Mobile devices and parts thereof
By using uniquely identified cylinders and connectors in the infusion system, ensuring that the drug cartridges are inserted into the correct pump chamber, solving the problem of users accidentally loading drugs into incorrect pump containers, and achieving the correct delivery of drugs and the expected effect. delivery.
Patent Information
- Application Number
- CN202080063025.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2020-06-10
- Filing Date
- 2020-07-15
- Publication Date
- 2025-01-03
- Estimated Expiration
- 2040-07-15
AI Technical Summary
The existing multi-drug infusion system is difficult to prevent users from accidentally loading drugs into incorrect pump containers, resulting in unexpected drug administration, which may have serious consequences.
A infusion system is designed with unique identification features and connectors to ensure that the cartridge can only be inserted into the correct pump chamber, preventing misinformation through geometric or shape features, including cartridges and connectors with unique distinctive features, allowing The correct cylinder interacts with the pump.
It effectively prevents incorrect administration and cross-transmission of drugs, ensures that the drugs are delivered as expected, and reduces the risk of patients' worsening of the disease.
Smart Images

Figure CN115243746B_ABST
Abstract
Description
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 037,472 filed on June 10, 2020, U.S. Provisional Patent Application No. 62 / 987,842 filed on March 10, 2020, U.S. Provisional Patent Application No. 62 / 874,928 filed on July 16, 2019, U.S. Provisional Patent Application No. 62 / 874,954 filed on July 16, 2019, and U.S. Provisional Patent Application No. 62 / 874,954 filed on July 16, 2019. No. 74,959, U.S. Provisional Patent Application No. 62 / 874,964, filed on July 16, 2019, U.S. Provisional Patent Application No. 62 / 874,972, filed on July 16, 2019, U.S. Provisional Patent Application No. 62 / 874,975, filed on July 16, 2019, and U.S. Provisional Patent Application No. 62 / 874,977, filed on July 16, 2019, the disclosures of each of which are incorporated herein by reference in their entirety. Technical Field
[0003] The present disclosure generally relates to the field of drug infusion systems (including systems configured to deliver multiple drugs to a subject), components thereof (e.g., pump systems, cartridge connectors, cartridges, connector sets, multi-channel lumen assemblies, infusion sets, etc.), methods of making each of the foregoing, and methods of using each of the foregoing. Background Art
[0004] Continuous delivery, pump-driven drug injection devices typically include a delivery cannula that is subcutaneously mounted through the patient's skin at the infusion site. The pump draws the drug from a reservoir and delivers the drug to the patient via the cannula. The injection device typically includes a channel that transfers the drug from an inlet to the delivery cannula, which results in delivery to the subcutaneous tissue layer where the delivery cannula terminates. Some infusion devices are configured to deliver a single drug to a patient, while other infusion devices are configured to deliver multiple drugs to a patient. Summary of the invention
[0005] Some example embodiments provide drug infusion systems (including systems configured to deliver multiple drugs to a subject), components thereof (e.g., pump systems, barrel connectors, barrels, connector sets, multi-channel tubing assemblies, infusion sets, etc.), methods of making each of the foregoing, and methods of using each of the foregoing.
[0006] Some embodiments relate to an infusion pump for delivering a drug to a patient. In some embodiments, the infusion pump includes a pump housing. In some embodiments, the pump housing includes a first container port configured to engage a first cartridge connector. In some embodiments, the pump housing includes a second container port configured to engage a second cartridge connector. In some embodiments, the pump housing includes a first drug cartridge container extending longitudinally from the first container port along a first side of the infusion pump to a first cartridge container hole. In some embodiments, the pump housing includes a second drug cartridge container extending longitudinally from the second container port along a second side of the infusion pump to a second cartridge container hole. In some embodiments, the pump includes an internal region. In some embodiments, the internal region includes a power source located between the first drug cartridge container and the second drug cartridge container. In some embodiments, the internal region includes a first motor in electronic communication with the power source. In some embodiments, the internal region includes a second motor in electronic communication with the power source. In some embodiments, the internal region includes a first laminated gear assembly. In some embodiments, the internal region includes a second laminated gear assembly. In some embodiments, the internal region includes a first lead screw. In some embodiments, the internal region includes a second lead screw. In some embodiments, the first motor and the second motor (if present) respectively include a first pinion and a second pinion (if present), the first pinion being a component of a first stacked gear assembly, and the second pinion being a component of a second stacked gear assembly (if present). In some embodiments, the first gear assembly extends laterally toward a first side of the infusion pump. In some embodiments, the second gear assembly extends laterally toward a second side of the infusion pump. In some embodiments, the first lead screw is in rotational communication with the first pinion through the first gear assembly. In some embodiments, the second lead screw is in rotational communication with the second pinion through the second gear assembly. In some embodiments, the pump includes a first drive nut having a length extending longitudinally along the pump housing and configured to travel into the first drug cartridge container via a first hole, the first drive nut being in communication with the first lead screw and configured to push forward or backward in response to a first rotational direction and a second rotational direction of the first lead screw, respectively. In some embodiments, the pump includes a second drive nut having a length extending longitudinally along the pump housing and configured to travel into the second drug cartridge container via the second hole, the second drive nut being connected to the second lead screw and configured to be pushed forward or backward in response to the first rotational direction and the second rotational direction of the second lead screw, respectively.
[0007] Any implementation described above or elsewhere herein may include one or more of the following features.
[0008] In some embodiments, the first container port has one or more identification features, and this identification feature is configured to engage with the consistent identification feature of the first barrel connector. In some embodiments, the second container port has one or more identification features, and this identification feature is configured to engage with the consistent identification feature of the second barrel connector. In some embodiments, the identification feature of the first container port is different from the identification feature of the second container port. In some embodiments, the first container port is configured to not allow the engagement of the second barrel connector, and the second container port is configured to not allow the engagement of the first barrel connector.
[0009] In some embodiments, the pump includes a first seal and / or a second seal. In some embodiments, the first seal provides a water-resistant barrier between an interior area of the infusion pump and the first drug cartridge container. In some embodiments, the second seal provides a water-resistant barrier between an interior area of the infusion pump and the second drug cartridge container. In some embodiments, the first seal is a first O-ring that circumferentially surrounds at least a portion of the first drive nut. In some embodiments, the second seal is a second O-ring that circumferentially surrounds at least a portion of the second drive nut. In some embodiments, the pump housing includes a first saddle. In some embodiments, the pump housing includes a second saddle. In some embodiments, the first saddle is configured to retain the first O-ring. In some embodiments, the second saddle is configured to retain the second O-ring. In some embodiments, the first saddle is positioned adjacent to the first cartridge container hole. In some embodiments, the second saddle is positioned adjacent to the second cartridge container hole.
[0010] In some embodiments, the first drive nut includes a protrusion on a proximal portion of the first drive nut that is retained within the interior region during extension of the drive nut into the first cartridge container. In some embodiments, the pump housing includes a recess configured to receive the protrusion of the first drive nut. In some embodiments, the protrusion of the first drive nut engages the recess to prevent rotation of the first drive nut. In some embodiments, the recess is provided as part of the housing or within a pump support portion of the housing.
[0011] In some embodiments, the housing includes a capacitive sensor configured to detect when a finger touches the surface. In some embodiments, the surface is a curved indentation on the housing, and the capacitive sensor includes an integrated circuit configured to measure the capacitance of the circuit. In some embodiments, the conductive foam fills a gap between the surface and the integrated circuit.
[0012] In some embodiments, the housing includes a lower metal portion and a frame that can be attached to the metal portion. In some embodiments, at least a portion of a side wall of the mobile medical device is covered only by the frame. In some embodiments, the circuit board is positioned adjacent to an inner surface of the frame. In some embodiments, the wireless antenna is fixed to the circuit board such that the wireless antenna is positioned toward the portion of the side wall of the mobile medical device that is covered only by the frame.
[0013] In some embodiments, the frame allows wireless signals to pass through, and the metal portion does not interfere with the signal from the antenna. In some embodiments, the circuit board is configured to process the wireless signal received by the antenna. In some embodiments, the first magnet is coaxially attached to the gear in the first gear assembly, and the first rotational position sensor measures the angular position of the first magnet.
[0014] In some embodiments, the first container port includes a latch arm recess extending longitudinally within the first cartridge container, the latch arm recess of the first cartridge container being configured to receive a latch arm of the first cartridge connector when the latch arm is extended over the first cartridge cover when the first cartridge is contained in the first cartridge container during engagement of the first cartridge. In some embodiments, the second container port includes a latch arm recess extending longitudinally within the second cartridge container, the latch arm recess of the second cartridge container being configured to receive a latch arm of the second cartridge connector when the latch arm is extended over the second cartridge cover when the second cartridge is contained in the second cartridge container during engagement of the second cartridge. In some embodiments, the latch arm recess of the first container port is configured not to receive a latch arm of the second cartridge connector.
[0015] In some embodiments, the first container port includes a lug opening and a radially extending lug track configured to receive a lug of the first cartridge connector when the first cartridge connector is inserted into the first container port and rotated into position. In some embodiments, the second container port includes a lug opening and a radially extending lug track configured to receive a lug of the second cartridge connector when the second cartridge connector is inserted into the second container port and rotated into position.
[0016] In some embodiments, the first container port includes a stop opening and a stop track, the stop track having a stop cam, the stop cam having a shallow first transition portion and a steep second transition portion, the stop opening and the stop track are configured to receive a stop of the first cartridge connector when the first cartridge connector is inserted into the first container port and rotated into place, the shallow first transition portion is configured to allow the stop of the first cartridge connector to be rotated into place within the infusion pump with less force than the force required to remove the first cartridge connector from the first container port in the direction of the steep second transition portion. In some embodiments, the second container port includes a stop opening and a stop track, the stop track having a stop cam, the stop cam having a shallow first transition portion and a steep second transition portion, the stop opening and the stop track are configured to receive a stop of the second cartridge connector when the second cartridge connector is inserted into the second container port and rotated into place, the shallow first transition portion is configured to allow the stop of the second cartridge connector to be rotated into place within the infusion pump with less force than the force required to remove the second cartridge connector from the second container port in the direction of the steep second transition portion.
[0017] In some embodiments, the pump housing includes a bezel configured to engage a lower portion of the pump housing and a display screen, the pump housing configured to hold the display screen.
[0018] Some embodiments provide an infusion pump comprising a housing having an interior space. In some embodiments, the pump housing comprises a hole through the housing, the hole having a first end and a second end, and the hole is configured to receive a drug cartridge. In some embodiments, the first end defines an opening into the housing, and the second end is located in the interior space of the housing. In some embodiments, an elongated shaft is disposed in the hole and is configured to engage the drug cartridge. In some embodiments, an O-ring is circumferentially disposed on the elongated shaft adjacent to the second end of the hole.
[0019] Some embodiments provide an infusion pump for providing a therapy change. In some embodiments, the pump includes a button that generates a wake-up signal when pressed. In some embodiments, the pump includes a touch screen display that is activated after receiving the wake-up signal. In some embodiments, the pump includes a therapy change user interface that is unlocked after receiving a first gesture on the touch screen display. In some embodiments, the therapy change user interface is capable of receiving a therapy change selection from the touch screen display. In some embodiments, the drug infusion component delivers the drug after receiving a second gesture on the touch screen display.
[0020] Some embodiments provide an infusion pump comprising a capacitive sensor that detects when a finger touches a surface. In some embodiments, the surface has a curved indentation. In some embodiments, the capacitive sensor comprises one or more of an integrated circuit that measures the capacitance of the circuit and / or a conductive foam between the surface and the integrated circuit.
[0021] Some embodiments provide an infusion pump comprising one or more of: a metal housing; a frame that can be attached to the metal housing; at least a portion of a side wall of a mobile medical device that is covered only by the frame; a circuit board positioned adjacent to an inner surface of the frame; and / or a wireless antenna secured to the circuit board such that the wireless antenna is positioned toward the portion of the side wall of the mobile medical device that is covered only by the frame.
[0022] Some embodiments provide an infusion pump comprising one or more of: a motor that rotates a shaft; a gear fixed to the end of the shaft that is used to rotate a gear assembly; a magnet coaxially attached to one of the gears in the gear assembly; and / or a rotational position sensor that measures the angular position of the magnet.
[0023] Some embodiments provide an infusion pump for delivering a drug to a patient. In some embodiments, the infusion pump includes a pump housing. In some embodiments, the infusion pump includes a first container port, including a card arm extension recess, which is configured to receive a first cartridge connector. In some embodiments, the infusion pump includes a first drug cartridge container, extending longitudinally from the first container port along the first side of the infusion pump to the first cartridge container hole. In some embodiments, the infusion pump includes an internal area. In some embodiments, the infusion pump includes a power supply. In some embodiments, the infusion pump includes a first motor, which communicates electronically with the power supply. In some embodiments, the infusion pump includes a first gear assembly. In some embodiments, the infusion pump includes a first lead screw. In some embodiments, the first motor includes a first pinion, which is a member of the first gear assembly. In some embodiments, the first lead screw is connected to the first pinion in rotation through the first gear assembly. In some embodiments, the infusion pump includes a first drive nut having a length extending longitudinally along the pump housing. In some embodiments, the first drive nut extends into the first drug cartridge container via the first hole and communicates with the first lead screw. In some embodiments, the first drive nut is configured to push forward or backward in response to a first rotational direction and a second rotational direction of the first lead screw, respectively.
[0024] Some embodiments provide an infusion pump for delivering a drug to a patient. In some embodiments, the infusion pump includes a pump housing. In some embodiments, the infusion pump includes a first container port configured to receive a first cartridge connector. In some embodiments, the infusion pump includes a first drug cartridge container extending longitudinally from the first container port along a first side of the infusion pump to a first cartridge container hole. In some embodiments, the infusion pump includes an internal area. In some embodiments, the infusion pump includes a power source. In some embodiments, the infusion pump includes a first motor, which is in electronic communication with the power source. In some embodiments, the infusion pump includes a first stacked gear assembly. In some embodiments, the infusion pump includes a first lead screw. In some embodiments, the first motor includes a first pinion, which is a member of the first stacked gear assembly. In some embodiments, the first gear assembly extends laterally toward the first side of the infusion pump. In some embodiments, the first lead screw is connected to the first pinion in rotation through the first gear assembly. In some embodiments, the infusion pump includes a first drive nut having a length extending longitudinally along the pump housing. In some embodiments, the first drive nut extends into the first drug cartridge container via the first hole and is connected to the first lead screw. In some embodiments, the first drive nut is configured to push forward or backward in response to a first rotational direction and a second rotational direction of the first lead screw, respectively.
[0025] Any implementation described above or elsewhere herein may include one or more of the following features.
[0026] In some embodiments, the first container port has one or more identification features configured to engage with a corresponding identification feature of the first cartridge connector.
[0027] In some embodiments, the infusion pump includes a second container port having one or more features configured to engage with conforming features of the second cartridge connector.
[0028] In some embodiments, the infusion pump includes a first seal that provides a water-resistant barrier between an interior area of the infusion pump and the first drug cartridge container. In some embodiments, the first seal is a first O-ring surrounding at least a portion of the first drive nut. In some embodiments, the infusion pump includes a first saddle that is configured to retain the first O-ring. In some embodiments, the first drive nut includes a protrusion and the pump housing includes a groove configured to receive the protrusion, wherein the protrusion engages the groove and prevents rotation of the first drive nut.
[0029] In some embodiments, the infusion pump includes a magnet coaxially attached to a gear of the first gear assembly and a rotational position sensor that measures the angular position of the magnet.
