Patent Application
20250001071
Disclosed embodiments are related to infusion pumps and related methods of use.
Medicinal fluids are administered to patients through a variety of methods. These conventional methods typically include injection by a syringe, ingestion, or delivery by an infusion pump and needle. In the case of administration by an infusion pump, controlled volumes of medicinal fluids may be delivered to the patient at pre-programmed rates or automated intervals. Conventional infusion pumps can be expensive, complex to operate, and can require delicate cleaning processes performed by a health care provider.
Typically, the delivery of medicinal fluids by an infusion pump is performed by an experienced health care provider who is responsible for operating the infusion pump to administer medicinal fluid as well as any maintenance or cleaning the infusion pump might require. A health care provider will also connect any accessories to the infusion pump to facilitate infusion, including needlesets, tubing, and containers of medicinal fluid.
In some embodiments, an infusion pump includes a holder configured to push and pull a syringe plunger, the holder configured to couple to the syringe plunger, the holder being moveable between a first position and a second position, and the holder being biased towards the first position, a loading actuator operatively coupled to the holder, wherein operation of the loading actuator causes the holder to move from the first position to the second position, and a lock configured to releasably fix the holder in the second position.
In some embodiments, a method of operating an infusion pump includes providing an infusion pump having a holder and a port, coupling a syringe plunger of a syringe to the holder, fluidly coupling a vial to the port, and moving the holder from a first position to a second position to cause the holder to move the syringe plunger in a fill direction and to cause liquid medicament from the vial to flow through the port and enter the syringe.
In some embodiments, an infusion pump includes a holder configured to removably couple to a syringe plunger, a loading actuator operatively coupled to the holder, the loading actuator being moveable between a first position and a second position, an energy storing member operatively coupled between the holder and the loading actuator, wherein movement of the loading actuator from the first position to the second position loads the energy storing member, and a lock configured to releasably fix the loading actuator in the second position.
In some embodiments, a method of operating an infusion pump includes providing an infusion pump having a holder, coupling a syringe plunger of a syringe to the holder, moving a loading actuator from a first position to a second position, causing loading of an energy storing member that is operatively coupled between the holder and the loading actuator, and locking the loading actuator in the second position. In some embodiments, the loaded energy storing member exerts a force on the holder, causing the holder to move the syringe plunger in a fill direction, and causing liquid medicament from a vial to enter the syringe.
In some embodiments, an infusion pump includes a contact surface configured to contact a syringe plunger, the contact surface being moveable between a first position and a second position, an energy storing assembly configured to move the contact surface from the second position to the first position by applying a substantially constant force to the contact surface, and a rate actuator operatively coupled to the energy storing assembly, the rate actuator configured to mechanically adjust a magnitude of the substantially constant force.
In some embodiments, a method of operating an infusion pump includes operating a loading actuator to load an energy storing assembly, the energy storing assembly becoming locked in a loaded state, unlocking the energy storing assembly from the loaded state, causing the energy storing assembly to unload and to produce a substantially constant force that is transmitted to a contact surface, causing the contact surface to abut against and move a syringe plunger in a dispensing direction, and operating a rate actuator to mechanically adjust a magnitude of the substantially constant force.
In some embodiments, an infusion pump includes a contact surface configured to contact a syringe plunger, the contact surface being moveable between a first position and a second position, and an energy storing assembly configured to move the contact surface from the second position to the first position by applying a substantially constant force to the contact surface. In some embodiments, the energy storing assembly includes a linkage operatively coupled to the contact surface, and an energy storing member. In some embodiments, the linkage is configured to convert a variable output force of the energy storing member into the substantially constant force.
In some embodiments, an infusion pump may include a first sledge operable by a loading actuator. The first sledge may be configured to linearly displace a syringe plunger. The infusion pump may include a second sledge that is operatively coupled to the first sledge. The infusion pump may include a lock engageable with the second sledge to retain the second sledge in a locked configuration. In some embodiments, the lock may be configured to permit the second sledge to be driven by energy stored within an energy storing member to linearly displace the first sledge in a dispensing direction in an unlocked configuration.
In some embodiments, a method of operating an infusion pump may include operating a loading actuator to linearly displace a first sledge, the first sledge configured to linearly displace a syringe plunger. The method may also include retaining a second sledge in a locked configuration with a lock engageable with the second sledge, wherein the second sledge is operatively coupled to the first sledge. The method may also include unlocking the lock to permit the second sledge to be driven by energy stored within an energy storing member to linearly displace the first sledge in a dispensing direction in an unlocked configuration.
In some embodiments, an infusion pump may include a holder configured to removably couple to a syringe and to push and pull at least a portion of the syringe. The infusion pump may include a loading actuator that is operatively coupled to the holder. The loading actuator may be configured to displace the holder. The infusion pump may include a port in removable fluid communication with the syringe, the port configured to removably couple to a fluid container. Operation of the loading actuator may urge fluid flow from the fluid container to the syringe.
In some embodiments, a method of operating an infusion pump may include operating a loading actuator that is operatively coupled to a holder to displace the holder. The holder may be configured to removably couple to a syringe and to push and pull at least a portion of the syringe. The method may include displacing the holder with the loading actuator. The method may include removably coupling a fluid container to a port. The port may be in removable fluid communication with the syringe. Operation of the loading actuator may urge fluid flow from the fluid container to the syringe.
In some embodiments, an infusion pump may include a holder configured to removably couple to a syringe plunger and to push and pull the syringe plunger. The infusion pump may include a rate actuator that is operatively coupled to the holder. The infusion pump may include an energy storing member that is operatively coupled between the rate actuator and the holder. In some embodiments, operation of the rate actuator may mechanically adjust energy stored within the energy storing member. The infusion pump may include a lock engageable with the holder to permit force transfer between the energy storing member and the holder to displace the holder when the lock is in an unlocked configuration.
In some embodiments, a method of operating an infusion pump may include operating a rate actuator to mechanically adjust energy stored within an energy storing member. The energy storing member may be operatively coupled between the rate actuator and a holder. The holder may be configured to removably couple to a syringe plunger and to push and pull the syringe plunger. The method may include permitting force transfer between the energy storing member and the holder by arranging a lock in an unlocked configuration. The lock may be engageable with the holder.
In some embodiments, an infusion pump may include a locking actuator configured to permit fluid flow out of a syringe in an unlocked configuration. The locking actuator may be configured to block fluid flow out of the syringe in a locked configuration. The infusion pump may include a ratchet wheel configured to engage with a portion of the locking actuator in the locked configuration of the locking actuator. The ratchet wheel may be rotationally coupled to a first gear. The infusion pump may include a second gear configured to engage with the first gear, the second gear being operatively coupled to the syringe. A gear ratio between the second gear and the first gear may be greater than 1:1.
In some embodiments, a method of operating an infusion pump may include permitting fluid flow out of a syringe by arranging a locking actuator in an unlocked configuration. The method may include blocking fluid flow out of the syringe by arranging the locking actuator in a locked configuration to engage a ratchet wheel with a portion of the locking actuator. The ratchet wheel may be rotationally coupled to a first gear. The first gear may be configured to engage with a second gear that is operatively coupled to the syringe. A gear ratio between the second gear and the first gear may be greater than 1:1.
In some embodiments, an infusion pump may include a holder configured to removably couple to a syringe plunger and to push and pull the syringe plunger. The infusion pump may include a loading actuator that is operatively coupled to the holder. Operation of the loading actuator may cause the holder to push and pull the syringe plunger. The infusion pump may include a lock configured to permit fluid flow out of a syringe barrel associated with the syringe plunger in an unlocked configuration. The lock may be configured to block fluid flow out of the syringe barrel in a locked configuration. The lock may be configured to releasably de-couple the holder and the loading actuator in the locked configuration.
In some embodiments, a method of operating an infusion pump may include operating a loading actuator to linearly actuate a holder. The holder may be configured to removably couple to a syringe plunger. The holder may be configured to push and pull the syringe plunger, permitting fluid flow out of a syringe barrel associated with the syringe plunger by arranging a lock in an unlocked configuration. The method may include blocking fluid flow out of the syringe barrel by arranging the lock in a locked configuration. The method may include releasably de-coupling the holder and the loading actuator in the locked configuration.
