. The biasing members 2106, 2122 are disposed to release energy to cause movement of the piston 2110 from a retracted first position to the extended second position, the piston 2110 bearing against the plunger seal 2060 to dispense medicine. The retainer 2115 is disposed to maintain the biasing members 2106, 2122 in the energized position and to release the biasing members 2106, 2122 to permit the piston 2110 to dispense the medicine. The drive mechanism 2100 may also include an end-of-dose indicator 2133 to identify at least one of when the sleeve assembly 2120 is disposed subjacent a window 2131 in the housing 2130, the relative motion of the sleeve assembly 2120 with reference to the window 2131 or another reference component, the stoppage of such motion, and the rated or change of rate of motion.
A fluid pathway connection (300) includes a piercing member (330), a connection hub (310), and a sliding pierceable seal (56), wherein the sliding pierceable seal (56) is configured to move from a first position, where the piercing member (330) is initially retained within a sterile cavity (311) between the connection hub (310) and the sliding pierceable seal (56), to a second position, where the pierceable seal (56) has been penetrated by the piercing member (330). A filter (309) may be utilized to enclose the sterile cavity (311) from the outside environment. The fluid pathway connection (300) may further be configured to move to a third position where one or more interconnects (61, 102) and/or one or more corresponding contacts (62, 104) are permitted to transmit a signal to the user. Such fluid pathway connections (300) may be integrated into a drug container (50) having a barrel (58) and a plunger seal (60). A drug delivery pump (10) includes such integrated fluid pathway connections (300) and drug containers (50).
A replaceable fluid restriction mechanism 500, 1500 includes: an aperture 520A residing adjacent to a fluid pathway connection and configured to permit flow of a drug fluid through the aperture 520A when the fluid pathway connection is open; an entry point 520B of a fluid channel 520C configured such that the flow of drug fluid can travel through aperture 520A to the entry point 520B and through the fluid channel 520C to an exit point 520D; and an outlet aperture 514 of a port 512 through which the flow of drug fluid may travel after exiting the exit point 520D, wherein a fluid conduit 30 is connected to the fluid restriction mechanism at the outlet aperture. A configurable fluid restriction mechanism 500, 1500 includes a plurality of fluid channels 520C, 521C, 522C, 523C, selectable to align with the entry point 520B and an exit point 520D of the fluid restriction mechanism.
A vial adapter (100) is provided for interconnecting a vial (300) having a closure (320) and a fluid delivery device such as a safety syringe (400). The vial adapter (100) comprises an adapter housing (110) having a base (120), a shroud (130) extending or projecting from the base (120) and a cannula (150) extending or projecting from the base 120) for penetrating a rubber seal (330) on the vial closure (320) to thereby establish fluid communication between the vial (300) and the vial adapter (100). The shroud (130) may comprise a plurality of latitudinal slits or windows (131) within each of which resides a flexion arm (132) connected to the shroud (130), each flexion arm (132) capable of engaging and/or retaining vial closures (320) of any of a variety of different sizes. The vial adapter (100) may comprise a conduit tip (160) in fluid communication with the cannula 150) to allow transfer of fluid to or from the safety syringe(400) while also preventing inadvertent activation of a safety syringe needle retraction mechanism.
A combination plunger, a mixing device and a mixing syringe comprising the same are provided. The mixing syringe comprises concentric outer and inner barrels that form an outer chamber, the inner barrel having an inner chamber. The combination plunger includes a mixing plunger and a delivery plunger and a biasing means. The mixing plunger is slidably located in the outer chamber and translated by coordinated depression of the delivery plunger to transfer a first substance from the outer chamber to mix with a second substance in the inner chamber. After the mixing stage is complete, the delivery plunger is disengaged from the mixing plunger and permitted, such as by rotation, to be further depressed in the axial direction to deliver fluid contents of the mixing syringe to a recipient. The mixing syringe needle is then retracted as result of engagement by the delivery plunger and activation of the biasing means.
