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
  • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
  • A61M5/2053—Media being expelled from injector by pressurised fluid or vacuum
• • 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
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/142—Pressure infusion, e.g. using pumps
  • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
  • A61M5/155—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by gas introduced into the reservoir
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
  • A61F9/007—Methods or devices for eye surgery
  • A61F9/00727—Apparatus for retinal reattachment
• • 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
  • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
  • A61M2005/2086—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically having piston damping means, e.g. axially or rotationally acting retarders
• • 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
  • A61M2005/3128—Incorporating one-way valves, e.g. pressure-relief or non-return valves
• • 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
  • A61M2005/3143—Damping means for syringe components executing relative movements, e.g. retarders or attenuators slowing down or timing syringe mechanisms
• • 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
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/142—Pressure infusion, e.g. using pumps
  • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
  • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
  • A61M5/14526—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons the piston being actuated by fluid pressure

Definitions

• the present application relates to devices and methods for delivering agents into a patient’s body and, more particularly, to syringe drivers and injector devices for use with external air sources, and systems and methods for using such drivers.
• injectors are often used to deliver viscous fluids into a patient’s eye, e.g., oil tamponades during retinal detachment surgery.
• injectors may be connected to an external air source, e.g., a surgical console, such as the Constellation® system manufactured by Alcon.
• a surgical console such as the Constellation® system manufactured by Alcon.
• Such consoles may have a variable air pressure source, e.g., providing pressure between about 0-80 psi, that may be foot-pedal controlled by the surgeon during use.
• a syringe containing highly viscous silicone oil tamponade may be connected to the air pressure line of the console and then inserted into a patient’s eye to deliver the oil into the posterior region of the eye.
• the syringe may be introduced into the eye through a 23g or 25g trocar cannula, and then air pressure from the console may be used to advance the syringe plunger to deliver the oil. Because of the high viscosity of the oil, the limited pressure available from the console, and the relatively small diameter of the delivery cannula, flow of the oil may be limited by the restriction due to the cannula.
• the present application is directed to devices and methods for delivering agents into a patient’s body and, more particularly, to syringe drivers and injector devices for use with external air sources, and systems and methods for using such drivers.
• a syringe driver for use with an external air source that includes a housing comprising a port communicating with a gas chamber within the housing and connectable to the external air source, and a cavity sized to receive a syringe containing an agent; a drive piston comprising a first end disposed adjacent the gas chamber and a second end comprising a plunger connectable to the syringe received within the cavity, the drive piston movable from an initial first position to a second position when gas is delivered from the air source into the gas chamber, thereby advancing the plunger to deliver the agent from the syringe; and a damping fluid chamber including a damper piston disposed therein between a first region filled with damping fluid and a second region of the damping fluid chamber and one or more passages, valves, and the like communicating between the first region and the second region such that movement of the drive piston between the first and second positions causes the damping fluid to flow through the one or more passages or valves from the first region
• a syringe driver in accordance with another example, includes a housing comprising a proximal end including a port communicating with a gas chamber within the housing and connectable to the external air source, and a distal end including a cavity sized to receive a syringe containing an agent; a drive piston comprising a first end disposed adjacent the gas chamber and a second end comprising a plunger connectable to the syringe received within the cavity, the drive piston movable from an initial proximal position to a distal position when gas is delivered from the air source into the gas chamber, thereby advancing the plunger to deliver the agent from the syringe; and a damping fluid chamber including a damper piston disposed therein between a first region filled with damping fluid and a second region of the damping fluid chamber and one or more passages, valves, and the like communicating between the first region and the second region such that movement of the drive piston between the proximal and distal positions causes the damping fluid to