[0030] Some embodiments provide a barrel connector. In some embodiments, the barrel connector includes a knob. In some embodiments, the knob is cam-shaped and has a flat portion. In some embodiments, the barrel connector includes a body. In some embodiments, the body includes a needle. In some embodiments, the body includes a lower surface portion extending circumferentially from the needle. In some embodiments, the body includes a shield extending axially away from the lower surface portion. In some embodiments, the shield is configured to receive and assemble on a portion of the first drug cartridge. In some embodiments, the first drug cartridge is configured to hold the first drug. In some embodiments, the lower surface portion is located in the shield. In some embodiments, the lower surface portion is configured to contact the cover of the first drug cartridge when the first drug cartridge is inserted into the barrel connector in the shield. In some embodiments, the needle extends axially away from the lower surface portion in the shield. In some embodiments, once inserted into the first pump container, the first barrel connector is configured to be positioned in the first pump container using a quarter turn, which aligns the flat portion of the cam with the consistent flat surface of the pump to indicate to the user: the first barrel connector is correctly placed in the pump.
[0031] Some embodiments provide a barrel connector. In some embodiments, the barrel connector includes a body. In some embodiments, the body includes a needle. In some embodiments, the body includes a lower surface portion extending circumferentially from the needle. In some embodiments, the body includes a shield extending axially away from the lower surface portion. In some embodiments, the shield is configured to receive and assemble on a portion of a first drug cartridge, and the first drug cartridge is configured to hold a first drug. In some embodiments, the lower surface portion is located in the shield. In some embodiments, the lower surface portion is configured to contact the cover of the first drug cartridge when the first drug cartridge is inserted into the barrel connector in the shield. In some embodiments, the needle extends axially away from the lower surface portion in the shield. In some embodiments, the connector includes a knob connected to the body. In some embodiments, the knob includes a lower side extending circumferentially from the shield of the body. In some embodiments, the knob includes a fluid outlet configured to deliver the first drug to a position outside the barrel connector. In some embodiments, the lower side of the knob includes one or more ductile nubs. In some embodiments, the ductile nub is configured to contact the upper surface of the infusion pump. In some embodiments, the malleable nubs are configured to deform (e.g., against an upper surface of an infusion pump) when the cartridge connector is twisted into place within the infusion pump. In some embodiments, one or more malleable nubs provide one or more contact points between the lower surface of the knob and the infusion pump.
[0032] Some embodiments provide a barrel connector. In some embodiments, the barrel connector includes a body. In some embodiments, the body includes a needle. In some embodiments, the body includes a lower surface portion extending circumferentially from the needle. In some embodiments, the lower surface includes a bowl-shaped concave surface. In some embodiments, the lower surface includes a peripheral lip. In some embodiments, the needle protrudes from the bowl-shaped concave surface and extends away from the bowl-shaped concave surface. In some embodiments, the body includes a shield extending axially away from the circumference of the lower surface portion. In some embodiments, the shield is configured to receive and assemble on a portion of a first drug cartridge, and the first drug cartridge is configured to hold the first drug. In some embodiments, the lower surface portion is located in the shield and is configured to contact the cover of the first drug cartridge when the first drug cartridge is inserted into the barrel connector in the shield. In some embodiments, the needle extends axially from the lower surface portion and is in the shield. In some embodiments, the barrel connector includes a knob portion. In some embodiments, the barrel connector includes a fluid outlet configured to deliver the drug to a position outside the barrel connector. In some embodiments, the knob is fixed to the body or is integral with the body.
[0033] Some embodiments provide a barrel connector. In some embodiments, the barrel connector includes a body. In some embodiments, the body includes a needle. In some embodiments, the body includes a lower surface portion extending circumferentially from the needle. In some embodiments, the body includes a shield extending axially away from the lower surface portion. In some embodiments, the shield is configured to receive and assemble on a portion of a first drug cartridge, and the first drug cartridge is configured to hold a first drug. In some embodiments, the body includes a protrusion extending axially upward from the upper surface of the body. In some embodiments, the protrusion includes a fluid outlet. In some embodiments, the lower surface portion is located in the shield. In some embodiments, the lower surface portion is configured to contact the cover of the first drug cartridge when the first drug cartridge is inserted into the barrel connector in the shield. In some embodiments, the needle extends axially from the lower surface portion and is in the shield. In some embodiments, the body is configured to receive the drug through the needle and deliver the drug from the fluid outlet of the body out of the body. In some embodiments, the fluid outlet of the needle and the body is fluidly connected and provides a fluid path through the body. In some embodiments, the barrel connector includes a knob portion. In some embodiments, the knob portion is configured to engage with the body. In some embodiments, the knob portion includes a container portion. In some embodiments, the container portion is configured to extend on at least a portion of the projection of the main body and receive at least a portion of the projection of the main body. In some embodiments, the fluid inlet is located in the container portion, and the fluid inlet is configured to receive medicine. In some embodiments, the knob includes a fluid outlet, which is configured to deliver medicine to the position outside the tube connector. In some embodiments, the connector includes a gap space (or region), between the projection of the main body and the container portion of the knob. In some embodiments, a flexible membrane is located in the gap space. In some embodiments, the flexible membrane extends on at least a portion of the projection of the main body. In some embodiments, the flexible membrane is configured to allow fluid to pass through and enter the knob inlet from the main body outlet only after the threshold fluid pressure of the medicine arrives.
[0034] Any implementation described above or elsewhere herein may include one or more of the following features.
[0035] In some embodiments, the knob is cam-shaped and has a flat portion. In some embodiments, once inserted into the first pump container, the first cartridge connector is configured to be positioned within the first pump container using a quarter turn that aligns the flat portion of the cam with a consistent flat surface of the pump to indicate to the user that the first cartridge connector is correctly placed in the pump.
[0036] In some embodiments, the knob includes a lower side extending circumferentially from a shield of the body, and wherein the lower side of the knob includes one or more malleable nubs. In some embodiments, the malleable nubs are configured to contact an upper surface of an infusion pump and deform when the cartridge connector is twisted into place within the infusion pump. In some embodiments, the one or more malleable nubs provide one or more contact points between a lower surface of the knob and the infusion pump.
[0037] In some embodiments, the lower surface portion of the body includes a bowl-shaped concave surface and a surrounding lip. In some embodiments, the needle protrudes from the bowl-shaped concave surface and extends away from the bowl-shaped concave surface.
[0038] In some embodiments, the body includes a protrusion extending axially upward from the upper surface of the body. In some embodiments, the protrusion includes a fluid outlet. In some embodiments, the body is configured to receive the drug through the needle and deliver the drug from the fluid outlet of the body out of the body. In some embodiments, the fluid outlet of the needle and the body is fluidly connected and provides a fluid path through the body. In some embodiments, the knob includes a container portion. In some embodiments, the container portion is configured to extend on at least a portion of the protrusion of the body and receive at least a portion of the protrusion of the body. In some embodiments, the fluid inlet is located in the container portion, and the fluid inlet is configured to receive the drug. In some embodiments, the fluid outlet is configured to deliver the drug to a position outside the barrel connector. In some embodiments, the connector includes a gap space, located between the protrusion of the body and the container portion of the knob. In some embodiments, the connector includes a flexible membrane, located in the gap space and extending on at least a portion of the protrusion of the body. In some embodiments, the flexible membrane is configured to allow fluid to pass from the body outlet and enter the knob inlet only after the threshold fluid pressure of the drug arrives.
[0039] In some embodiments, the cartridge connector is further configured to engage the first port of an infusion pump.
[0040] In some embodiments, the needle of the cartridge connector is configured to pierce the septum of the cap of the first drug cartridge.
[0041] In some embodiments, the knob is fixed to and / or integral with the body.
[0042] In some embodiments, the shield includes one or more latch arms configured to engage a cap, a stopper, and / or a lug of the first drug cartridge.
[0043] Some embodiments relate to a drug connector set for delivering one or more drugs to a patient, the drug connector set comprising a first barrel connector and a first fluid conduit as disclosed herein, the first fluid conduit being configured to receive a first drug from the first barrel connector. In some embodiments, the connector set further comprises a first infusion connector in fluid communication with the first fluid conduit (e.g., fixed and / or connected to the fluid conduit).
[0044] Some embodiments relate to a drug connector group for delivering one or more drugs to a patient, the drug connector group including a barrel connector as disclosed elsewhere herein as a first barrel connector, and a second barrel connector, configured to engage a second drug barrel. In some embodiments, the second drug barrel includes a body. In some embodiments, the second drug barrel includes a needle. In some embodiments, the second drug barrel includes a lower surface portion extending circumferentially from the needle. In some embodiments, the second drug barrel includes a shield extending axially away from the lower surface portion and configured to receive and assemble on a portion of the second drug barrel, the second drug barrel configured to hold the second drug. In some embodiments, the lower surface portion is located in the shield and is configured to contact the cover of the second drug barrel when the second drug barrel is inserted into the barrel connector in the shield. In some embodiments, the second drug barrel includes a bowl-shaped concave surface. In some embodiments, the needle extends axially away from the lower surface portion in the shield. In some embodiments, the second drug barrel includes a knob connected to the body. In some embodiments, the knob includes a lower side extending circumferentially from the shield of the body, and the knob includes a fluid outlet configured to deliver the first drug to a position outside the barrel connector. In some embodiments, the second cartridge connector is configured to engage a second port of an infusion pump. In some embodiments, the shield of the second cartridge connector includes one or more latch arms configured to engage a cap, a stopper, and / or a lug of a second drug cartridge.
[0045] In some embodiments, one or more latches, stops, and / or lugs in the first barrel connector are different from the latches, stops, and / or lugs of the second barrel connector. In some embodiments, the first barrel connector is configured to not engage the second drug cartridge and / or the second barrel connector is configured to not engage the first drug cartridge. In some embodiments, the first barrel connector is configured to not engage the second port of an infusion pump and / or wherein the second barrel connector is configured to not engage the first port of an infusion pump.
[0046] Some embodiments relate to an infusion system.In some embodiments, the system includes a connector or connector set as disclosed elsewhere herein and an infusion pump.
[0047] Some embodiments disclosed herein relate to an infusion pump for delivering multiple fluids to a patient. In some embodiments, the infusion pump includes a pump housing. In some embodiments, the housing includes a first container port and a second container port. In some embodiments, the infusion pump includes a first drug cartridge container. In some embodiments, the container extends longitudinally from the first container port along the first side of the infusion pump to the first cartridge container hole. In some embodiments, the infusion pump includes a second drug cartridge container, extending longitudinally from the second container port along the second side of the infusion pump to the second cartridge container hole. In some embodiments, the infusion pump includes an internal area, the internal area including one or more power sources between the first motor and the second motor. In some embodiments, the motor includes a first pinion, the first pinion is part of a first stacked gear assembly. In some embodiments, the pump includes a first gear assembly, the first gear assembly extending laterally toward the first side of the infusion pump. In some embodiments, the pump includes a first drive nut, which is connected to the first pinion through the first gear assembly. In some embodiments, the pump includes a first drive nut in communication with the first drive nut, the first piston being located within the interior region of the infusion pump when fully retracted and being configured to extend outwardly from the interior region of the pump via the first container aperture when not fully retracted, the first drive nut being configured to push the plunger of the first drug cartridge forward to dispense the first drug from the first drug cartridge. In some embodiments, the pump includes a first O-ring surrounding at least a portion of the drive nut and providing a water-resistant barrier to the interior region of the infusion pump.
[0048] In some embodiments, the housing includes a capacitive sensor configured to detect when a finger touches the surface. In some embodiments, the surface is a curved indentation on the housing, and the capacitive sensor includes an integrated circuit configured to measure the capacitance of the circuit. In some embodiments, a conductive foam is provided to fill a gap between the surface and the integrated circuit. In some embodiments, the capacitive sensor generates a wake-up signal after being pressed. In some embodiments, a touch screen display of the pump is activated after receiving the wake-up signal. In some embodiments, the therapy change user interface is unlocked after receiving a first gesture on the touch screen display. In some embodiments, the therapy change user interface is capable of receiving a therapy change selection from the touch screen display. In some embodiments, the drug infusion component delivers the drug after receiving a second gesture on the touch screen display.
[0049] In some embodiments, the housing includes a metal portion and a frame that can be attached to the metal portion. In some embodiments, at least a portion of a side wall of the mobile medical device is covered by the frame, rather than by the metal housing. In some embodiments, the circuit board is positioned adjacent to an inner surface of the frame. In some embodiments, the wireless antenna is fixed to the circuit board such that the wireless antenna is positioned toward a portion of the side wall of the mobile medical device that is only covered by the frame.
[0050] In some embodiments, the first motor rotates the shaft. In some embodiments, the pump includes a gear fixed to the end of the shaft, the gear rotating the gear assembly. In some embodiments, the pump includes a magnet coaxially attached to one of the gears in the gear assembly. In some embodiments, the pump includes a rotational position sensor that measures the angular position of the magnet.
[0051] In some embodiments, the housing includes an interior space. In some embodiments, the housing includes a hole through the housing, the hole having a first end and a second end, and the hole is configured to receive a drug cartridge. In some embodiments, the first end defines an opening into the housing, and the second end is located in the interior space of the housing. In some embodiments, the housing includes an elongated shaft disposed in the hole and configured to engage the drug cartridge. In some embodiments, the housing includes an O-ring circumferentially disposed on the elongated shaft adjacent to the second end of the hole.
[0052] Some embodiments relate to a drug infusion system for delivering one or more drugs to a patient. In some embodiments, the drug infusion system includes a first barrel connector configured to engage a first drug barrel and an infusion pump. In some embodiments, the first barrel connector includes a needle configured to allow access to the first drug in the first drug barrel. In some embodiments, the first barrel connector includes a knob that is cam-shaped and has a flat portion. In some embodiments, the knob includes at least one stopper. In some embodiments, the knob includes a card arm. In some embodiments, the knob includes a skirt. In some embodiments, the knob includes a grip rib. In some embodiments, the first barrel connector is configured to engage the first pump container of the pump. In some embodiments, the first pump container has a receiving track consistent with the position and shape of at least one stopper. In some embodiments, once inserted into the first pump container, the first barrel connector is configured to be positioned in the first pump container using a quarter turn, which aligns the flat portion of the cam with the consistent flat surface of the pump (e.g., indicating to the user that the first barrel connector has been correctly placed in the pump).
[0053] Some embodiments relate to a barrel connector. In some embodiments, the barrel connector includes a body. In some embodiments, the body includes a needle. In some embodiments, the body includes a lower surface portion extending circumferentially from the needle. In some embodiments, the body includes a shield extending axially away from the lower surface portion and configured to receive and assemble on a portion of the first drug cartridge (for example, the first drug cartridge is configured to hold the first drug). In some embodiments, the body includes a protrusion extending axially upward from the upper surface of the body. In some embodiments, the protrusion includes a fluid outlet. In some embodiments, the lower surface portion is located in the shield and is configured to contact the cover of the first drug cartridge when the first drug cartridge is inserted into the barrel connector via the shield. In some embodiments, the needle extends axially from the lower surface portion and is in the shield. In some embodiments, the body is configured to receive the drug by the needle and deliver the drug from the fluid outlet of the body out of the body. In some embodiments, the fluid outlet of the needle and the body is fluidly connected. In some embodiments, the fluid outlet of the needle and the body provides a fluid path through the body. In some embodiments, the connector includes a knob portion configured to engage with the body. In some embodiments, the knob includes a container portion. In some embodiments, the container portion is configured to extend on at least a portion of the projection of the main body and receive at least a portion of the projection of the main body. In some embodiments, the fluid inlet is located in the container portion, and the fluid inlet is configured to receive medicine. In some embodiments, the fluid outlet of the knob is configured to deliver medicine to the position outside the barrel connector. In some embodiments, the connector includes a gap space between the projection of the main body and the container portion of the knob. In some embodiments, the flexible membrane is located in the gap space and extends on at least a portion of the projection of the main body. In some embodiments, the flexible membrane is configured to allow fluid to pass from the main body outlet and enter the knob inlet only after the threshold fluid pressure of the medicine arrives.
