WO2020021060A1

WO2020021060A1 - Infusion device having a syringe plunger control comprising a joystick

Info

Publication number: WO2020021060A1
Application number: PCT/EP2019/070170
Authority: WO
Inventors: Christian FISCHLEIN; Allan Lester KIERKEGAARD
Original assignee: CSL Behring Lengnau AG
Priority date: 2018-07-27
Filing date: 2019-07-26
Publication date: 2020-01-30

Abstract

An infusion device is disclosed. The infusion device may have a receptacle configured to receive a syringe. The infusion device may also have a plunger driver configured to releasably engage an end of a plunger of the syringe. Further, the infusion device may have a joystick configured to generate signals responsive to force being applied to the joystick in a first direction and in a second direction. In addition, the infusion device may have a controller configured to generate signals controlling travel of the plunger driver corresponding to the signals generated by the joystick.

Description

INFUSION DEVICE HAVING A SYRINGE PLUNGER CONTROL COMPRISING A JOYSTICK

Technical Field

The present disclosure relates generally to an infusion device, and more particularly, to an infusion device having a syringe plunger control.

Background

Patients with chronic diseases and conditions may require regular injections of intravenous treatment. For hemophilia, this often requires injection of a clotting factor (such as, but not limited to, factor VIII and IX) on a regular basis as determined by a treating physician. For certain patients, including younger and less-able patients, care is often provided in a clinical setting. However, this requires patients (and caregivers) to be present at a treatment location. Many clinics therefore, when possible, educate patients and caregivers so they can administer intravenous infusion at home. This reduces burdens on all parties. However, difficulties may arise when self-administering treatment, including determining correct dosages and ensuring the infusion takes place at the appropriate rate. Improvements in existing methods are desired.

Certain intravenous treatments involve the infusion of a volume of a reconstituted drug (i.e., a dried drug restored to its original state by adding liquid). The amount of reconstituted drug necessary may depend on many factors, including the type of drug, the condition of the patent, and the type or stage of the disease (or condition). For hemophilia, the presence of clotting factor antibodies may also affect the volume of treatment that must be infused. In addition to dosage, intravenous treatments must be administered at a controlled rate, as the capacity of a given vein to receive the drug, in addition to blood flow rate and volume in the vein, is limited. It is therefore possible to infuse an intravenous treatment at an excessive flow rate, particularly if administered via a syringe. This can result in too much drug being infused and can even result in physical damage to the vein. This is particularly true for longer-duration infusions, which require greater control over a longer period of time. Excessive flow rates, at the extreme, can cause a vein to“blow out” or balloon, potentially injuring the patient. Therefore, controlling the flow rate and volume of an infusion is imperative. Moreover, certain drugs, including hemophilia drugs, are prohibitively expensive. Thus, administering the correct amount and at the correct rate reduces the likelihood of wasted product, and thus reduces expense.

Automating treatments administered by infusion improves existing methods. Automation improves patient safety, improves the repeatability of each treatment, and minimizes user error. This ultimately improves patient outcomes. In most instances, infusions are accomplished using a syringe and a needle. However, intravenous injections may also be administered using a syringe coupled to a subcutaneous port or a PICC line. The present disclosure contemplates the automated administration of intravenous treatments performed via any of these methods.

In particular, the present disclosure describes an infusion device that may improve the ability to control the flow of an intravenous treatment while not depending on the manual application of force to a syringe. Patients of all ages, including those who may have difficulty maintaining consistent pressure on a syringe plunger over a long period of time may benefit. Moreover, patients with limited manual dexterity may benefit. Hemophilia patients may particularly benefit, as repeated bleed events over time often cause injury to patients’ musculoskeletal joints. The present disclosure is directed to overcoming these and other problems.

Summary of the Disclosure

In one aspect, the present disclosure is directed to an infusion device. The infusion device may include a receptacle configured to receive a syringe. The infusion device may also include a plunger driver configured to releasably engage an end of a plunger of the syringe. Further, the infusion device may include a joystick configured to generate signals responsive to force being applied to the joystick in a first direction and in a second direction. In addition, the infusion device may include a controller configured to generate signals controlling travel of the plunger driver corresponding to the signals generated by the joystick.

In another aspect, the present disclosure is directed to a method of controlling flow of a liquid from a syringe. The method may include engaging a plunger driver with an end of a plunger of the syringe. The method may also include measuring a force applied to a joystick. In addition, the method may include controlling travel of the plunger driver corresponding to the force applied to the joystick.

In yet another aspect, the present disclosure is directed to an infusion device for a syringe. The syringe may include a syringe body and a plunger having a plunger flange. The infusion device may include a receptacle configured to receive the syringe. The infusion device may also include a plunger driver configured to move the plunger in a first direction and in a second direction opposite to the first direction. The plunger driver may include a base and a pair of arms. The arms may be spaced apart from each other and may be connected to the base. The arms may be configured to pull the plunger flange when the plunger driver moves the plunger in the second direction. The infusion device may also include a controller configured to generate signals to control a travel of the base in the first direction and in the second direction.

In another aspect the present disclosure is directed to a method of infusing using an infusion device. The infusion device may include a plunger driver and may be configured to receive a syringe. The syringe may include a syringe body and a plunger having a plunger flange. The method may include receiving the syringe in a receptacle of the infusion device. The method may further include grasping the plunger flange at a pair of spaced apart locations, using a pair of arms of the plunger driver. Further, the method may include receiving a first signal for moving the plunger in a first direction. The method may also include advancing, in response to the first signal, the plunger driver in the first direction to push the plunger into the syringe body. The method may include receiving a second signal for withdrawing the plunger from the syringe body. In addition, the method may include advancing, in response to the second signal, the plunger driver in a second direction opposite to the first direction to pull the plunger outward from the syringe body via the pair of arms engaged with the plunger flange. Brief of the

Fig. 1 is a diagrammatic illustration of an exemplary disclosed infusion device.

Fig. 2 is an isometric view of an exemplary disclosed infusion device having a lid in an open state and an inlay extending along an upper part of a base of the infusion device;

Fig. 3 is another isometric view of an exemplary disclosed infusion device having a lid in an open state;

Fig. 4 is a diagrammatic illustration of an exemplary disclosed plunger driver assembly;

Fig. 5 is a system diagram illustration of an exemplary disclosed control system of the infusion device;

Fig. 6 is a cross-section view of an exemplary disclosed joystick of the infusion device;

Fig. 7 is an isometric view of an exemplary disclosed joystick of the infusion device;

Fig. 8 is a diagrammatic illustration of an exemplary disclosed joystick sensor of the infusion device;

Fig. 9 is a circuit diagram of an exemplary disclosed joystick sensor of the infusion device;

Fig. 10 is an exemplary chart illustrating force applied to a joystick versus motor speed of a plunger driver;

Fig. 1 1 is a diagrammatic illustration of an exemplary disclosed infusion device being used to remove air from an infusion line;

Fig. 12 is a diagrammatic illustration of an exemplary disclosed infusion device being used to draw blood into an infusion line;

Fig. 13A is a diagrammatic illustration of an exemplary disclosed plunger driver approaching a syringe; Fig. 13B is a diagrammatic illustration of the plunger driver of Fig. 13A engaging with an exemplary disclosed plunger of the syringe;

Fig. 13C is a diagrammatic illustration of the plunger driver of Fig. 13A after it has engaged with the plunger of the syringe;

Fig. 14 is an isometric view of an exemplary disclosed gripper mechanism of the exemplary disclosed plunger driver;

Fig. 15 is a bottom view illustration of the exemplary disclosed plunger driver;

Fig. 16A is a diagrammatic view of a portion of the exemplary disclosed gripper mechanism;

Fig. 16B is a diagrammatic view of an exemplary disclosed sensor associated with the exemplary disclosed plunger driver;

Fig. 17A is another bottom view illustration of the exemplary disclosed plunger driver;

Fig. 17B is a top view illustration of the exemplary disclosed plunger driver;

Fig. 18 is a diagrammatic illustration of an exemplary disclosed latch release mechanism;

Fig. 19 is a flow chart illustrating an exemplary disclosed pre-infusion process performed by the infusion device of Fig. 1 ;

Fig. 20 is a flow chart illustrating an exemplary disclosed infusion process performed by the infusion device of Fig. 1 ;

Fig. 21 is a flow chart illustrating an exemplary method of using the infusion device of Fig.

1 ;

Fig. 22 is a flow chart illustrating an exemplary method of operating the infusion device of Fig. 1 ; and Fig. 23 is a flow chart illustrating an exemplary method of reconstituting and infusing a treatment agent.

Detailed Description

Figs. 1 through 3 illustrate an exemplary disclosed infusion device 10. Infusion device 10 comprises housing 12 that may be configured to support syringe 14 and to control syringe 14 for the administration of a fluid into and from syringe 14. In one embodiment, syringe 14 may be a generic, over-the-counter syringe device including plunger 36 that is movable, e.g., by hand, to administer fluids and/or a treatment agent (e.g., medication or drug, such as, for example, a reconstituted drug) intravenously. In other embodiments, syringe 14 may be a specially-designed syringe, e.g., that is specifically suited for administering a treatment agent. Infusion device 10 may include syringe selector 1 1 that may be configured to be moved to change a size of a region in the housing that receives the syringe for use with the infusion device. For example, sliding syringe selector 1 1 in one position may cause a movable spacer (not shown) to be moved into the syringe-receiving region of housing 12 to allow infusion device 10 to accommodate a 5 mL syringe. Sliding syringe selector 1 1 to an opposite position may cause a movable spacer (not shown) to be moved from the syringe-receiving region of housing 12 to allow infusion device 10 to accommodate a larger, for example, 10 mL syringe. Housing 12 of infusion device 10 may include base 16 with proximal end 18, distal end 20, and lid 22 that may be substantially coextensive with an upper portion of base 16. Syringe 14 may be supported within receptacle 24 in an interior of housing 12 such that end 26 of syringe 14 and/or infusion line 28 coupled to syringe 14 may extend through distal end 20 of infusion device 10. In one embodiment, end 26 of syringe 14 and/or infusion line 28 may extend through opening 30 at distal end 20 of the infusion device 10.

Syringe 14 may include syringe barrel 32, finger grip 34, and plunger 36. Syringe barrel 32 may have a generally cylindrical shape, although other shapes are also contemplated. A portion of syringe barrel 32 may be disposed within base 16 while a remaining portion of syringe barrel 32 may project out of base 16 through opening 30. Finger grip 34 may form an end of syringe barrel 32 that may be disposed within base 16. In one exemplary embodiment as illustrated in Fig. 3, finger grip 34 may be in the form of a flange extending radially outward from syringe barrel 32. A lengthwise direction of base 16 may be disposed along a longer dimension of base 16 in a direction of arrow 38 shown in Fig. 3. Plunger 36 may be slidably received within syringe barrel 32. For example, syringe barrel 32 may include a generally hollow and elongated enclosure and plunger 36 may be slidingly disposed in the enclosure within syringe barrel 32. Plunger 36 may extend from driver end 40 disposed outside syringe barrel 32 to plunger end 42 disposed within syringe barrel 32. Plunger 36 may include plunger flange 44 at driver end 40. Plunger body 46 may extend from front face 48 of plunger flange 44 to plunger end 42 of plunger 36. Rear face 50 of plunger flange 44 may be disposed opposite to front face 48. Plunger end 42 may be configured in the form of a movable piston that forms a seal with syringe barrel 32.

Infusion device 10 may include plunger driver 52, which may be configured to engage with plunger flange 44 of plunger 36 to move plunger 36 in a first direction from driver end 40 towards plunger end 42, in the direction of arrow 38. Plunger driver 52 may also be configured to move plunger 36 in a second direction, opposite the first direction (i.e., opposite the direction of arrow 38), from plunger end 42 towards driver end 40. Plunger driver 52 may be configured to engage with and/or grasp plunger flange 44 of plunger 36 regardless of a position of plunger flange 44 relative to the proximal end 18 or finger grip 34. For example, plunger driver 52 may be configured to engage with and/or grasp plunger flange 44 when plunger flange 44 is located adjacent proximal end 18, when plunger flange 44 is located adjacent finger grip 34, or when plunger flange 44 is in any position between a position adjacent to proximal end 18 and a position adjacent to finger grip 34.