In some embodiments, an infusion pump may include a holder configured to removably couple to a syringe plunger and to push and pull the syringe plunger. The infusion pump may include an energy storing assembly configured to apply a substantially constant force to the holder to displace the holder. In some embodiments, the energy storing assembly may include an energy storing member configured to provide a variable output force. The energy storing assembly may include a drive arm configured to apply the substantially constant force to the holder. The infusion pump may include a linkage that is operatively coupled between the drive arm and the energy storing member. The linkage may be configured to convert the variable output force of the energy storing member into the substantially constant force.
It should be appreciated that the foregoing concepts, and additional concepts discussed below, may be arranged in any suitable combination, as the present disclosure is not limited in this respect. Further, other advantages and novel features of the present disclosure will become apparent from the following detailed description of various non-limiting embodiments when considered in conjunction with the accompanying figures.
The accompanying drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component that is illustrated in various figures may be represented by a like numeral. For purposes of clarity, not every component may be labeled in every drawing. In the drawings:
During a typical administration process of medicinal fluid using an infusion pump, a nurse or other health care provider performs numerous steps to prepare the infusion pump for operation, operates the pump to deliver the medicinal fluid, and maintains the pump for subsequent administrations. At each step, the health care provider takes care to maintain sterility as fittings, medicinal fluid containers, and other accessories are connected and disconnected from the infusion pump. Generally, the health care provider undertakes regularly scheduled cleanings of an infusion pump which are complex processes which require numerous steps to complete. Accordingly, conventional infusion pumps are expensive, difficult to operate, and typically require time consuming steps to set up and operate.
In some cases, due to the type, duration and/or frequency of treatment using some medicinal fluids, self-administration can be a desirable option for convenience and/or cost. Infusion pumps which are already complex and difficult to operate for health care providers can be even more challenging to operate and maintain for a patient practicing self-administration. For example, a patient may need to fill one or more syringes with medicinal fluid from one or more vials, connect new needlesets for each treatment, align and connect tubing to the pump, handle and connect one or more containers of medicinal fluid, and perform other steps for a single administration which may be difficult and time consuming. Additionally, a patient may need to perform complicated cleaning and maintenance processes to prepare their infusion pump for subsequent administrations.
The inventors have recognized a need for an infusion pump with reduced complexity, inexpensive operation (e.g., not requiring costly and/or specialized equipment or processes), and improved sterility of medicinal fluid administration which may be readily used by health care professionals and/or self-administering patients (hereinafter referred to as “users”).
In view of the above, the inventors have recognized the benefits of an inexpensive and mechanically operated infusion pump that may be used to deliver a medicinal fluid in an easy to operate manner. The infusion pump may be configured to subcutaneously deliver a large volume of medicinal fluid at a desired fluid flow rate.
According to exemplary embodiments described herein, an infusion pump may be used with any number of medicinal or nutritional fluids (both of which are hereinafter referred to as “fluid”) which are delivered to the body (e.g., subcutaneously). In some embodiments, the fluid may be a liquid medicament. In some embodiments, an infusion pump may be configured to deliver Immune Globulin Infusion 10% (Human), Immune Globulin Subcutaneous (Human) 20% (e.g., CUVITRU), Recombinant Human Hyaluronidase (e.g., HYQVIA), other immune globulin drugs, and/or any other suitable medicament. Infusion pumps described herein may, in some embodiments, be configured to deliver fluids having a viscosity between 10 and 30 cP at 35° C., between 1 and 4.54 cP at 35° C. or any other suitable viscosity.
With conventional syringe infusion pumps, a syringe is typically manually filled by a user with fluid from one or more vials prior to coupling the syringe to the infusion pump. With such arrangements, the infusion pump itself does not assist the user in filling the syringe. The process of filling the syringe can be cumbersome and time-consuming. Thus, the inventors have recognized the need for an infusion pump that assists users with loading fluid into a syringe. In some embodiments, the infusion pump may include a syringe loading assembly that helps to reduce the amount of force and/or coordination needed from the user. In some embodiments, a syringe loading assembly may be configured to reduce air bubbles during loading of the syringe with fluid.
In some embodiments, the syringe loading assembly of an infusion pump may be purely mechanically operated. In other words, the process of loading a syringe with fluid using the infusion pump may occur mechanically, without requiring electricity. In some embodiments, the syringe loading assembly may include a user-operable handle to allow a user to select the volume of fluid to be loaded into a syringe. The handle may be operatively coupled to a plunger of the syringe, such that movement of the handle may translate the plunger through a barrel of the syringe. In some embodiments, the handle may be operatively coupled to a plunger via an elastic coupling. In some embodiments, the force applied to the handle by the user may be modulated by the elastic coupling, and the modulated force may then be transferred to the plunger by the energy storing member. In some embodiments, the elastic coupling may include an energy storing member. In some embodiments, the energy storing member may allow the plunger to translate at a lower speed than the speed at which the handle was moved. In some embodiments, the slower translation of the plunger may result in less frothing in the syringe. As a result, the filling of the syringe may not need to rely on a user spending time pulling back on the syringe plunger sufficiently slowly (e.g., to avoid potential bubble formation and/or damage to the medicament) and/or the user pulling back on the syringe plunger at a sufficiently steady rate. In some embodiments, the user may be able to move the handle to set a fill volume at any desired speed and rate without worrying about bubble formation and/or causing the syringe to fill too quickly.
In some embodiments, the syringe loading assembly of an infusion pump may be manually operated by mechanical means (e.g., without requiring electricity). In some embodiments, an infusion pump may include a user-operable loading actuator operatively coupled to a plunger holder configured to push or pull a syringe plunger relative to the syringe barrel. The user may operate the actuator to pull the plunger away from the barrel, forming a vacuum. As will be described in greater detail below, in cases where the syringe is in fluid communication with a vial of fluid, this movement may result in the syringe being filled with fluid. In some embodiments, the infusion pump may employ load reduction features such as gear trains to reduce the force and dexterity to operate the loading actuator.
In some embodiments, the infusion pump may be able to load a syringe by extracting fluid (e.g., medication) from any suitable pre-existing vial sizes and shapes. For example, the infusion pump may be able to extract fluid from a vial with a standard 20 mm opening, or any other suitable opening size. In some embodiments, the infusion pump may be able to extract fluid from vials containing at least 2 mL, 5 mL, 10 mL, 15 mL, 20 mL, 25 mL, 30 mL, 35 mL, 40 mL, 45 mL, 50 mL, 55 mL, 60 mL, 65 mL, 70 mL, 75 mL, 80 mL, 85 mL, 90 mL, 95 mL, 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL, 400 mL, 450 mL, 500 mL, and/or any other suitable vial volume. In some embodiments, the infusion pump may be able to extract fluid from vials containing less than or equal to 500 mL, 450 mL, 400 mL, 350 mL, 300 mL, 250 mL, 200 mL, 150 mL, 100 mL, 95 mL, 90 mL, 85 mL, 80 mL, 75 mL, 70 mL, 65 mL, 60 mL, 55 mL, 50 mL, 45 mL, 40 mL, 35 mL, 30 mL, 25 mL, 20 mL, 15 mL, 10 mL, 5 mL, 2 mL, and/or any other suitable vial volume. Combinations of ranges for the vial volume are also contemplated, including between 5 mL and 50 mL, 2 mL and 500 mL, 10 mL and 30 mL, 50 mL and 500 mL, and/or any other suitable combinations of vial volumes. Of course, other ranges, including ranges both greater than and less than those noted above are also contemplated as the present disclosure is not so limited. It should be appreciated that the infusion pump may be able to extract fluid from any suitable vial volume, as the present disclosure is not so limited.