[0054] Some embodiments provide an infusion system comprising a connector set and any pump disclosed above or elsewhere in this article. Some embodiments provide an infusion system comprising any connector and any pump disclosed above or elsewhere in this article. In some embodiments, the infusion system further comprises an infusion system.
[0055] Some embodiments provide an infusion pump. In some embodiments, the infusion pump includes a housing, the housing including a capacitive sensor configured to detect when a finger touches a surface. In some embodiments, the surface is a curved indentation on the housing. In some embodiments, the capacitive sensor includes an integrated circuit configured to measure the capacitance of the circuit. In some embodiments, the infusion pump includes a conductive foam that fills a gap between the surface and the integrated circuit.
[0056] In some embodiments, a surface having a curved indent is integrated into a frame of a medical device. In some embodiments, the curved indent is formed to the size of a user's finger. In some embodiments, the curved indent has tactile feedback. In some embodiments, the tactile feedback indicates when the capacitive sensor detects the finger touching the surface. In some embodiments, the tactile feedback indicates when the capacitive sensor detects the finger continuously for about 0.5 seconds. In some embodiments, an infusion pump includes a light below the curved indent. In some embodiments, the output of the light responds based on input received from the capacitive sensor. In some embodiments, the infusion pump includes a pump chamber that delivers one or more hormones into the user's body. In some embodiments, the infusion pump is activated when the capacitive sensor detects the finger continuously for more than about 0.5 seconds.
[0057] Some embodiments provide an infusion pump comprising a button that generates a wake-up signal when pressed. In some embodiments, the infusion pump comprises a touch screen display that is activated after receiving the wake-up signal. In some embodiments, the infusion pump comprises a therapy change user interface that is unlocked after receiving a first gesture on the touch screen display (e.g., after unlocking). In some embodiments, the therapy change user interface is capable of receiving a therapy change selection from the touch screen display. In some embodiments, the drug infusion component delivers the drug after receiving a second gesture on the touch screen display.
[0058] In some embodiments, the therapeutic change selection includes receiving a selection between one or more hormones that regulate the user's blood glucose level. In some embodiments, the therapeutic change selection includes the amount of one or more hormones that regulate the user's blood glucose level. In some embodiments, if the button is pressed for less than about 0.5 seconds before the button is pressed, the button does not generate a wake-up signal. In some embodiments, the first gesture on the touch screen display also includes a predetermined input sequence. In some embodiments, after the button is pressed, the button does not generate a wake-up signal until the button is released. In some embodiments, if the button is released more than about 1.5 seconds after being pressed, the button does not generate a wake-up signal.
[0059] Some embodiments provide a method of preventing accidental therapy changes on a medical device. In some embodiments, the method includes generating a wake-up signal upon pressing a button. In some embodiments, the method includes activating a touch screen display upon receiving the wake-up signal. In some embodiments, the method includes unlocking a therapy change user interface upon receiving a first gesture on the touch screen display. In some embodiments, the method includes receiving a therapy change selection on the touch screen display. In some embodiments, the method includes receiving a second gesture before delivering a drug based on the therapy change selection.
[0060] In some embodiments, the method includes receiving a treatment change selection, and also includes receiving a selection between one or more hormones that regulate the user's blood sugar level. In some embodiments, the method includes receiving a treatment change selection, including receiving the amount of one or more hormones that regulate the user's blood sugar level. In some embodiments, the treatment change selection also includes a selection between one or more hormones to include insulin or glucagon. In some embodiments, receiving a second gesture is based on the treatment change selection. In some embodiments, the method includes receiving a predetermined sequence of digital inputs to deliver the treatment change selection. In some embodiments, the first gesture also includes completing a predetermined sequence of inputs. In some embodiments, generating a wake-up signal also includes pressing a button for at least about 0.5 seconds. In some embodiments, generating a wake-up signal also includes releasing the button after pressing the button. In some embodiments, the button is released less than about 1.5 seconds after being pressed.
[0061] Some embodiments provide a medical device for providing a treatment change. In some embodiments, the medical device includes a button that generates a wake-up signal after being pressed. In some embodiments, the medical device includes a touch screen display that is activated after receiving the wake-up signal. In some embodiments, the medical device includes a treatment change user interface that is unlocked after receiving a first gesture on the touch screen display. In some embodiments, the treatment change user interface is capable of receiving a treatment change selection from the touch screen display. In some embodiments, the drug infusion component delivers the drug after receiving a second gesture on the touch screen display. In some embodiments, the treatment change selection includes receiving a selection between one or more hormones that regulate the user's blood sugar level. In some embodiments, the treatment change selection includes the amount of one or more hormones that regulate the user's blood sugar level. In some embodiments, if the button is pressed for less than about 0.5 seconds before the button is pressed, the button does not generate a wake-up signal. In some embodiments, the first gesture on the touch screen display also includes a predetermined input sequence. In some embodiments, the button does not generate a wake-up signal after the button is pressed until the button is released. In some embodiments, if the button is released for more than about 1.5 seconds after being pressed, the button does not generate a wake-up signal.
[0062] Some embodiments provide a method for preventing accidental treatment changes on a medical device. In some embodiments, the method includes activating a touch screen display after receiving a signal from a wake-up button. In some embodiments, the method includes unlocking a treatment change user interface after receiving a first gesture on the touch screen display. In some embodiments, the method includes receiving a treatment change selection on the touch screen display. In some embodiments, the method includes receiving a second gesture before delivering treatment. In some embodiments, the method includes receiving a treatment change selection, and also includes receiving a selection between one or more hormones that regulate a user's blood glucose level. In some embodiments, receiving the treatment change selection includes receiving the amount of one or more hormones that regulate a user's blood glucose level. In some embodiments, the second gesture corresponds to the treatment change selection. In some embodiments, receiving the second gesture also includes receiving a selection of an indicator box corresponding to insulin or glucagon. In some embodiments, the method includes receiving a predetermined sequence of digital inputs to deliver the treatment change selection. In some embodiments, the method includes receiving the second gesture, and also includes confirming that the selection of the indicator box is consistent with the treatment change selection. In some embodiments, receiving the first gesture also includes completing a predetermined sequence of inputs to unlock the treatment change user interface. In some embodiments, delivering treatment also includes receiving a wireless signal from the touch screen display by the treatment delivery device. In some embodiments, the touch screen display includes at least one of an OLED, LCD, or E-ink display; and wherein the wake-up button includes at least one of a single input button in a capacitive form or a mechanical form.
[0063] Some embodiments provide an infusion pump. In some embodiments, the infusion pump includes a capacitive sensor that detects when a finger touches a surface. In some embodiments, the infusion pump includes a surface having curved indentations. In some embodiments, the capacitive sensor includes an integrated circuit that measures the capacitance of the circuit. In some embodiments, the infusion pump includes a conductive foam between the surface and the integrated circuit.
[0064] In some embodiments, a surface having a curved indent is integrated into a frame of a medical device. In some embodiments, the size of the curved indent is modified to fit the shape of a user's finger. In some embodiments, the curved indent has tactile feedback. In some embodiments, the tactile feedback indicates when the capacitive sensor detects the finger touching the surface. In some embodiments, the tactile feedback indicates when the capacitive sensor detects the finger continuously for about 0.5 seconds.
[0065] In some embodiments, the infusion pump includes a light below the curved indentation. In some embodiments, the output of the light is responsive based on detection of a finger by a capacitive sensor.
[0066] In some embodiments, the infusion pump delivers one or more hormones into the user. In some embodiments, the infusion pump is activated when the capacitive sensor detects the finger continuously for more than about 0.5 seconds.
[0067] Some embodiments provide a method for preventing accidental therapy changes on a medical device. In some embodiments, the method includes generating a wake-up signal after a capacitive sensor detects a user's touch in a curved indentation of the medical device. In some embodiments, the method includes activating a touch screen display after receiving the wake-up signal. In some embodiments, the method includes unlocking a therapy change user interface after receiving a first gesture on the touch screen display. In some embodiments, the method includes receiving a therapy change selection on the touch screen display. In some embodiments, the method includes receiving a second gesture before delivering a drug based on the therapy change selection.
[0068] Some embodiments provide an infusion pump. In some embodiments, the infusion pump includes a housing having a metal lower portion. In some embodiments, the infusion pump includes a frame that can be attached to the metal portion of the housing. In some embodiments, at least a portion of a side wall of the mobile medical device is covered only by the frame. In some embodiments, the circuit board is positioned adjacent to an inner surface of the frame. In some embodiments, the wireless antenna is fixed to the circuit board so that the wireless antenna is positioned toward the portion of the side wall of the mobile medical device that is covered only by the frame.
[0069] Some embodiments include a mobile medical device. In some embodiments, the device includes a metal housing. In some embodiments, the device includes a frame that can be attached to the metal housing. In some embodiments, at least a portion of the side wall of the mobile medical device is covered only by the frame. In some embodiments, the device includes a circuit board positioned adjacent to the inner surface of the frame. In some embodiments, the device includes a wireless antenna fixed to the circuit board so that the wireless antenna is positioned toward the portion of the side wall of the mobile medical device that is only covered by the frame. In some embodiments, the conductive layer of the circuit board is removed from a portion of the circuit board fixed to the wireless antenna. In some embodiments, a portion of the circuit board is positioned within the portion of the side wall of the mobile medical device that is only covered by the frame. In some embodiments, the wireless antenna extends toward the portion of one side of the mobile medical device that is only covered by the frame. In some embodiments, the metal housing covers the length and width of the mobile medical device on at least one side of the mobile medical device. In some embodiments, the metal housing covers the height of at least one side of the mobile medical device. In some embodiments, the metal housing is aluminum. In some embodiments, the frame is plastic.
[0070] In some embodiments, the mobile device includes a capacitive sensor secured to a circuit board. In some embodiments, the mobile device includes a curved indentation on an outer side of a bezel located on opposite sides of the capacitive sensor. In some embodiments, the mobile device includes a display connected to a main circuit board. In some embodiments, the mobile device includes a circuit board positioned orthogonally to the main circuit board.
[0071] Some embodiments provide an infusion pump. In some embodiments, the infusion pump includes an antenna secured to a circuit board. In some embodiments, the infusion pump includes a frame surrounding the antenna. In some embodiments, a metal housing is attached to the frame. In some embodiments, the antenna sends and receives wireless signals. In some embodiments, the frame allows wireless signals to pass through. In some embodiments, the frame is made of plastic. In some embodiments, the metal housing is below the antenna. In some embodiments, the circuit board processes the wireless signals received by the antenna.
[0072] Some embodiments provide a method for detecting touch in a mobile medical device. In some embodiments, the method includes receiving a touch of a finger to a frame. In some embodiments, the method includes measuring a change in capacitance via a capacitive touch pad positioned adjacent to the frame. In some embodiments, the method includes detecting the presence of a finger. In some embodiments, the frame has a curved indentation. In some embodiments, the method includes detecting a change in capacitance when the finger is removed from the frame. In some embodiments, the method includes generating an activation signal in response to the detection of the finger.
[0073] Some embodiments provide a method for receiving input in a mobile medical device. In some embodiments, the method includes receiving a touch of a finger to a border. In some embodiments, the method includes measuring a change in capacitance via a capacitive touch pad positioned adjacent to the border. In some embodiments, the method includes detecting the presence of a finger. In some embodiments, the border has a curved indentation. In some embodiments, the method includes detecting a change in capacitance when the finger is removed from the border. In some embodiments, the method includes generating an activation signal in response to the detection of the finger.
[0074] Some embodiments provide a mobile medical device (e.g., an infusion pump). In some embodiments, the infusion pump includes a motor that rotates a shaft. In some embodiments, the infusion pump includes a gear fixed to the end of the shaft that rotates a gear assembly. In some embodiments, the infusion pump includes a magnet coaxially attached to one of the gears in the gear assembly. In some embodiments, the infusion pump includes a rotational position sensor that measures the angular position of the magnet.
[0075] In some embodiments, the pump includes a circuit board positioned to be orthogonal to the rotation angle of the gear to which the magnet is fixed. In some embodiments, a rotational position sensor is attached to the circuit board. In some embodiments, the pump includes a sensor that measures the rotation of the shaft. In some embodiments, the pump includes a computer that receives data from the sensor and the rotational position sensor. In some embodiments, the computer verifies that the data from the sensor and the data from the rotational position sensor are synchronized. In some embodiments, the pump includes a first drive nut that is operated by rotating the gear assembly. In some embodiments, the pump delivers medication to a user of the mobile medical device. In some embodiments, if the data from the sensor and the data from the rotational position sensor are not synchronized, the computer generates an error signal. In some embodiments, the computer determines the amount of medication delivered to the user based on the data from the rotational position sensor.
[0076] In some embodiments, the pump includes a second motor that operates a second drive nut. In some embodiments, the pump includes a housing for a first drug cartridge and a housing for a second drug cartridge. In some embodiments, the first infusion drive nut delivers drug from the first drug cartridge. In some embodiments, the second drive nut delivers drug from the second drug cartridge. In some embodiments, the housing for the first drug cartridge will not accept the second drug cartridge. In some embodiments, the housing for the second drug cartridge will not accept the first drug cartridge. In some embodiments, the computer determines the amount of drug to be delivered from the second infusion pump based on verification of synchronization of data from the sensor and data from the rotational position sensor.
[0077] Some embodiments provide a method for error detection in a mobile medical device. In some embodiments, the method includes receiving a rotational position of a motor via one or more sensors. In some embodiments, the method includes receiving a rotational position of an output shaft via a rotational position sensor. In some embodiments, the method includes determining that the motor and the output shaft are not rotating synchronously. In some embodiments, the method includes notifying a user that the motor and the output shaft are not rotating synchronously.
[0078] Some embodiments provide a method for error detection in a mobile medical device. In some embodiments, the method includes receiving a rotational position of a first motor via one or more sensors. In some embodiments, the method includes receiving a rotational position of an output shaft via a rotational position sensor. In some embodiments, the method includes determining that the first motor and the output shaft are not rotating synchronously. In some embodiments, the method includes switching operation of the mobile medical device to a second motor based on determining that the first motor and the output shaft are not rotating synchronously.
[0079] Some embodiments provide a method for error detection in a mobile medical device. In some embodiments, the method includes providing a motor configured to rotate a shaft. In some embodiments, the method includes providing a gear fixed to an end of the shaft, the gear rotating a gear assembly. In some embodiments, the method includes providing a magnet coaxially attached to one of the gears in the gear assembly. In some embodiments, the method includes measuring the angular position of the magnet using a rotational position sensor.
[0080] In some embodiments, the method includes positioning the circuit board to be orthogonal to the rotation angle of the gear to which the magnet is fixed. In some embodiments, the method includes attaching a rotational position sensor to the circuit board. In some embodiments, the method includes measuring the rotation of the shaft using the sensor. In some embodiments, the method includes receiving data from the computer from the sensor and the rotational position sensor by a computer. In some embodiments, the data is transmitted wirelessly. In some embodiments, the method includes verifying by a computer that the data from the sensor and the data from the rotational position sensor are synchronized. In some embodiments, the method includes rotating the gear assembly to operate the first drive nut. In some embodiments, the method includes delivering a drug to a user using actuation of the first drive nut. In some embodiments, the method includes generating an error signal by a computer in response to the data from the sensor and the data from the rotational position sensor being asynchronous. In some embodiments, the computer determines the amount of drug delivered to the user based on the data from the rotational position sensor. In some embodiments, there is a second motor operating the second drive nut. In some embodiments, a housing for a first drug cartridge and a housing for a second drug cartridge are provided. In some embodiments, the first drive nut causes the drug from the first drug cartridge to be delivered. In some embodiments, the second drive nut causes the drug from the second drug cartridge to be delivered. In some embodiments, the housing (e.g., cartridge chamber) for the first drug cartridge will not accept the second drug cartridge and / or the housing (e.g., cartridge chamber) for the second drug cartridge will not accept the first drug cartridge. In some embodiments, the computer determines the amount of drug to be delivered from the second infusion drug cartridge based on verification of synchronization of data from the sensor and data from the rotational position sensor.