Infusion device 10 may also include joystick 54 that may be configured to receive inputs from a user and control movement of plunger 36 of syringe 14 when syringe 14 is supported by infusion device 10. Joystick 54 may provide inputs to controller 1 10 (see Fig. 5) of infusion device 10 to control a travel of plunger 36 in the first direction or in the second direction. In one embodiment, joystick 54 may be positioned on upper surface of lid 22 and along a substantially middle region 56 thereof, adjacent to an edge of lid 22, as illustrated in the embodiment of Fig. 1 . The placement of joystick 54 along middle region 56 in this embodiment may allow a user to grip infusion device 10 with one hand and make inputs to joystick 54 with the user’s thumb.

Joystick 54 preferably comprises an input device that allows for inputs in first direction 58 and second direction 60. In certain embodiments, joystick 54 may comprise a rocker switch, a two-way joystick, a single-axis joystick, or equivalent structure that is configured to receive inputs in first direction 58 and in second direction 60 when a user presses or pulls joystick 54 accordingly. In some embodiments, joystick 54 may articulate in first direction 58 and second direction 60 when pressed or pulled in those directions, where joystick 54 has limited degrees of freedom to only those directions. In yet other embodiments, joystick 54 may remain substantially static or exhibit only minor movement when pressed or pulled by the user (e.g., when force is applied in first direction 58 or second direction 60). In use, joystick 54 may control a movement of plunger 36 of syringe 14, moving plunger 36 into and out of syringe barrel 32 of syringe 14. Joystick 54 may control plunger 36 and may be configured for expelling air from infusion line 28 before infusion of an intravenous treatment agent, and for aspirating fluid (e.g., blood) into infusion line 28 once needle 62 has been entered a vein. This latter action may draw a vacuum on infusion line 28 to draw blood, confirming needle 62 and/or infusion line 28 is positioned in the vein. Joystick 54 may include raised protrusions or guards 64 disposed along the sides of joystick 54 to prevent errant inputs to joystick 54 (e.g., in directions substantially perpendicular to first and second directions 58 and 60) if infusion device 10 is dropped or mishandled.

In addition to joystick 54, in certain embodiments, exterior of housing 12 may include display 66 and one or more user controls 68. Display 66 may include a digital display and/or touch screen display, while user controls 68 may include buttons, switches, or any other interface that is configured to receive input from a user and provide signals to controller 1 10 of infusion device 10. In some embodiments, user controls 68 may comprise mechanical and/or electronic interfaces that can receive inputs from the touch of a user or a motion imparted by the user and provide signals to controller 1 10 of infusion device 10. Exemplary electronic interfaces include resistive touch, capacitive, or equivalent interfaces. Further still, user controls 68 may be integrated into display 66 by way of a touchscreen display. User controls 68 and display 66 may be preferably disposed on lid 22, adjacent to joystick 54.

Lid 22 of infusion device 10 is movable with respect to base 16. Lid 22 may secure over the upper edge of base 16 and may form an interior volume of infusion device 10 when in a closed state. In one embodiment, lid 22 may be connected to base 16 by one or more hinges 70, allowing lid 22 to rotate relative to base 16 when transitioning between an open state and the closed state. Together with hinges 70, one or more latches 72 or connectors may also be disposed along an edge of lid 22 to secure lid 22 to base 16. The one or more latches 72 may be disposed on an edge of base 16 and lid 22 that are not shared with the one or more hinges 70. Lid 22 may be preferably opened by pivoting about hinges 70, revealing the interior volume of infusion device 10 when inserting syringe 14 into or removing syringe 14 from infusion device 10.

Within the interior of infusion device 10, syringe 14 may be preferably supported within receptacle 24 that may maintain barrel 32 of syringe 14 in a substantially static condition within infusion device 10. In one embodiment, receptacle 24 may comprise a channel 74 or opening extending along the interior of infusion device 10. Channel 74 may include sidewalls 76 configured to support barrel 32 of syringe 14 bearing against it. Channel 74 may preferably include a hollow interior configured to receive barrel 32 therein. Receptacle 24 may extend within the interior to opening 30 at distal end 20 of infusion device 10, allowing barrel 32 of syringe 14 and/or an infusion line 28 to extend therethrough while being supported by receptacle 24.

In another embodiment, receptacle 24 may be defined in-part by inlay 78 extending through the interior of infusion device 10. Inlay 78 may comprise a surface, wherein the surface may be substantially coextensive with an open upper part of base 16. Inlay 78 may be configured to secure over the working components of infusion device 10 within its interior. When inlay 78 is in a working position over the open upper portion of base 16, inlay 78 may prevent a user from interfering, interacting, or otherwise tampering with the working components of infusion device 10. Fig. 2 shows inlay 78 in its working position, secured over the open upper portion of base 16. In certain embodiments, inlay 78 may be fastened to base 16 to further prevent tampering. In other embodiments, inlay 78 may be pivotable from its working position and may share the same hinges 70 as lid 22 of base 16 such that access to the interior components of infusion device 10 is afforded during servicing or troubleshooting.

Inlay 78 may further include portions of sidewalls 76 and of opening 30 of receptacle 24 and may support barrel 32 of syringe 14 when syringe 14 is placed within infusion device 10. In this embodiment, inlay 78 may also include one or more slots 80 extending from sidewalls 76 of receptacle 24. The one or more slots 80 may be configured to receive finger grips 34 of syringe barrel 32 therein. Slots 80 may extend through inlay 78 and secure around finger grips 34 of syringe barrel 32. Slots 80 may secure finger grips 34 such that barrel 32 remains statically disposed within infusion device 10 as plunger 36 of syringe 14 is moved within barrel 32. That is, slots 80 may secure finger grips 34, preventing movement of barrel 32 along a lengthwise direction of housing 12 as plunger 36 of syringe 14 is moved within barrel 32. Channel 74 and slots 80 may additionally be formed partially through inlay 78 and partially in lower surface 82 of lid 22, as shown in Fig. 2. In this manner, both lid 22 and inlay 78 may secure syringe 14 in infusion device 10 when lid 22 is placed in a closed position against base 16. It is contemplated, however, that sidewalls 76 and channel 74 of receptacle 24 may be formed as part of only base 16, and that lid 22 may not include structure contributing to control of syringe 14 within infusion device 10.

Receptacle 24 may preferably extend along a substantial portion of infusion device 10 such that a length of receptacle 24 may be configured to accommodate syringe 14 and plunger 36 when plunger 36 is fully extended (as shown in Fig. 2) and positioned within receptacle 24. However, it is also contemplated that receptacle 24 may be formed merely by opening 30 through distal end 20 of infusion device 10, wherein opening 30 alone may support barrel 32 of syringe 14. Therefore, it is not desired to limit the scope of receptacle 24 to the embodiment presented in Figs. 1 -3. Rather receptacle 24 may include one or more alternative structures configured to support barrel 32 of syringe 14 in a substantially static position when positioned within infusion device 10.

In operation, infusion device 10 may engage plunger flange 44 of syringe plunger 36 using plunger driver 52, as shown in Figs. 3-4. Plunger flange 44 of plunger 36 may be pushed (i.e. pressed) in a first direction or pulled in a second direction by plunger driver 52. When pressed, plunger 36 may be pushed towards barrel 32 of syringe 14 such that plunger 36 may be inserted into barrel 32 and air and/or liquid is expelled from syringe 14. When pulled by plunger driver 52, plunger flange 44 of plunger 36 may be grasped and pulled such that plunger 36 moves in an opposite direction as compared to when pushed (e.g., pulled from barrel 32 of syringe 14), thereby causing air and/or liquid to be drawn into barrel 32 and/or into an attached infusion line 28.

Infusion device 10 may therefore be configured to receive syringe 14 within its interior such that barrel 32 may be supported, and an end 26 of syringe 14 and/or the infusion line 28 may extend through opening 30 along distal end 20 of infusion device 10. To place syringe 14 within the interior of infusion device 10, lid 22 may be rotated away from base 16 or otherwise removed from base 16 to expose the interior of infusion device 10. Once opened, syringe 14 may be placed within receptacle 24 and lid 22 may be closed and latched to base 16 to secure syringe 14 therein. Once positioned in infusion device 10, plungerflange 44 of plunger 36 of syringe 14 may be engaged by plunger driver 52. Plunger driver 52 may be movable within the interior of infusion device 10. Plunger driver 52 may move in the first direction and the second direction along the length of receptacle 24 and/or in the direction of travel of plunger 36 relative to barrel 32. Electric motor 84 may drive plunger driver 52. Electric motor 84 may be controlled by one or more controllers 1 10 that may receive inputs from joystick 54, user controls 68, and/or one or more signals generated from control algorithms stored in memory 106 (see Fig. 5).

Referring to Fig. 4, there is shown an embodiment of plunger driver assembly 86 for controlling plunger driver 52. Plunger driver assembly 86 may include plunger driver 52, electric motor 84, and drivetrain assembly 88 between plunger driver 52 and electric motor 84 for transforming rotational input of electric motor 84 into linear input of plunger driver 52. In one embodiment, drivetrain assembly 88 may comprise elongated lead screw 90 that may be configured to be rotated by electric motor 84, causing plunger driver 52 to translate in the first direction or in the second direction based on a direction of rotation of lead screw 90. Lead screw 90 may preferably extend along a length of infusion device 10 such that lead screw 90 can control the position plunger driver 52 along the length of receptacle 24. A length of travel of plunger driver 52 may be determined by a length of lead screw 90. Plunger driver 52 may be configured to engage plunger flange 44 of plunger 36 when plunger 36 is fully extended from or fully inserted into the syringe barrel 32, and anywhere in between. Thus, plunger driver 52 may be configured to engage an extended plunger 36 and drive plunger 36 completely into barrel 32 of syringe 14 to administer and/or otherwise evacuate the entire contents of syringe 14. Similarly, plunger driver 52 may be configured to engage plunger 36 regardless of how far plunger 36 is inserted into syringe barrel 32, and to retract plunger 36 in barrel 32 of syringe 14 to load and/or otherwise fill syringe 14.

Electric motor 84 of infusion device 10 may receive inputs from one or more controllers 1 10 and may either directly drive lead screw 90 or indirectly drive lead screw 90 via drivetrain assembly 88. Drivetrain assembly 88 may include one or more intermediate gears to reduce or increase the rotational speed and torque of electric motor 84 on lead screw 90. In one embodiment, electric motor 84 may comprise an output shaft 92 that supports driving gear 94. Electric motor 84 may rotate driving gear 94, which may be coupled to driven gear 96 affixed to an end of lead screw 90.

Driving gear 94 and driven gear 96 may comprise a meshed pair of gears having complementary gear teeth such that the gears may be rotationally coupled to one another. Therefore, rotation of driving gear 94 in a first rotational direction may impart a rotation on driven gear 96 in an opposite rotational direction. The relative size of each gear and the gear tooth design may vary based on a desired gear reduction or amplification between electric motor 84 and lead screw 90, and the anticipated load being imparted on the gear teeth.