In some embodiments, the infusion pump may be able to sequentially extract fluid from one or more vials. In some embodiments, the infusion pump may be able to sequentially extract fluid from at least 1 vial, 2 vials, 3 vials, 4 vials, 5 vials, and/or any other suitable number of vials. In some embodiments, the infusion pump may be able to sequentially extract fluid from less than or equal to 5 vials, 4 vials, 3 vials, 2 vials, 1 vial, and/or any other suitable number of vials. Combinations of ranges for the number of vials used are also contemplated, including between 1 vial and 5 vials and between 2 vials and 5 vials, and/or any other suitable combination. Of course, other ranges, including ranges both greater than and less than those noted above are also contemplated as the present disclosure is not so limited. It should be appreciated that the infusion pump may be able to extract fluid from any number of vials, as the present disclosure is not so limited.
Existing infusion pumps with adjustable flow rates may include elastomeric components which may be incompatible with certain fluids. Thus, the inventors have also recognized the benefits of an infusion pump capable of delivering large volumes of fluid at an adjustable fluid delivery flow rate using components not directly in contact with the fluid. The infusion pump may have a user-operable control to allow the user to set the fluid delivery flow rate based on user input. The infusion pump may control the fluid delivery flow rate by controlling a force applied to a plunger of a syringe. The flow rate control may be integrated into the fluid delivery system, allowing a user to adjust the fluid delivery flow rate without throttling the fluid flow.
In some embodiments, an infusion pump may include a mechanically operated drug delivery assembly. The drug delivery assembly may include a variety of mechanical components arranged to apply an adjustable constant force to a plunger of a syringe. The constant force applied to the plunger may result in a substantially constant fluid flow rate out of the syringe. In some embodiments, the user may easily adjust the constant force by operating a rate actuator at any point (e.g., before, during, or after) of an infusion process. The user may adjust the fluid flow rate in response to comfort needs, timing needs (e.g., if the user has limited time to conduct the infusion process), biological needs (e.g., as recommended by a health care professional), or any other suitable set of needs. In some embodiments, the infusion pump may also include a lock or a toggle in order to stop and/or start infusion at any point during the infusion process.
In some embodiments, the infusion pump may deliver between 2 and 100 mL of a fluid during a single infusion process. In particular, an infusion pump may deliver a fluid volume of at least 2 mL, 5 mL, 10 mL, 15 mL, 20 mL, 25 mL, 30 mL, 35 mL, 40 mL, 45 mL, 50 mL, 55 mL, 60 mL, 65 mL, 70 mL, 75 mL, 80 mL, 85 mL, 90 mL, 95 mL, 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL, 400 mL, 450 mL, 500 mL, and/or any other appropriate volume during a single infusion process. In some embodiments, the infusion pump may deliver a fluid volume less than or equal to 500 mL, 450 mL, 400 mL, 350 mL, 300 mL, 250 mL, 200 mL, 150 mL, 100 mL, 95 mL, 90 mL, 85 mL, 80 mL, 75 mL, 70 mL, 65 mL, 60 mL, 55 mL, 50 mL, 45 mL, 40 mL, 35 mL, 30 mL, 25 mL, 20 mL, 15 mL, 10 mL, 5 mL, 2 mL, and/or any other suitable volume. Combinations of ranges for the delivered fluid volume are also contemplated, including between 5 mL and 60 mL, 2 mL and 500 mL, 10 mL and 30 mL, 50 mL and 500 mL, and/or any other suitable combinations of delivered fluid volumes. Of course, other ranges, including ranges both greater than and less than those noted above are also contemplated as the present disclosure is not so limited. It should be appreciated that the infusion pump may be able to deliver any suitable volume of fluid, as the present disclosure is not so limited. In some embodiments, the infusion pump may deliver a substantial portion of the fluid loaded into the syringe (whether manually or mechanically, using the system described above). In some embodiments, the infusion pump may deliver greater than 95% of the fluid loaded into the syringe. Of course, embodiments in which the infusion pump may deliver significantly less fluid than is loaded in the syringe are also contemplated.
Additionally, the infusion pump may deliver fluids of the above-noted volumes with viscosities greater than 1 cP, 2.5 cP, 5 cP, 10 cP, 15 cP, 20 cP, 25 cP, 30 cP, 35 cP, and/or any other appropriate viscosity during a single infusion process. Correspondingly, the infusion pump may deliver fluids of the above-noted volumes with viscosities less than 50 cP, 45 cP, 40 cP, 30 cP, 20 cP, 15 cP, 10 cP, and/or any other appropriate viscosity during a single infusion process. In other embodiments, the infusion pump may deliver between 26.25 mL and 1260 mL of a fluid having a viscosity between 1 and 4.54 cP at 35° C. during a single infusion process. Combinations of ranges for the delivered fluid viscosities are also contemplated, including between 1 cP and 50 cP, 5 cP and 25 cP, and/or any other suitable combinations of delivered fluid viscosities. Of course, other ranges, including ranges both greater than and less than those noted above are also contemplated as the present disclosure is not so limited. It should be appreciated that the infusion pump may be able to deliver any suitable volume of fluid with any suitable viscosity, as the present disclosure is not so limited.
The user may be able to adjust the delivery flow rate of the fluid based on the properties of the fluid. In some embodiments, it may be desirable to infuse a more viscous fluid at a lower flow rate than a less viscous fluid. The delivery flow rate may be continuously adjustable in any desirable range. In other words, a user may be able to select any delivery flow rate within a given range, as opposed to step-wise, discontinuous flow rate settings. In some embodiments, the delivery flow rate may be continuously adjustable between 50 mL/hr and 300 mL/hr. As will be described in further detail below, the user may be able to adjust the delivery flow rate by manipulating a rate actuator. In some embodiments, the infusion pump may include visual markers on an external face of the pump to allow the user to select a desired flow rate.
In some embodiments, an infusion pump may deliver fluid at a rate of at least 10 mL/hr, 20 mL/hr, 30 mL/hr, 40 mL/hr, 50 mL/hr, 60 mL/hr, 80 mL/hr, 100 mL/hr, 120 mL/hr, 150 mL/hr, 180 mL/hr, 200 mL/hr, 250 mL/hr, 300 mL/hr, 400 mL/hr, 500 mL/hr, and/or any other suitable delivery flow rate. In some embodiments, the infusion pump may deliver fluid at a rate less than or equal to 500 mL/hr, 400 mL/hr, 300 mL/hr, 250 mL/hr, 200 mL/hr, 180 mL/hr, 150 mL/hr, 120 mL/hr, 100 mL/hr, 80 mL/hr, 60 mL/hr, 50 mL/hr, 40 mL/hr, 30 mL/hr, 20 mL/hr, 10 mL/hr, and/or any other suitable delivery flow rate. Combinations of ranges for the fluid delivery rate are also contemplated, including between 10 mL/hr and 500 mL/hr, 50 mL/hr and 300 mL/hr, and/or any other suitable combinations of fluid delivery flow rate. Of course, other ranges, including ranges both greater than and less than those noted above are also contemplated as the present disclosure is not so limited. It should be appreciated that the infusion pump may be able to deliver fluid at any suitable flow rate, as the present disclosure is not so limited.
According to some embodiments, the infusion pump may be capable of delivering fluid to one or more infusion sites. Such an arrangement may be desirable to reduce the time of infusion or administration and/or reduce the localization of the administered fluid. Accordingly, the infusion pump may be compatible with a needleset which may include any suitable number of needles to facilitate administration of a fluid. In some embodiments, the needleset may be bifurcated (for delivery to two infusion sites), trifurcated (for delivery to three infusion sites), quadfurcated (for delivery to four infusion sites), quintfurcated (for delivery to five infusion sites), or may have any other desirable number of needle hubs. It should be appreciated that the infusion pumps described herein may be compatible with any pre-existing needlesets, such as the KORU HIGH-Flo needleset.
In some embodiments, the infusion pump may be able to deliver fluid with a viscosity of 16 cP at up to 60 mL/hr/site through a 24 gauge or 27 gauge needleset. In some embodiments, the infusion pump may be able to deliver fluid through five 27 gauge needles of a needleset.
The inventors have also recognized the benefits of an infusion pump including a bubble trap that can be used to limit the delivery of air bubbles to an infusion site. The air bubbles may be formed as a result of frothing during syringe filling, or may be introduced into the fluid at any other point prior to infusion.