[0081] Some embodiments provide an infusion pump. In some embodiments, the infusion pump includes a housing having an interior space. In some embodiments, the infusion pump includes a hole through the housing, the hole having a first end and a second end, and the hole is configured to receive a drug cartridge. In some embodiments, the first end defines an opening into the housing, and the second end is located in the interior space of the housing. In some embodiments, the elongated shaft is disposed in the hole and is configured to engage the drug cartridge. In some embodiments, the infusion pump includes an O-ring circumferentially disposed on the elongated shaft adjacent to the second end of the hole.
[0082] In some embodiments, the O-ring forms a barrier that blocks water and debris from entering the interior space of the housing. In some embodiments, the position of the O-ring is configured to allow water or air to move around the drug cartridge. In some embodiments, the O-ring is configured to allow the pressure difference between the infusion site and the drug cartridge to be balanced. In some embodiments, when the O-ring is circumferentially arranged on the elongated shaft, the O-ring applies pressure on the elongated shaft. In some embodiments, the O-ring includes a lubricant to lubricate the elongated shaft to reduce the friction between the O-ring and the elongated shaft. In some embodiments, the O-ring is configured to maintain the pressure difference between the ambient pressure and the interior space of the housing. In some embodiments, the O-ring is configured to maintain the pressure difference between the interior space of the housing and the inside of the hole. In some embodiments, the hole is configured to be exposed to ambient pressure and balance ambient pressure. In some embodiments, the hole is configured to be exposed to ambient pressure and balance the ambient pressure around the drug cartridge. In some embodiments, the O-ring is compressed and assembled on the elongated shaft, and the O-ring is configured to form a barrier that blocks water and air from entering the interior space of the housing.
[0083] Some embodiments provide a method. In some embodiments, the method includes achieving a seal between an interface of a cartridge receiving chamber and the cartridge, the cartridge receiving chamber being configured to mate with the cartridge in an abutting relationship. In some embodiments, the method includes placing an O-ring adjacent to a first end of an elongated shaft, opposite a second end of the elongated shaft, engaging a lead screw of the elongated shaft, and connected to a lead screw nut. In some embodiments, the method includes driving a gear engaging the lead screw so as to translate the lead screw nut longitudinally toward the first end of the elongated shaft during drug delivery.
[0084] In some embodiments, the O-ring remains fixed in the cartridge receiving chamber, but is circumferentially arranged on the lead screw nut. In some embodiments, when the O-ring is circumferentially arranged on the elongated shaft, the O-ring applies pressure on the elongated shaft. In some embodiments, a lubricant is used to lubricate the elongated shaft to reduce the friction between the O-ring and the elongated shaft. In some embodiments, the cartridge is a glucagon cartridge. In some embodiments, the cartridge is an insulin cartridge. In some embodiments, a transmission system assembly and a spur gear are used to mechanically actuate the elongated shaft. In some embodiments, the O-ring helps maintain a pressure difference between the ambient pressure and the inside of the cartridge receiving chamber. In some embodiments, the position of the O-ring is configured to allow water or air to move around the cartridge. In some embodiments, the O-ring comprises a polymeric material.
[0085] Some embodiments provide a barrel connector set. In some embodiments, the barrel connector set includes a first barrel connector configured to engage a first drug barrel and an infusion pump. In some embodiments, the first barrel connector includes a needle configured to allow access to the first drug in the first drug barrel. In some embodiments, the first barrel connector includes a knob that is cam-shaped and has a flat portion. In some embodiments, the body of the connector includes one or more of a knob and a stopper, a clamp arm, a skirt and / or a gripping rib. In some embodiments, the first barrel connector is configured to engage the first pump container of the pump, and the first pump container has a receiving track consistent with the position and shape of at least one stopper. In some embodiments, once inserted into the first pump container, the first barrel connector is configured to be positioned in the first pump container using a quarter turn, which aligns the flat portion of the cam with the consistent flat surface of the pump to indicate to the user: the first barrel connector is correctly placed in the pump.
[0086] Some embodiments provide an infusion pump. In some embodiments, the infusion pump includes a housing having an interior space. In some embodiments, the infusion pump includes a hole through the housing, the hole having a first end and a second end, and the hole is configured to receive a drug cartridge. In some embodiments, the first end defines an opening into the housing, and the second end is located in the interior space of the housing. In some embodiments, the elongated shaft is disposed in the hole and is configured to engage the drug cartridge. In some embodiments, the infusion pump includes an O-ring circumferentially disposed on the elongated shaft adjacent to the second end of the hole.
[0087] Some embodiments provide a method for preventing damage to an infusion pump. In some embodiments, the method includes achieving a seal between an interface of a cartridge receiving chamber and the cartridge, the cartridge receiving chamber being configured to mate with the cartridge in an abutting relationship. In some embodiments, the method includes placing an O-ring adjacent to a first end of an elongated shaft, opposite a second end of the elongated shaft, engaging a lead screw of the elongated shaft, and connected to a lead screw nut. In some embodiments, the method includes driving a gear engaging the lead screw so as to translate the lead screw nut longitudinally toward the first end of the elongated shaft during drug delivery.
[0088] Some embodiments relate to a barrel connector. In some embodiments, the barrel includes a body. In some embodiments, the body includes a needle. In some embodiments, the body includes a lower surface portion extending circumferentially from the needle. In some embodiments, the body includes a shield extending axially away from the lower surface portion, the shield being configured to receive and assemble on a portion of a first drug barrel, the first drug barrel being configured to hold a first drug. In some embodiments, the body includes a protrusion extending axially upward from the upper surface of the body, the protrusion including a fluid outlet. In some embodiments, the lower surface portion is located within the shield and is configured to contact the cover of the first drug barrel when the first drug barrel is inserted into the barrel connector within the shield. In some embodiments, the needle extends axially from the lower surface portion and is within the shield. In some embodiments, the body is configured to receive the drug through the needle and deliver the drug out of the body from the fluid outlet of the body, the needle and the fluid outlet of the body are fluidly connected and provide a fluid path through the body. In some embodiments, the barrel includes a knob portion configured to engage with the body. In some embodiments, the knob includes a container portion configured to extend on at least a portion of the protrusion of the body and receive at least a portion of the protrusion of the body. In some embodiments, the knob comprises a fluid inlet, which is located in the container portion, and the fluid inlet is configured to receive medicine. In some embodiments, the tube comprises a fluid outlet, which is configured to deliver medicine to the position outside the tube connector. In some embodiments, the tube comprises a gap space, which is located between the projection of the main body and the container portion of the knob. In some embodiments, the tube comprises a flexible membrane, which is located in the gap space, and extends on at least a portion of the projection of the main body, and the flexible membrane is configured to allow fluid to pass from the main body outlet and enter the knob inlet only after the threshold fluid pressure of the medicine arrives.
[0089] Some embodiments provide a drug infusion system for delivering a single or multiple drugs to a patient. In some embodiments, the infusion system includes a first barrel connector configured to engage a first drug barrel and an infusion pump. In some embodiments, the first barrel connector includes a needle configured to allow access to the first drug in the first drug barrel. In some embodiments, the first barrel connector includes a knob that is cam-shaped and has a flat portion. In some embodiments, the first barrel connector includes at least one stopper. In some embodiments, the first barrel connector includes a card arm. In some embodiments, the first barrel connector includes a skirt. In some embodiments, the skirt includes one or more card arms, a stopper and / or a lug. In some embodiments, the knob includes a gripping rib. In some embodiments, the first barrel connector is configured to engage a first pump container of a pump, and the first pump container has a receiving track consistent with the position and shape of at least one stopper. In some embodiments, once inserted into the first pump container, the first barrel connector is configured to be positioned in the first pump container using a quarter turn, which aligns the flat portion of the cam with the consistent flat surface of the pump to indicate to the user: the first barrel connector is correctly placed in the pump.
[0090] In some embodiments, the connector set (or the infusion system disclosed herein) includes a second barrel connector configured to engage a second drug cartridge and an infusion pump. In some embodiments, the second barrel connector includes a needle configured to allow access to the second drug in the second drug cartridge. In some embodiments, the second barrel connector includes a knob that is cam-shaped and has a flat portion. In some embodiments, the second barrel connector includes at least one stopper. In some embodiments, the second barrel connector includes a clamp arm. In some embodiments, the second barrel connector includes a skirt (e.g., a shield). In some embodiments, the skirt includes one or more clamp arms, a stopper and / or a lug. In some embodiments, the knob of the second barrel connector includes a grip rib.
[0091] In some embodiments, the second cartridge connector includes a pump second container configured to engage the pump. In some embodiments, the second pump container has a receiving track that conforms to the position and shape of the at least one stop. In some embodiments, once inserted into the second pump container, the second cartridge connector is configured to be positioned within the second pump container using a quarter turn that aligns the flat portion of the cam with the second conforming flat surface of the pump to indicate to a user that the second cartridge connector is correctly placed in the pump.
[0092] In some embodiments, the infusion system includes a first connector and a second connector (e.g., a connector set), and further includes a pump. In some embodiments, the connector set includes a first connector and a second connector. In some embodiments, the infusion system further includes a first drug cartridge and / or a second drug cartridge.
[0093] In some embodiments, the skirt of the second cartridge connector is longer than the skirt of the first cartridge connector. In some embodiments, the skirt of the second cartridge connector is configured to prevent the second cartridge connector from being attached to the first drug cartridge.
[0094] In some embodiments, the identification feature of the second cartridge connector is configured to prevent attachment of the second cartridge connector within the first pump container. In some embodiments, the identification feature of the first cartridge connector is configured to prevent attachment of the first cartridge connector within the second pump container.
[0095] In some embodiments, the first drug is insulin and the second drug is glucagon. In some embodiments, the rotation direction of the quarter turn of the flat portion of the cam of the first barrel connector to align with the first consistent flat surface of the pump is opposite to the rotation direction of the quarter turn of the flat portion of the cam of the second barrel connector to align with the second consistent flat surface of the pump. In some embodiments, the quarter turn of the flat portion of the cam of the first barrel connector to align with the first consistent flat surface of the pump is clockwise, while the quarter turn of the flat portion of the cam of the second barrel connector to align with the second consistent flat surface of the pump is counterclockwise. In some embodiments, the first drug and the second drug are both insulin. In some embodiments, the first barrel connector includes a first check valve that allows fluid to flow out of the first reservoir after reaching a first threshold pressure.
[0096] In some embodiments, a pump (e.g., of an infusion system) includes a pump housing having a first inlet port configured to engage a first barrel connector. In some embodiments, a pump includes a power supply located in the pump housing. In some embodiments, a pump includes a first pump container configured to receive a first drug cartridge when inserted through the first inlet port. In some embodiments, a pump includes a second inlet port configured to engage a second barrel connector, and a second pump container configured to receive a second drug cartridge when inserted through the second inlet port. In some embodiments, the first container and the second container are located in the pump housing and are laterally spaced apart from each other. In some embodiments, a power supply is located at a position in the pump housing and between the first container and the second container. In some embodiments, the first inlet port is configured to cooperate with the first barrel connector, and the second inlet port is configured to cooperate with the second barrel connector. In some embodiments, a pump includes a pumping mechanism configured to deliver a first drug from a first drug cartridge.
[0097] In some embodiments, the first container includes a first identification feature that prevents proper docking of the second drug cartridge in the first chamber. In some embodiments, the second container includes a second identification feature that prevents proper docking of the first drug cartridge in the second container. In some embodiments, the power source is an inductively charged battery. In some embodiments, the infusion pump is waterproof or water resistant.
[0098] Some embodiments provide an infusion pump, including a housing having an interior space. In some embodiments, the infusion pump includes a hole through the housing, the hole having a first end and a second end, and the hole is configured to receive a drug cartridge. In some embodiments, the first end defines an opening into the housing, and the second end is located in the interior space of the housing. In some embodiments, the infusion pump includes an elongated shaft disposed in the hole and configured to engage the drug cartridge. In some embodiments, the infusion pump includes an O-ring disposed circumferentially on the elongated shaft adjacent to the second end of the hole. In some embodiments, the O-ring forms a barrier that blocks water and debris from entering the interior space of the housing. In some embodiments, the position of the O-ring is configured to allow water or air to move around the drug cartridge. In some embodiments, the O-ring is configured to allow the pressure difference between the infusion site and the drug cartridge to be equalized. In some embodiments, when the O-ring is disposed circumferentially on the elongated shaft, the O-ring applies pressure on the elongated shaft; and the O-ring also includes a lubricant to lubricate the elongated shaft to reduce friction between the O-ring and the elongated shaft. In some embodiments, the O-ring is configured to maintain a pressure difference between ambient pressure and the interior space of the housing. In some embodiments, the O-ring is configured to maintain a pressure difference between the interior space of the housing and the interior of the hole. In some embodiments, the hole is configured to be exposed to ambient pressure and to balance ambient pressure. In some embodiments, the hole is configured to be exposed to ambient pressure and balance the ambient pressure around the drug cartridge. In some embodiments, the O-ring is compression-fitted on the elongated shaft, and the O-ring is configured to form a barrier that blocks water and air from entering the interior space of the housing.
[0099] Some embodiments provide a battery charging station including a docking area for inductive charging. In some embodiments, the docking area is configured to receive an infusion pump as disclosed elsewhere herein.
[0100] Some embodiments provide a method comprising achieving a seal between an interface of a cartridge receiving chamber and the cartridge. In some embodiments of the method, the cartridge receiving chamber is configured to cooperate with the cartridge in an abutting relationship. In some embodiments, the method comprises placing an O-ring adjacent to the first end of the elongated shaft, opposite the second end of the elongated shaft, engaging the lead screw of the elongated shaft, and connecting to a lead screw nut. In some embodiments, the method comprises driving a gear engaging the lead screw so that the lead screw nut is translated longitudinally toward the first end of the elongated shaft during drug delivery. In some embodiments, the O-ring remains fixed in the cartridge receiving chamber, but is circumferentially disposed on the lead screw nut.
[0101] Some embodiments provide a barrel connector. In some embodiments, the barrel connector includes a body. In some embodiments, the body includes a needle. In some embodiments, the body includes a lower surface portion extending circumferentially from the needle. In some embodiments, the body includes a shield extending axially away from the lower surface portion and configured to receive and assemble on a portion of a first drug cartridge, the first drug cartridge being configured to hold a first drug. In some embodiments, the body includes a protrusion extending axially upward from the upper surface of the body, the protrusion including a fluid outlet. In some embodiments, the lower surface portion is located within the shield and is configured to contact the cover of the drug cartridge when the drug cartridge is inserted into the barrel connector within the shield. In some embodiments, the needle extends axially from the lower surface portion and is within the shield. In some embodiments, the body is configured to receive the drug through the needle and deliver the drug from the fluid outlet of the body out of the body, the needle and the fluid outlet of the body are fluidly connected and provide a fluid path through the body. In some embodiments, the barrel connector includes a knob portion configured to engage with the body. In some embodiments, the knob includes a container portion configured to extend on at least a portion of the protrusion of the body and receive at least a portion of the protrusion of the body. In some embodiments, the knob includes a fluid inlet, which is located in the container portion, and the fluid inlet is configured to receive medicine. In some embodiments, the knob includes a fluid outlet, which is configured to deliver medicine to a position outside the tube connector. In some embodiments, the gap space is between the projection of the main body and the container portion of the knob. In some embodiments, the flexible membrane is located in the gap space and extends on at least a portion of the projection of the main body. In some embodiments, the flexible membrane is configured to allow fluid to pass from the main body outlet and enter the knob inlet only after the threshold fluid pressure of the medicine arrives.