Lead screw 90 may preferably include a threaded outer surface having a thread pitch and a thread direction. Lead screw 90 may be coupled to plunger driver 52, whereby rotation of lead screw 90 may cause the threads of lead screw 90 to impart a translation on plunger driver 52 along a length of lead screw 90. In one embodiment, plunger driver 52 may comprise an elongated aperture 98 having internal splines or threads that may be configured to mesh with the threads of lead screw 90. To prevent rotation of plunger driver 52, plunger driver 52 may be supported by infusion device 10 such that it does not rotate as lead screw 90 rotates within elongated aperture 98 of plunger driver 52. In this embodiment, rotation of lead screw 90 and its meshed connection with the splines of plunger driver’s elongated aperture 98 may cause plunger driver 52 to translate along a length of lead screw 90. Electric motor 84, imparting a rotation on lead screw 90, may control the position of plunger driver 52 by controlling a direction of rotation and rotational velocity of lead screw 90. One or more controllers 1 10 may send signals to electric motor 84 to control the direction of travel and speed of plunger driver 45. As will be described, plunger driver 45 may include a pair of arms 100 configured to engage with plunger flange 44 of syringe plunger 36. Thus, controller 1 10, by way of electric motor 84 and lead screw 90, may control the position and motion of syringe plunger 36 when plunger driver 52 is engaged with plungerflange 44 of plunger 36. One or more controllers 1 10 may also control plunger driver 52 when it attaches to plunger 36 and when plunger driver 52 is otherwise being moved or positioned within the interior of infusion device 10. Referring to Fig. 5, there is shown an exemplary control system 102 of infusion device 10. Control system 102 may include, for example, joystick 54, display 66, user controls 68, electric motor 84, plunger driver assembly 86, joystick sensor 104, memory 106, indicators 108, and controller 1 10. Control system 102 is configured to receive signals from joystick 54, user controls 68, and plunger driver assembly 86, and control the operation of plunger driver 52, by for example, controlling the operation of electric motor 84. Control system 102 may be further configured to provide indications to the user via one or more indicators 108 and/or via display 66 while infusion device 10 is in operation. In one exemplary embodiment, infusion device 10 may include an orientation sensor (e.g. accelerometer, not shown) that may be configured to determine an orientation of infusion device 10 relative to the gravitational direction. The orientation sensor may provide inputs to controller 1 10, which may display the orientation on display 66.

Control system 102 may control plunger driver 52 in different ways depending on the procedure. In one instance, control system 102 may be configured to respond to inputs from joystick 54 and may control a position of plunger driver 52 when an infusion line or needle is being evacuated of air, or when blood is being aspirated from a vein. During an infusion, when fluid and/or treatment agent is being administered into a vein, predefined algorithms stored in memory 106, defining the administration rate for a particular infusion may be executed by control system 102 to control the position of plunger driver 52 while an infusion is taking place. During an infusion, control system 102 may also receive inputs from user controls 68 to change the infusion rate or other characteristics of the infusion. In a preferred embodiment, infusions may be carried out via one or more of stored algorithms and user controls 68, while joystick 54 may provide inputs on the position of plunger driver 52 only prior to an infusion. That is, joystick 54 may provide inputs on the position of plunger driver 52 only when evacuating air from syringe 14 and infusion line 28, and/or when aspirating blood into infusion line 28 from a vein.

In one embodiment, controller 1 10 may be configured to receive and send signals to plunger driver assembly 86. Controller 1 10 may include, for example, one or more processors. The one or more processors of controller 1 10 may embody a programmable processor, e.g., a central processing unit (CPU). The one or more processors of controller 1 10 may be configured to execute instructions stored in one or more memories 106. Memories 106 may comprise or may include non-transitory computer-readable media and include one or more memory units of non-transitory computer-readable media. Non-transitory computer- readable media of memory 106 may be or include any type of volatile or non-volatile memory, for example, including ROMs, RAMs, EPROMs, EEPROMs, DRAMs, VRAMs, flash memory devices, magnetic or optical cards, or any type of media or device suitable for storing instructions and/or data. Memory units may include permanent and/or removable portions of non-transitory computer-readable media. Memory 106 may have instructions stored therein. Non-transitory computer-readable media associated with memory 106 may also be configured to store logic, code and/or program instructions executable by controller 1 10 to perform embodiments of the methods described herein. For example, non-transitory computer-readable media associated with memory 106 may be configured to store computer-readable instructions that, when executed by a processor of controller 1 10, may cause controller 1 10 to perform a method comprising one or more steps.

Controller 1 10 may send signals to plunger driver assembly 86 (e.g., to electric motor 84 or to a motor controller associated with the electric motor) to control the position, velocity, and direction of travel of plunger driver 52 within infusion device 10. Controller 1 10 may control plunger driver 52 using one or more of the user controls 68, joystick 54, and/or stored program logic in memory 106, and may alter which of these is employed to control the position, velocity, and direction of travel of plunger driver 52 depending on a given procedure. Different procedures may include aspirating blood from a vein prior to an infusion, clearing air from an infusion line prior to an infusion, and infusing fluid and/or treatment agent into a vein.

For example, prior to an infusion, air within syringe 14 (e.g., within barrel 32 or infusion line 28) may be expelled so that air is not injected into the vein of a user. During this procedure, joystick 54 may be used to control the position, velocity, and direction of travel of plunger driver 52. In particular, controller 1 10 may receive signals from joystick 54 via joystick sensor 104, indicating that joystick 54 is being pressed or otherwise manipulated by a user in either first direction 58 or second direction 60. Correspondingly, controller 1 10 may send signals to plunger driver assembly 86 (e.g., to electric motor 84 or a motor controller of the electric motor) to move plunger driver 52 in a first direction or a second direction corresponding to the joystick’s first direction 58 and second direction 60. In one exemplary embodiment controller 1 10 may be configured to move plunger driver 52 in the first direction along arrow 38 when joystick 54 is pressed or manipulated in first direction 58. Similarly, controller 1 10 may be configured to move plunger driver 52 in a second direction opposite to the direction of arrow 38 when joystick 54 is pressed or manipulated in second direction 60.

In addition to a direction of travel, one or more signals from joystick 54 may include a magnitude indicating a desired speed for plunger driver 52 in the given direction. For instance, a force applied to joystick 54 may be determined by joystick sensor 104 associated with joystick 54, and a signal corresponding to that force may be sent to controller 1 10. Controller 1 10 may then determine the magnitude from the signal to move plunger driver 52 in the desired direction of travel at a speed corresponding to the magnitude from the signal generated by joystick 54 and joystick sensor 104. As will be discussed below, the signal from joystick 54 and joystick sensor 104 may correspond to a magnitude in a limited range, or the signal sent from controller 1 10 to plunger driver assembly 86 may be limited to a defined range (e.g., limited to a maximum speed despite a higher input to joystick 54). Joystick sensor 104 may generate the signal from joystick 54 and may transform a user’s input on joystick 54 into an electrical signal from which direction and speed may be determined by controller 1 10. Thus, a user may control a speed, direction of travel, and position of plunger driver 52 via joystick 54 while aspirating blood from a vein or clearing air from an infusion line prior to an infusion.

During an infusion procedure, controller 1 10 may utilize inputs from joystick 54, or in other embodiments may only receive inputs from user controls 68 and stored algorithms in memory 106. For example, it may be desirable to control an infusion using a predefined infusion algorithm stored in memory 106 rather than allowing a user to control the speed at which fluid and treatment agent is administered. For example, certain treatment agents may require a particular infusion rate based on different variables. These variables may relate to characteristics of the user (e.g., height, weight, blood diagnostics, etc.), and they may relate to the type of fluid or treatment agent being infused. Therefore, it may be desirable to carefully control the infusion rate without allowing the user to interfere, for instance, by speeding up or slowing down an infusion. In this situation, a stored algorithm in memory 106 may be executed by controller 1 10, whereby controller 1 10 may carry out specific sequences by sending signals to plunger driver assembly 86 (e.g., to electric motor 84 or a motor controller of the electric motor) to control the movement of plunger driver 52 and thus movement of syringe plunger 36. The particular algorithm selected for an infusion and the variables serving as inputs for the algorithm may be loaded in various ways into memory 106 or provided to controller 1 10. For instance, user controls 68 and/or display 66 may allow a user to manually input characteristics necessary to determine the infusion rate (e.g., by selecting the treatment agent to be infused, entering information about the user, etc.)· Display 66 may prompt the user for necessary inputs and either the display itself (e.g., a touchscreen display) may be used or user controls 68 may be utilized to respond to the prompts before the infusion begins. Alternatively, the infusion variables for the infusion algorithm may be preloaded or loaded using an alternative data transfer protocol that does not rely on manual input using infusion device 10. For instance, infusion device 10 may include a serial interface, near- field communications (e.g., RFID, BlueTooth, WiFi, etc.), or equivalent wired or wireless data transfer protocol for transferring information relating to algorithms that may be stored in memory 106 for execution by controller 1 10. In some exemplary embodiments, infusion device 10 may have a NFC reader capable of wirelessly reading the infusion variables or other information from a label or other description on a vial containing a fluid and/or a treatment agent. A third-party device, such as a smartphone or PC computer may also be used to prepare the algorithm and enter the necessary variables, after which the algorithm may be transferred to infusion device 10 for execution by controller 1 10. It is understood that a combination of inputs may be utilized to select and configure an infusion algorithm used to carry out the infusion. The algorithm may also operate completely independently of user input during execution (e.g., from input via joystick 54 or user controls 68), or controller 1 10 may accept and process inputs from the user to alter, stop, or initiate the infusion algorithm.

For embodiments in which inputs may alter the infusion algorithm, user controls 68, such as buttons, switches, or a touchscreen interface, may be used to, among other things, increase the infusion rate, decrease the infusion rate, start the infusion, or cease the infusion. Alternatively, the inputs may be provided using joystick 54. During an infusion, the user may also receive feed back from infusion device 10 in the form of visual, audible, and/or tactile responses. In one embodiment, display 66 may provide the user with visual information about the infusion setup and its progress, or may provide any other indication necessary during, prior to, or after an infusion. For example, display 66 may display images, icons, and/or text for providing instructions to the user regarding use of infusion device 10. In addition, display 66 may indicate a current status of the infusion or provide instructions for operating joystick 54 prior to, during, or after an infusion. Further still, these functions may be provided using an indicator 108, which may include an audible noise generator, a tactile feedback device such as a vibratory device, or equivalent device providing auditory or tactile feedback for a user.

When clearing infusion line 28 of air or when aspirating blood from a vein, indicator 108 and/or display 66 may provide the user with an indication of when to begin and when to end operation of joystick 54 so as not to expel any treatment agent from infusion line 28 or draw too much blood from the vein. In some embodiments when clearing infusion line 28 of air, indicator 55 may provide a series of audible tones at a given pitch, frequency, duration, or magnitude. The tones may change depending on an amount of force applied to joystick 54 by the user, indicating how fast plunger driver 52 is moving and how fast syringe plunger 36 is being driven. In one embodiment, an audible or tactile signal may be generated that changes in at least one of frequency, pitch, duration, and/or magnitude proportionally to the force applied to joystick 54. This may be particularly useful when clearing air from infusion line 28. The user may be provided with feedback as to how fast air is being expelled so that the user can slow down plunger driver 52 before any treatment agent and/orfluid is expelled from infusion line 28. For treatment agent or fluids that are particularly expensive and/or scarce, this may prevent spillage and may allow the user to predict when to stop applying force to joystick 54 when clearing air from infusion line 28 prior to an infusion. Examples of such expensive treatment may include hemophilia treatment agents, which are generally administered in small doses and the contents of which are very expensive. The joystick input and its proportional movement of plunger driver 52 may allow for precise control of plunger driver 52 and syringe plunger 36, and thus for the evacuation of air from infusion line 28 so as not to spill any of the treatment from infusion line 28, while also effectively clearing the line of air prior to an infusion.

Referring now to Figs 6-9, there are shown views of joystick 54 and joystick sensor 104. Joystick 54 comprises base surface 1 12 and upstanding member 1 14. Upstanding member 1 14 may secure to base surface 1 12 in several alternative ways. In one embodiment, base surface 1 12 and upstanding member 1 14 may be rigidly connected or may be formed of a unitary material such that a force applied to upstanding member 1 14 may cause flat-plate bending of base surface 1 12. For example, when a user presses on one side of upstanding member 1 14, upstanding member 1 14 may deflect, even minimally, causing, based on its connection to base surface 1 12, a small deflection of base surface 1 12 such that joystick sensor 104 below base surface 1 12 is acted upon. The force caused by a deflection of base surface 1 12 may be registered by sensor 104 and may be used to generate a signal to controller 1 10. Printed circuit board 1 16 may generate the signal and/or convey the signal to controller 1 10. Printed circuit board 1 16 is coupled to joystick sensor 104 and to controller 1 10. Joystick support structure 1 18 may be disposed below joystick 54. Joystick support structure 1 18 may be suitable for supporting base surface 1 12, sensor 104, and printed circuit board 1 16 in a static condition.