• an injector device in accordance with still another example, includes a housing comprising a proximal end including a port communicating with a gas chamber within the housing and connectable to the external air source, and a distal end; an agent chamber within the distal end including an agent piston and an outlet port extending from the distal end; a drive piston comprising a first end disposed adjacent the gas chamber and a second end comprising a plunger connected to the agent piston, the drive piston movable from an initial proximal position to a distal position when gas is delivered from the air source into the gas chamber, thereby advancing the plunger and agent piston to deliver the agent from the from the agent chamber through the outlet port; and a damping fluid chamber including a damper piston disposed therein between a first region filled with damping fluid and a second region of the damping fluid chamber and one or more passages, valves, and the like communicating between the first region and the second region such that movement of the drive piston between the proximal and distal positions causes the damping fluid to
• an injector device for use with an external air source that includes a housing comprising a proximal end including a port communicating with a gas chamber within the housing and connectable to the external air source, and a distal end; an agent chamber within the distal end including an agent piston and an outlet port extending from the distal end; a drive piston comprising a first end disposed adjacent the gas chamber and a second end comprising a plunger connected to the agent piston, the drive piston movable from an initial proximal position to a distal position when gas is delivered from the air source into the gas chamber, thereby advancing the plunger and agent piston to deliver the agent from the from the agent chamber through the outlet port; a damping fluid chamber within the drive piston; and a damper piston mounted on a shaft axially fixed relative to the housing and disposed within the damping fluid chamber between a first region filled with damping fluid and a second region of the damping fluid chamber, and one or more passages in the damper piston communicating between the first
• a system for performing an injection that includes an injector device comprising a housing comprising a proximal end including a port communicating with a gas chamber within the housing and connectable to the external air source, and a distal end; an agent chamber within the distal end including an agent piston and an outlet port extending from the distal end; a drive piston comprising a first end disposed adjacent the gas chamber and a second end comprising a plunger connected to the agent piston, the drive piston movable from an initial proximal position to a distal position when gas is delivered from the air source into the gas chamber, thereby advancing the plunger and agent piston to deliver the agent from the from the agent chamber through the outlet port; a damping fluid chamber within the drive piston; and a damper piston mounted on a shaft axially fixed relative to the housing and disposed within the damping fluid chamber between a first region filled with damping fluid and a second region of the damping fluid chamber, and one or more passages in the damper piston communicating between
• a method for performing an injection includes providing a syringe driver including a housing comprising a proximal end including a port communicating with a gas chamber within the housing, a distal end, a drive piston, and a damping mechanism including a damping fluid chamber including a damper piston disposed therein between a first region filled with damping fluid and a second region of the damping fluid chamber and one or more passages, valves, and the like communicating between the first region and the second region; inserting a syringe containing one or more agents into a cavity of the housing such that an agent piston of the syringe is coupled to a drive piston within the housing and an outlet port of the syringe is disposed adjacent the distal end; connecting an external air source to the port; connecting a cannula to the outlet port; introducing the cannula into a patient’s body; and activating the external air source such that the drive piston moves from an initial first position to a second
• FIG. 1 A is a perspective view of an example of a syringe driver.
• FIGS. IB and 1C are side views of the syringe driver of FIG. 1A.
• FIGS. 2A and 2B are cross-sectional views of the syringe driver of FIGS. 1A-1C.
• FIG. 3 is a cross-sectional view of the syringe driver of FIGS. 1A-1C showing operation when the driver is powered by an external air source.
• FIG. 3 A is a detail showing a damper piston of the syringe driver of FIG. 3.
• FIG. 4 is a schematic of the syringe driver of FIGS. 1A-1C.
• FIG. 5 is a schematic of an alternative example of a syringe driver.
• FIGS. 1A-1C show an example of an injector device 8 that includes a syringe driver 10 for use with an external air source (not shown) and a syringe or other container 80 containing one or more agents, e.g., for delivery into a patient’s eye or another location within the patient’s body.
• a syringe 80 may be loaded into the syringe driver 10, which may be connected to an external air source, such as a surgical console (not shown), which may be actuated to deliver the agent into a patient’s body.
• the devices, systems, and methods herein may be used for controlled delivery of therapies into the back of a patient’s eye, such as subretinal tissue plasminogen activators, subretinal gene therapies, retinal adhesives, and the like.