A61M 5/28 - Syringe ampoules or cartridges, i.e. ampoules or cartridges provided with a needle
B01F 11/00 - Mixers with shaking, oscillating, or vibrating mechanisms
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
B01F 13/00 - Other mixers; Mixing plant, including combinations of dissimilar mixers
A variable rate controlled delivery drive mechanism includes a drive mechanism housing, at least partially within which initially resides a biasing member positioned in an initially energized state within an inner cavity of a piston. The drive mechanism may include a gear drive having one or more screws and one or more corresponding nuts. The piston contacts a plunger seal and is configured to axially translate the plunger seal, by force asserted upon it from the biasing member, from a first position to a second position within a drug container for drug delivery. The biasing member is metered from free expansion from its energized state by the gear drive and a gear assembly mechanism having a motor. A drug delivery pump utilizes such variable rate controlled delivery mechanisms. A status reader configured to recognize one or more corresponding status triggers is utilized to provide feedback to a user.
A controlled delivery drive mechanism includes a drive housing, a piston, and a biasing member initially retained in an energized state and is configured to bear upon an interface surface of the piston. The piston is configured to translate a plunger seal and a barrel. A tether is connected between the piston and the winch drum to restrain the free expansion of the biasing member and the free axial translation of the piston upon which the biasing member bears upon. The drive mechanism may further include a gear assembly having a motor configured to drive the gear assembly to release the tether from the winch drum. The metering of the tether by the motor controls the rate or profile of drug delivery to a user. A drug delivery pump includes such a controlled delivery drive mechanism. A control system may be utilized to control the desired drug delivery rate/profile.
A variable rate controlled delivery drive mechanism includes a drive mechanism housing, at least partially within which initially resides a biasing member positioned in an initially energized state within an inner cavity of a piston. The drive mechanism may include a gear drive having one or more screws and one or more corresponding nuts. The piston contacts a plunger seal and is configured to axially translate the plunger seal, by force asserted upon it from the biasing member, from a first position to a second position within a drug container for drug delivery. The biasing member is metered from free expansion from its energized state by the gear drive and a gear assembly mechanism having a motor. A drug delivery pump utilizes such variable rate controlled delivery mechanisms. A status reader configured to recognize one or more corresponding status triggers is utilized to provide feedback to a user.
A controlled delivery drive mechanism includes a drug container having a barrel and a plunger seal; a drive housing within which at least initially partially resides a piston having an interface surface and a drive rack; and a power spring. The piston is configured to contact and axially translate the plunger seal within barrel. The mechanism may be configured to convert rotational movement of a drive pinion to axial translation of the drive rack, or to convert axial force of a linear power spring into torsional motion of a drive pinion. A regulating mechanism meters the drive pinion such that the piston is axially translated at a controlled rate. The drug container may contain a drug fluid within a drug chamber for drug delivery at a controlled rate. The regulating mechanism may be an escapement regulating mechanism. A drug delivery pump includes such controlled delivery drive mechanisms.
An insertion mechanism having a vented fluid pathway includes an insertion biasing member 210, a hub 212, a needle 214, a retraction biasing member 216, and a manifold 240 having a septum 230 and a cannula 234, wherein the annular space between the septum 230 and the cannula 234 defines a manifold header 242. The manifold and fluid conduit are ventable through the membrane prior to or just after needle 214 and cannula 234 are inserted into the user. Such insertion is caused by the insertion biasing member(s) 210, after which only the needle 214 or another occlusion element is retracted. Such retraction may open a fluid pathway from the manifold header 242 to the body through the cannula 234 and/or needle 214. A drug delivery pump 10 includes such an insertion mechanism 200 having a vented fluid pathway. The drug delivery pump 10 may contain the insertion mechanism 200 having a vented fluid pathway in either an internally i or an externally tethered configuration.
A61M 5/36 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests with means for eliminating or preventing injection or infusion of air into body
A61M 5/38 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests with means for eliminating or preventing injection or infusion of air into body using hydrophilic or hydrophobic filters
49.