Alternative configurations of joystick 54 are also contemplated, including those with defined joints, degrees of freedom, and/or sensors equipped to measure movement and/or force applied thereto. These alternatives include, among other things, rocker switches, two-way joysticks, single-axis joysticks, or equivalent structures configured to receive inputs in first direction 58 and second direction 60 when a user presses or pulls joystick 54. In some of these embodiments, joystick 54 may be configured to move from an initial position and articulate or deflect in the first and second directions. Joystick 54 may be further biased to return to the initial position after being articulated or deflected.

In the preferred embodiment, joystick 54 may be substantially static and may deform when pressed or pulled, generating signals via joystick sensor 104 responsive to a force being applied to joystick 54 in the first direction and the second direction. The generated signals may be interpreted by joystick printed circuit board 1 16 and/or may be transmitted to controller 1 10. As shown in Fig. 7, controller 1 10 may be disposed on another printed circuit board, such as lid printed circuit board 120 that may be affixed to lid 22 of infusion device 10.

In a preferred embodiment, the signals from joystick sensor 104 may be used as inputs by controller 1 10 to control speed of the travel of plunger driver 52, where the speed may be set proportionally to the force applied to joystick 54. The signals may also be generated from, and the speed may be set proportionally to, a deformation or articulation of joystick 54 in other embodiments. Upon receiving the signals from joystick sensor 104, controller 1 10 may be configured to generate signals to move plunger driver 52 in a first direction when the force applied to joystick 54 is substantially in the first direction. Controller 1 10 likewise may be configured to generate signals to move plunger driver 52 in a second direction, opposite of the first direction, when the force applied to joystick 54 is substantially in the second direction. Thus, the speed and the direction of plunger driver 52 may be controlled using inputs to joystick 54. In the preferred embodiment, the inputs may include a force applied to joystick 54 by a human finger and registered by joystick sensor 104. Therefore, a force applied to joystick 54 and/or a force registered by joystick sensor 104 may be used to control plunger driver 52, in a preferred embodiment.

Referring to Figs. 8 and 9, there are shown views of an exemplary joystick sensor 104. In a preferred embodiment, sensor 60 may comprise a strain gauge disposed below and in contact with joystick 54. The strain gauge may comprise first measurement grid 122, second measurement grid 124, first terminal 126, second terminal 128, and ground terminal 130. The two measurement grids, shown as resistors R₃ and R₄ in Fig. 9, may have a known resistance. When base surface 1 12 of joystick 54 deflects because of user inputs on upstanding member 1 14, a resistance of one or both resistors may change accordingly. Base 30 may deform, press against strain gauge sensor 104 and on measurement grids 122, 124, which may also be deformed. The deformation may include bending, and the deformation may cause the resistors of each measurement grid to change resistance, thus providing a signal to printed circuit board 1 16 and controller 1 10 that can be compared to a corresponding, pre-calibrated force. In one embodiment, a lower surface of joystick base surface 1 12 may be bonded to strain gauge sensor 60 to impart any bending thereon. Thus, when a user’s finger pushes upstanding member 1 14 of joystick 54 in the first or second direction, the strain gauge bonding area may deform. This deformation may register a change in resistance to the resistors of measurement grids 122 and 124.

Referring to Fig. 9, a circuit diagram of an embodiment of strain gauge sensor 60 is illustrated. In this embodiment, measurement grids 122 and 124 (e.g., resistors R₃ and R₄) are disposed in a Wheatstone bridge circuit. This circuit enables the resistance of R₃ and R₄ to be measured with relatively good accuracy and allows for even small changes in resistance to be registered. When base surface 1 12 deforms it may press into and deform strain gauge measurement grids 122 and 124, whose resistance may change according to the deformation. Measurement grids 122 and 124 may generate signals, based on which controller 1 10 may register and recognize changes in the force applied to and/or movement of joystick 54. Controller 1 10 may rely on these signals to control plunger driver 52. In a preferred embodiment, base surface 1 12 of joystick 54 may be in contact with the measurement grids of the strain gauge, and when a force is applied to joystick upstanding member 1 14 in a first direction, first measurement grid 35 may register the force. When a force is applied to joystick upstanding member 1 14 in a second direction opposite of the first direction, second measurement grid 35 may register the force. Alternative embodiments of sensor 104, other than a strain gauge with a Wheatstone Bridge, may include at least one force sensitive resistor disposed below and in contact with joystick 54 to register force and/or movement.

Referring to Fig. 10, there is shown a diagram 132 of the speed of electric motor 84 as a function of force applied to joystick 54. In a preferred embodiment, the speed of electric motor 84 may be limited to an upper limit 134 (e.g., a maximum value) and/or a lower limit 136. The signals generated by the force applied to joystick 54 may be either registered and limited by controller 1 10, or limited by one or more of joystick sensor 104, joystick printed circuit board 1 16, or a motor controller of electric motor 84. In operation, the speed of electric motor 84 may be limited to an upper limit 134, whereby force applied greater than this upper limit (shown as“10 N” in Fig. 10) may not register as a higher output motor speed. Therefore, if a user presses too hard on joystick 54, there may be an upper limit as to the speed of electric motor 84, which may be adjustable to various speeds, for safety of the user, to maintain a controlled process of evacuating air from the infusion line or blood into the line, or to ensure electric motor 84 is not operated above a given operating threshold. Along with an upper limit 134, the motor speed may have a lower limit 136, whereby a predefined force may be required to activate the electric motor 84 (shown as“1 N” in Fig. 10). As a result, errant touches of joystick 54 may not result in movement of electric motor 84, and a deliberate application of force may be required to cause electric motor 84 to rotate. Once the lower limit 136 of applied force is reached, electric motor 84 may begin to rotate. Between the lower limit 136 and upper limit 134, the speed of electric motor 84 may increase linearly. While alternative speed curves are contemplated, a linear correlation between applied force and motor speed may be desired. Therefore, the speed of electric motor 84 may correspond to the magnitude of force applied in a given direction against joystick 54 for controlled movement of plunger driver 52. In this way, controller 1 10 may set the speed of electric motor 84 proportionally to the force applied to joystick 54.

In an embodiment, during an infusion, signals from joystick 54 may be ignored by controller 1 10 and may not be used to control the speed of electric motor 84. However, user inputs may be used to speed up or slow down the infusion rate by changing the speed of electric motor 84, and thus the speed of plunger driver 52 coupled to syringe 14. In one embodiment, a first input and a second input may be provided, wherein controller 1 10 may be configured to generate, in response to user input via the first input, signals to increase speed of the travel of plunger driver 52 (e.g., electric motor 84) in a given direction of travel. Controller 1 10 may also be configured to generate, in response to user input via the second input, signals to decrease speed of the travel of plunger driver 52 (e.g., electric motor 84) in a given direction of travel. Thus, a user may be able to change an infusion rate using one or more user controls 68 provided on an exterior of the infusion device.

Referring to Figs. 1 1 and 12, there are shown views of an embodiment of infusion device 10 being used to evacuate air 138 from an infusion line 28 and to aspirate blood 140 into the infusion line 28, respectively. Prior to an infusion, a user may prime infusion line 28 with a fluid and/or treatment agent that will be administered during the infusion procedure. This may involve clearing infusion line 28 of any air before inserting needle 62 into a vein. Generally, this process may be conducted by pressing on plunger 36 of syringe 14 while inverting syringe 14, thereby forcing pockets of air to move to the end of infusion line 28 and to be expelled from needle 62. Plunger 36 may be depressed into barrel 32 of syringe 14, causing the air to evacuate and the fluid/treatment agent to advance to the end of infusion line 28 and/or needle 62. This may prevent air from being injected into an individual’s vein. Once all air has been evacuated, needle 62 can be inserted into a vein.

Using infusion device 50, plunger flange 44 of syringe plunger 36 may be first grasped by plunger driver 52. Plunger driver 52 may then be used to push plunger 36 into barrel 32 of syringe 14 to evacuate air 138 from infusion line 28 and/or needle 62. After needle 62 has been inserted into a vein, to ensure needle 62 and/or infusion line 28 are within the interior of the vein, blood 140 may be drawn into the needle 62 and/or infusion line 28. Using infusion device 10, plunger driver 52 may be used to pull on plunger flange 44 of syringe plunger 36 to withdraw plunger 36 from barrel 32 of syringe 14. This may create a vacuum in barrel 32 and may draw blood into needle 62 and/or infusion line 28.

In a preferred embodiment, these pre-infusion operations of removing air 138 and drawing blood 140 into the infusion line 28 may be controlled by joystick 54. In particular, a user may control the position of plunger driver 52, and thus plunger 36 of syringe 14, after plunger driver 52 has secured to plunger flange 44 of plunger 36. A user may press or pull joystick 54 by hand, and preferably by using the user’s thumb 130, placing a force on joystick 54 in a first direction 58 or second direction 60. When a force is placed on joystick 54 in the first direction 58, plunger driver 52 may be driven by electric motor 84 in a corresponding direction, advancing plunger 36 into barrel 32 of syringe 14. This may expel air 138 prior to an infusion. When the user places a force on joystick 54 in the second direction 58, plunger driver 52 may be driven by electric motor 84 in a corresponding direction that is opposite of the first direction, withdrawing plunger 36 from barrel 32 of syringe 14 to draw blood into needle 62 and/or infusion line 28. While engaging in this pre- infusion procedure, the speed and position of the plunger driver may be controlled by the user’s input on joystick 54, and preferably a feedback mechanism in the form of an indication on display 66 is provided that may correspond to the speed of plunger driver 52 while inputs are being made to joystick 54. This may allow the user to gauge the speed of plunger driver 52 and thus the rate at which plunger 36 is moving in syringe 14 so that the user can prevent spillage of any significant quantity of a fluid or treatment agent prior to an infusion procedure. By viewing the fluid and/or treatment agent advance through infusion line 28, which may be generally transparent, combined with the feedback on display 66, a user may be able to stop expelling of air before treatment agent is expelled from needle 62 or infusion line 28. This may avoid wasting treatment agent.

The structure of plunger driver 52 and its engagement with end 53 of syringe plunger 36 will now be explained. Fig. 13A illustrates a diagrammatic view of plunger driver 52 disposed adjacent to plunger 36 when plunger driver 52 moves in the first direction (i.e. direction of arrow 38) and approaches plunger flange 44. In one exemplary embodiment as illustrated in Fig. 13A, plunger driver 52 may include driver base 150 and at least a pair of arms 100. Arms 100 may be connected at one end to driver base 150 and may project outward from driver base 150. Arms 100 may be spaced apart from each other and may be configured to engage with plunger flange 44 of plunger 36 at a pair of diametrically opposite locations 152. It is contemplated, however, that arms 100 may engage with plunger flange 44 at a pair of locations that may not be diametrically opposed. In one exemplary embodiment as illustrated in Fig. 13A, arms 100 may define a plane that may be disposed generally perpendicular to plunger flange 44. As used in this disclosure the term“generally” should be interpreted to encompass typical design and manufacturing tolerances. For example, the term“generally perpendicular” may encompass angles ranging between 90° ± 1 °, although smaller or larger tolerances are also contemplated. In other exemplary embodiments, arms 100 may define a plane that may be generally inclined relative to plunger flange 44. As used in this disclosure, the term “generally inclined” should be interpreted to mean that the respective objects are not disposed generally perpendicular to each other.

Fig. 14 illustrates an isometric view of gripper arm mechanism 154 of plunger driver 52. In one exemplary embodiment as illustrated in Fig. 14, gripper arm mechanism 154 may include first link member 156, second link member 158, third link member 160, fourth link member 162, and arms 100. First link member 156 may extend from first proximal end 164 to first distal end 166. Second link member 158 may extend from second proximal end 168 to second distal end 170. First and second proximal ends 164 and 168 may be disposed adjacent to and spaced apart from each other. Likewise, first and second distal ends 166 and 170 may be disposed adjacent to and spaced apart from each other. First and second link members 156 and 158 may be disposed adjacent to and generally parallel to each other. As used in this disclosure the term “generally parallel” may encompass angles ranging between 0° ± 1 °, although smaller or larger tolerances are also contemplated.