According to exemplary embodiments described herein, an infusion pump may include a bubble trap coupled to and/or in fluid communication with an outlet of a syringe at one end and a port at an opposing end, such that fluid flowing into and out of the syringe may pass through the bubble trap. The port may be connected to a vial when the infusion pump is used to extract fluid from the vial and fill the syringe, or may be connected to a needleset when the infusion pump is used to deliver fluid to an infusion site on a user. The bubble trap may be configured to permit fluid to pass through while limiting the number of air bubbles (or, in some embodiments, inhibit the passage of air bubbles) delivered to the infusion site with a combination of a gas-permeable hydrophobic membrane and a one-way check valve, as will be described in greater detail below. It should be appreciated that the bubble trap may be compatible with any of the fluid volumes/viscosities listed above.
In some embodiments, an infusion pump may be entirely mechanically operated. In some embodiments, an infusion pump may not include any electrically operated components. Accordingly, operation of the infusion pump may not be limited by the proximity of a power source (e.g., an electrical outlet). A user may operate the infusion pump at any suitable location. In some embodiments, the user may operate the infusion pump while in a mobile state. In addition, without the need for a battery to power the infusion pump, the user need not monitor a battery charge state or be concerned with recharging a battery.
In some embodiments, the infusion pump may include one or more wearable components (discussed in further detail below) to allow for hands-free operation of the infusion pump. It should be appreciated that instances in which different benefits are offered by the systems and methods disclosed herein are also possible.
In other embodiments, the primary functions of the infusion pump (syringe loading and/or drug delivery) may be mechanically operated, while other secondary functions of the infusion pump may be electrically operated and/or motorized (e.g., may require electrical power). In some embodiments, the limitation of electrical components may reduce the cost of manufacturing of an infusion pump, thereby reducing the cost of an infusion pump for the user, which may result in greater accessibility of the infusion pump.
In some embodiments, the infusion pump may be portable. For example, the infusion pump may either include a portable power source (e.g., a battery) or may not require any power sources to function, such that a user may operate the infusion pump without concern of a nearby charging outlet and/or port. In some embodiments, the infusion pump may be portable during an infusion process. The infusion pump may include one or more wearable accessories (e.g., straps, clips, etc.) to allow the user to move around without being hindered by the infusion pump. In some embodiments, the infusion pump may be used on a flat surface, such as a table-top or any other suitable surface.
In some embodiments, the infusion pump may include one or more components which may be in contact with the fluid. Accordingly, these one or more components may be disposable. For example, the infusion pump may include a disposable syringe, a disposable bubble trap, disposable tubing/connectors between various components, disposable needlesets, and/or any other disposable components. In some embodiments, all fluid-contacting components of the infusion pump may be silicone-free. In other embodiments, the infusion pump may include one or more components formed at least partially of silicone. In some embodiments, components formed at least partially of silicone may be in contact with fluid for less than 2 hours. In some embodiments, the fluid-contacting components of the infusion pump may be compatible with sensitive plasma-derived proteins. Of course, any suitable (e.g., compatible) material may be used within the infusion pump, as the present disclosure is not so limited.
In some embodiments, the infusion pump may be used to prime a needleset prior to infusion to allow a user to visually confirm fluid flow along the needleset. In some embodiments, the infusion pump may be used to check for blood backflow prior to infusion. Any of these verification processes (or any other suitable processes) may be conducted by operating one or more actuators of the infusion pump, which may simplify the process(es) for self-administering users.
In some embodiments, the infusion pump may include one or more features that provide a mechanical assist to decrease the required amount of input force from a user to operate. As will be described in greater detail below, the infusion pump may include one or more mechanical components which may amplify and/or modulate forces applied by the user to conduct one or more functions. For example, the infusion pump may convert a rotational torque applied to a lever to axial translation of a syringe plunger. In some embodiments, the infusion pump may require rotational torques less than 2 N m and forces less than 6 N to operate. Of course, the infusion pump may require any other suitable torque and/or force, as the present disclosure is not limited by the magnitude of input forces applied by the user.
In some embodiments, the infusion pump may convert a user input (e.g., rotation of a lever, rotation of a knob, sliding of a slider, etc.) into a substantially constant force applied to a syringe plunger. The substantially constant force applied to the syringe plunger may be related to the fluid viscosity, syringe size, needleset gauge, needleset length, needle diameter, number of infusion sites, intermediate tubing diameters, and/or any other relevant parameter. In some embodiments, the substantially constant force applied to the syringe plunger may be calibrated to a substantially constant fluid delivery flow rate, ranges of which have been described above. For example, an infusion pump using an 18″ needleset, a 0.7 mm inner diameter, and a 27 gauge diameter may convert a user input torque and/or force into about 15-75 N applied to the syringe plunger for delivering fluid flow rates between 5-60 mL/hr. In some embodiments, the substantially constant force applied to the syringe plunger may be at least 10 N, 12 N, 15 N, 20 N, 25 N, 30 N, 35 N, 40 N, 45 N, 50 N, 55 N, 60 N, 65 N, 70 N, 75 N, 80 N, 100 N, 125 N, 150 N, 175 N, 200 N, 300 N, and/or any other suitable force. In some embodiments, the substantially constant force applied to the syringe plunger may be less than or equal to 300 N, 200 N, 175 N, 150 N, 125 N, 100 N, 80 N, 75 N, 70 N, 65 N, 60 N, 55 N, 50 N, 45 N, 40 N, 35 N, 30 N, 25 N, 20 N, 15 N, 12 N, 10 N, and/or any other suitable force. Combinations of ranges for substantially constant force are also contemplated, including between 15 N to 60 N, 15 N to 75 N, 100 N to 200 N, 10 N to 200 N, and/or any other suitable combinations of substantially constant forces. Of course, other ranges, including ranges both greater than and less than those noted above are also contemplated as the present disclosure is not so limited. It should be appreciated that the infusion pump may be able to convert user input force to any suitable substantially constant force in order to deliver fluid to an infusion site.
Turning to the figures, specific non-limiting embodiments are described in further detail. It should be understood that the various systems, components, features, and methods described relative to these embodiments may be used either individually and/or in any desired combination as the disclosure is not limited to only the specific embodiments described herein.
In some embodiments, the syringe 60 may include a barrel 62 to hold a fluid (e.g., medication) and a plunger 64 to move the fluid through the barrel 62. The plunger 64 may be coaxially located within the barrel 62 and may be axially moveable relative to the barrel 62, such that movement of the plunger 64 in the proximal direction D1 along an axial direction AX may cause fluid to enter through an outlet port 63 and fill the barrel 62 and movement in the opposing distal direction D2 along the axial direction AX may expel fluid from the barrel 62 through the outlet port 63. The syringe 60 may also include a plunger flange 66. The syringe 60 described herein may be any standard syringe known in the art. For example, the syringe 60 may be a standard 60 mL syringe (Becton Dickinson, 309653).
As shown in
The loading assembly 50 may further include a slider 56 coupled to the holder 52 via an energy storing member 54. In some embodiments, the energy storing member 54 may be a spring, as will be discussed in further detail below. Movement (e.g., linear translation) of the slider 56 may result in movement (e.g., linear translation) of the holder 52, which may in turn result in the movement of the plunger 64 in the axial direction AX. In some embodiments, the energy storing member 54 may modulate the rate of translation between the slider 56 and holder 52. For example, if the slider 56 is translated a distance rapidly between two positions, the energy storing member 54 may allow the holder 52 to travel a similar distance in a less rapid manner. In embodiments where the energy storing member 54 may be a spring, the rapid movement of the slider 56 stores energy within the energy storing member 54 (e.g., via elongation of a spring), which may then be slowly released (e.g., via contraction of the spring toward its original length) when translating the holder 52.
In some embodiments, the loading assembly 50 and syringe 60 may be axially fixed to one another. For example, the holder 52 and/or the slider 56 may be positioned on a rail (not shown), such that its movement may be confined to axial translation. In other embodiments, the loading assembly 50 (or one or more components of the loading assembly 50, e.g., the slider 56) may be positioned off-axially from the syringe 60. It should be appreciated that any component of the loading assembly 50 may be arranged in any suitable manner with respect to the syringe 60 such that movement of the slider 56 may result in translation of the holder 52, and subsequently translation of the plunger 64.