• Such procedures may involve delivering relatively low viscosity agents, e.g., fluids having a viscosity of one centipoise (1 cP) or less, and/or agents having a variable viscosity (e.g., in the case of retinal adhesives). Due to the low viscosity of such fluids, the overall flow rate using conventional injectors may be highly variable and/or unpredictable.
• the devices, systems, and methods herein may provide damping that provides the primary resistance to the flow of the agent being delivered, e.g., resulting in a throttling action that provides an upper, safe limit to the flow rate of the agent and/or allowing for extraordinarily control of the delivery flow rate, as described elsewhere herein.
• the injector devices herein may be used for other applications, e.g., during retinal detachment surgery, to deliver silicone oil tamponade or other highly viscous material, e.g., having a viscosity between about 1000-5000 cP, into the posterior region of a patient’s eye, as described elsewhere herein.
• the syringe driver 10 includes a housing 20 including a proximal end 22 and a distal end 24 defining a longitudinal axis 26 therebetween, and one or more chambers or cavities therein.
• the housing 20 may be an elongate tubular body including one or more internal partitions or other structures to support its internal components.
• the housing may be formed using conventional materials and materials, e.g., formed from plastic, metal, and/or composite materials.
• the housing 20 may have a size, e.g., diameter and/or length to accommodate manipulation of the injector device 8, optionally, including texturing and/or other features (not shown) to facilitate holding and/or otherwise manipulating the injector device 8 during use.
• the housing 20 may include a port 30 on the proximal end 22 connectable to an external air source (not shown) that communicates with a gas chamber 28 within the housing 20.
• a plug 32 may be inserted into and/or otherwise attached to the proximal end 22 of the housing 20 that includes the port 30 and a gas inlet passage 34 extending from the port 30 to a distal end 36 of the plug 32, which may define a proximal wall of the gas chamber 28.
• the gas chamber 28 may include a tubular inner wall 29 mounted within the housing 20 or, alternatively, the gas chamber 28 wall may be formed directly in and/or be defined by surfaces of the housing 20 itself.
• the proximal end 22 of the housing 20 and the plug 32 may include cooperating connectors to secure the plug within the proximal end 22.
• the proximal end 22 may include an annular ridge 23 and the plug 32 may include a corresponding recess 31 into which the ridge 23 may be received to permanently (or optionally removably) attach the plug 32 to the housing 20.
• the plug 32 may be attached to the housing 20 using one or more of bonding with adhesives, fusing, welding, and the like.
• the port 30 and gas inlet passage 32 may be integrally formed in the housing 20, e.g., by molding or otherwise integrally forming an end wall including the port 30 on the proximal end 22.
• the port 30 may include one or more connectors that allow an external air source, e.g., tubing communicating with a surgical console (not shown), to be connected to the port 30 to provide pressurized air or other compressible gas to operate the syringe driver 10, as described elsewhere herein.
• an external air source e.g., tubing communicating with a surgical console (not shown)
• the port 30 may include a male nipple, e.g., which may be inserted into an end of tubing, thereby providing a substantially airtight interference fit.
• a Luer fitting, one or more threads, and/or other connector may be provided on the port 30 and/or tubing from the air source (not shown) to provide a desired connection.
• the housing 20 also includes a cavity 40 adjacent the distal end 24 sized to receive a syringe 80 or other container for one or more agents intended for delivery into a patient’s body.
• the housing 20 may include an interior partition 42 offset proximally from the distal end 24 a distance sufficient to allow insertion of the syringe 80, e.g., to limit insertion of the syringe 80 into the housing 20.
• the syringe 80 includes a barrel 82 including a proximal end 84, a substantially closed distal end 86, and an agent chamber 88 for containing the agent.
• a syringe piston 90 is slidably disposed in the proximal end 84 that may be coupled to the syringe driver 10, as described elsewhere herein, such that the agent may be delivered through an outlet 92 in the distal end 86.