Third link member 160 may extend from third proximal end 172 to third distal end 174. Fourth link member 162 may extend from fourth proximal end 176 to fourth distal end 178. Third and fourth proximal ends 172 and 176 may be disposed adjacent to and spaced apart from each other. Likewise, third and fourth distal ends 174 and 178 may be disposed adjacent to and spaced apart from each other. Third and fourth link members 160 and 162 may be disposed adjacent to and generally parallel to each other. As also illustrated in Fig. 14, first and third link members 156 and 160 may be disposed between second and fourth link members 158 and 162 (i.e. in a space defined by second and fourth link members 158 and 162).

Arm 100 may include crank member 180 and gripper arm 182. Crank member 180 may extend from first end 184 to second end 186. Gripper arm 182 may be connected to crank member 180 and may extend from second end 186 to gripper arm end 188. In one exemplary embodiment as illustrated in Fig. 14, gripper arm 182 may be disposed generally perpendicular to crank member 180. It is contemplated, however, that in other exemplary embodiments gripper arm 182 may be disposed generally inclined relative to crank member 180. Gripper arm 182 may include pad 190 disposed at gripper arm end 188. Pad 190 may be disposed generally inclined relative to first, second, third, and fourth link members 156, 158, 160, 162, crank member 180, and gripper arm 182. Pad 190 may include flange engaging surface 192 configured to engage with plunger flange 44. Like pad 190, flange engaging surface 192 may also be disposed generally inclined relative to first, second, third, and fourth link members 156, 158, 160, 162, crank member 180, and gripper arm 182.

First link member 158 may be pivotally connected to crank member 180 at first end 184. Second link member 158 may be pivotally connected to crank member 180 at a location between first end 184 and second end 186. Likewise, third link member 160 may be pivotally connected to crank member 180 at first end 184. Fourth link member 162 may be pivotally connected to crank member 180 at a location between first end 184 and second end 186.

Fig. 15 is a bottom view illustration of plunger driver 52. As illustrated in Fig. 15, first link member 156 may be pivotably connected to driver base 150 of plunger driver 52 at first proximal end 164. Second link member 158 may be pivotably connected to driver base 150 at second proximal end 168. Likewise, third and fourth link members 160 and 162 may be pivotably connected to driver base 150 at third and fourth proximal ends 172 and 176, respectively.

Thus, as illustrated in the exemplary embodiments of Figs. 14 and 15, first link member 156, second link member 158, crank member 180 and driver base 150 may form a four-bar linkage mechanism. Likewise, third link member 160, fourth link member 162, crank member 180 and driver base 150 may form a four-bar linkage mechanism. Furthermore, because first and second link members 156 and 158 are disposed generally parallel to each other, first and second link members 156 and 158 may remain generally parallel to each other as first and second link members 156 and 158 rotate about pivotable connections at first and second proximal ends 164 and 168, respectively. Further, pivoting first and second link members 156 and 158 about pivotable connections at first and second proximal ends 164 and 168 may cause arm 100 to move in a direction generally perpendicular to arm 100 without causing rotational movement of arm 100. Likewise, because third and fourth link members 160 and 162 are disposed generally parallel to each other, third and fourth link members 160 and 162 may remain generally parallel to each other as third and fourth link members 156 and 158 rotate about pivotable connections at third and fourth proximal ends 172 and 176, respectively. Further, pivoting third and fourth link members 160 and 162 about pivotable connections at third and fourth proximal ends 172 and 176 may cause arm 100 to move in a direction generally perpendicular to arm 100 without causing rotational movement of arm 100.

As also illustrated in the exemplary embodiment of Fig. 15, first link member 156, second link member 158, third link member 160, and fourth link member 162 may be disposed at angles“qi,”“0₂,”“0₃,” and“0₄,” respectively, relative to longitudinal axis 194. Angles 0i, 0₂, 0₃, and 0₄ may be equal or unequal. In one exemplary embodiment as illustrated in Fig. 15, each of angles 0i, 0₂, 03, and 0₄ may be acute.

Plunger driver 52 may also include biasing member 196, the opposite ends of which may be attached, for example, to second and fourth link members 158 and 162. Biasing member 196 may be configured to bias second and fourth link members 158 and 162 towards each other. In one exemplary embodiment as illustrated in Fig. 15, biasing member 196 may be in the form of a spring. It is contemplated that in another exemplary embodiment, opposite ends of biasing member 196 may be connected to first and third link members 156 and 160. It is further contemplated that in some exemplary embodiments, one end of biasing member 196 may be connected to any of first and second link members 156 or 158, while the other end of biasing member 194 may be connected to any of third and fourth link members 160 or 162. In some exemplary embodiments, plunger driver 52 may include more than one biasing member 196, with separate biasing members 196 connecting one or more of first, second, third, and/or fourth link members 156, 158, 160, 162 with a portion of driver base 150 of plunger driver 52. The one or more biasing members 196 may be configured to bias movement of first and second members 156 and 158 towards third and fourth link members 160 and 162, and vice-versa. It is also contemplated that biasing mechanisms other than a linear spring may be used to bias movement of first and second members 156 and 158 towards third and fourth link members 160 and 162, and vice-versa. For example, biasing member 196 may be in the form of a spiral spring. As also illustrated in Fig. 15, pad 190 may extend from ledge 198 to pad outer end 200. Ledge 198 of pad 190 may be disposed between second end 186 and gripper arm end 188. Gripper arm end 188 may be disposed between ledge 198 and outer end 200. Ledge 198 may include flange engaging surface 202, which may be disposed generally parallel to base front face 204 of driver base 150, and inclined relative to flange engaging surface 192 of pad 190.

Returning to Fig. 13A, flange engaging surfaces 192 of arms 100 may be disposed generally inclined relative to plunger flange 44. As driver base 150 moves in the first direction (i.e. in the direction of arrow 38), flange engaging surfaces 192 of arms 100 may engage with (i.e. come into contact with) plunger flange 44. As driver base 150 continues to move in the first direction, the interaction of flange engaging surfaces 192 and plunger flange 44 may cause arms 100 to move laterally. For example, as shown in Fig. 13B, a spacing between arms 100 may increase from a first spacing “Wi” (see Fig. 13A) to a second larger spacing“W2” (see Fig. 13B) as base front face 204 continues to approach plunger flange 44.

As illustrated in Fig. 13C, further movement of driver base 150 in the first direction (i.e. in the direction of arrow 38) may cause plunger flange 44 to disengage with flange engaging surfaces 192 of arms 100 when plunger flange 44 is disposed between base front face 204 and ledge 198. When plunger flange 44 disengages or loses contact with flange engaging surfaces 192, biasing member 194 may force first and second link members 156 and 158, and third and fourth link members 160 and 162 to move towards each other, which in turn may cause arms 100 to move towards each other. For example, as shown in Fig. 13C, a spacing between arms 100 may decrease from a second spacing“W2” (see Fig. 13B) to a third smaller spacing“W₃” (see Fig. 13C) when first and second link members 156 and 158 move towards third and fourth link members 160 and 162. Spacing Ws may be equal to or different from spacing W-i.

As also illustrated in Fig. 13C, as driver base 150 continues to move in the first direction of arrow 38, base front face 204 of driver base 150 may contact rear face 50 of plunger flange 44 and may push plunger flange 44 in the first direction (e.g. in a direction of arrow 38). This in turn may cause plunger 36 to slide into syringe barrel 32, propelling treatment agent out of the syringe. When however, driver base 150 moves in a second direction opposite to the first direction (i.e. in an opposite direction to arrow 38), flange engaging surfaces 202 of ledges 198 of arms 100 may engage with front face 48 of plunger flange 44, causing plunger 36 to move in the second direction. This in turn may cause plunger 36 to slide out of syringe barrel 32, allowing treatment agent and/or another fluid to enter syringe barrel 32.

As discussed above the angles qi, q₂, Q3, and 0₄ (see Fig. 15) between longitudinal axis 194 and first link member 156, second link member 158, third link member 160, and fourth link member 162, respectively may be acute angles. As a result, any reaction force exerted on ledges 198 by plunger flange 44 may produce a torque at the pivotable joints at first, second, third, and fourth proximal ends 164, 168, 172, and 176 to cause first link member 156, second link member 158, third link member 160, and fourth link member 162 to move towards each other. This in turn may cause arms 100 to move towards each other causing arms 100 to grip plunger flange 44 tighter thereby helping to prevent disengagement of plunger flange 44 from arms 100.

Fig. 16A illustrates one of the two arms 100 and third and fourth link members 160 and 162 connected to arm 100. In one exemplary embodiment as illustrated in Fig. 16A, fourth link member 162 may include bore 210. Magnet 212 may be disposed within bore 210. Although not shown in Fig. 16A, second link member 158 may also include a bore having a magnet disposed therein. It is contemplated that in some exemplary embodiments, one or more of first link member 156, second link member 52, third link member 54, and/or fourth link member 162 may include bores with magnets 212 disposed therein.

Fig. 16B illustrates sensor board 214, which may be mounted to base 16. Sensor board 214 may be configured to detect movement of arms 100. Sensor board 214 may include one or more hall elements 216. Each hall element 216 may generate a signal having a signal strength that may be proportional to a distance between magnet 212 and hall element 216. Thus, for example, before arms 100 engage with plunger flange 44, magnets 212 located in second and fourth link members 158 and 162 may be aligned with hall elements 216 (i.e. magnets 212 may be positioned on top of or adjacent to hall elements 216). In this configuration, hall elements 212 may generate a signal having a first strength. When plungerflange 44 engages flange engaging surfaces 192 of pads 190 and pushes arms 100 away, first and second link members 156 and 158 may rotate in, for example, a counterclockwise direction while third and fourth link members 160 and 162 may rotate in, for example, a clockwise direction. Rotation of first, second, third, and fourth link members 156, 158, 160, and 162 in this manner may cause magnets 212 disposed in first, second, third, and fourth link members 156, 158, 160, and 162 to be laterally separated from one or more hall elements 216. In response, the one or more hall elements 216 may generate signals having a second strength lower than the first strength.

When flange engaging surfaces 192 disengage from plunger flange 44 and plunger flange 44 is disposed between base front face 204 and ledges 198, arms 100 may move towards each other. Movement of arms 100 towards each other may cause first and second link members 156 and 158 to rotate in, for example, a clockwise direction and may further cause third and fourth link members 160 and 162 to rotate in, for example, a counterclockwise direction. Rotation of first, second, third, and fourth link members 156, 158, 160, and 162 in this manner may cause magnets 212 disposed in first, second, third, and fourth link members 156, 158, 160, and 162 to move closer to hall elements 216. In response, the one or more hall elements 216 may produce signals having a third strength that may be smaller than the second strength. Controller 1 10 may control a movement of plunger driver 52 in the first direction or the second direction based on a strength of the signals generated by hall elements 216. Although sensor board 214 in Fig. 16B is illustrated as having two hall elements 216, it is contemplated that sensor board 214 may include any number of hall elements 216. In one exemplary embodiment, a number of hall elements 216 on sensor board 214 may equal a number of magnets present in first, second, third, and fourth link members 156, 158, 160, and 162. In other exemplary embodiments each hall effect sensor 216 on sensor board 214 may generate a signal corresponding to a distance of more than one magnet 212 associated with first, second, third, and fourth link members 156, 158, 160, and 162.

Fig. 17A is a bottom view illustration of plunger driver 52. As illustrated in Fig. 17A, plunger driver 52 may include rotational arm 218. Rotational arm 218 may be configured to rotate about axis 220. As illustrated in the exemplary embodiment of Fig. 17A, axis 220 may be disposed between first end 222 and second end 224 of rotational arm 218. Axis 220 of rotational arm 108 may also be disposed between first link member 156 and third link member 160. Biasing member 226 may connect first end 222 of rotational arm 218 to driver base 150. Biasing member 226 may be configured to cause rotation of rotational arm 218, for example, in a counterclockwise direction as illustrated in Fig. 17A. In one exemplary embodiment as illustrated in Fig. 17A, biasing member 226 may be a helical spring. It is contemplated however, that other biasing mechanisms, for example, a spiral spring may be used to bias rotational member 218.

Plunger driver 52 may include latch 228 that may be configured to rotate about axis 230, which may be spatially separated from axis 220. Latch 228 may include tip 232 that may be in contact with rotational arm 218 adjacent second end 224 of rotational arm 218. Tip 232 of latch 228 may prevent rotational arm 218 from rotating under the biasing influence of biasing mechanism 226.