The slider 56 may be operated with a loading actuator 90, as shown in
As described previously, a syringe plunger 64 may be axially moveable with respect to a syringe barrel 62. In some embodiments, the syringe barrel 62 may be fixed in place. In some embodiments, the loading actuator 90 may be biased towards the syringe 60 in the distal direction D2, such that absent an external force (e.g., a user operating the actuator 90), the loading actuator 90 may urge the slider 56, and subsequently the holder 52 (via the energy storing member 54) and the plunger 64 towards the outlet port 63, as shown in
In some embodiments, in operation, a user may fill a syringe 60 with fluid from a vial 80 by first attaching a bubble trap 70 to an outlet port 63 of the empty syringe 60 and subsequently loading the bubble trap and syringe assembly within an infusion pump 1, ensuring that the plunger flange 66 is coupled to the holder 52. In some embodiments, the bubble trap 70 may be attached to the syringe 60 after the syringe 60 has been loaded into the infusion pump 1. The user may then load the vial 80 (which may include any suitable fluid, e.g., medication) into the infusion pump 1 through any suitable connector. In some embodiments, the vial 80 may be loaded into the infusion pump 1 via a spike connector, such that attachment of the vial 80 to the connector may pierce the vial 80 to allow fluid flow out of the vial 80. Accordingly, in some embodiments, the spike connector may be removably coupled to the vial 80 and/or an outlet port of the infusion pump. In some embodiments, the spike connector may be vented. The infusion pump 1 may include any number of couplings (e.g., a Luer-lock hub positioned by the outlet port) to ensure suitably fluid-tight connections between the syringe 60, bubble trap 70, and vial 80.
The user may then engage a directional lock 40 with a loading actuator 90 to prohibit movement of the loading actuator 90 in at least one direction (e.g., in the direction of the loading actuator bias). The user may subsequently apply a force F1 to the loading actuator 90 in a direction opposite of the loading actuator bias, as shown in
In some embodiments, axial translation of the holder 52 may be limited by surface tension of fluid exiting the vial 80, passing through the bubble trap 70, and entering the barrel 62, as well as stiction between the plunger 64 and the barrel 62 (e.g., the plunger may include a rubber tip positioned at an opposing end to the flange 66, which may interact frictionally with the inner walls of the barrel 62). In some embodiments, the stiffness of the energy storing member 54 may be less than the fluid resistance force from the surface tension of the fluid flowing through the various components and syringe barrel/plunger stiction, such that movement of the slider 56 away from the holder 52 initially causes the energy storing member 54 to elongate first, prior to movement of the holder 52 toward the slider 56. Locking the loading actuator 90 in a proximal position (e.g., as shown in
In some embodiments, fluid flow between the vial 80 and the barrel 62 may stop once the holder 52 reaches its proximal most position (e.g., wherein the energy storing member 54 is no longer under tension). The user may then remove the vial 80 from the infusion pump 1, and replace with a new vial, if desired. Operation of the loading actuator 90 may be repeated as many times as desired to fill the syringe 60 with a suitable volume of fluid. In each loading process, the loading actuator 90 may be actuated by a magnitude which corresponds to the volume of the vial 80. The infusion pump 1 may include a visual indicator to allow the user to calibrate the actuation force (e.g., force F1) with the desired filling volume of the syringe 60, as described in further detail below. In embodiments where the syringe 60 volume capacity is equivalent to a single vial 80, the loading process may only need to take place once.
In block 250, the user may let go of the loading actuator and wait for a desired volume of fluid to flow from the vial into the syringe. It should be appreciated that in embodiments where the directional lock is engaged with the loading actuator, the loading actuator may remain stationary after being released by the user, despite being biased in an opposing direction. Accordingly, the user may not be required to operate the infusion pump in block 250. In block 260, the user may remove the emptied vial from the infusion pump and optionally replace with a new vial. The process of blocks 240-260 may be repeated any number of times to fill the syringe with a desired volume of fluid.
In some embodiments, the holder 52 of infusion pump 10 may be coupled to an energy storing assembly 20 configured to apply a substantially constant force F2 to the holder 52, as shown in
In some embodiments, the infusion pump 10 may also include a directional lock 40. The directional lock 40 may be similar in operation to that described in accordance with infusion pump 1. Namely, the directional lock 40 may be engaged to lock or temporarily fix the holder 52 to prevent axial translation in at least one direction. In some embodiments, the directional lock 40 may be operated when flow fluid out of or into the infusion pump 10 are undesirable. For example, the directional lock 40 may be engaged to stop fluid flow out of the syringe 60 in the middle of an infusion process. In another example, the directional lock 40 may be engaged to stop fluid flow out of the syringe 60 prior to operation. The directional lock 40 may include an actuator operable by a user to operate the lock 40. In some embodiments, the actuator may operate as an on/off toggle controlling fluid flow out of the infusion pump 10, as will be described in further detail below.
It should be appreciated that processes involving delivery of fluid out of the syringe 60 may begin with the syringe 60 containing a desired volume of fluid. A method of filling a syringe with fluid according to some embodiments is described in greater detail above. Accordingly, as shown in
In operation, a user may deliver fluid from a syringe 60 to a patient via a needleset 85 by first positioning the syringe plunger 64 in a distal position, as shown in
In some embodiments, the user may choose to adjust the flow rate at any point during the infusion process. It should be appreciated that the adjustment in flow rate may be continuous (e.g., not discretized), such that minute adjustments may be made for comfort or other suitable reasons. As described earlier, the user may also stop fluid delivery at any point during the infusion process by engaging the directional lock 40.
As shown in
As shown in
As described previously, the sledge 25 may be slidable on the track 27. In some embodiments, the sledge 25 may be connected to the rate actuator 30 via a lead screw 35. The rate actuator 30 may be rotatably coupled to the lead screw 35, such that rotation of the rate actuator 30 may result in rotation of the lead screw 35, which in turn, may cause axial translation of the sledge 25 along the track 27. Accordingly, the rate actuator 30 may be used to translate the sledge 25 along the track 27 in any desired direction. Although a rotatable rate actuator 30 is shown in
In some embodiments, the stored energy within the energy storing assembly 20 may be adjusted by operation of the rate actuator 30. For example, in embodiments where the energy storing assembly 20 includes a spring 22, operation of the rate actuator 30 (e.g., rotation of the knob shown in
It should be appreciated that the connection mechanism between the sledge 25 and the rate actuator 30 may be sufficiently robust to avoid movement (e.g., translation) of the sledge on the track 27 without direct operation of the rate actuator 30. In other words, the maximum tension in the spring 22 may not be sufficient to overcome the connection between the rate actuator 30 and the sledge 25 to move the sledge 25 without user interference.
In some embodiments, the closer the second end 22B of the spring 22 is positioned to the roller 26, the greater the extension of the spring 22. For example, when the second end 22B of the spring 22 is positioned closer to the roller 26, the spring 22 may be under greater tension than when the second end 22B is positioned further away from the roller 26. Accordingly, the closer the second end 22B is positioned to the roller 26, the greater its stored energy. For example,
As described previously, a portion of the connector wire 24 may be coupled to the second end 22B of the spring 22, as shown in
In some embodiments, the loading actuator 90 may be fixed to a slider 56 of the loading assembly 50, as shown in
As described previously, in some embodiments, the slider 56 may be connected to a holder 52 via an energy storing member 54 (e.g., a spring, as shown in
In some embodiments, the barrel 62 of the syringe 60 may be fixed in place with one or more holders 68, as shown in
The syringe 60 may include an outlet port 63 in fluid communication with a bubble trap 70 and subsequently, a connector 82. In some embodiments, the connector 82 may be configured to couple to a vial 80 for filling the syringe 60 and/or a needleset 85 for delivering fluid out of the syringe 60. The outlet port 63 may be connected to a first port 72 of the bubble trap 70 via a connection 65. In some embodiments, the connection 65 may be tubing, although any other suitable fluid-tight connection between the outlet port 63 and the bubble trap 70 may be employed. Similarly, the connector 82 may be connected to the bubble trap via a connection 83, which may, in some embodiments, be fluid-tight tubing. It should be appreciated that the present disclosure is not limited by the connection means between the syringe 60, bubble trap 70, and/or connector 82.