INSERTION MECHANISMS HAVING VENTED FLUID PATHWAYS FOR DRUG DELIVERY PUMPS
An insertion mechanism having a vented fluid pathway includes an insertion biasing member 210, a hub 212, a needle 214, a retraction biasing member 216, and a manifold 240 having a septum 230 and a cannula 234, wherein the annular space between the septum 230 and the cannula 234 defines a manifold header 242. The manifold and fluid conduit are ventable through the membrane prior to or just after needle 214 and cannula 234 are inserted into the user. Such insertion is caused by the insertion biasing member(s) 210, after which only the needle 214 or another occlusion element is retracted. Such retraction may open a fluid pathway from the manifold header 242 to the body through the cannula 234 and/or needle 214. A drug delivery pump 10 includes such an insertion mechanism 200 having a vented fluid pathway. The drug delivery pump 10 may contain the insertion mechanism 200 having a vented fluid pathway in either an internally i or an externally tethered configuration.
A61M 5/36 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests with means for eliminating or preventing injection or infusion of air into body
A61M 5/38 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests with means for eliminating or preventing injection or infusion of air into body using hydrophilic or hydrophobic filters
A61M 5/14 - Infusion devices, e.g. infusing by gravityBlood infusionAccessories therefor
50.
AUTOMATIC INJECTORS FOR INJECTABLE CARTRIDGES AND DRIVE CONTROL MECHANISMS THEREFOR
An automatic injector (50) includes a housing (52, 236) having a guide (158), a drive control mechanism, a transmission assembly (110), a motor (106), and an energy source. The housing (52, 236) may further include a cartridge cover (72). A drive control mechanism includes a drive screw (114), a cartridge carrier (126, 202), a plunger carrier (138, 194, 226, 242), and one or more control transfer instruments (150, 204), such as a puck or cylinder. The drive screw (114) interfaces and connects with the plunger carrier (138, 194, 226, 242). The automatic injector (50) is configured to accept a variety of syringes as cartridges (54, 224) for drug delivery. The cartridges (54, 224) may be ejected from the injector (50) and safely disposed after use, making the injector a reusable automatic injector (50). The reusable automatic injector (50) may further include one or more sensors (160, 165), such as a cartridge sensor (160) and a patient sensor (165). The novel incorporation of the drive control mechanisms into the automatic injectors (50) of the present invention enables a single motor (106) and transmission assembly (110) to drive the function of multiple components, which may include the steps of: preparation and alignment of a cartridge (54, 224) for injection, removal of a safety cap or needle shield (60), needle injection, drug dose delivery, and syringe and/or needle (58) retraction. Methods of manufacture and methods of use are also disclosed.
An automatic injector (50) includes a housing (52, 236) having a guide (158), a drive control mechanism, a transmission assembly (110), a motor (106), and an energy source. The housing (52, 236) may further include a cartridge cover (72). A drive control mechanism includes a drive screw (114), a cartridge carrier (126, 202), a plunger carrier (138, 194, 226, 242), and one or more control transfer instruments (150, 204), such as a puck or cylinder. The drive screw (114) interfaces and connects with the plunger carrier (138, 194, 226, 242). The automatic injector (50) is configured to accept a variety of syringes as cartridges (54, 224) for drug delivery. The cartridges (54, 224) may be ejected from the injector (50) and safely disposed after use, making the injector a reusable automatic injector (50). The reusable automatic injector (50) may further include one or more sensors (160, 165), such as a cartridge sensor (160) and a patient sensor (165). The novel incorporation of the drive control mechanisms into the automatic injectors (50) of the present invention enables a single motor (106) and transmission assembly (110) to drive the function of multiple components, which may include the steps of: preparation and alignment of a cartridge (54, 224) for injection, removal of a safety cap or needle shield (60), needle injection, drug dose delivery, and syringe and/or needle (58) retraction. Methods of manufacture and methods of use are also disclosed.