Fig. 18 is a partial schematic illustration of release mechanism 240 for latch 228. Release mechanism 240 may be attached to base 16 and may be configured to release latch 228 to allow rotational arm 218 to rotate. In one exemplary embodiment as illustrated in Fig. 18, release mechanism 240 may include wire 242 attached to base 16. As illustrated in Fig. 18, wire 242 may extend between first attachment point 244 and second attachment point 246. First attachment point 244 may be disposed adjacent proximal end 18 of base 16, and second attachment point 246 may be disposed adjacent distal end 20 of base 16. Wire 242 may be attached to first and second attachment points 244 and 246 such that wire 242 may be held taut between first and second attachment points 244 and 246. Toggle pusher 248 may be attached to wire 242 adjacent proximal end 18 of base 16. Toggle activator 250 may extend between toggle pusher 248 and second attachment point 246 of wire 242. Toggle activator 250 may be in contact with latch 228 adjacent latch release end 254 of latch 228.

In one exemplary embodiment, to release latch 228, an operator may activate a button (not shown), which may cause an electric current to flow through wire 242. The flow of electric current in wire 242 may cause wire 242 to heat up. For example, wire 242 may be made of a material that contracts (reduces in length) when it is heated. In one exemplary embodiment, wire 242 may be made of Nitinol. Because wire 242 is fixedly attached to first and second attachment points 244 and 246, contraction of wire 242 may cause toggle pusher 248 to move in a direction from proximal end 18 towards distal end 20. Toggle pusher 248 in turn may push toggle activator 250 to move in the direction from proximal end 18 towards distal end 20. Toggle activator 250 may be configured to also move in a lateral direction shown by arrow 252, when it is moved in the direction from proximal end 18 towards distal end 20. In one exemplary embodiment, the lateral direction of movement shown by arrow 252 may be generally perpendicular to both a direction of arrow 38 and longitudinal axis 194. Movement of toggle activator 250 in the lateral direction may cause toggle activator 250 to push latch release end 254 of latch 228. Although a Nitinol wire is described above, other ways of moving toggle activator are contemplated. For example, infusion device may include a motor (not shown) capable of winding or unwinding wire 242 in response to activation of a button (not shown) by a user. Winding or unwinding of wire 242 may also cause movement of toggle activator 250 both in a direction from proximal end 18 towards distal end 20 and in a lateral direction. Other arrangements for moving toggle activator 250 and pushing latch release end 254 are also contemplated.

Returning to Fig. 17A, movement of latch release end 254 may cause latch 228 to rotate, for example, in a generally clockwise direction about axis 230, which in turn may cause tip 232 to lose contact with second end 224 of rotational arm 218, releasing latch 228. Biasing mechanism 226 may cause rotational arm 218 to rotate, for example, in a generally counterclockwise direction once tip 232 releases second end 224 of rotational arm 218.

Fig. 17B is a top view illustration of plunger driver 52. As illustrated in Fig. 17B, rotation of rotational arm 218 may cause second end 224 of rotational arm 218 to contact third link member 160. A biasing force exerted by biasing mechanism 226 may cause second end 224 of rotational arm 218 to cause third link member 160 to rotate in a clockwise direction. Rotation of third link member 160 may in turn cause rotation of fourth link member 162 in a clockwise direction via crank member 180.

As further illustrated in Fig. 17B, first and third link members 156 and 160 may be equipped with cam mechanisms 256 engaged with each other. Cam mechanisms 256 of first and third link members 156 and 160 may be disposed adjacent first and third proximal ends 164 and 172 of first and third link members 156 and 160, respectively. A rotation of cam mechanism 256 associated with third link member 160 in a clockwise direction may cause a rotation of cam mechanism 256 associated with first link member 156 in a counterclockwise direction because of an interaction between cams mechanisms 256. Rotation of first link member 156 in a counterclockwise direction may in turn cause rotation of second link member 158 in the counterclockwise direction via crank member 180. Rotation of the first, second, third, and fourth link members 156, 52, 54, and 56 in this manner, may cause arms 100 to move in lateral direction 258 away from each other.

As discussed above, upon receiving the signals from the joystick sensor 104, controller 1 10 may be configured to generate signals to move the plunger driver 52 in a first direction of arrow 38 when the force applied to the joystick 54 is substantially in the first direction 58. Plunger driver 52 may move in the direction of arrow 38 towards plunger flange 44 at a first speed until flange engaging surfaces 192 of arms 100 may come into contact with plunger flange 44. Further movement of plunger driver 52 towards plunger flange 44 may cause arms 100 to laterally move apart from each other as illustrated by arrow 258 in Fig. 17B. Movement of arms 100 may cause magnets 212 to move away from hall elements 216, which may in turn cause hall elements 216 to generate and transmit a signal to controller 1 10. Controller 1 10 may detect that flange engaging surfaces 192 have come into contact with plunger flange 44 when the signal received by controller 1 10 exceeds a threshold value. In response, controller 1 10 may be configured to generate signals to control a rotation of electric motor 84 such that plunger driver 52 may move in a first direction of arrow 38 at a second speed lower than the first speed.

Controller 1 10 may cause plunger driver 52 to continue to move in the direction of arrow 38 towards plunger flange 44 at the second speed until flange engaging surfaces 192 loose contact with plunger flange 44 and plunger flange 44 is received between ledges 198 of arms 100 and base front surface 204. As illustrated in Fig. 13C, when plunger flange 44 is received between ledges 198 of arms 100 and base front surface 204, biasing member 256 may cause arms 100 to move towards each other in a direction opposite to that of arrow 258 (see Fig. 17B). As a result, magnets 212 may move closer to hall elements 216 thereby increasing a strength of the signals generated by hall elements 216. In response, controller 1 10 may be configured to generate signals to stop further rotation of electric motor 84, which in turn may stop movement of plunger driver 52 in a direction of arrow 38. Thus, controller 1 10 may be configured to control a speed of plunger driver 52 to safely engage arms 100 with plunger flange 44.

Plunger driver 52 may be used in the infusion process and in pre-infusion processes, such as filling of a syringe, evacuating air from infusion line 28, and drawing blood from a vein prior to initiating the infusion process. Referring to Fig. 19, there is shown a flow diagram outlining an embodiment of the pre-infusion process 1900, used to clear infusion line 28 and/or syringe 14 of air and then ensure needle 62 is in a vein before initiating infusion of a fluid and/or treatment agent. It is contemplated that method 1900 may be performed either by a user preparing to inject a treatment agent into the user’s own vein using infusion device 10, or by a user preparing to inject a treatment agent into another user’s vein (e.g. a patient’s vein) using infusion device 10. In one example, a syringe may be first filled with a treatment agent and/or fluid by drawing the same into syringe 14 via manually withdrawing syringe plunger 36 from syringe barrel 32 before loading the syringe in infusion device 10 (or a syringe that has been pre-filled may be used). In an alternative example, a syringe may be filled with a treatment agent and/or fluid after the syringe is loaded in infusion device 10 by using infusion device 10 to withdraw syringe plunger 36 from syringe barrel 32 while the syringe is in flow communication with a treatment agent/fluid source. To load the syringe, infusion device 10 may be opened and syringe 14 may be placed within receptacle 24. In certain embodiments, syringe grip 34 may be placed into slots 80 to secure syringe barrel 32 within receptacle 24. Lid 22 may then be closed and syringe 14 may be enclosed within the interior of infusion device 10. Once loading of the syringe complete, a user may operate user controls 68, display 66, and/or other inputs to direct controller 1 10 to initiate plunger driver 52 to engage plunger flange 44 of syringe plunger 36 (Step 1902). Controller 1 10 may control plunger driver 52 during this initialization process such that arms 100 of plunger driver 52 may engage plunger flange 44 of syringe plunger 36. When the syringe is pre-filled before being loaded in infusion device, arms 100 may engage plunger flange 44 without moving plunger 36 relative to syringe barrel 32, such that no fluid is forced from syringe barrel 32 and/or infusion line 28 in the process. When infusion device 10 is used to fill syringe with a treatment agent and/or other fluid, the syringe may be placed in flow communication with a source of treatment agent or fluid, and a user may provide inputs via user controls 68 and/or display 66 to direct controller 1 10 to execute filling algorithms stored in memory 106 and executed by one or more processors of controller 1 10 to provide predefined control of plunger driver 52.

After engaging plunger driver 52 with plunger flange 44 (and providing any filling of the syringe), a user may make inputs to joystick 54 to control the movement of plunger driver 52, and thus movement of plunger 36 relative to barrel 32, to evacuate air from infusion line 28. At this stage, user may press joystick 54 in a direction that corresponds with a direction a user would push syringe plunger 36 if the plunger 36 was manually operated. The user’s input on joystick 54, in some embodiments, may be registered as a force applied to and measured by joystick sensor 104 (Step 1904). Using the measured force, including the magnitude and direction, controller 1 10 may send signals to electric motor 84 to drive plunger driver 52 in a direction corresponding to, and at a rate corresponding to, the force applied to joystick 54 (Step 1906). When the user applies force to joystick 54 in the direction of inserting plunger 36 into syringe barrel 32 (e.g., in a first direction), and while syringe 14 and infusion line 28 are inverted, air is forced to an end of infusion line 28. Air can then be expelled from infusion line 28 and infusion line 55 and syringe barrel 32 will be complete filled with a fluid and/or treatment agent. That is, the user applies inputs to joystick 54 and plunger 36 is driven into syringe barrel 32 (e.g., the body of syringe 14) while a liquid and/or treatment agent is conveyed from syringe 14 to infusion line 28, where air is expelled from infusion line 28.

While expelling air, feedback may be generated (Step 1908) in the form of indicators 108, providing a user with audible, tactile, or alternative feedback indicating the speed of plunger driver 52 while the user makes inputs to joystick 54. This may allow the user to watch the infusion line 28 and receive additional feedback from infusion device 10 such that no fluid and/or treatment agent is evacuated from syringe 14 or infusion line 28 when removing air. The feedback may continue while inputs are made to joystick 54 and controller 1 10 controls plunger driver 52.

After air is expelled, needle 62 can be inserted into a vein and blood can be drawn into infusion line 28 to confirm a vein is struck. To do this, a user may apply force to joystick 54 in the direction of withdrawing plunger 36 from syringe barrel 32 (e.g., in a second direction) while needle 62 is inserted into a vein. A vacuum may then be drawn on infusion line 28, and blood may be drawn into infusion line 28 if needle 62 and/or infusion line 28 are within a vein. Thus, a user may apply inputs to joystick 54 to cause plunger 51 to be pulled from syringe barrel 32 (e.g., the body of syringe 14) and thereby draw blood into infusion line 28.

Referring to Fig. 20, there is shown a flow diagram of an infusion process 2000. It is contemplated that method 2000 may be performed either by a user preparing to inject a treatment agent into the user’s own vein using infusion device 10, or by a user preparing to inject a treatment agent into another user’s vein (e.g. a patient’s vein) using infusion device 10. As with pre-infusion process 1900, plunger driver 52 may engage flange 44 of syringe plunger 36 (Step 2002). After expelling air from infusion line 28 (Step 2004), needle 62 is inserted into a vein, and blood may be drawn into infusion line 28 by operating joystick 54 (Step 2006). After blood is withdrawn into infusion line 28, the infusion may be initiated. In one embodiment, an infusion may be initiated by a user providing inputs via user controls 68 and/or display 66 to direct controller 1 10 to execute an infusion algorithm (Step 2008). Infusion algorithms are stored in memory 106 and executed by one or more processors of controller 1 10 and include predefined control of plunger driver 52 based on one or more inputs from the user prior to initiating the infusion. The algorithm controls the rate at which plunger driver 52 may push plunger 36 of syringe 14, and thus the administration rate of fluid and/or treatment agent into a vein. During the infusion, in some embodiments a user may speed up, slow down, or make other inputs that change the infusion process. These inputs may be received by controller 1 10 (Step 505) and may be used to update the infusion algorithm being executed by controller 1 10.