In some embodiments, the infusion pump 100 may also include a directional lock 40 which may limit movement (e.g., rotation) of the loading actuator 90 in at least one direction. The directional lock 40 may include a ratchet wheel 46, an actuator 42, and a pawl 44. The actuator 42 may be user operable, such that a user may choose to lock or unlock the lock 40 using the actuator 42. The locking actuator 42 may be a lever, a knob, a button, a rotary dial, a slider, or any other suitable user-operable structure. In some embodiments, the actuator 42 may act as a toggle to operate the lock 40. The ratchet wheel 46 may be rotationally coupled to the loading actuator at the pivot point 92. Accordingly, when the ratchet wheel 46 is blocked from rotating (as will be described below), the loading actuator 90 may also be blocked from movement.
As shown in
Of course, other locking arrangements for the directional lock 40 are also contemplated. For example, rotation of the loading actuator may be permitted/limited by a friction brake and pad (or any other frictional engagement, e.g., a friction pad such as a shoe), such that toggling the locking actuator between its locked and unlocked configurations may frictionally engage or disengage the friction brake from its corresponding pad (e.g. a shoe), effectively blocking or unblocking rotation of the loading actuator. Engagement between the friction brake and pad may generate enough friction to temporarily inhibit rotation of the loading actuator.
Although
It should be appreciated that the greater the extension of the spring 22 (e.g., when the second end 22B of the spring 22 is positioned close to the roller 26 by operation of the rate actuator), the greater the force which may be transferred from the spring 22 to the loading actuator 90. Accordingly, the rate actuator 30 may control the rate of fluid flow out of the syringe 60 by controlling the extension of the spring 22. As described earlier, adjusting the extension of the spring 22 may result in a change in the force exerted by the spring 22 on the loading actuator 90, which may subsequently result in a greater force exerted by the loading actuator 90 on the holder 52. The greater the tension (e.g., stored clastic energy) in the spring 22, the greater the force which may be transferred to the plunger 64, resulting in a greater fluid flow rate out of the syringe 60.
In operation, a user may begin an infusion process by first attaching a bubble trap 70 to an empty syringe 60, and inserting the assembly into the infusion pump 100. The user may then attach a connector 82 to the infusion pump 100, which may subsequently be coupled to a vial 80 filled with fluid (e.g., medication). In this way, the vial 80, connector 82, bubble trap 70, and syringe 60 (through outlet port 63) may be in fluid communication. As described previously, the connector 82 may include a spike to pierce a cap or seal of the vial 80 in order to open fluid communication into the vial. At this point, even with the vial 80 in fluid communication with the syringe 60, in some embodiments, fluid does not flow from the vial into the syringe until the syringe plunger 64 is pulled back by operating the loading actuator 90.
To help decrease the amount of force needed to operate the loading actuator 90 in order to fill the syringe, in some embodiments, the user may decrease the biasing force of the spring 22 acting on the loading actuator 90 by setting the rate actuator 30 to the lowest possible setting. Doing so may move the spring 22 to a position that is closer to the loading actuator 90, which may reduce the bias on the loading actuator 90 from the spring 22.
Prior to operating the loading actuator 90, a user may engage the directional lock 40 by locking the actuator 42. In this way, the ratchet 46 may rotate in one direction (e.g., clockwise around pivot point 92, as shown in
As described previously, the slider 56 may be coupled to the loading actuator 90 such that rotation of the handle 94 may result in direct linear translation of the slider 56 on track 58, as shown in
In some embodiments, when the energy storing member 54 reaches its contracted configuration, wherein the holder 52 is positioned near the slider 56, the filling process may be completed as depicted in
Once the syringe 60 is filled with a sufficient volume of fluid (e.g., medication), the user may prepare for the infusion process. The emptied vial 80 may be removed from the connector 82 and disposed of appropriately. The user may then attach a needleset 85 to the connector 82 in a fluid-tight manner (e.g., using a luer lock connection). As described previously, the needleset 85 may be coupled to the connector 82 at one end a priming process may take place. In some embodiments, a user may prime the needleset 85 by first setting the rate actuator 30 at its lowest possible setting and unlocking the directional lock 40 to allow fluid to flow out of the pump 100 and into the needleset 85, towards a needle tip. Once proper flow has been observed, the user may then insert a second end of the needleset 85 into an infusion site 88 on a patient. Once the needleset 85 is inserted into the appropriate infusion site, a user may verify the location of the infusion site by checking for blood backflow. In some embodiments, the user may move the loading actuator 90 slightly as if to fill the syringe 60 (e.g., rotate in a clockwise direction with respect to
To begin delivery of fluid from the syringe 60 to the infusion site 88, the user may adjust the rate actuator 30 to a desired fluid flow rate. The rate actuator 30 may include visual markers to indicate the range of selectable fluid flow rate. It should be appreciated that the rate actuator 30 may be continuously operable, such that the user may select any desired fluid flow rate within the acceptable range determined by the translation distance of the sledge 25. In other words, the user may be able to precisely select a fluid flow rate based on comfort, timing, or any other suitable reason. In some embodiments, the acceptable range of fluid flow may be limited by acceptable flow rates as determined by the FDA (or any other regulatory agencies), medical professionals, the manufacturers of the medication, and/or any other suitable reason.
As discussed previously, adjustment (e.g., rotation) of the rate actuator 30 (e.g., a knob) may result in linear translation of the sledge 25. Accordingly, the spring 22 may be extended based on the degree of adjustment, such that a significantly extended spring 22 may correspond to a greater fluid flow rate out of the syringe 60 compared to a partially extended spring 22. It should be appreciated that adjustment of the spring 22 tension (via the rate actuator 30) may be conducted while the directional lock 40 is locked. In this way, the loading actuator 90 (and associated loading assembly 50 and syringe plunger 64) may remain stationary during the adjustment process, preventing premature fluid outflow from the syringe 60.
Upon selection of a suitable flow rate with the rate actuator 30, the user may release the directional lock 40 to allow fluid to flow out of the syringe 60 at a flow rate commensurate with the selection on the rate actuator 30. In some embodiments, a user may elect to prime the needleset 85 prior to inserting the needleset 85 into the infusion site. The user may then check for blood backflow and subsequently select a suitable flow rate with the rate actuator 30. The user may visually inspect the needleset 85 to track the fluid from the syringe 60 as it flows towards the infusion site 88. The user may then lock the directional lock 40, and operate the loading actuator 90 as described previously to check if the needleset 85 was inserted into/near a blood vessel. Once the user confirms that the needleset 85 was installed properly (e.g., no blood outflow from infusion site 88 and into tubing 83), the directional lock 40 may be unlocked to restart infusion.
In operation, unlocking the directional lock 40 with locking actuator 42 may disengage pawl 44 from the ratchet wheel 46, as shown in dashed lines in
During fluid delivery, tension within the spring 22 and connector wire 24 work to move (e.g., rotate) the loading actuator 90 towards the plunger 64 in order to pressurize fluid within the barrel 62 to cause fluid outflow out through the outlet port 63 and into the infusion site 88. It should be appreciated that the energy storing member 54 may limit the speed of movement of the holder 52 with respect to the slider 56 in its tensioned state. In other words, when the energy storing member 54 is compressed, it may act as a solid, non-deforming body. Accordingly, the energy storing member 54 may simply transfer the axial displacement of the slider 56 to the holder 52 with limited slack or lag.
In some embodiments, a user may be able to determine whether the infusion process is complete by visually inspecting the position and/or movement of the loading actuator 90. If the loading actuator 90 is positioned close to the barrel 62, the infusion process may be nearly or substantially completed, as the fluid within the barrel 62 may have been expelled out through the outlet port 63 and into the infusion site 88. In some embodiments, the user may be able to visually inspect the syringe to verify the remaining fluid volume and determine whether or not the infusion process is complete.