A fluid pathway assembly 20, 120, 220, 320, 420, 520 includes a needle insertion mechanism 24, 124, 224, 324, 424, 524, a fluid conduit 26, 126, 226, 326, 426, 526, and a fluid pathway connection 22, 122, 222, 322, 422, 522. The fluid pathway assembly may further include a drug container 18, 118, 218, 318, 418, 518 to hold a drug fluid prior to initiation of the injection. The assembly may include a carrier 140, 141, 142, 240, 242, 280, 341a, 341b, 342 disposed along at least a portion of the fluid pathway assembly and/or a drug container. A fill-finish cartridge 16, 116, 216, 316, 416, 516 functions to retain the components of the fluid pathway assembly in a sterile condition, while allowing for easy integration of the fluid pathway assembly and the drug container into a standard fill-finish process. Methods of constructing a cartridge, filling a drug container included in a cartridge, and incorporating the same into a drug delivery device 10, 310 are disclosed.
An implant delivery syringe 10, 100 includes a barrel 18, 118, a plunger assembly 12, 112, and a barrel adapter 20, 120. A barrel adapter 20, 120 mountable to a syringe barrel 18, 118 includes a barrel tip 32, 132, needle retraction mechanism 21, needle assembly 42 and stylet 54, 154 slidably disposed within the needle lumen 29. The needle retraction mechanism 21 includes a biasing member 30, 130, actuable locking arrangement 31 and locking mechanism 22, 122. When the actuable locking arrangement 31 is actuated, the biasing member 30, 130 causes the needle 28, 128 to axially translate over the stylet 54, 154 during retraction to cause delivery of an implant 49, 129 to a target location. The stylet 54, 154 may be retracted following delivery. Methods of assembling, manufacturing, and using are also provided.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 37/00 - Other apparatus for introducing media into the bodyPercutany, i.e. introducing medicines into the body by diffusion through the skin
A safety syringe 10 includes a barrel 18, plunger assembly 12, and barrel adapter 20. A barrel adapter 20 mountable to a syringe barrel 18 includes a barrel tip 32, needle assembly 42, and needle retraction mechanism 21. The needle assembly 42 includes a needle hub 24, needle seal 26, and needle 28, which is configured to pass-through the needle assembly 42, locking mechanism 22, biasing member 30, and barrel tip 32. The needle retraction mechanism 21 includes a biasing member 30 and locking mechanism 22 such that actuation of the locking mechanism 22 allows the biasing member 30 to cause retraction of the needle 28 into the barrel tip 32. Methods of assembling, manufacturing, and using such syringes 10 are also provided.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
55.
PLUNGER SUB-ASSEMBLIES AND AUTO-INJECTORS HAVING LOW RETRACTION ACTIVATION FORCE
A low retraction activation force plunger sub-assembly (200) for an automatic injector (100) includes: a plunger outer (220) having one or more engagement prongs (220A), a plunger inner (210) having a shoulder (210A), and a plunger biasing member (270) retained in a first energized state between said plunger outer (220) and plunger inner (210) when the engagement prongs (220A) of the plunger outer (220) are releasably engaged with the shoulder (210A) of the plunger inner (210). An automatic injector (100) includes a housing (14, 16), an activation mechanism (12), an actuation mechanism (10), and a syringe cartridge (20) having the plunger sub-assembly (200) and a needle assembly (40), wherein the actuation mechanism (10) comprises an actuation biasing member (102) residing in an initial energized state substantially within an upper portion of an actuation pill (104). A method of assembling the automatic injector (100) includes the steps of: assembling the plunger sub-assembly (200) and inserting the plunger sub-assembly (200) into the housing (14,16) such that a proximal end of the plunger sub-assembly (200) contacts the actuation pill (104).
A61M 5/20 - Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
A61M 5/315 - PistonsPiston-rodsGuiding, blocking or restricting the movement of the rodAppliances on the rod for facilitating dosing
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
56.