• the distal end 86 may include an outlet port 94, e.g., including a Luer fitting and/or other connector, to which a needle or other tubular cannula (not shown) may be connected to deliver the agent.
• a needle or other cannula may be permanently attached to and/or integrated into the distal end 86 of the barrel 82.
• the syringe 80 may be integrated into the housing of the syringe driver, e.g., by forming an agent chamber directly in the driver housing and forming or attaching an outlet port on the distal end of the housing (not shown).
• the housing 20 and/or syringe 80 may include one or more connectors for securing the syringe 80 once received in the cavity 40, e.g., to allow the syringe 80 to be removably or permanently received in the cavity 40.
• one or more detents, threads, and the like may be provided on the syringe 80 and housing 20, e.g., on the internal partition 42 and proximal end 84 of the syringe 80 and/or inside the distal end 24 of the housing 20 and on the distal end 86 of the barrel 80.
• a desired syringe 80 may be selected and simply inserted into the cavity 40, whereupon the connectors may automatically secure the syringe 80 and ready the injector device 8 for use.
• the housing 20 may include one or more windows or other transparent surfaces, e.g., window 25, to allow a user to visually observe the syringe 80 within the cavity 40, e.g., to monitor flow of the agent from the injector device 8 during delivery.
• windows or other transparent surfaces e.g., window 25, to allow a user to visually observe the syringe 80 within the cavity 40, e.g., to monitor flow of the agent from the injector device 8 during delivery.
• a drive piston 50 is provided within the housing 20 that includes a first or proximal end 52 disposed adjacent the gas chamber 28 and a second or distal end 54 including a plunger 56 connectable to the agent piston 90 of the syringe 80 received within the cavity 40.
• the internal partition 42 includes a passage 43 therethrough through which the second end 54 of the driver piston 50 is slidably received to provide the plunger 56 within the syringe cavity 40.
• the agent piston 90 may include a recess 91 into which the plunger 56 may be received when the syringe 80 is inserted into the cavity 40 such that subsequent distal movement of the drive piston 50 causes corresponding distal movement to the agent piston 90.
• the plunger 56 and/or agent piston 90 may include one or more connectors to further couple them together, e.g., one or more detents, threads, and the like (not shown) that permanently or removably connect the piston 90 the plunger 56.
• the drive piston 50 moves from an initial proximal position (e.g., as shown in FIG. 3) distally towards a distal position (not shown), e.g., to the left as represented by arrow 102, thereby advancing the plunger 56 distally to deliver the agent from the syringe 80, as represented by arrow 104.
• the proximal end 52 of the drive piston 50 includes an outer O-ring 53 that is slidable along the inner wall 29 of the gas chamber 28, e.g., to provide a substantially airtight seal.
• pressurized gas introduced into the gas chamber 28 from the external air source may generate a pressure within the gas chamber 28 that applies a distal force to the proximal end 52 of the drive piston 50.
• the O-ring 53 may slide along the inner wall 29 and the distal end 54 of the driver piston, thereby guiding the drive piston 50 as it advances, e.g., alone or in combination with the passage 43 through the internal partition 42.
• the housing 20 may include one or more additional partitions or supports, e.g., internal support 44 that may further support and/or guide the drive piston 50.
• the syringe driver 10 also includes a damping mechanism, e.g., configured to provide an upper limit to the speed at which the driver piston 50 advances from the proximal position when the air source is actuated.
• a damping fluid chamber 60 may be provided within the housing 20 that includes a damper piston 70 therein that are operatively coupled to the drive piston 50 to limit flow of a damping fluid within the damping fluid chamber 60 to provide a resistance to advancement of the drive piston 50.
• the damping fluid chamber 60 is located within the drive piston 50, e.g., adjacent the proximal end 52, with the distal end 54 of the drive piston 50 extending distally from the damping fluid chamber 60.
• the damper piston 60 is provided within at an intermediate location within the damping fluid chamber 50, thereby separating the damping fluid chamber 60 into a first region 60a and a second region 60b. As shown in FIGS.