Once the infusion process is determined to be complete, the user may lock the directional lock 40 to prevent further flow into or out of the syringe 60. The user may then remove the needleset 85 from the infusion site 88 and bubble trap 70. In order to decrease the force required to operate the loading actuator 90, the user may adjust the rate actuator to be at its lowest possible setting. While the loading actuator 90 may be always biased by the energy storing assembly 20, this bias may be reduced as a first end 22A of the spring 22 is moved closer to the anchor point 95. In some embodiments, this reduction in bias may occur by operation of the rate actuator 30. In some embodiments, a user may lock the loading actuator 90 when not in use. The syringe 60, bubble trap 70, and connector 82 assembly may then be removed from the infusion pump 100 and appropriately disposed of, along with the vial(s) 80 and needleset 85.
It should be appreciated that while the infusion pump 100 of
The bubble trap 70 may include ports 72, 74 to interface with tubing 65, 83 (see
In operation, fluid flowing through the bubble trap 70 (either from port 73 to port 74 or from port 74 to port 73) may pass over the membrane 75. Given the hydrophobic properties of the membrane 75 as well as the pore size, the membrane 75 may not allow any fluid (e.g., medication) to pass through the port 73 to the check valve 77. During delivery, wherein fluid is passing from the outlet port of a syringe to a needleset, the fluid passing through the bubble trap 70 may be at a positive pressure relative to atmosphere. Accordingly, as fluid flows from the syringe through the bubble trap 70 to the needleset, any air bubbles in the fluid may be driven out through the membrane 75 by the drug fluid pressure. The bubbles may subsequently pass through the check valve 77 to the atmosphere. As noted previously, alignment of the check valve against the direction of gravity may facilitate the flow of air bubbles near the membrane 75 interface, which may then ensure that the bubbles are driven out of the trap 70. During syringe loading and in instances of checking for blood backflow, the fluid within the body 78 may be at a negative pressure relative to atmosphere. In other words, there may be a slight vacuum formed within the fluid connection lines of the infusion pump. Accordingly, the check valve 77 may reduce the likelihood of air being drawn through the membrane 75 into the fluid.
It should be appreciated that in some embodiments, air may be pulled into the syringe during the loading process. However, the bubble trap 70 may help to reduce the amount of air bubbles delivered to the infusion site.
In some embodiments, the infusion pump 1000 may also include one or more hooks 2 for attachment to straps which may allow the user to carry the infusion pump 1000. In some embodiments, the infusion pump 1000 may be wearable using any combination of features such as straps, buckles, snaps, or any other suitable feature to allow the user to carry the infusion pump 1000. In some embodiments, the infusion pump 1000 may be portable. In some embodiments, the infusion pump 1000 may be portable during fluid (e.g., medication) delivery.
As shown in
In operation, the syringe 60 may be inserted into a cutout 61 of the infusion pump 1000, as shown in
It should be appreciated that the cutout 61 may allow the user to visually inspect the syringe 60. Similarly, the infusion pump 1000 may include a loading indicator 97, which may allow the user to operate the handle 94 to a suitable position corresponding to a desired dosage amount. For example, the loading indicator 97 may include markers indicating various volumes corresponding to the filling volume of the syringe 60. It should be appreciated that the loading indicator may be readily visible to the user during syringe loading. Accordingly, in some embodiments, the loading indicator 97 may be located on the top surface of the pump 1000. The infusion pump 1000 may also include a rate scale 32, as shown in
As shown in
In some embodiments, the infusion pump 2000 may include a hinged cover 599 over the syringe plunger during operation. The cover 599 may be formed of a translucent or transparent material to allow the user to observe the movement of the plunger with reduced risk of accidentally interfering with its movement. In some embodiments, the cover 599 may be closed with the aid of magnets in housing 2100. The user may be able to open the hinged cover 599 to place or remove the syringe from the infusion pump.
In some embodiments, the rate actuator 530 may be coupled to a delivery spring 522. As discussed previously in relation to other embodiments of the infusion pump, the spring 522 may be tensioned to adjust the delivery rate of fluid out of the pump. In embodiments captured by
In some embodiments, the delivery spring 522 may be coupled to a connector wire 524, shown in
As shown in
As noted previously, in some embodiments, an infusion pump 2000 may include a rate indicator 532 to communicate the delivery rate setting to the user. In some embodiments, the rate indicator may be operated mechanically. For example, as shown in
In operation, a user may first load a syringe (see syringe 60 in
To fill a syringe with fluid from a vial, a user may first couple the syringe plunger to the pump via the plunger holder 568. In operation, the user may position the empty syringe in the pump, abutting the barrel 62 portion of the syringe against surface 2120 (see
To linearly actuate the plunger holder 568, and subsequently the syringe plunger, the user may operate the loading actuator 580 shown in
Once a syringe has been latched into infusion pump 2000 via the plunger holder 568, the user can fill the syringe with fluid (e.g., medicament) from a vial. The vial 80 may be installed on adapter 570, shown in
Subsequently, the user may rotate the loading actuator 580 to linearly displace the syringe plunger 66 relative to the barrel, filling the barrel with fluid from the vial 80. It should be appreciated that at this stage of the filling process, the locking actuator 542 is configured in its “off” position, such that movement of the loading sledge 560 is controlled substantially by the loading actuator 580. Of course, movement of the syringe may also be partially limited by the hydraulic resistance of fluid from the vial into the syringe through the adapter.
In some embodiments, the capacity of the syringe barrel may be greater than the volume of the vial. Therefore, more than one vial may be used to fill a given syringe. Once a first vial is depleted into the syringe, the user may remove the vial from the adapter 570 and replace it with a new vial, repeating the same filling process (e.g., manipulating the loading actuator to linearly displace the plunger relative to the barrel). This process may be repeated until the syringe is filled with the desired volume of fluid.
To begin the infusion process, the user may remove the last vial 80 from the infusion pump 2000 and place a needleset 85 in port 574 of the adapter 570. The needleset 85 may then be placed on an infusion site 88 (e.g., on a patient). In some embodiments, the user may elect to conduct a blood back flow test to verify that the infusion site 88 is not in a blood vessel. To do so, the user may first manually turn the loading actuator 580 to urge fluid out of the syringe 60 and into the needleset 85. In some embodiments, the anti-clockwise rotation of the loading actuator 580 may result in the syringe plunger 66 moving closer towards the barrel 62, pushing fluid out of the syringe tip. Once the fluid has reached the infusion site, which may be verified visually, the user may then gently turn the loading actuator 580 in the opposite direction (e.g., clockwise) to urge generate suction in the syringe. The user may then monitor the needleset line to check for signs of blood, as described previously.
Once the user has verified that the infusion site 88 is not positioned in a blood vessel, the infusion process may begin. In embodiments depicted by
The force within the delivery spring 522 may be transferred to connecting wire 524, which is wrapped around a projection 528 on a drive arm. The tension within the wire 524 may serve to rotate the drive arm 529 (which is fixed relative to the projection 528) in an anti-clockwise direction (in
As described previously relative to infusion pumps of
In some embodiments, the infusion pump may include a damper 511 configured to mitigate the risk of the delivery sledge 550 moving the syringe plunger too quickly towards the syringe barrel. The damper 511, shown in
As will be described in detail below, in some embodiments, the ratchet shaft 515 may be coupled to the driving sledge 550 through rack 552 and pinion 553 (see
To begin infusion, a user may first need to unlock the pump 2000 by manipulating a locking actuator 542 to its “on” position. The actuator may serve to unlock the pump and allow the fluid to be delivered to the infusion site without the user having to manually manipulate the loading actuator 580.
As shown in
Therefore, if the locking actuator 542 is in the “off” position, meaning that the pump is locked, the locking arm 545 may be in the position depicted in
When the user turns the locking actuator 542 to the “on” position to begin infusion, the locking arm 545 may rotate along with the actuator 542, bringing the pawl 544 out of engagement with the ratchet wheel 546, as shown in
In some embodiments, the fluid delivery rate may be continuously adjusted (e.g., for comfort or logistical reasons) during delivery (e.g., infusion) by manipulating the rate actuator 530. For example, the user may rotate the rate actuator 530 in a clockwise direction to increase the delivery rate or in an anti-clockwise direction to decrease the delivery rate. It should be appreciated that fluid delivery need not be stopped during this process.