ACCURATE DOSE CONTROL MECHANISMS AND DRUG DELIVERY SYRINGES
A dose control mechanism 10 for a syringe includes a plunger 14 having a coarse pitch screw 14B on its exterior surface, a housing 20 having a corresponding coarse pitch guide 20C along the interior surface of the housing 20, a screw 30 having a fine pitch screw 30B which interfaces with a fine pitch nut 18B of an adapter 18, wherein the plunger 14 has an internal annular space 14C within which screw 30 at least partially resides. An accurate dose drug delivery syringe includes such a dose control mechanism 10, a barrel 140, a plunger seal 136, and a barrel adapter assembly 150 having a barrel tip 152 and a needle 154. The syringe may be a fill-at-time-of-use syringe 100, a pre-filled syringe 200, or a safety syringe 300 having integrated needle retraction or needle sheathing safety features, or a combination thereof. Methods of assembly, manufacturing, and operation are similarly disclosed.
A retractable needle is provided for a syringe comprising a barrel and a plunger that comprises a portion capable of engaging the retractable needle for retraction. The retractable needle comprises a cannula, a needle body having a plunger-engaging member, at least one aperture and an elongate portion which houses the cannula, the cannula comprising an end which is in fluid communication with the at least one aperture, wherein the at least one aperture is located between the plunger-engaging member and the elongate portion. The positioning of the at least one aperture distal to the plunger-engaging member maximizes the efficiency of fluid delivery.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 5/50 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
58.
STERILE FLUID PATHWAY CONNECTION TO DRUG CONTAINERS FOR DRUG DELIVERY PUMPS
A drug delivery pump includes: a housing, assembly platform, activation mechanism, insertion mechanism, fluid pathway connection, power and control system, and drive mechanism having a drug container. The fluid pathway connection has a connection hub, a piercing member connected to the connection hub, and a sterile sleeve. The drug container has a cap, a pierceable seal, a barrel and a plunger seal, with the piercing member and the pierceable seal being substantially co-axial. The pierceable seal and the connection hub are adapted for movement between an unactivated position, and an activated position in which the piercing member extends through the seal. The sterile sleeve is coupled to the connection hub, and to the drug container at an opposing end. The sterile sleeve is compressible or collapsible and compresses or collapses as the connection hub and the pierceable seal are moved towards one another to pierce the seal.
A user-initiated fluid pathway connection 300 includes: a connection hub 310, a piercing member 330, a sterile sleeve 320, and a drug container 50 having a cap 52, a pierceable seal 56, a barrel 58, and a plunger seal 60, wherein the piercing member 330 is initially retained within the sterile sleeve 320 between the connection hub 310 and the pierceable seal 56 of the drug container 50. The connection hub 3310 may include an internal aperture 3310D within the connection hub 3310 which functions as a flow restrictor and wherein a piercing member 3330 is connected to one end of the internal aperture 3310D and a fluid conduit 3030 is connected to another end of the internal aperture 3310D. A drug delivery pump 10 with integrated sterility maintenance features includes a housing 12, upon which an activation mechanism 14, an insertion mechanism 200, a fluid pathway connection 300 as described above, a power and control system 400, and a drive mechanism 100 connected to a drug container 50 are mounted. Methods of assembly and operation are also provided.
An insertion mechanism (200) for a drug pump (10) includes an insertion mechanism housing (202); a manifold guide (220); an insertion biasing member (210) initially held in an energized state; a retraction biasing member (216) and a hub (212) connected to a proximal end of a needle (214), wherein the retraction biasing member (216) is held initially in an energized state between the hub (212) and the manifold guide (220); and a manifold (240) having a septum (230) and a cannula (234), wherein the annular space between the septum (230) and the cannula (234) defines a manifold header (242). The needle (214) and cannula (234) are inserted into the body of a user by the insertion biasing member(s) (210), after which only the needle (214) is retracted. Retraction of the needle (214) may open a fluid pathway from the manifold header (242) to the body through the cannula (234). A drug delivery pump (10) includes an activation mechanism (12), a drive mechanism (100), a fluid pathway connection (300), and the insertion mechanism 200. Assembly and operation methods are provided.