[0102] In some embodiments, the knob is cam-shaped and has a flat portion. In some embodiments, the knob includes a gripping rib configured to facilitate manipulation and / or twisting of the barrel connector. In some embodiments, the gripping rib is configured to fit between the index finger and thumb of the user. In some embodiments, the body includes at least one stopper. In some embodiments, the barrel connector is configured to engage the first pump container of the pump. In some embodiments, the first pump container has a receiving track consistent with the position and shape of at least one stopper. In some embodiments, once inserted into the first pump container by a quarter turn, the barrel connector is configured to lock in the first pump container, and the quarter turn aligns the flat portion of the cam with the consistent flat surface of the pump. In some embodiments, the alignment of the flat portion of the cam indicates that the user barrel connector is correctly placed in the pump. In some embodiments, the barrel connector includes at least one card arm, which is configured to deform outward from the shield when the cover of the first drug cartridge is inserted into the shield, and the card arm includes a protruding mating piece. In some embodiments, the card arm is configured to snap back into place after the cover abuts the upper surface of the body of the barrel connector, thereby engaging the cover via the protruding mating piece. In some embodiments, the shield abuts an upper surface of the cap of the drug cartridge.In some embodiments, the body and the knob portion are integral.
[0103] Some embodiments provide a drug infusion group including one or more barrel connectors disclosed above or elsewhere in this article. In some embodiments, the infusion group also includes a second barrel connector, which is configured to engage the second drug barrel and an infusion pump. In some embodiments, the second barrel connector includes a needle configured to allow access to the second drug in the second drug barrel. In some embodiments, the second barrel connector includes a knob that is cam-shaped and has a flat portion. In some embodiments, the second barrel connector includes at least one stopper. In some embodiments, the second barrel connector includes a card arm. In some embodiments, the second barrel connector includes a shield. In some embodiments, the knob of the second barrel connector includes a grip rib. In some embodiments, the second barrel connector is configured to engage the second container of the pump, and the second pump container has a receiving track consistent with the position and shape of at least one stopper of the second barrel connector. In some embodiments, once inserted into the second pump container, the second barrel connector is configured to be positioned in the second pump container using a quarter turn, and the quarter turn aligns the flat portion of the cam with the second consistent flat surface of the pump to indicate to the user: the second barrel connector is correctly placed in the pump. In some embodiments, the shield of the second tube connector is longer than the shield of the first tube connector. In some embodiments, the shield of the second tube connector is configured to stop the second tube connector from being attached to the first drug cartridge. In some embodiments, the identification feature of the second tube connector is configured to stop the attachment of the second tube connector in the first pump container. In some embodiments, the second tube connector comprises the identification feature of the first tube connector, and this identification feature is configured to stop the attachment of the first tube connector in the second pump container.
[0104] In some embodiments, the first drug is insulin and the second drug is glucagon. In some embodiments, the direction of rotation of the quarter turn to align the flat portion of the cam of the first cartridge connector with the first conforming flat surface of the pump is opposite to the direction of rotation of the quarter turn to align the flat portion of the cam of the second cartridge connector with the second conforming flat surface of the pump. In some embodiments, the quarter turn to align the flat portion of the cam of the first cartridge connector with the first conforming flat surface of the pump is clockwise, while the quarter turn to align the flat portion of the cam of the second cartridge connector with the second conforming flat surface of the pump is counterclockwise. In some embodiments, the direction of rotation of the quarter turn to align the flat portion of the cam of the first cartridge connector with the first conforming flat surface of the pump is the same as the direction of rotation of the quarter turn to align the flat portion of the cam of the second cartridge connector with the second conforming flat surface of the pump. BRIEF DESCRIPTION OF THE DRAWINGS
[0105] Various embodiments are described in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of the embodiments. Any features, structures, components, materials and / or steps of any embodiment may be combined or replaced with any features, structures, components, materials and / or steps of any other embodiment to form another embodiment as part of the present disclosure. The embodiments shown are intended to illustrate (but not limit) the present disclosure. The proportions and relative sizes and dimensions of each component shown in these drawings constitute part of the supporting disclosure of this specification, but should not limit the scope of this specification unless these proportions, dimensions or dimensions are included in any separate claim.
[0106] Figure 1A A perspective view of an embodiment of a pump system coupled to a cartridge connector set and showing fluid passageways of an underside surface of the pump.
[0107] Figure 1B yes Figure 1A 0026] A second perspective view of an embodiment of the invention, this time showing the upper surface of the pump.
[0108] Figure 1C yes Figure 1A Another perspective view of an embodiment showing the upper surface of the pump device with the connector assembly removed.
[0109] Figure 1D yes Figure 1A Another perspective view of an embodiment showing the upper surface of the pump.
[0110] Figure 1E yes Figure 1A Another perspective view of an embodiment showing the underside of the pump.
[0111] Figure 1F yes Figure 1A Another perspective view of an embodiment showing the lower surface of the pump and the cartridge container.
[0112] Figure 1G yes Figure 1A A view of an embodiment showing a cartridge container of a pump.
[0113] Figure 1H yes Figure 1A Another view of an embodiment showing a cartridge container of a pump.
[0114] Fig. 1I yes Figure 1A Another view of an embodiment showing a cartridge container of a pump.
[0115] Figure 1J yes Figure 1A A view of the upper surface of an embodiment showing the cartridge container of the pump.
[0116] FIG. 2A to FIG. 2C Shows Figure 1A A view of an embodiment of a pump having its display screen and / or pump face and other portions of its housing removed, revealing various internal components of the pump. Figure 2A Shows Figure 1A A view of an embodiment of the invention with its display screen and pump face removed, revealing various internal components of the pump. Figure 2B Shows Figure 1A Another view of an embodiment of the invention with its display screen and pump face removed, revealing various internal components of the pump. Figure 2C Shows Figure 1A The cartridge drive assembly of the pump is part of the pump.
[0117] Figure 2D Shows the plane being equally divided along the length and width of the pump Figure 1A A view of an implementation method of FIG.
[0118] Figure 2E and Figure 2F Shown along the length and height of the pump in a flat Figure 1A A cross-sectional view of an embodiment of the present invention, with the first cartridge container and the second cartridge container cut separately.
[0119] Figure 2G and Figure 2H Shows Figure 1A A partially exploded view of an embodiment of the present invention, wherein the display and the frame are removed. Figure 2H As shown in , the pump includes a lead screw, a threaded insert and a drive nut.
[0120] Fig.2I Shows the plane being equally divided along the length and width of the pump Figure 1A In this view, the drug cartridge set and cartridge connector set are present and / or engaged with the pump.
[0121] Figure 3A Shows Figure 1A A top view of an embodiment of the present invention.
[0122] Figure 3B Shows Figure 1A A perspective view of an embodiment of the invention.
[0123] Figure 3C Shows Figure 1A A bottom view of an embodiment of the present invention.
[0124] Figure 3D Shows Figure 1A A view of the upper surface of an embodiment of the present invention.
[0125] Figure 4A A perspective view of another embodiment of a pump is shown, showing the upper surface of the pump.
[0126] Figure 4B Shown is the display removed Figure 4A A perspective view of an embodiment of the invention.
[0127] Figure 4C Shows Figure 4A A perspective view of a lower portion of a housing of an embodiment of the present invention.
[0128] Figure 4D Shows Figure 4A A partially exploded perspective view of a lower portion of a housing and a drive nut of an embodiment of the present invention.
[0129] Figure 4E Shows the plane being equally divided along the length and width of the pump Figure 4A In this view, the drug cartridge set and cartridge connector set are present and / or engaged with the pump (in line with the fluid conduit).
[0130] Figure 5A They are shown respectively Figure 1A and Figure 4A A view of the upper surface of an embodiment of the present invention.
[0131] Figure 5B yes Figure 1A and Figure 4A An isometric side view of a portion of a pump.
[0132] Fig. 6A and Figure 6B They are Figure 1A Illustration of a pump in which the frame shown is transparent or has a cross-section taken across the width of the pump.
[0133] Figure 6C is a schematic diagram showing components of a capacitive sensor in a mobile medical device.
[0134] Fig.6D is a schematic diagram showing components of a mobile medical device having a capacitive sensor.
[0135] Fig. 6E is a flow chart of a process for preventing accidental treatment on a mobile device.
[0136] Fig. 6F is a schematic diagram showing components of a mobile medical device having a capacitive sensor activated by a user.
[0137] Figure 6G is a diagram of a capacitive sensing plate on a PCB board.
[0138] Fig. 7A is an illustration of another embodiment of a pump shown without a display.
[0139] Figure 7B yes Fig. 7A Illustration of an exploded view of a pump.
[0140] Figure 7C Has a transparent border Figure 1A Illustration of a pump.
[0141] Fig.7D yes Figure 1A Illustration of the pump with the transparent metal housing and frame removed.
[0142] Fig. 7E It is equipped with an output shaft angular position error detection system Fig. 7A Illustration of a pump.
[0143] Figure 7F is a flow chart of a process for determining the presence of an error in medication delivery in a mobile medical device.
[0144] Figure 7G is a diagram of a pump having an output shaft angular position error detection system.
[0145] Figure 7H is a diagrammatic representation of a pump having two or more drug cartridges.
[0146] Fig.7I is a diagram of a mobile medical device having an output shaft angular position error detection system.
[0147] Figure 7J is a perspective view of an interior space of an infusion pump housing according to an exemplary embodiment.
[0148] Figure 7K is a cross-sectional view of an interior space including an infusion pump housing according to an exemplary embodiment.
[0149] Figure 7L is a top view of components in an infusion pump according to an exemplary embodiment.
[0150] Figure 7M is a perspective view of an elongated shaft member of an infusion pump according to an exemplary embodiment.
[0151] Figure 7N is a perspective view of two O-rings of an infusion pump according to an exemplary embodiment.
[0152] Fig.7O is a cross-sectional view of an elongated shaft member of an infusion pump according to an exemplary embodiment.
[0153] Figure 7P is a top cross-sectional view of components of an infusion pump according to an exemplary embodiment.
[0154] Figure 7Q is an exploded view of components of an infusion pump according to an exemplary embodiment.
[0155] Figure 8 is a perspective view of an embodiment of an inductive charger.
[0156] Fig.9A and Fig. 9B is a view of a cartridge connector set including two cartridge connectors and a consistent fluid conduit (tube). Fig.9A A perspective view of a cartridge connector (eg, a connector set) is shown. Fig. 9B A bottom view of the cartridge connector is shown.
[0157] Fig. 9C Embodiments of cartridge connectors are shown that provide a visual indication of when connectors in a connector set are unlocked or locked within a pump chamber, respectively.
[0158] Fig.9D Shows Fig.9A A cross-sectional view of a connector.
[0159] Fig.9E Shows Fig.9A A view of the connectors with the body of one connector separated from its knob.
[0160] FIG. 9F to FIG. 9G Shows Fig.9A A view of one of the connectors in FIG. 1 , with the body of the connector separated from its knob.
[0161] Figure 9H Shows Fig.9A A cross-sectional view of one of the connectors.
[0162] Fig.9I Shows Fig.9A Another cross-sectional view of the connector.
[0163] Fig. 10A is a view of another embodiment of a cartridge connector set including two cartridge connectors.
[0164] Fig. 10B Shows Fig. 10A A cross-sectional view of a connector.
[0165] Fig. 10C Shows Fig. 10A Bottom view of the connector.
[0166] FIG. 10D to FIG. 10E Shows Fig.9A and Fig. 10A of the connector.
[0167] Fig.10FA cross-sectional view of an embodiment of a connector set coupled to a drug cartridge is shown.
[0168] FIG. 10G to FIG. 10H A view showing a connector with a check valve is shown.
[0169] FIG. 11A to FIG. 11B A cross-sectional view of an embodiment of a connector set coupled to a drug cartridge within a pump is shown.
[0170] FIG. 11C to FIG. 11D A cross-sectional view of an embodiment of a connector set coupled to a drug cartridge is shown.
[0171] Fig.11E Views showing an embodiment of a connector set coupled to a drug cartridge.
[0172] Fig. 12A An embodiment of a dual lumen portion of a multi-channel lumen assembly is shown.
[0173] Fig.13A The components and steps for filling or refilling a drug cartridge are shown.
[0174] Fig. 13B Additional components and steps for filling or refilling a drug cartridge are shown.
[0175] Fig. 13C Additional components and steps for filling or refilling a drug cartridge are shown.
[0176] Fig.13D Additional components and steps for filling or refilling a drug cartridge are shown.
[0177] Fig.13E Additional components and steps for filling or refilling a drug cartridge are shown.
[0178] FIG. 14A to FIG. 14B A perspective view of a dual infusion set base is shown, wherein Fig.14A An insertion tool is also shown.
[0179] FIG. 15A to FIG. 15B A perspective view of a dual drug dispensing connector is shown, wherein Fig.15A A cover for the dispensing connector is also shown.
[0180] FIG. 16A to FIG. 16B A view of a dual drug infusion set is shown, wherein Fig. 16B is a cross-sectional view viewed from the top.
[0181] FIG. 17A to FIG. 17B A single drug infusion housing set base is shown with an insertion tool attached ( Fig.17A ) or separation ( Fig. 17B ).
[0182] FIG. 18A to FIG. 18B A perspective view of a single drug dispensing connector is shown, wherein Fig.18A A cover for the dispensing connector is also shown.
[0183] FIG. 19A to FIG. 19B A view of a single drug infusion base set is shown, wherein Fig.19B is a cross-sectional view viewed from the top.
[0184] FIG. 20A to FIG. 20E Various configurations of dual drug infusion set bases, connectors, and covers are shown. Fig. 20A An embodiment is shown having a right site base connected to a right site base cover. Fig. 20B A second site base is shown connected to a second site base cover. Fig. 20C A first site connector is shown connected to a first site connector cover. Fig.20D The second (left) site connector is shown connected to the second (left) site connector cover. Fig.20E A dual medication infusion site base is shown connected to a dual medication site base cover.
[0185] Fig.21A A perspective view of a drug dispensing connector is shown. DETAILED DESCRIPTION
[0186] Some embodiments described herein relate to drug infusion systems for one or more drugs and components of such systems (e.g., infusion pumps, drug cartridges, cartridge connectors, lumen assemblies, infusion connectors, infusion groups, etc.). Some embodiments relate to drug refilling systems. Some embodiments relate to methods for manufacturing infusion systems and components thereof. Some embodiments relate to methods for infusing one or more drugs to a patient using any of the aforementioned systems or components. Several embodiments disclosed herein ensure that the drug is correctly delivered to the patient. Although multiple identification features can be used on various components disclosed herein to reduce the chance of any miscommunication, no single component or collection of components is necessary or essential. For example, some embodiments may include each identification feature and / or component disclosed herein, while other embodiments may not include or may not have one or more features or components disclosed herein, while still achieving correct delivery. As an exemplary illustration, an infusion system may include an infusion pump, but not a drug cartridge. An infusion system may include a drug cartridge and a cartridge connector, but not a pump. An infusion system may include a cartridge connector and an infusion pump, but not a drug cartridge. Infusion system can comprise infusion connector, tubing chamber assembly, barrel connector, infusion pump, but does not comprise drug barrel or infusion group.Any feature, structure, component, material, step or method described and / or shown in any embodiment in this specification sheet can be used together with any feature, structure, component, material, step or method described and / or shown in any other embodiment in this specification sheet or replace any feature, structure, component, material, step or method described and / or shown in any other embodiment in this specification sheet.In addition, any feature, structure, component, material, step or method described and / or shown in one embodiment can not exist in another embodiment.