Fig. 21 illustrates an exemplary method 2100 of using infusion device 10. It is contemplated that method 2100 may be performed either by a user preparing to inject a treatment agent into the user’s own vein using infusion device 10, or by a user preparing to inject a treatment agent into another user’s vein (e.g. a patient’s vein) using infusion device 10. Method 2100 may include a step of receiving syringe 14 in receptacle 24 (Step 2102). In step 2102, syringe 14 may be placed within receptacle 24 by, for example, a user and lid 22 may be closed to secure syringe 14 therein. Syringe 14 may be placed in receptacle 24 such that finger grips 34 of syringe barrel 32 may be received in the one or more slots 80 in receptacle 24.

Method 2100 may include a step of engaging arms 100 of plunger driver 52 with plunger flange 44 (Step 2104). In step 2104, controller 1 10 may control plunger driver 52 during this initialization process such that arms 100 of plunger driver 52 may engage with plunger flange 44 of syringe plunger 36 without moving plunger 36 relative to syringe barrel 32. Step 2104 of method 2100 may include activity similar to that discussed in, for example, step 1902 of method 1900. Step 2104 of method 2100 may also include activity similar to that disclosed below, for example, with respect to method 2200.

Method 2100 may include a step of receiving a first signal for moving plunger 36 in a first direction along a direction of arrow 38 (see Fig. 3) (Step 2106). In step 2106, controller 1 10 may receive a signal from joystick sensor 104 or from user controls 68. For example, a user may press or manipulate joystick 54 in first direction 58. In response, joystick sensor 104 may generate and send one or more signals to controller 1 10, which in turn may generate and send signals to electric motor 84. Rotation of electric motor 84 in one direction (e.g. clockwise direction) may cause plunger driver 52 to advance, for example, in a direction from proximal end 18 towards distal end 20 of receptacle 24. As plunger driver 52 advances in the direction of arrow 38, base front face 204 of driver base 150 may contact rear face 50 of plunger flange 44 and push plunger flange 44 in the direction of arrow 38 (Step 2108). This may cause plunger 36 to be driven into syringe barrel 32, expelling any contents (air or treatment agents) in syringe barrel 32 out via infusion line 28.

Method 2100 may include a step of receiving a second signal for moving plunger 36 in a second direction opposite to the direction of arrow 38 (see Fig. 3) (Step 21 10). In step 21 10, controller 1 10 may receive a signal from joystick sensor 104 or from user controls 68. For example, a user may press or manipulate joystick 54 in second direction 60. In response, joystick sensor 104 may generate and send one or more signals to controller 1 10, which in turn may generate and send signals to electric motor 84. Rotation of electric motor 84 in a second direction (e.g. counterclockwise direction) may cause plunger driver 52 to travel, for example, in a direction from distal end 20 toward proximal end 18 of receptacle 24. As plunger driver 52 advances in the opposite direction of arrow 38, flange engaging surfaces 202 of ledges 198 of arms 100 of plunger driver 52 may contact front face 48 of plunger flange 44 and pull plunger flange 44 in a direction opposite to the direction of arrow 38 (Step 21 12). This may cause plunger 36 to be driven out of syringe barrel 32, causing blood and/or treatment agents to be drawn into syringe barrel 32 and/or infusion line 28.

Method 2100 may include a step of activating release mechanism 240 (Step 21 14). In step 21 14 controller 1 10 may receive a signal from user control 68 for disengaging plunger driver 52 from syringe 14. In response, in one exemplary embodiment, controller 1 10 may allow an electric current to flow through Nitinol wire 242. As a result, wire 242 may contract and cause toggle pusher 248 and toggle activator 250 to move in a direction from proximal end 18 towards distal end 20. Toggle activator 250 may move in a lateral direction shown by arrow 252, pushing latch release end 254 and causing rotation and release of latch 228. Method 2100 may include a step of moving arms 100 away from each other (Step 21 16). In step 21 16, release of latch 228 may cause rotation of rotational arm 218 under the biasing force of biasing member 226, which in turn may cause rotation of first and second link members 156, 158 in a rotational direction opposite to that of third and fourth link members 160, 162. The rotation of first, second, third, and fourth link members 156, 158, 160, and 162 may cause arms 100 to laterally move away from each other.

Fig. 22 illustrates an exemplary method 2200 of engaging plunger driver 52 with syringe 14 using infusion device 10. It is contemplated that method 2200 may be performed either by a user preparing to inject a treatment agent into the user’s own vein using infusion device 10, or by a user preparing to inject a treatment agent into another user’s vein (e.g. a patient’s vein) using infusion device 10. Method 2200 may include a step of advancing plunger driver 52 towards plunger 36 of syringe 14 (Step 2202). In step 2202, controller 1 10 may receive a signal from joystick sensor 104 or from user controls 68. For example, a user may press or manipulate joystick 54 in a first direction 58. In response, joystick sensor 104 may generate and send one or more signals to controller 1 10, which in turn may generate and send signals to electric motor 84. Rotation of electric motor 84 in one direction (e.g. clockwise direction) may cause plunger driver 52 to advance, for example, in a direction from proximal end 18 towards distal end 20 of receptacle 24. Controller 1 10 may control a speed of rotation of electric motor 84 so that plunger driver 52 may advance towards plunger flange 44 at a first speed.

Method 2200 may include a step of detecting contact of plunger driver 52 with plunger flange 44 (Step 2204). For example, controller 1 10 may monitor signals generated by one or more hall elements 216. Controller 1 10 may detect contact of plunger driver 52 with plunger flange 44 when one or more signals from hall elements 216 exceed a predetermined threshold value. As discussed above, as plunger driver 52 moves towards plunger flange 44, flange engaging surfaces 192 of arms 100 may come into contact with plunger flange 44. Because flange engaging surfaces 192 are inclined relative to plunger flange 44, advancing plunger driver 52 in the direction of arrow 38 (from proximal end 18 towards distal end 20) may cause arms 100 to move apart from each other. This in turn may cause one or more magnets 212 in one or more of first, second, third, or fourth links 156, 158, 160, 162 to be spatially separated from the one or more hall elements 216, causing signals from hall elements 216 to increase in strength. Controller 1 10 may detect that arms 100 of plunger driver 52 have contacted plunger flange 44 when an increase in strength of the signals from the one or more hall elements 216 exceeds a threshold value. A strength of the signals from the one or more hall elements 216 may continue to increase to a maximum strength as driver base 150 continues to move in a direction of arrow 38 (i.e. in a direction from proximal end 18 towards distal end 20).

Method 2200 may include a step of advancing plunger driver 52 towards plunger 36 at a second speed lower than the first speed (Step 2206). Upon detecting contact of arms 100 with plungerflange 44, controller 1 10 may generate and send one or more signals to electric motor 84 to reduce a rotational speed of electric motor 84. This in turn may cause driver base 150 to move towards plunger flange 44 at a second speed lower than the first speed achieved in, for example, step 2202.

Method 2200 may include a step of detecting that arms 100 of plunger driver 52 have captured (i.e. grasped) plunger flange 52 (Step 2208). Controller 1 10 may continue to monitor the one or more signals generated by the one or more hall elements 216. As discussed above, as arms 100 move further apart from an initial spacing Wi to a spacing W₂, a spacing between magnets 212 and hall elements 216 may continue to increase. As a result, a strength of the signals generated by hall elements 216 may also continue to increase. As driver base 150 continues to advance in the direction of arrow 38, flange engaging surfaces 192 of arms 100 may lose contact with plunger flange 44 when plunger flange 44 is disposed between base front face 204 and flange engaging surfaces 202 of ledges 198. When arms 100 lose contact with plunger flange 44, a biasing force of biasing member 196 may cause first and second link members 156, 158 and third and fourth link members 160, 162 to rotate towards each other, causing arms 100 to move towards each other. This in turn may cause a spatial distance between one or more magnets 212 and hall elements 216 to decrease. As a result, a strength of signals generated by hall elements 216 may also decrease to a level below the maximum strength discussed in, for example, step 2204. Controller 1 10 may detect that arms 100 have captured plunger flange 44 when a strength of the one or more signals generated by the one or more hall elements 216 decreases by more than a threshold value.

Method 2200 may include a step of stopping movement of plunger driver 52 (Step 2210). When controller 1 10 detects that the strength of the one or more signals generated by the one or more hall elements decreases by more than a threshold value, controller 1 10 may generate a signal to stop rotation of electric motor 84, which in turn may stop movement of driver base 150.

Fig. 23 illustrates an exemplary method 2300 of reconstituting and infusing a treatment agent into a patient, using infusion device 10. It is contemplated that method 2300 may be performed either by a user preparing to inject a treatment agent into the user’s own vein using infusion device 10, or by a user preparing to inject a treatment agent into another user’s vein (e.g. a patient’s vein) using infusion device 10. Method 2300 may include a step of receiving syringe 14 in receptacle 24 (Step 2302). In step 2302, syringe 14 may be placed within receptacle 24 by, for example, a user, and lid 22 may be closed to secure syringe 14 therein. Syringe 14 may be placed in receptacle 24 such that finger grips 34 of syringe barrel 32 may be received in the one or more slots 80 in receptacle 24. It is contemplated that in one example, syringe 14 placed in receptacle 24 may be a syringe pre-filled with a diluent (e.g. saline or other fluid) and that plunger flange 44 may be separated from finger grip 34 so that plunger flange 44 may be disposed between proximal end 18 and finger grip 34.

Method 2300 may include a step of attaching infusion device 10 to a vial (Step 2304), which may contain, for example, a lyophilized substance. In one example, the vial may include a lyophilized hemophilia treatment agent, e.g., a clotting factor, such as, but not limited to factor VIII and/or factor IX, although other treatment agents are also contemplated. The vial may be attached to infusion device 10 by allowing, for example, a needle or other sharp end associated with end 26 of syringe 14 to penetrate a septum in the vial. Other techniques for attaching the vial using couplings, such as coupling adapters, are also contemplated.

Method 2300 may include a step of injecting the contents of the syringe (e.g., diluent) into the vial (Step 2306). In step 2306, for example, a user may press or manipulate one or more of user controls 68 or display 66. In response, controller 1 10 may cause plunger driver 52 to move in the direction of arrow 38 towards plunger flange 44. Plunger driver 52 may engage with plunger flange 44 using one or more processes similar to those discussed above with respect to method 2200. In addition, controller 1 10 may cause plunger driver 52 to push plunger flange 44 in the direction of arrow 38. This in turn may force plunger 36 to move into syringe barrel 32 and cause the diluent to flow from syringe 14 through end 26 into the vial.

Method 2300 may include a step of mixing the contents of the vial (Step 2308). In this step, controller 1 10 may cause display 66 to show icons, images, or text to provide instructions to the user, regarding the step of mixing. For example, the instructions may instruct the user to orient infusion device 10 with its longitudinal axis in a generally vertical orientation so that the vial may be located below the infusion device 10 (with respect to the gravitational direction). Further the user may receive instructions to move infusion device 10, for example, in a swirling motion so that the diluent may mix in the vial with the original contents of the vial.

Method 2300 may include a step of drawing the contents of the vial into syringe 14 (Step 2310). In this step, for example, controller 1 10 may cause display 66 to show icons, images, or text to provide instructions to the user to re-orient infusion device 10 with its longitudinal axis in a generally opposite vertical orientation so that the vial may be located above the infusion device 10 (with respect to the gravitational direction). Further in this step, for example, a user may press or manipulate one or more of user controls 68 or display 66. In response, controller 1 10 may cause plunger driver 52 to move in a direction opposite to arrow 38 towards proximal end 18. Plunger driver 52 may pull plunger flange 44 in the direction opposite to arrow 38 causing the plunger to move out of syringe barrel 32. This in turn may cause the contents of the vial (e.g., a treatment agent) to be drawn into syringe 14.