An insertion mechanism (200) for a drug pump (10) includes an insertion mechanism housing (202); a manifold guide (220); an insertion biasing member (210) initially held in an energized state; a retraction biasing member (216) and a hub (212) connected to a proximal end of a needle (214), wherein the retraction biasing member (216) is held initially in an energized state between the hub (212) and the manifold guide (220); and a manifold (240) having a septum (230) and a cannula (234), wherein the annular space between the septum (230) and the cannula (234) defines a manifold header (242). The needle (214) and cannula (234) are inserted into the body of a user by the insertion biasing member(s) (210), after which only the needle (214) is retracted. Retraction of the needle (214) may open a fluid pathway from the manifold header (242) to the body through the cannula (234). A drug delivery pump (10) includes an activation mechanism (12), a drive mechanism (100), a fluid pathway connection (300), and the insertion mechanism 200. Assembly and operation methods are provided.
A drive mechanism (100) having integrated status indication includes a drive housing (130), a status switch interconnect (132), a drive biasing member (122), a piston (110), and a drug container (50) having a cap (52), a pierceable seal (56), a barrel (58), and a plunger seal (60), wherein the drive biasing member (122) is configured to bear upon an interface surface (110C) of the piston (110). Drive mechanism (100) may include an incremental status stem (650) having a stem interconnect (652), wherein the stem (650) resides within the drive housing (630) and the piston (610), and wherein the stem (650) has an interconnect which engages one or more contacts on the piston (610) to provide incremental feedback. A drug delivery pump (10) with integrated status indication includes a housing (12) and an assembly platform (20), upon which an activation mechanism (14), an insertion mechanism (200), a fluid pathway connection (300), a power and control system (400), and the drive mechanism (100) having a drug container (50) may be mounted.
An automatic mixing device, an actuating device removably mounted to the automatic mixing device and a retractable syringe having the automatic mixing device are provided. The actuating device has an initially compressed spring and a trigger member that initiates spring decompression to drive depression of a mixing plunger of the automatic mixing device. A seal located in the outer chamber is capable of axial movement upon depression of the mixing plunger, from a first position in sealing engagement with one or more apertures in an inner barrel to a second position intermediate the apertures and vents in an outer barrel. This allows depression of the mixing plunger to force a first substance from the outer chamber through the apertures to mix with a second substance in an inner chamber of the inner barrel. The mixed substance in the inner barrel is then delivered by the syringe with subsequent needle retraction.
A61M 5/00 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests
An actuation mechanism 10 for an automatic injector 100 includes a first actuation spring 102, a first actuation pill 104, a second actuation spring 106, and a second actuation pill 108. In an initial configuration the first actuation spring 102 resides in a compressed, energized state substantially within an upper portion of first actuation pill 104 and the second actuation spring 106 resides in a compressed, energized state between the first actuation pill 104 and the second actuation pill 108. An automatic injector 100 includes a housing 14, 16, an activation mechanism 12, an actuation mechanism 10, and a syringe cartridge 20 having a plunger 200 and a needle assembly 40. A retractable syringe may be utilized as a syringe cartridge 20, such as a prefilled retractable syringe with integrated safety features which retract the needle 420 after use. The automatic injector 100 may be utilized to inject the needle 420, deliver a drug treatment, and activate retraction of the needle 420. Methods of assembly and operation are also provided.
A mixing device and a retractable syringe comprising same are provided. The mixing device comprises concentric outer and inner barrels that form an outer chamber, the inner barrel having an inner chamber. A mixing plunger is slidably located in the outer chamber. A seal located in the outer chamber is capable of axial movement, in response to depression of the mixing plunger, from a first position in sealing engagement with one or more apertures in the inner barrel to a second position intermediate the apertures and vents in the outer barrel. This allows depression of the mixing plunger to force a first substance from the outer chamber through the apertures to mix with a second substance in the inner chamber. The mixed substance in the inner barrel is then delivered by the syringe with subsequent needle retraction.