[0187] introduction
[0188] As disclosed elsewhere herein, a continuously delivered, pump-driven drug injection device typically includes a delivery cannula installed at an infusion site through the patient's skin in a subcutaneous manner. The pump draws the drug from a reservoir and delivers it to the patient via the cannula. The injection device may include a channel that transmits the drug, receives the drug via an inlet port and provides a fluid path to the delivery cannula. The drug can be delivered to the patient via the cannula, which delivers the drug to the subcutaneous tissue layer, where the delivery cannula terminates. The infusion device can be configured to deliver a single drug to the patient, or to deliver multiple drugs to the patient.
[0189] Although multi-drug delivery systems exist, a disadvantage is that a patient or physician may accidentally load, and thereby administer or cause administration of, an incorrect medication (e.g., drug, hormone, etc.). For example, in a multi-drug infusion device, a user may load a medication into an incorrect pump container, which leads the user to mistakenly believe that he or she is administering one medication, while they inadvertently administer another medication. Accidentally administering an incorrect medication to a patient can have serious and potentially fatal consequences.
[0190] For example, the standard care insulin therapy for regulating the blood sugar of diabetic patients can involve subcutaneous infusion of insulin via an insulin pump. If the amount of insulin administered is excessive, it may lead to hypoglycemia or the situation of impending hypoglycemia. In order to counteract and / or reverse this unfavorable situation, individuals usually consume other carbohydrates (e.g., sweet juice or glucose tablets). Individuals optionally and / or additionally apply the counter-regulator of so-called "rescue dose", such as glucagon. The counter-regulator antagonizes the effect of excessive regulator dose (e.g., excessive insulin), thereby alleviating or substantially preventing the adverse effects associated with excessive doses. However, if the patient is given additional insulin instead of the expected glucagon rescue dose, the result may be catastrophic, potentially leading to death. Similarly, during the onset of diabetes, if the patient needs insulin but gives glucagon instead, the administration may aggravate the onset and may lead to destructive effects and may be fatal.
[0191] Therefore, correct delivery in drug administration is critical, especially when one drug is used to achieve one effect and another drug is used to achieve a different and / or opposite effect (e.g., as in the case of insulin and glucagon). In a multi-drug automatic system, if the drug is accidentally loaded in an incorrect barrel or incorrect barrel chamber of the pump, the automatic system may deliver ineffective (and / or potentially harmful) drugs to the patient. This phenomenon of incorrect drug loading and / or administration in an automatic system is called cross delivery (or misdelivery). As described above, cross delivery is dangerous, not only because the wrong drug may not have the expected therapeutic effect, but also because the wrong drug may have an effect opposite to the expected effect (or some other side effects that are not expected or required). As also described above, incorrect delivery not only cannot alleviate the patient's condition, but also worsens the patient's condition, or causes a new problem state for the patient. Incorrect delivery (e.g., misdelivery) may lead to a negative feedback loop, in which the control system attempts to adjust the patient's disease state in one direction, but the delivery of incorrect drugs aggravates the disease state or has no effect on the disease state. Sensing this, the control system may trigger further doses of the incorrect medication in an attempt to control the patient's condition while actually causing the patient's condition to worsen further (or resulting in an overdose of the incorrect medication).
[0192] Additionally, in certain situations or environments, commercial diabetes medication infusion systems may not adequately prevent incorrect dosing, even when the correct medication is administered. For example, escape dosing may occur in some situations, or inappropriate dosing may occur in other situations.
[0193] Although diabetes drugs (e.g., insulin and glucagon) are used as exemplary drugs above and elsewhere in this article, incorrect delivery (or administration) may have harmful effects in many multi-drug regimens because the drug is not administered to the patient at the necessary time (and / or at the necessary level), or the incorrect drug is administered at a dangerous level. In other drug combinations that regulate pancreatic enzymes, miscommunication may be harmful, and other drug combinations are meant to maintain body balance in one direction or another, or simply that the patient needs multiple drugs, regardless of any relationship or common disease state between the drugs (e.g., in the case where one drug treats a disease state and another drug treats a completely unrelated disease state). Therefore, the embodiments and considerations provided herein are applicable to any drug combination. In addition, although cross-delivery may refer to a system with two drugs, the term cross-delivery as used herein may also refer to a system using more than two drugs and / or using a single drug (e.g., when a single drug is incorrectly placed in a distribution system).
[0194] Some embodiments disclosed herein solve one or more problems associated with these problems (e.g., miscommunication, escape or inappropriate administration, etc.) or other problems. In this article, an infusion system for a single drug or multiple drugs is described, as well as various connectors, tubes, barrels, pumps, infusion groups, and / or systems including any one or more of the above, which ensure, help ensure and / or substantially help provide the correct transmission and / or administration of each drug to the patient. Certain embodiments of the infusion system described herein and its components are configured to minimize, reduce and / or otherwise help avoid the occurrence of cross transmission and / or the incorrect administration of the drug. In some embodiments, when the drug is supplied by the infusion system disclosed herein, the components including the identification features as described herein are configured to prevent, prevent, minimize or otherwise prohibit the user from accidentally placing the drug in an incorrect position and / or delivering an incorrect drug (and / or the incorrect amount of the correct drug).
[0195] Cross transmission can be avoided by providing identification features (e.g., unique distinguishing identification elements), which allow only specific shape parts to be matched in the infusion system. In some embodiments, the infusion system includes an infusion pump with one, two or more infusion chambers (or pump chambers) and one or more identification features. In some embodiments, the system also includes a barrel filled with different drugs, and a connector and a tube, which have identification features, and the barrel is connected to the infusion pump in a manner to prevent the miscommunication or cross transmission of the drug. In some variations, each type of barrel for each type of drug has one or more unique distinguishing features (as an integral part of the barrel or as a part attached to or fixed to the barrel). Identification features can include, for example, geometric or shape-based features, which allow unique connections between the parts of the system. A type of connector with unique distinguishing features can engage corresponding features in the pump housing, and allows the correct barrel to be inserted into the correct infusion chamber. The barrel with unique features can interact with a pump infusion pump with corresponding features (e.g., a drive shaft or pump chamber with corresponding features). Improper drug administration may be avoided using certain design features disclosed herein, including seals, valves, and other tools incorporated into the components disclosed herein.
[0196] The following disclosure provides additional details regarding the configuration of systems and components for avoiding cross-transfers.While the following description provides context and examples, it should not be construed as limiting the scope of the invention as encompassed by the claims appended hereto.
[0197] Infusion System
[0198] Some embodiments disclosed herein relate to an infusion system configured to deliver one or more drugs without cross-transfer and / or configured to prevent incorrect administration of drugs. In some variations, the system includes one or more of the following: an infusion pump (configured to receive one or more drug cartridges in one or more cartridge containers), one or more cartridge connectors (configured to simultaneously engage one or more drug cartridges, an infusion pump, and / or both), one or more drug cartridges, an infusion set (configured to deliver the drug to the patient via a piercing element, which may include a cannula or needle that penetrates the patient's skin), one or more infusion connectors configured to engage with the infusion set, and a fluid conduit that is fluidly connected to one or more cartridge connectors and / or one or more infusion connectors. In several embodiments, the infusion system (or its components) includes one or more design features that make it compact. In some variations, the infusion system (or its components) is particularly suitable for moving and / or wearing on the patient, thereby allowing the patient to move freely (e.g., daily activities, including but not limited to work, exercise, swimming, air travel, etc.).
[0199] In some embodiments, when the infusion system is configured to deliver multiple drugs (rather than just one drug), the infusion system can be adapted to receive the multiple drugs from multiple drug cartridges. As an example, in a two drug infusion system, the system can include components in a variety of different configurations, including or not having one or more components selected from two drug cartridges, an infusion pump configured to receive the two cartridges (e.g., in different cartridge containers), a cartridge connector configured to engage the drug cartridges and / or the infusion pump (e.g., at or near the cartridge container), an infusion group configured to deliver the drugs to a patient (e.g., a piercing element for a first drug and a piercing element for a second drug), two infusion connectors configured to engage with the infusion group, and fluid conduits, each fluid conduit being in fluid communication with one cartridge connector and one infusion connector (e.g., providing separate flow paths). Figure 1A A two-drug infusion system is shown in the , wherein the system includes two different cartridge connectors, a consistent fluid conduit and a pump. In addition, where the system is configured to deliver three or more drugs, additional cartridges, cartridge containers, cartridge connectors, infusion connectors, and piercing elements may be provided as needed (although the system may also be devoid of any one or more of these components). As disclosed elsewhere herein, although two or more drugs may be delivered by an infusion system, several embodiments relate to pumps that deliver a single drug (e.g., a pump having only one cartridge container or multiple cartridge containers, configured to receive a single type of drug cartridge, such as insulin).
[0200] In some embodiments, as disclosed elsewhere herein, the system and / or its components include unique matching features and design elements (identification features). These identification features can ensure that each part of the system can only be connected in the system in a unique manner or configuration (e.g., the correct manner), thereby preventing cross transmission (e.g., miscommunication). In some embodiments, in the case of delivering different drugs by a single system (or its components), the drugs can remain completely separated throughout the entire residence time in the system (or its components), and can have different fluid paths to the patient. For example, a barrel connector and a fluid conduit can be used to provide a separate fluid path, which terminates at a designated delivery member (e.g., needle, cannula, etc.) in a base (e.g., an infusion set), so that the drugs can be delivered separately and independently (e.g., subcutaneously or in other ways).
[0201] In certain embodiments, the design features of the disclosed systems (and / or components thereof) produce the following or other advantages: (1) allowing a user to easily connect and disconnect components independently of any drug source and infusion port or site; (2) reducing the possibility of miscommunication when a user accidentally connects the wrong components together; (3) reducing the possibility of incorrect dosing levels; (4) reducing loss and / or contamination of medication; (5) allowing single-step or multi-step insertion of a dual-cannula infusion site or port. In some embodiments, the systems and components described herein may include visual or Braille annotations in addition to or in lieu of the various paired physical features disclosed herein. For example, in some implementations, a component may include an annotation with wording indicating the correct medication. In some variations, different colors (red, blue, yellow, green, orange, purple, etc.) or lengths (or other variables) provide visual feedback about the appropriate medication for the appropriate component.
[0202] In some embodiments, as described elsewhere in this article, the infusion system can be used for providing a separate fluid path for various drugs (e.g., medicines, hormones, proteins, drugs, biologics, etc.) dissolved in various liquid carriers (and / or liquid medicines). In some embodiments, based on the solubility, stability or sensitivity of the drug in a specific carrier, different liquid vehicles may be preferred. In some embodiments, an aqueous solution (buffer, etc.) is used as a delivery vehicle for the drug. In some variations, a solvent such as DMSO is used to dissolve the drug. In some embodiments, a solvent / aqueous mixture is used.
[0203] In some implementations, a dual drug system configured to receive insulin and glucagon cartridges is provided. In another implementation, the system may include a pump with multiple cartridge containers (e.g., chambers), the cartridge containers being configured to receive cartridges containing the same drug (rather than different drugs), and / or being configured to interact with multiple identical cartridge connectors. For example, in some embodiments, an infusion pump may have two identical cartridges that include the same identification feature. These containers may be configured to receive the same cartridge and / or may be configured to engage the same cartridge connector (e.g., two cartridges containing insulin and / or two cartridge connectors, both configured to engage insulin cartridges). In this configuration, the system and its components (e.g., cartridges, infusion pumps, cartridge connectors, infusion groups, infusion connectors, and fluid conduits) are configured to receive two (or more) cartridges containing specific drugs (e.g., insulin), rather than cartridges containing different drugs (e.g., glucagon). By providing a system that accommodates two or more cartridges of the same drug (and prevents or prohibits the insertion or connection of cartridges with other drugs), the system operates for a longer period of time without the need to refill or add additional cartridges. In addition, the user can instantly replace a single cartridge that is exhausted (e.g., an empty or nearly empty cartridge) without interrupting and / or delaying the flow of drug from a second cartridge that provides the drug to the patient. In some embodiments, the pump is configured to receive a single drug cartridge, and the system includes a single component to allow its delivery (e.g., a single cartridge connector, a single channel lumen assembly (which may include a cartridge connector), a single infusion connector, a single infusion base, a single drug cartridge, etc.).
[0204] The following part provides additional information about the various components of the infusion system disclosed in this article. Although these components can be described as a part of the infusion system, it should be understood that each of these components (such as infusion pump, barrel connector, drug barrel, infusion group, infusion connector and fluid conduit) can be separated from the system independently. Similarly, in the case of describing the components separately, it can be a part of the infusion system, as disclosed in this article. Any combination of identification features in the infusion system can be mixed and matched to solve the miscommunication problem, because any drug administration safety features can be mixed and matched to solve the incorrect application problem. In several implementations, all identification features or safety features disclosed in this article do not need to be used in a specific embodiment. For example, as disclosed elsewhere in this article, the barrel connector can be uniquely shaped in a way that allows it to engage only with a drug bottle (rather than other drug bottles), and uniquely with threads so that it only engages with the consistent barrel container in the pump. In this embodiment, this feature can be enough to avoid miscommunication, and other features do not need to be included. For example, in such a configuration, the cartridge container of the pump may not have an identification feature configured to prevent insertion of a cartridge, and instead the connector is configured to engage a specific drug cartridge and a specific cartridge port in the pump.
[0205] Pump system
[0206] As disclosed elsewhere herein, some embodiments relate to an infusion pump (eg, a pump system). In some implementations, an infusion pump as disclosed herein is a part and / or component of an ambulatory infusion system.
[0207] In some embodiments, Figure 1A , Figure 1B and Figure 1E As shown in , the pump may include a face P1002, a backing P1003, a bottom side P1005 (e.g., a lower surface), a top side P1004 (e.g., an upper surface), a first side surface P1006' (e.g., a right side surface), and a second side surface P1006" (left side surface). As shown in Figure 1A and Figure 1B As shown in , the pump face P1002 and the pump backing P1003 can each extend along the upper surface P1004 and the lower surface P1005 of the pump P1000 (e.g., extending laterally as a plane), thereby providing a pump width P(w). The pump face P1002 and the pump backing P1003 can each extend between the lower surface P1005 and the upper surface P1004 in the direction of the first side surface P1006' and the second side surface P1006" of the pump P1000 (e.g., extending longitudinally as a plane), thereby providing a pump length P(1). As shown in Figure 1A As shown in , pump P1000 can also have a height P(h) extending between the pump face P1002 and the pump backing P1003 in the direction of the first side surface P1006' (and / or along the second side surface P1006"). In some embodiments, the face P1002, the backing P1003, the lower side surface P1005, the upper side surface P1004, the first side surface P1006' and the second side surface P1006" provide the outer periphery of the pump.
[0208] In several variations, the infusion pump P1000 includes a pump housing P1001 that encapsulates and / or houses one or more internal components of the infusion pump. Figure 1C As shown in (also in Figure 1A , Figure 1B and Figures 1D to 1F In some embodiments, the pump housing P1001 may include a frame P1001' and a lower portion P1001". In some embodiments, the lower portion P1001" provides a frame to which the frame is assembled and / or connected. Figure 1CAs shown in , a portion of the lower portion P1001" can extend to the pump face P1002. In some embodiments, the lower portion P1001" and / or the frame of the lower portion extends to the face of the pump to provide an upper surface P1004 of the pump P1000. In some embodiments, the upper and lower portions of the housing can be sonically welded together, snap-fit, glued, or otherwise secured to each other. In some embodiments, the connection between the frame and the lower portion (in combination with one or more features) is waterproof and / or water-resistant. In some embodiments, the pump prevents water ingress at a depth of 1m for a time period equal to or at least about: 5 minutes, 10 minutes, 15 minutes, 30 minutes, or within a range spanning and / or including the above values. In some embodiments, the upper and lower portions of the housing can be different materials or the same material. In certain implementations, for example, the lower portion is metal and the upper portion is not metal. In some implementations, the upper portion is polymeric and / or plastic and the lower portion is not. In some embodiments, the lower portion and the upper portion are independently a polymeric material (eg, plastic) or a metal.