Method 2300 may include a step of infusing the contents of the syringe into an individual. In this step, for example, controller 1 10 may cause display 66 to show icons, images, or text to provide instructions to the user to remove the vial from end 26 of syringe 14. Further, controller 1 10 may cause display 66 to show instructions to insert needle 62 into the user’s vein. In this step, a user may manipulate joystick 64 and/or provide inputs using user controls 68. In response, controller 1 10 may cause plunger driver 52 to push plunger flange 44 in the direction of arrow 38. This in turn may cause plunger 36 to travel into syringe barrel 32 causing the contents of the syringe to be infused into an individual at a rate controlled by controller 1 10, using one or more processes similar to those discussed for example, in step 2008. In some alternative examples, it is contemplated that steps 2304 through 2310 may be sequentially performed repeatedly to reconstitute a treatment agent by pooling multiple vials of one or more treatment agents into syringe 14. For example, a reconstituted treatment agent may require combination of more than one lyophilized treatment agent with a diluent. In this example, a user may execute steps 2304 through 2310 once to create a first reconstituted mixture/solution of a treatment agent from a first vial and diluent from syringe 14. The user may then replace the first vial with a second vial and execute steps 2304 through 2310 a second time, during which the reconstituted mixture of the diluent and the treatment agent from the first vial would be injected into the second vial. Mixing the contents of the second vial would provide a reconstituted mixture/solution that would include the treatment agent from the first vial, the treatment agent from the second vial, and the diluent from the syringe. This reconstituted mixture would be drawn into the syringe. Subsequent execution of step 2310 would allow this reconstituted mixture to be infused into an individual. Steps 2304 through 2310 may be repeated as many times as necessary with vials containing the same or different treatment agents to form a reconstituted mixture for infusion into an individual.

It is contemplated that one or more steps may be added to or removed from the steps disclosed above for methods 1900, 2000, 2100, 2200, and 2300. It is also contemplated that one or more steps of methods 1900, 2000, 2100, 2200, and 2300 may be modified. Further, it is contemplated that the order in which the steps of the one or more methods 1900, 2000, 2100, 2200, and 2300 are performed may be altered from that disclosed above.

It will be apparent to those skilled in the art that various modifications and variations can be made to the infusion device. Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice of the disclosed infusion device. It is intended that the specification and examples be considered as exemplary only. LIST OF ELEMENTS

TITLE: INFUSION DEVICE HAVING A SYRINGE PLUNGER CONTROL FILE: 12815.6001-00000

10. Infusion Device

1 1. Syringe Selector

12. Housing

14. Syringe

16. Base

18. Proximal End

20. Distal End

22. Lid

24. Receptacle

26. End

28. Infusion Line

30. Opening

32. Syringe Barrel

34. Finger Grip

36. Plunger

38. Arrow

40. Driver End

42. Plunger End

44. Plunger Flange

46. Plunger Body

48. Front Face

50. Rear Face

52. Plunger Driver

54. Joystick

56. Middle Region

58. First Direction

60. Second Direction

62. Needle

64. Raised Protrusion or Guard 66. Display

68. User Controls

70. Hinges

72. Latches

74. Channel

76. Sidewalls

78. Inlay

80. Slot

82. Lower Surface

84. Electric Motor

86. Plunger Driver Assembly

88. Drivetrain Assembly

90. Lead Screw

92. Output Shaft

94. Driving Gear

96. Driven Gear

98. Aperture

100. Arm

102, Control System

104. Joystick Sensor

106. Memory

108. Indicator

1 10. Controller

1 12. Base Surface

1 14. Upstanding Member

1 16. Printed Circuit Board

1 18. Joystick Support Structure

120. Lid Printed Circuit Board

122. First Measurement Grid

124. Second Measurement Grid

126. First Terminal

128. Second Terminal

130. Ground Terminal

132. Diagram134. Upper Limit 136. Lower Limit

138. Air

140. Blood

150. Driver Base

152. Location

154. Gripper Arm Mechanism 156. First Link Member 158. Second Link Member 160. Third Link Member 162. Fourth Link Member 164. First Proximal End 166. First Distal End

168. Second Proximal End 170 Second Distal End 172. Third Proximal End 174. Third Distal End

176. Fourth Proximal End 178. Fourth Distal End 180. Crank Member

182. Gripper Arm

184. First End

186. Second End

188. Gripper Arm End 190. Pad

192. Flange Engaging Surface

194. Longitudinal Axis

196. Biasing Member

198. Ledge

200. Outer End

202. Flange Engaging Surface

204. Base Front Face

210. Bore

212. Magnet

214. Sensor Board 216. Hall Element

218. Rotational Arm

220. Axis

222. First End

224. Second End

226. Biasing Mechanism

228. Latch

230. Axis

232. Tip

240. Release Mechanism

242. Wire

244. First Attachment Point

246. Second Attachment Point

248. Toggle Pusher

250. Toggle Activator

252. Arrow

254. Latch Release End

256. Cam Mechanism

258. Arrow

1900. Method of Performing a Pre-Infusion Process

1902. Step: ENGAGE PLUNGER

1904. Step: MEASURE FORCE APPLIED TO JOYSTICK

1906. Step: CONTROL TRAVEL OF PLUNGER DRIVER BASED ON MEASURED FORCE

1908. Step: GENERATE FEEDBACK

2000. Method of Performing an Infusion Process

2002. Step: ENGAGE PLUNGER

2004. Step: CLEAR AIR FROM INFUSION LINE

2006. Step: ASPIRATE VEIN

2008. Step: EXECUTE INFUSION ALGORITHM

2010. Step: RECEIVE INPUTS

2100. Method of Using Infusion Device

2102. Step: RECEIVE SYRINGE IN RECEPTACLE

2104. Step: ENGAGE ARMS OF PLUNGER DRIVER WITH PLUNGER FLANGE 2106. Step: RECEIVE SIGNAL FOR MOVING PLUNGER IN FIRST DIRECTION 2108. Step: ADVANCE PLUNGER IN FIRST DIRECTION

2110. Step: RECEIVE SIGNAL FOR MOVING PLUNGER IN SECOND

DIRECTION

2112. Step: ADVANCE PLUNGER IN SECOND DIRECTION

2114. Step: ACTIVATE RELEASE MECHANISM

2116. Step: MOVE ARMS AWAY FROM EACH OTHER

2200. Method of Using Infusion Device

2202. Step: ADVANCE PLUNGER DRIVER TOWARDS PLUNGER AT FIRST

SPEED

2204. Step: DETECT CONTACT OF PLUNGER DRIVER WITH PLUNGER FLANGE 2206. Step: ADVANCE PLUNGER DRIVER TOWARDS PLUNGER AT SECOND

SPEED LOWER THAN THE FIRST SPEED

2208. Step: DETECT CAPTURE OF PLUNGER FLANGE BY PLUNGER DRIVER 2210. Step: STOP MOVEMENT OF PLUNGER DRIVER

2300. Method of Reconstituting and Infusing a Treatment Agent

2302. Step: RECEIVE SYRINGE IN RECEPTACLE

2304. Step: ATTACH INFUSION DEVICE TO VIAL

2306. Step: INJECT SYRINGE CONTENTS INTO A VIAL

2308. Step: MIX CONTENTS OF VIAL

2310. Step: DRAW CONTENTS OF VIAL INTO SYRINGE

2312. Step: INFUSE CONTENTS OF SYRINGE INTO PATIENT

Claims

Claims What is claimed is:

1. An infusion device, comprising:

a receptacle configured to receive a syringe;

a plunger driver configured to releasably engage an end of a plunger of the syringe; a joystick configured to generate signals responsive to force being applied to the joystick in a first direction and in a second direction; and

a controller configured to generate signals controlling travel of the plunger driver corresponding to the signals generated by the joystick.

2. The infusion device of claim 1 , wherein the joystick is configured to be moved from an initial position in response to the force applied to the joystick and biased to return to the initial position when the force is no longer applied to the joystick.

3. The infusion device of claim 1 , wherein the controller is further configured to control speed of the travel of the plunger driver, the speed being proportional to the force applied to the joystick.

4. The infusion device of claim 1 , wherein the controller is further configured to generate signals to move the plunger driver in a first direction when the force applied to the joystick is substantially in the first direction, and to generate signals to move the plunger driver in a second direction, opposite to the first direction, when the force applied to the joystick is substantially in the second direction.

5. The infusion device of claim 1 , further comprising an indicator configured to generate an audible signal when the force is applied to the joystick.

6. The infusion device of claim 5, wherein the audible signal increases in at least one of frequency, duration, or magnitude proportionally to the force applied to the joystick.

7. The infusion device of claim 1 , wherein the joystick further comprises a sensor configured to:

generate a first signal that is proportional to the force applied to the joystick in a first direction, and

generate a second signal that is proportional to the force applied to the joystick in a second direction, opposite to the first direction.

8. The infusion device of claim 7, wherein the sensor further comprises a strain gauge disposed below and in contact with the joystick.

9. The infusion device of claim 8, wherein:

the sensor comprises a first measurement grid on the strain gauge, and a second measurement grid on the strain gauge,

the joystick further comprises a base surface and an upstanding member extending from the base surface,

the base surface is in contact with the first measurement grid on the strain gauge when the force applied to the joystick is in a first direction, and the base surface is in contact with the second measurement grid on the strain gauge when the force applied to the joystick is in a second direction, opposite to the first direction.

10. The infusion device of claim 7, wherein the sensor further comprises at least one force sensitive resistor disposed below and in contact with the joystick.

1 1. The infusion device of claim 1 , further comprising a lead screw and an electric motor being coupled to the plunger driver by the lead screw, wherein the signals generated by the controller control the electric motor.

12. The infusion device of claim 11 , wherein:

the controller is configured to set speed of the electric motor to be proportional to the force applied to the joystick, and to limit the speed of the electric motor to a maximum value.

13. The infusion device of claim 1 , wherein the plunger driver further comprises:

a driver body; and

a pair of gripper arms spaced apart from each other and connected to the driver body, the gripper arms being configured to releasably engage with the end of the plunger of the syringe such that the plunger driver is configured to push and pull the end of the plunger when engaged with the plunger.

14. The infusion device of claim 13, wherein the controller is configured to generate, in response to force applied to the joystick in a first direction, signals controlling the plunger driver to push the plunger, and configured to generate, in response to force applied to the joystick in a second direction opposite to the first direction, signals controlling the plunger driver to pull the plunger.

15. The infusion device of claim 1 , further comprising:

a first input and a second input, wherein the controller is configured to generate, in response to user input via the first input, signals to increase speed of the travel of the plunger driver, and wherein the controller is configured to generate, in response to user input via the second input, signals to decrease speed of the travel of the plunger driver.

16. The infusion device of claim 1 , wherein:

the infusion device further comprises a housing having an upper surface, and the joystick is disposed along a middle region of the upper surface of the housing.

17. A method of controlling flow of a liquid from a syringe, comprising:

engaging a plunger driver with an end of a plunger of the syringe;

measuring a force applied to a joystick; and

controlling travel of the plunger driver corresponding to the force applied to the joystick.

18. The method of claim 17, wherein the controlling comprises:

setting a speed of the plunger driver that is proportional to the force applied to the joystick.

19. The method of claim 18, further comprising limiting the speed of the plunger driver to a maximum value.

20. The method of claim 17, wherein the controlling comprises

generating signals to move the plunger driver in a first direction when the force applied to the joystick is substantially in the first direction; and generating signals to move the plunger driver in a second direction opposite to the first direction when the force applied to the joystick is substantially in the second direction.

21 . The method of claim 17, further comprising generating an audible signal when the force is applied to the joystick.

22. The method of claim 21 , wherein the audible signal increases in at least one of frequency, duration, or magnitude proportionally to the force applied to the joystick.

23. The method of claim 17, further comprising:

generating a first signal from a sensor that is proportional to force applied to the joystick in a first direction; and

generating a second signal from the sensor that is proportional to force applied to the joystick in a second direction opposite to the first direction.

24. The method of claim 17, wherein the controlling further comprises:

controlling an electric motor, the electric motor being coupled to the plunger driver by a lead screw.

25. The method of claim 17, wherein:

the applying force comprises applying the force to the joystick in a first direction, the plunger is driven into a body of the syringe,

the liquid is conveyed from the syringe to an infusion line, and

air is expelled from the infusion line.

26. The method of claim 17, wherein the liquid is a hemophilia treatment agent.

27. The method of claim 17, wherein:

the applying force further comprises applying the force to the joystick in a second direction opposite to the first direction,

the plunger is pulled from a body of the syringe, and

blood is conveyed into the infusion line.