It should be appreciated that the inclusion of two independent sledges (loading sledge 560 and driving sledge 550) allows the user to move the plunger holder 568 (fixed to the loading sledge 560) without having to overcome the force applied by the drive arm 529 on the driving sledge 550 when the pump is locked. In other words, a user may linearly displace the syringe plunger without significant dexterity or force, when the pump is locked. Although embodiments with a single sledge capable of both loading and driving are also contemplated, wherein the ratchet lock acts directly on the drive arm, the large torques exerted on the drive arm may require larger gears than the two-sledge configuration, which may increase the overall footprint of the pump.
In some embodiments, the gear ratio between gear 557 and gear 547 may be 5:1 to maximize the resolution of the lock. In other words, fluid delivery may be stopped much sooner after locking the actuator (and engaging the pawl 544 with the ratchet wheel 546) than if the gear was larger, as the time to stop is dependent on the size of the teeth of the gear 547. It should be appreciated that the gear ratio between gear 557 and gear 547 may be any suitable ratio, including, but not limited to, at least 1:1, 2:1, 3:1, 4:1, 5:1, 7:1, 10:1, 20:1, and/or any other suitable ratio. The gear ratio between gear 557 and gear 547 may also be less than or equal to 20:1, 10:1, 7:1, 5:1, 4:1, 3:1, 2:1, 1:1, and/or any other suitable ratio. Combinations of the foregoing ranges, including from 1:1 to 20:1 are also contemplated, as the present disclosure is not limited by the gear ratio between gear 557 and gear 547.
It should be appreciated that the function of the loading actuator to linearly actuate the plunger holder via the engagement of the rack of the loading sledge and pinion of the loading actuator may provide a finer control over the linear actuation of the plunger. As noted previously, if the user elects to adjust the delivery rate to its minimum value, the user may not need to be working against the driving spring to operate the loading actuator. These two features enable the user to load fluid from a vial into a syringe with less force and dexterity compared to current state of the art systems. In some embodiments, the infusion systems described herein may be operated one-handedly, which could enhance the usability and accessibility of the pumps.
In some embodiments, unlocking the locking actuator 542 may include a secondary function of decoupling the loading actuator 580 from the loading sledge 550 (and therefore the plunger holder 568) during infusion. This may reduce the risk of the user accidentally interacting with the loading actuator 580 and disrupting the constant flow of fluid to the infusion site. This safety feature may be accomplished using a clutch mechanism.
In some embodiments, turning the locking actuator 542 to the “on” position may also disengage a spring dog clutch between the loading actuator 580 and the pinion 564, located on the same shaft 581 (shown in
As shown in
In some embodiments, rotating the locking actuator 542 to the “on” position may urge a pin 545B (see
In block 602, the user may connect a primary adaptor (e.g., a female-to-female Luer lock adapter) to a syringe and place the assembly of the syringe and primary adapter into the infusion pump. As discussed previously, the infusion pump housing may include one or more features to align and retain the syringe relative to the pump. In block 604, the user may then connect a right-angle adapter to the primary adapter on the syringe. It should be appreciated that although a right-angle adapter is described herein, alternative arrangements of adapters may be employed as the present disclosure is not so limited.
In block 606, the user may then turn the loading actuator anti-clockwise to engage or latch the plunger flange of the syringe with a plunger holder of the pump. As described previously, this engagement will allow the user to push and pull the syringe plunger with a loading sledge operatively connected to the plunger holder. In block 608, the user may load a vial of fluid (e.g., medicament) on to the right-angle adapter, placing the vial in fluid communication with the syringe. In block 610, the user may turn the loading actuator clockwise to draw fluid from the vial into the syringe. Once a desired volume of fluid has been loaded into the syringe, the user may then remove the vial, as depicted in block 612. In some embodiments, a user may optionally elect to load another vial of fluid to further fill the syringe.
It should be appreciated that infusion pump 2000 shown in
It should be appreciated that while the infusion pumps described herein may be mechanically operated, the pumps may include electrical features for purposes other than syringe loading and/or drug delivery. For example, an infusion pump according to some embodiments may be able to communicate, wirelessly and/or via a wired connection, with one or more external devices, such as a mobile device (e.g., a smartphone, tablet). The mobile device may be running an application that is designed for use with the infusion pump. For example, the infusion pump may include a transmitter, which may collect information from one or more sensors within the infusion pump (e.g., humidity sensors, temperature sensors, timers) and communicate associated information to an external device.
According to one aspect, an infusion pump may directly and/or indirectly interact with a multitude of different parties that may utilize information from the infusion pump. In some embodiments, an infusion pump may communicate directly or indirectly with a healthcare provider, such as a hospital, clinic, and personnel such as a nurse or physician. The healthcare provider may obtain the information from a remote server or other external device such as a mobile device that receives the information from the infusion pump. In some embodiments, the healthcare provider may be in direct communication with the infusion pump. Information that may be sent to a healthcare provider includes, but is not limited to, when an infusion process was completed, much medication was delivered, what the infusion delivery profile was, patient symptoms experienced, and so on. The healthcare provider may use the information to monitor patient adherence and/or to determine efficacy of the medication and/or the dosage regimen of the medication for the patient. In some embodiments, the information communicated from the infusion pump may be integrated with a patient's Electronic Health Record.
In some embodiments, an infusion pump may communicate directly or indirectly with payers, also known as insurance companies. Payers may use information from the infusion pump to monitor aspects such as patient adherence, medication efficacy, and treatment regimen efficacy.
In some embodiments, information relayed through communication from and/or to an infusion pump may be used for data analytics, which may be used by a variety of parties. For example, a supplier (e.g., a producer of a medication and/or an infusion pump) may use information from an infusion pump to determine what features are used most by users, and when (e.g., what buttons/control options are users selecting, on the infusion pump and/or on a companion app on a mobile device), what errors or issues are occurring, and so on. The information may be filterable into different categories such as age, gender, income, experience level, etc.
In some embodiments, information gathered for data analytics may be anonymous and free of PHI (patient health information). In other embodiments, however, the information may contain PHI.
In some embodiments, information gathered from an infusion pump may help provide performance of a medication. The inventors have appreciated that, outside of clinical trials, it can be difficult to assess the performance of a medication when it has been disseminated into the wider public. Communication from infusion pumps and other sources such as mobile devices and/or healthcare providers can help provide information regarding a medication and/or an infusion pump's performance. Information regarding a patient's symptoms and treatment progress may be gathered from patients, e.g., via an electronic symptom diary built into an infusion pump or into a companion app running on a mobile device, and/or may be gathered from a healthcare provider's notes taken during a patient's office visit. The gathered information may help to inform future formulations and/or infusion pump designs for the supplier, and positive performance may be used to help promote use of the medication.
While several embodiments of the present disclosure have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the functions and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the present disclosure. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present disclosure is/are used. Those skilled in the art will recognize or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the disclosure described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the disclosure may be practiced otherwise than as specifically described and claimed. The present disclosure is directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the scope of the present disclosure.
Any terms as used herein related to shape, orientation, alignment, and/or geometric relationship of or between, for example, one or more articles, structures, forces, fields, flows, directions/trajectories, and/or subcomponents thereof and/or combinations thereof and/or any other tangible or intangible elements not listed above amenable to characterization by such terms, unless otherwise defined or indicated, shall be understood to not require absolute conformance to a mathematical definition of such term, but, rather, shall be understood to indicate conformance to the mathematical definition of such term to the extent possible for the subject matter so characterized as would be understood by one skilled in the art most closely related to such subject matter.
This application claims the benefit under 35 U.S.C. 119(e) of U.S. Provisional Application No. 63/242,968 filed on Sep. 10, 2021, U.S. Provisional Application No. 63/396,926 filed on Aug. 10, 2022, and U.S. Provisional Application No. 63/397,350 filed on Aug. 11, 2022, the entireties of which are incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2022/000507 | 9/9/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63242968 | Sep 2021 | US | |
| 63396926 | Aug 2022 | US | |
| 63397350 | Aug 2022 | US |