[0209] In several embodiments, it has been found that the generally rectangular prism-shaped configuration of the pump P1000 (as shown) advantageously accommodates internal pump components in a compact manner (e.g., suitable for wear). The compact nature of the rectangular prism configuration, as well as one or more other disclosed design features, reduces the volume and increases the ease with which the disclosed infusion system can be worn and / or used. In several embodiments, the compact nature of the design increases user compliance and convenience. Although the rectangular prism provides certain advantages regarding the configuration of the internal components of the pump, in other embodiments, other shapes (e.g., generally cubic, rectangular, cylindrical, elliptical, cylindrical, etc.) may be employed. In some embodiments, as disclosed elsewhere herein, the housing of the pump P1001 has rounded edges to improve shock absorption and / or crack resistance upon impact (e.g., by falling, etc.).
[0210] In certain implementations, the ratio of the length of the pump P1000 to the width of the pump is equal to or at least about: 3:1, 5:2, 2:1, 5:3, 4:3, or a range that spans and / or includes the above ratios. For example, in some embodiments, the ratio of the length of the pump to the width of the pump can be between 3:1 and 2:1, between 5:2 and 5:3, etc. In some configurations, the ratio of the width of the pump P1000 to the height of the pump P1000 is equal to or at least about 7:1, 5:1, 4:1, 3:1, 5:2, or a range that spans and / or includes the above ratios. For example, in some embodiments, the ratio of the width of the pump to the height of the pump can be between 7:1 and 4:1, etc.
[0211] In certain embodiments, such as in Figure 1AAs shown in , the pump P1000 includes a display area P1007. In some embodiments, as disclosed elsewhere herein, the display area P1007 is a display screen and / or a touch screen. In some variations, the display area P1007 can be configured to provide data (e.g., alphanumeric, image-based, etc.) to the user regarding medication levels, medication dosage rates, information regarding blood glucose levels, and / or other diagnostic information. In certain configurations, as disclosed elsewhere herein, the display screen allows the user to adjust medication dispensing or other pump and delivery settings (including one or more control features disclosed herein). In some embodiments, the bezel provides support and / or engagement for the display screen, holding it in place.
[0212] In some embodiments, as in Figure 1A and Figure 1B , the underside surface P1005 of the pump P1000 may include a touch pad P1010. In some embodiments, the touch pad P1010 is a finger pad having a curved indentation configured to receive a user's finger. In several variations, as disclosed elsewhere herein, a capacitive touch sensor may be located below and / or in electronic communication with the finger pad P1010. In other embodiments, additional capacitive touch sensors may be in communication with different surfaces of the pump (e.g., elsewhere on the pump face, pump backing, upper side surface, first side surface, or second side surface).
[0213] In certain variations, additionally or alternatively, the display P1007 may be a capacitive touch sensor and / or the capacitive touch sensor may be located at or behind a portion of the pump face P1002 (e.g., making the display a touch screen). In some embodiments, the capacitive touch sensor of the display P1007 may be activated by touching the display P1007 at a specified location and / or by touching a separate finger pad P1010 (and / or a different surface) of the pump P1000. In some embodiments, the capacitive touch sensor of the display P1007 may be used to control and / or send signals to components within the pump P1000, for example, allowing a user to control one or more aspects of a drug delivered from a reservoir located within the pump. For example, in some embodiments, a user may slide (or drag) a finger in one direction (i.e., left, right, down, up, or other) on the capacitive touch sensor display P1007 to change the delivery capacity (e.g., rate, etc.).
[0214] Pump cartridge container
[0215] Figure 1A and Figure 1BA multi-drug pump P1000 is shown coupled to two cartridge connectors C1001, C1101 (e.g., a first cartridge connector and a second cartridge connector). These cartridge connectors can be configured to attach to different drug cartridges and engage the pump simultaneously via cartridge containers (e.g., a first cartridge container and a second cartridge container). As shown, a first fluid conduit T1001 and a second fluid conduit T1101 are coupled to the first cartridge connector C1001 and the second cartridge connector C1101, respectively. Although in Figure 1A and Figure 1B It is not visible in the , but the drug cartridge can be housed in a chamber that engages with the cartridge connector C1001, cartridge connector C1101. Figure 1A and Figure 1B Also visible are tubing first tube T4001 and second tube T4002, which are configured to provide a fluid path to an infusion set and / or an infusion connector (not shown).
[0216] As in Figure 1C and Figure 1D As shown in FIG. 1 , the pump 1000 includes a cartridge container P1100 , P1110 (eg, a cartridge holder, a cartridge chamber, and / or a cartridge reservoir). As shown, the cartridge container includes a drug container inlet port P1100 ′, P1110 ″. Figure 1C-1F in Figure 1A and Figure 1B The cartridge connectors C1001, C1002 (and Fig.2I 100) has been detached and removed from the pump P1000, such that the cartridge containers P1100, P1110 and the inlet ports P1100', P1110" are visible. In some embodiments, these cartridge containers are configured to accommodate (e.g., receive, secure in place, hold, etc.) drug cartridges M1001, M1101 (e.g., in Fig.2I ).
[0217] As in Figure 1A , Figure 1B and Figures 1D to 1F As shown in , the pump P1000 may include a first medicament chamber P1100 that is different from a second medicament chamber P1110. In some variations, one or more design features (e.g., identification features) of the inlet port P1100', P1110" and / or other features within the cartridge container P1100, P1110 prevent proper engagement of the cartridge connector and / or prevent insertion of an incorrect cartridge into an incorrect chamber. For example, as shown in Figure 1E-1J As shown in FIG, these chambers P1100, P1110 or inlet ports P1100', P1110" may include one or more identification features P1101, P1102, P1103, P1111, P1112, P1113 that prevent or inhibit coupling to an incorrect component.
[0218] In some embodiments, the cartridge container is configured to receive a specific drug bottle and not receive other drug bottles. For example, a given container may be configured not to receive an incorrect drug cartridge (e.g., depending on the diameter, length, size, or shape of the drug cartridge). In other embodiments, the cartridge container may be configured to receive different types of cartridges indiscriminately. In such embodiments, even in the case where a given cartridge container can receive drug cartridges of different shapes and / or cartridges for different drugs (e.g., a first container can receive a glucagon cartridge or an insulin cartridge), miscommunication can still be avoided depending on the cartridge connector and inlet port P1100', P1110".
[0219] For example, as disclosed elsewhere herein, the first cartridge connector C1001 can be configured to engage only a specific drug cartridge M1001 (e.g., a first drug cartridge), while the second cartridge connector C1101 can be configured to engage only a consistent specific drug cartridge M1101 (e.g., a second drug cartridge). Although the pump containers P1100, P1110 themselves may not be configured to prevent the insertion of incorrect drug cartridges, the inlet ports P1100', P1110" may include unique mating features (e.g., identification features) that only allow them to engage specific drug cartridge connectors with consistent mating features. For example, the first container can be configured to engage the first cartridge connector but not the second cartridge connector. The second container can be configured to engage the second cartridge connector but not the first cartridge connector.
[0220] In other embodiments, a given container may be configured to not receive an incorrect drug cartridge (eg, depending on the shape of the drug cartridge) and also not engage an incorrect cartridge connector.
[0221] In some embodiments, the pump is configured to receive the drug cartridge that has been connected to the connector. For example, the drug cartridge can be connected to the barrel connector, and then the pump can receive the barrel and connector (only allowing to engage the appropriate connector and / or barrel) at the same time. Alternatively, or additionally, in some embodiments, the pump can receive the drug cartridge (for example, loosely, without and / or disengage the barrel connector). Then, the pump can be configured to receive the barrel connector in the barrel container on the barrel, wherein the connector can be locked in the appropriate position in the pump (for example, twisted in place). In this embodiment, the connector can be configured to engage the bottle and the pump simultaneously. In the case where the connector or drug cartridge is incorrect for a given container, some identification features can prevent the engagement of the connector. For example, in the case where the barrel and the connector are not paired, the diameter of the barrel is not enough to receive the barrel, thereby preventing the barrel connector from engaging on the barrel, and the barrel connector is maintained at a position too far from the pump that cannot engage the inlet port. Alternatively, the connector can receive an incorrect bottle, but may travel too deep in the container and cannot engage the inlet identification feature of the pump.
[0222] As in Fig.2I As shown in , the inlet port P1100' of the first medicament chamber P1100 can be configured to engage the first cartridge connector C1001 and / or receive the first cartridge M1001. In some embodiments, as shown in the figure, the inlet port P1110" of the second medicament chamber P1110 is configured to engage the second cartridge connector C1101 and / or receive the second cartridge M1101. In some embodiments, the inlet port P1100' of the first medicament chamber P1100 is configured to not engage a cartridge connector (e.g., the second cartridge connector C1101) that is engaged with the second inlet port P1110". In some embodiments, additionally or alternatively, the inlet port P1110" of the second medicament chamber P1110 is configured to not engage a cartridge connector (the first cartridge connector C1001) that is engaged with the first inlet port P1100'. Figure 1D In the embodiment shown in , the first container P1100 is configured to accommodate or receive a cartridge and cartridge connector for a regulator (eg, insulin), while the second drug chamber P1110 is configured to accommodate or receive a cartridge and cartridge connector for a counter-regulator (eg, glucagon).
[0223] As in FIG. 1D to FIG. 1I As shown in, each of the pump chambers P1100, P1110 includes one or more identification features P1101, P1102, P1103, P1111, P1112, P1113, and the identification features P1101, P1102, P1103, P1111, P1112, P1113 are configured to prevent or prohibit miscommunication. As shown in the figure, the feature can be an opening of a protruding shape (for example, a recess, a hole, a through space, a stop groove, a lug groove, a radial lug or a stop shape, a notch, a notch, etc.), configured and / or formed to receive the corresponding protruding features (for example, protrusion, a lug, a lug, a stopper, etc.) of the barrel connector consistent with the pump chamber. These matching features facilitate the attachment of appropriate components and / or prevent the connection of appropriate components. Although in the depicted embodiment, radial recesses (e.g., recesses or notches shaped to receive conforming protruding features) are distributed circumferentially about the inlet ports P1100', P1110", in other embodiments, protrusions (e.g., tabs, lugs, stops) and / or a mixture of protrusions and recesses may be provided on or within the inlet port to prevent or inhibit miscommunication (not shown). In such an embodiment, conforming radial recesses and / or protrusions may be provided on the corresponding barrel connector.
[0224] In some embodiments, as shown, features of the pump container P1100, P1110 may be located proximate to the inlet of the container (eg, at the inlet port P1100', P1110") to allow interaction with a corresponding cartridge connector. Figure 9A-9BAs shown in , the cartridge connectors C1001, C1101 corresponding to the pump containers P1100, P1110, respectively, include conforming protrusions (e.g., tabs, lugs, stops). In some embodiments, these protrusions include lugs C1010, C1011, C1110, C1111 and / or stops C1012, C1112. In some embodiments, as described elsewhere herein, the protrusions (e.g., projections) are configured to mate with (e.g., slide into) conforming openings configured to receive such protrusions. As shown in Figure 1D-1J and Fig. 9B As shown in , each cartridge chamber may have a plurality of identification features configured to mate with corresponding identification features of the cartridge connector. Figure 1D-1J In the embodiment of the present invention, each pump chamber P1100, P1110 includes three radial notches configured to engage with the corresponding cartridge connector C1001, C1101, respectively, as shown in Fig. 9B These identification features can be configured to engage the appropriate connector, to prevent or inhibit engagement of an incorrect cartridge connector (eg, one that does not correspond and does not have one or more coinciding protrusions), or both.
[0225] Although in Figures 1D to 1J In the illustrated embodiment, each inlet port 1100', 1110" has three radial recesses as identification features, but in some embodiments, each pump chamber can independently have one, two, three, four, five or more identification features (e.g., recesses and / or protrusions) configured to receive a consistent identification feature (e.g., protrusion and / or recess) from a corresponding cartridge connector. In addition, as will be apparent herein, while the cartridge container has been described as including recesses and the cartridge connector including protrusions, the opposite configuration is possible (where the recesses are on the cartridge connector and the protrusions are on the container). Likewise, in some embodiments, the types of identification features can be mixed and matched on a particular container or cartridge connector (whereby the container includes protrusions and recesses, and the corresponding cartridge connector has consistent recesses). In yet another variation, the cartridge container may include only recesses, and different cartridge containers in the same pump may include only projections. In such an embodiment, the corresponding cartridge connector groups may include connectors with consistent projections and connectors with consistent recesses, respectively. As an exemplary embodiment, where the first cartridge connector includes five protruding features (e.g., three lugs and two stops; not shown), the corresponding first container (e.g., the first inlet port) will include five recesses to receive these projections (e.g., three lug openings and two stop openings). The second cartridge connector may include four recesses (e.g., two lug openings and two stop openings) configured to engage a corresponding second container, the second container including four projections (e.g., two lugs and two stops) received in the recesses.
[0226] In some embodiments, as in Figures 1D to 1J As shown in , the lug opening and the stop opening can have various different sizes (e.g., circumferential length, radial height, etc.). For example, as shown in Figure 1J As shown in the figure, the lug opening of one cartridge container can be a length lug (1') and the second can be a second length lug (1"), and these lengths can be different from each other and / or different from the lug lengths of the second cartridge container lug (1"'), lug (1""). As shown in the figure, the stop opening of one cartridge container can be a length det(1') that is different from the stop opening length det(1") of the other cartridge container. In some embodiments, these openings are configured to receive a corresponding cartridge connector (e.g., as shown in Fig. 9B ) on the correspondingly sized lugs and stops (e.g., of consistent length).
[0227] As in Figure 1J As shown in , the stop openings and lug openings of two different drug containers P1100, P1110 can have corresponding positions. For example, the stop openings P1103, P1113 for the two inlets P1100', P1110" are located at the 12 o'clock position of the container P1100, P1110, the first lug openings P1101, P1111 are located at the 9 o'clock position, and the second lug openings P1102, P1112 are located at the 3 o'clock position. In some variations, the lugs and stops are not at corresponding positions, or only a portion of the lugs and stops are at corresponding positions. In some embodiments, even if the lug openings and stop openings are at corresponding positions on different inlets (or separate connectors), by providing different features of those equivalent positioning Dimensions that can prevent and / or substantially hinder the attachment of incorrect barrel connectors. It has been discovered that by providing a feature on a first container (e.g., a lug opening, a stop opening, a lug, a stop, etc.) that is at least 15% (e.g., 15% larger or less) different in size than an equivalent feature on a second container (e.g., a feature at the same relative position), miscommunication can be prevented and / or substantially inhibited. In certain implementations, the ratio of the length of a feature on one container to the length of an equivalent feature on a different container is equal to or at least about 3:1, 5:2, 2:1, 5:3, 4:3, 20:17, or a range spanning and / or including the above ratios.