A cannula (24) for administration of a medicine to a target location (26) includes a tube 40 ()with at least one nodule (50) disposed along the circumferential surface (46) and spaced at a defined distance (54) from the distal end (42) of the tube (40). An arrangement (20) for delivery of a medicine to a target location (26) includes the cannula (24) and a pump (22) fluidly coupled to the cannula (24). The distal end (42) of the cannula (24) may be inserted into a target location (26) until the nodule (50) reaches a surface (46) that limits a depth of penetration before delivery of the medication.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 5/46 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for controlling depth of insertion
(1) Medical devices, namely, syringes, auto-injectors, mixing and reconstitution syringes, subcutaneous and intramuscular pump drug delivery systems and other drug delivery devices and systems, namely, injection instruments with needles, all for the delivery of parenteral drugs or treatments, excluding orthopaedic implants which are substance-eluting or are coated with a substance and orthopaedic instruments.
An adapter mountable to a retractable syringe barrel comprises a body that includes a needle portion and a barrel-engaging portion and a needle aperture. The adapter facilitates mounting a needle assembly to the barrel. The needle assembly comprises a needle body and cannula and an immobile, compressible needle seal, wherein the needle body and the needle seal are releasably engaged. The needle seal is engageable with a needle portion of the adapter. The needle body comprises one or more fluid reclaim channels that facilitate efficient delivery of the fluid contents of the retractable syringe. The retractable syringe also comprises dual locking systems to impede or prevent re-use.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 5/50 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
69.
RETRACTABLE SYRINGE WITH IMPROVED DELIVERY EFFICIENCY AND LOCKING SYSTEM
A plunger, a needle assembly and a retractable syringe comprising same are provided. The plunger comprises a plunger member and a plunger outer having a lock spring that prevents or impedes movement of the plunger member after needle retraction. The plunger further comprises another locking member for engaging the barrel to prevent or impede further movement of the plunger outer after delivery of fluid contents. The plunger member has a plunger seal which engages a retractable needle of the needle assembly for retraction. The retractable needle comprises a cannula and needle body with a plurality of fluid channels that co-operate with a fluid conduit of the plunger seal to efficiently direct fluid to the cannula. A needle retainer comprises a plurality of barbed arms releasably coupled to the needle body, whereby an ejector with tabs facilitates release of the retractable needle from the needle retainer to allow compressed spring-driven retraction.
A61M 5/50 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
A61M 5/315 - PistonsPiston-rodsGuiding, blocking or restricting the movement of the rodAppliances on the rod for facilitating dosing
A replaceable needle assembly is provided for a retractable, prefilled syringe comprising a barrel having a mounting member and a plunger, whereby the retractable needle can be replaced by a user without affecting the retraction mechanism. The replaceable needle assembly comprises a needle fitted to a retractable needle mount and a needle retainer. The needle mount is removably, screw-threadedly mountable to the mounting member of the barrel. The needle retainer comprises a plurality of fingers that releasably engage the retractable needle to thereby prevent inadvertent retraction of the retractable needle before engagement by the plunger. The plunger comprises a plunger seal comprising an outer member and an inner member that engages the needle for spring-driven retraction. At the end of retraction, a lock is formed between the plunger and barrel to prevent re-use of the syringe.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A replaceable needle assembly is provided for a retractable syringe comprising a barrel and a plunger, whereby the retractable needle can be replaced by a user without affecting the retraction mechanism. A mounting member is removably mountable to the barrel by way of a screw-thread connection and a needle mount is removably coupled to the mounting member. A needle is mounted to the needle mount. The barrel comprises a needle mount retainer that comprises a plurality of fingers that engage the retractable needle mount to prevent inadvertent retraction. The plunger comprises a collapsible seal which maximizes the efficiency of fluid delivery prior to the plunger engaging the retractable needle mount for retraction. An initially compressed spring decompresses to drive retraction of the plunger and the engaged needle mount. A lock formed between the plunger and barrel prevents further use of the plunger after retraction.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 5/315 - PistonsPiston-rodsGuiding, blocking or restricting the movement of the rodAppliances on the rod for facilitating dosing
A syringe adapter mountable to a syringe, particularly a retractable syringe having a retractable needle, comprises a sealing member and an adapter body that comprises two or more body members that co-operate to retain the sealing member in the adapter. One or the other body members is removably mountable to a barrel of the syringe and one or the other body members comprises a mounting member. A filter member may be removably mounted to, or formed integrally with, the mounting member to filters fluid when filling the syringe to thereby remove particular material, impurities or the like. Alternatively, a filter material may be provided in the syringe adapter. In addition, or alternatively, a filling needle is provided which is removably mountable to the syringe adapter and may prevent bending or burring of the retractable needle.