• the first region 60a may initially contain a damping fluid 62, e.g., filled with an incompressible oil or other liquid having a viscosity substantially higher than the viscosity of the agent within the syringe 80, e.g., having a viscosity between about ten and one hundred thousand centipoise (10-100,000 cP).
• a damping fluid 62 e.g., filled with an incompressible oil or other liquid having a viscosity substantially higher than the viscosity of the agent within the syringe 80, e.g., having a viscosity between about ten and one hundred thousand centipoise (10-100,000 cP).
• the damper piston 70 includes one or more orifices or other passages 72 extending therethrough, e.g., communicating between the first and second regions 60a, 60b of the damping fluid chamber 60, to allow the damping fluid 62 to flow between the regions 60a, 60b.
• the damper piston 70 may be axially fixed relative to the damping fluid chamber 60, e.g., such that the damper piston 70 remains substantially stationary as the drive piston 50 and, consequently, the damping fluid chamber 60, advances, e.g., during delivery of the agent.
• the damping mechanism may be reversed, e.g., such that the damper piston 70 moves with the driver piston 50 while the damping fluid chamber 60 remains stationary (not shown).
• axial movement of one of the damping fluid chamber 60 and damper piston relative to one another causes the damping fluid 62 to flow between the first and second regions 60a, 60b, e.g., as represented by arrows 106 in FIG. 3A.
• distal movement of the drive piston 50 e.g., from the proximal position shown, causes the damping fluid chamber 60 to move distally, while the damper piston 70 remains stationary.
• This relative movement reduces the volume of the first chamber 60a, thereby generating a pressure that forces the damping fluid 62 to flow through the passage(s) 72 from the first region 60a into the second region 60b.
• flow of the damping fluid may be limited, thereby limiting the speed of axial movement of the drive piston 50, as described further elsewhere herein.
• the damper piston 70 may be mounted on a shaft 74 including a proximal or first end 76 fixed relative to the plug 32 on the housing 20 and a distal or second end 78 located distal to the damping fluid chamber 60.
• the damping fluid chamber 60 may include one or more seals, e.g., O-rings 66, to accommodate the shaft 74 passing through the damping fluid chamber 60 and allowing relative axial movement, while providing a fluid tight to prevent the damping fluid 62 from leaking from the damping fluid chamber 60.
• seals e.g., O-rings 66
• one or more parameters of the damping mechanism may be modified to provide a desired resistance to limit the speed of axial movement of the driver piston 50.
• one or more of a) the viscosity of the damping fluid, b) the number and/or cross-sectional orifice size of the passage(s) 72, c) the diameter or other cross-section of the damping fluid chamber 60, and d) the diameter or other cross-section of the driver piston 50 may be modified as desired to adjust the maximum volumetric flowrate of the agent delivered from the syringe 80, e.g., for a given air pressure from the external air source.
• the one or more passages may be provided in walls of the drive piston 50 and/or other structure within the housing 20 (not shown), i.e., to provide a narrow path between the first and second regions 60a, 60b.
• a valve (not shown) may be provided that communicates between the first and second regions 60a, 60b, e.g., within the damper piston 70 and/or other component within the housing 20, e.g., a pressure relief valve, a spring-loaded disk, a spring-loaded ball valve, and the like, to limit flow of the damping fluid 62 between the first and second regions 60a, 60b of the damping fluid chamber 60 in a desired manner.
• the damping mechanism may be provided in parallel or inline with the driver piston and the syringe piston, as desired.
• a syringe driver 110 is provided that includes an air chamber 128 that may be connected to an external air source (not shown), e.g., via a port 130, to apply a distal force to the proximal end 152 of the driver piston 150, similar to the injector device 8.
• the distal end 154 of the driver piston 150 is coupled to the syringe piston 90 of syringe 80 such that distal movement of the drive piston 150 causes corresponding distal movement of the syringe piston 90 to deliver the agent within the interior 88 of the syringe 80, also similar to the injector device 8.