Medical devices, namely, syringes, safety sharps, and drug delivery devices in this class, * excluding orthopaedic implants which are substance-eluting or are coated with a substance and orthopaedic instruments *
(1) Medical devices, namely, syringes for medical purposes, syringes for injections, single-use syringes, safety syringes, prefillable syringes, auto-injectors, hypodermic syringes, needles for medical purposes, and other injectable drug delivery devices, namely, injection instruments with needles.
(1) Medical devices, namely, syringes for medical purposes, syringes for injections, single-use syringes, safety syringes, prefillable syringes, auto-injectors, hypodermic syringes, needles for medical purposes, and other injectable drug delivery devices, namely, injection instruments with needles.
(1) Medical devices, namely, safety syringes, and other injectable drug delivery devices, namely, injection instruments with needles, excluding orthopaedic implants which are substance-eluting or are coated with a substance and excluding orthopaedic instruments.
80.
PREFILLED RETRACTABLE SYRINGE, PLUNGER AND NEEDLE ASSEMBLY THEREFOR
A retractable syringe, plunger and releasable needle retaining assembly are provided. The retractable syringe typically has a glass barrel and is prefilled with fluid contents before use. The releasable needle retaining system comprises a retractable needle, a needle seal, a retaining member and an ejector member that is operable to release the retractable needle from the retaining member. The retaining member has a mating surface for mounting to a complementary mating surface of an interior wall of a syringe barrel. The plunger comprises a plunger outer, a plunger rod frangibly connected to a controlling member, a spring and a unitary plunger seal capable of engaging the retractable needle, wherein the plunger rod, plunger outer and the controlling member co-operate to releasably maintain the spring in an initially compressed state. After delivery of fluid contents of the syringe, the plunger forces the ejector member to release the retractable needle from the retaining member. Decompression of the spring at the end of depression of the plunger facilitates retraction of the retractable needle when engaged with the unitary plunger seal. Dual locking systems prevent re-use of the syringe after needle retraction.
A61M 5/50 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
81.
IMPROVED CONTROLLED RETRACTION SYRINGE AND PLUNGER THEREFOR
A retractable syringe (10) and plunger (20) therefore are provided, the syringe having a barrel (20), a retractable needl mount (40) to which is mounted or is mountable a needle (11), and a plunger (80), the plunger comprising an initially compressed spring (60), a means for engaging the retractable needle mount, an integrally formed plunger seal (22) and a removable controlling means (70) for facilitating control of the rate of retraction of needle mount when engaged wit plunger. The needle mount is held in the barrel by a holding means which prevents inadvertent retraction of the needle mount when the plunger is withdrawn to fill the syringe. The holding means comprises a plurality of clips (196A, 196B, 196C) that may be integrally formed with the barrel or may be present on a cap mounted to the barrel. An ejector means (52) is also provided, whereby plunger depression can urge the ejector means to release the needle from the holding means and thereby allow retraction of the needle mount following decompression of the spring.
A61M 5/50 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