• the syringe driver 110 includes a damping fluid chamber 160 that is substantially stationary relative to the driver housing and, consequently, relative to the drive piston 150.
• a damping fluid chamber may be mounted in or formed from surfaces of the housing.
• a damper piston 170 is provided within the damping fluid chamber 160, e.g., separating the damping fluid chamber 160 into first and second regions 160a, 160b, that is coupled directly to the drive piston 150.
• One or more orifices or pressure relief valves 172 are provided, e.g., in the damper piston 170, the drive piston 150, and/or otherwise within the housing 1120, to allow damping fluid within the first region 160a to flow therethrough into the second region 160b.
• distal movement of the drive piston 150 causes corresponding distal movement to the damper piston 170, thereby pressurizing the damping fluid within the first region 160a and causing the damping fluid to flow through the passage(s) 172 into the second region 160b, thereby limiting flow of the agent, similar to the syringe driver 10.
• a syringe 80 containing one or more agents may be inserted into the cavity 40 of the housing 20 such that the agent piston 90 of the syringe 80 is coupled to the distal end 54 of the drive piston 50.
• the outlet port 94 of the syringe 80 may be disposed adjacent the distal end 24 of the housing 20, e.g., including a Luer fitting or other connector extending from the distal end 24.
• a cannula may be connected to the outlet port 94, e.g., a needle or other elongate tubular member sized for introduction into the target location.
• a trocar or other tubular device may be positioned into the eye, e.g., using conventional methods, that is sized to receive the cannula connected to the outlet port 94.
• An external air source e.g., a surgical console, may be connected to the inlet gas port 30 on the syringe driver 10, which may be readied using conventional methods.
• the cannula on the outlet port 94 may be introduced into the patient’s body, e.g., into the patient’s eye through a trocar to position a tip of the cannula adjacent the posterior region.
• the external air source may be activated to deliver pressurized gas into the port 30 and the gas chamber 28 to advance the drive piston from the initial proximal position towards the distal position, thereby advancing the plunger 56 and the agent piton 90 to deliver the agent from the syringe 80 into the target region.
• a surgical console may include a foot pedal that the surgeon or other practitioner may actuate to increase the air pressure as desired to control the speed of advancement of the driver piston 50 and flow rate of the agent.
• Movement of the driver piston 50 is opposed by the pressure in the damping fluid chamber 60 acting on the damper piston 70 resulting from the resistance of flow of the damping fluid 62 through the passage(s) 72 between the regions 60a, 60b.
• the force balances between the air side (i.e., from the external air source pressure) and the damping fluid side (i.e., from the pressure generated in the damping fluid chamber 60) the velocity of the drive piston 50 and plunger 56 and, therefore the volumetric flowrate of the agent from the syringe 80 is at its maximum.
• the damping mechanism may provide the primary resistance to the flow of the agent being delivered, i.e., given the relatively high viscosity of the damping fluid relative to the other resistances involved in the injector device, agent, and/or patient’s anatomy, resulting in a throttling action that provides an upper, safe limit to the flow rate of the agent and/or allowing for extremely control of the delivery flow rate.
• the specification may have presented the method and/or process as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth herein, the method or process should not be limited to the particular sequence of steps described. As one of ordinary skill in the art would appreciate, other sequences of steps may be possible. Therefore, the particular order of the steps set forth in the specification should not be construed as limitations on the claims.

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• Health & Medical Sciences (AREA)
• Vascular Medicine (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

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• 2022
  • 2022-02-12 CA CA3208032A patent/CA3208032A1/en active Pending
  • 2022-02-12 EP EP22753474.0A patent/EP4291265A4/en active Pending
  • 2022-02-12 WO PCT/US2022/016245 patent/WO2022174125A1/en not_active Ceased
  • 2022-02-12 US US17/670,441 patent/US20220257863A1/en active Pending
  • 2022-02-12 JP JP2023548622A patent/JP2024508715A/ja active Pending

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