[0228] In certain embodiments, such as in Figure 3D and Fig. 9B As shown in , one or more identification features (e.g., lugs, stops, openings configured to receive lugs or stops, etc.) can be distributed around the periphery of the inlet P1100', P1110" or the cartridge connector C1001, C1101. For example, as shown in Figure 1JAs shown in , the midpoint of one identification feature can be located at the 9 o'clock position and the adjacent identification feature can have a midpoint at 12 o'clock, thereby being 90° apart. In some embodiments, adjacent identification features of inlets P1100', P1110" or connectors C1001, C1101 can be separated by values independently selected from the following: equal to or less than approximately: 180°, 160°, 140°, 120°, 100°, 90°, 80°, 70°, 60°, 50°, 40°, 30°, 20°, 10°, values between the above values, or other values. As shown in Figure 1J and Fig. 9B As shown in , in some embodiments, non-adjacent identification features of inlets P1100', P1110" or connectors C1001, C1101 can be separated by values independently selected from: equal to or less than approximately: 180°, 160°, 140°, 120°, 100°, 90°, 80°, 70°, 60°, 50°, 40°, 30°, 20°, 10°, values between the above values or other values.
[0229] It should be understood that any recess, recess of any size described herein, the position of the recess, or the relationship of the recess to another recess (e.g., a second recess) also applies to projections or relationships between projections. For the sake of brevity, such relationships have been shortened or omitted because they will be readily understood from this disclosure. Likewise, any identification features described with respect to cartridge containers (e.g., notches, projections, etc.) apply to identification features of cartridge connectors, as disclosed elsewhere herein.
[0230] As in Figure 1D-Figure 1I As shown in , in some embodiments, a recess (e.g., a notch, a protruding shaped opening, etc.) can open to tracks P1101', P1103', P1111', P1113' (e.g., a slot, a path, etc.). In some embodiments, these paths travel and / or are circumferentially positioned within the drug container P1100, P1110. In certain variations, once the cartridge connector is inserted into the pump chamber opening, the connector is rotated to lock the cartridge connector in the container. For example, in Figure 1A-1JIn the illustrated embodiment, connector can rotate a quarter turn each, to lock them in place in the pump chamber each.As shown in the figure, in some embodiments, the lug of the tube connector is initially inserted through the lug opening P1101, then rotates a quarter turn to its position below another stop opening P1102 of the pump chamber P1100. The lug advances to its locking position along the lug path.In other embodiments, larger lugs can be positioned below the opening for less lugs.In some embodiments, the alignment of the lugs below the lesser stopper or lesser lug openings prohibits the removal of the tube connector from the pump chamber once locked, because larger lugs can not pass lesser stop openings or lug openings.As mentioned above, when the container inlet comprises a protrusion (not shown), consistent recesses and tracks are positioned on the corresponding tube connector.
[0231] from Figure 1E-1J In the embodiment of the present invention, it can be understood that when using different drugs, the barrel connector can be configured to need to rotate clockwise to lock a barrel connector (and barrel) in the appropriate position in its corresponding container, and need to rotate counterclockwise to lock another barrel connector (and barrel) in the appropriate position in its corresponding container. Therefore, the torsion direction is another optional indicator that allows the user to avoid miscommunication. In another embodiment not shown, the barrel connector and the barrel container can be configured to allow clockwise rotation to lock the barrel in the appropriate position. In another embodiment not shown, the barrel connector and the barrel container can be configured to allow counterclockwise rotation to lock the barrel in the appropriate position.
[0232] In some embodiments, as in Figure 1G and Figure 1HAs shown in , the cartridge container P1100, P1110 may include a first "shallow" stop cam P1103', P1113', which includes a smaller transition angle than a second "steep" stop cam P1103", P1113", which includes a larger transition angle. In some embodiments, when the cartridge connector (and corresponding stop lugs) are inserted into the opening of the corresponding pump chamber, the cartridge connector is rotated in a first direction to lock the connector into the pump chamber. In some embodiments, when the connector is rotated within the container, the stop may abut against the first "shallow" stop cam and then travel on the first "shallow" stop cam until the stop reaches the transition portion P1103'", P1113'. As rotation continues, the stop travels over the transition portion P1103'", P1113'" and passes the second steep stop cam P1103", P1113", to a stop gap configured to receive the stop. At the same time, the lugs reach the end of their tracks, stopping or preventing further twisting of the cartridge connector. The stop gap may be bounded on one side by a second "steep" stop cam P1103", P1113", which would require a larger rotational force in the opposite direction to allow the stop to overcome the second cam and remove the stop from the gap. Therefore, in some embodiments, the combination of different stop cams causes the cartridge connector to require a greater force to remove and / or unlock the cartridge connector from the pump chamber when the cartridge connector is locked into the pump, compared to the initial force required to lock the cartridge connector to the pump chamber. In certain implementations, the ratio of the angle of the steep cam to the angle of the shallow cam is equal to or at least about: 5:1, 3:1, 5:2, 2:1, 5:3, 4:3, or a range spanning and / or including the above ratios. In other embodiments, the steep cam and the shallow cam can be configured to lock the lug in place (instead of or in addition to the stop). As described above, in the case where the container inlet includes a protrusion (not shown), the consistent cam and track are located on the corresponding cartridge connector.
[0233] In some embodiments, as in Figure 1F and Figure 1G As shown in , the container P1100, P1110 may include one or more arm clearance recesses P1105a, P1105b, P1115a, P1115b (e.g., arm extension recesses). In some embodiments, the arm clearance recesses extend a portion of one or more drug containers downwardly (e.g., axially). In some embodiments, these recesses are configured to allow and / or provide space for the arm C1105a, C1105b, C1115a, C1115b on the cartridge connector C1001, C1101 (e.g., Fig.9DIn some embodiments, as disclosed elsewhere in this article, in order to fix the drug cartridge in the pump, first one or more barrels are placed in the pump via pump container P1100, P1110. In some embodiments, as disclosed elsewhere in this article, the barrel connector can then be inserted into the container. When the appropriate barrel connector receives the corresponding barrel via the barrel connector shield, the clamp arm is deployed when the clamp arm crosses the periphery of the drug cartridge cover. The clamp arm recess allows this expansion of the connector and / or barrel of appropriate placement. Once the cover crosses the clamp arm, the clamp arm snaps back to the position where the lip (for example, teeth, edge, step or other cover locking mechanism) engages the drug cartridge cover. In the absence of the clamp arm gap, the clamp arm cannot expand on the cover of the barrel, thereby preventing and / or hindering the connection of inappropriate medicine.
[0234] In certain variations, as described elsewhere herein, the containers themselves can be of different shapes or sizes such that they accept one type of drug cartridge but not another type of drug cartridge. For example, the chambers can have different diameters, shapes, or lengths such that one drug can be received and / or engaged but another drug cannot be received and / or engaged. In some embodiments, for example, as in Figure 2D , the chamber diameter can be different. As disclosed elsewhere in this article, the glucagon chamber can have a lip, which transitions the glucagon chamber from one diameter to another smaller diameter that travels from the entrance to the distal end. In this embodiment, the insulin cartridge may not be inserted into the glucagon chamber. In some embodiments, the glucagon cartridge (which has a smaller diameter) can enter the insulin chamber. However, in some embodiments, the stop ribs at the bottom of the chamber prevent the full insertion of the glucagon cartridge. It will be appreciated that, similarly, the glucagon cartridge can be larger than the insulin chamber to achieve the opposite effect. In some embodiments, the glucagon cartridge includes an insertion stop rib. In some embodiments, the stop rib prevents the glucagon cartridge from being seated low enough to allow connection in the insulin chamber. In other embodiments, the cartridge has the same diameter, and other aspects disclosed in this article can be implemented to avoid miscommunication.
[0235] Pump housing configuration
[0236] In some variations, such as in Figure 2D-Figure 2I As shown in , cartridge containers P1100, P1110 are laterally spaced apart within housing P1001. As indicated elsewhere herein, in some embodiments, when a pump is configured to deliver different drugs (e.g., Figure 1A-Figure 2IIn the case of a pump configured to receive multiple drug cartridges having the same drug (not shown), each drug cartridge container (and / or its inlet) may be different depending on the drug it is configured to receive. Each different container may be configured to receive only a designated drug cartridge and / or cartridge connector, and not another incorrect drug cartridge and / or cartridge connector. Alternatively, in a pump configured to receive multiple drug cartridges having the same drug (not shown), the pump may have drug containers that are identical or substantially identical (although located at different locations within the pump housing).
[0237] In some embodiments, as described elsewhere herein, cross transmission is avoided by providing design features and / or matching connectors or adapters on some parts of the infusion system. For example, in some embodiments, the infusion system includes an infusion pump with one, two or more infusion chambers (or pump chambers). In some variations, the system also includes a barrel filled with different drugs, and a barrel connector and a tube, and the barrel connector and the tube connect the barrel to the infusion pump to prevent the miscommunication or cross transmission of the drug. In some variations, for example, each type of barrel for each type of drug has one or more unique distinguishing features (as an integral part of the barrel or as a part attached to or fixed to the barrel), such as geometric or shape-based features (e.g., protrusions, stops, lugs, holes, feature containers, grooves, etc.), which allow unique connection with a type of connector, the connector itself has unique distinguishing features (e.g., holes, feature containers, grooves, protrusions, stops, lugs, etc.), which engage with corresponding features in the pump housing and allow the correct barrel to be inserted into the correct pump chamber in the infusion pump. In certain embodiments, each type of cartridge for each type of drug has one or more unique distinguishing features (either as an integral part of the cartridge or as a component attached or secured to the cartridge), such as geometric or shape-based features (e.g., protrusions, stops, tabs, holes, feature receptacles, slots, etc.) that allow for a unique connection with a cartridge connector having a unique distinguishing feature (e.g., holes, feature receptacles, slots, protrusions, stops, tabs, etc.).
[0238] As described elsewhere herein, the improved infusion system including the infusion pump P1000 for multiple drugs and multiple connectors ensures, helps ensure and / or substantially helps provide the correct delivery of each drug to the patient. In other words, in the case of multiple drugs supplied by the infusion system, the features and / or components described herein are configured to prevent, minimize or otherwise prohibit the user from accidentally placing the drug in an incorrect barrel or placing the barrel in an incorrect pump chamber. In some embodiments, optionally, in the case of more than one barrel, both barrels can include a single drug (e.g., insulin).
[0239] In some embodiments, as in Figure 2A-2IAs shown in FIG. 1 , PCB P1080 (eg, main PCB) may be located at a position within the pump housing P1001 and between the cartridge containers P1100, P1110. The pump P1001 has a plurality of PCBs as shown in FIG. Figure 2A As shown in the inner area P1008. Figure 2A As shown in , the pump chamber is at least partially isolated from the interior area by chamber walls P1100", P1110". In some embodiments, the power source P1050 can be located at a position within the pump housing P1001 and between the cartridge containers P1100, P1110 (such as in Figure 2B and Figure 2D In some variations, the power source P1050 is an inductively rechargeable battery that can be located below the PCB (as in Figure 2B and Figure 2D In some embodiments, the pump 1000 includes an inductive charging plate P1003' (as shown in Figure 1E ), configured to allow charging of the inductively charged battery P1050. In certain variations, as disclosed elsewhere herein, the infusion pump is configured low to facilitate transportation of the infusion pump in a pocket, on a belt, or under clothing. For example, as in Figure 2A As shown in , the flexible cable P1055 provides input to the motor P1060 of the infusion pump P1000. In some embodiments, the motor P1060 moves the drive gear P1071 (e.g., a pinion) in a gear assembly including four gear components P1071, P1072, P1073, P1074, and facilitates the movement of the lead screws P1152, P1154. The drive paths of the motor and the lead screw are each configured to be parallel to each other and on the same axis as the reservoir. In some implementations, this configuration enables the infusion pump to have a compact design.
[0240] Figure 2D A cross-sectional view of the pump is provided, with planes extending along the length and width of the pump cutting through its height. Figure 2D As shown in , the first drug container P1100 can have a substantially equal inner diameter from the inlet port P1100' to the end of the hole. Figure 2D As shown in, in some embodiments, the second drug container P1110 can have a lip or transition portion where the container transitions from a first inner diameter to a second smaller inner diameter. In some embodiments, the second smaller inner diameter of the second container P1110 is configured to receive a first drug bottle, but not a second drug bottle. In some embodiments, the first drug container can be configured to receive either the first drug bottle or the second drug bottle. In some embodiments, the diameter of the smaller inner diameter is smaller than the diameter of a drug bottle that is not configured to be dispensed from the second drug container.
[0241] Figure 2E A cross-sectional view through the second cartridge container P1110 is shown (with the bezel and display removed). Figure 2F A cross-sectional view through a first cartridge container P1100 is shown (with the bezel and display removed). Fig.2I Another cross-sectional view of the pump is provided, with a plane extending along the length and width of the pump cutting through its height, this time with the cartridge M1001 , M1101 and cartridge connector C1001 , C1101 engaged.
[0242] Figure 4A Another embodiment of the pump P2000 is shown. Although not mentioned for the sake of brevity, Figure 4A all features of the pump embodiment of FIG. 1 , but pump 2000 may have features related to Figure 1A Each feature described in the embodiments of the present invention is not specifically identified unless such feature is explicitly distinguished. In addition, it should be recognized that throughout the present disclosure, similar and / or identical features for separate embodiments of devices or system components (e.g., pumps, connectors, etc.), although not described for each different embodiment, are only numerically offset by a factor of 1000 in the figures (even though they share hundreds, tens, and numbers of values). For example, Figure 4A The characteristics of the container inlet ports P2100', P2110' of the pump P2000 can be Figure 1A The features of the container inlet ports P1100', P1110' of the pump P1000 are the same, although the features of any of these inlet ports may not be specifically described in detail if they are redundant in the description elsewhere in the present disclosure. For convenience, certain features indicated or annotated with reference numerals in some figures and embodiments are not shown or annotated with reference numerals in other figures and embodiments. Unless the context clearly requires otherwise, these omissions should not be interpreted as meaning that features omitted from the drawings of one figure cannot be equivalently incorporated or implemented in the configuration of the disclosed methods, devices, and systems, which are related to or embodied in other figures. On the contrary, unless the context clearly requires otherwise, it should not be assumed that the presence of certain features in some figures of the present disclosure means that the disclosed methods, devices, and systems related to or embodied in these figures must necessarily include these features.
[0243] Figure 4B Shown is the display removed Figure 4A A perspective view of an embodiment of the invention. Figure 4C Shows Figure 4A A perspective view of a lower portion of a housing of an embodiment of the present invention. Figure 4D Shows Figure 4A A perspective view of a lower portion of a housing and a drive nut (e.g., a piston shaft, etc.) of an embodiment of the present invention. Figure 4E shows that the height of the pump 2000 is equally divided Figure 4A As shown in the figure, the pump 2000 is connected to the connector set C2001, C2101 via the first cartridge container inlet P2100' and the second cartridge container inlet P2110' respectively. Also as shown in the figure, the first fluid conduit T2001 and the second fluid conduit T2101 are connected to the first cartridge connector C2001 and the second cartridge connector C2101 respectively.
[0244] As in Figure 2D-Figure 2I and Figure 4E As shown in , in some embodiments, O-rings P1150a, P1150b, P2150a, P2150b are placed within the saddles P1132, P1134, P2132, P2134. In several variations, as disclosed elsewhere herein, these O-rings provide a water-resistant and / or waterproof barrier between the pump chambers P1100, P1110, P2100, P2110 and the interior area P1008, P2008 of the pump. In some embodiments, the saddle is molded into the lower portion of the pump housing P1001", P2001" and / or is an integral part of the lower portion of the housing. In several embodiments, the saddle is located at the bottom of the pump chambers P1100, P1110, P2100, P2110 and / or constitutes a portion of the bottom of the pump chambers. In several embodiments, the saddle P1032, P1034, P2032, P2034 provides a circumferentially inwardly extending bottom of the pump chamber P1100, P1110, P2100, P2110. In some embodiments, the saddle P1132, P1134, P2132, P2134 is configured to engage and / or retain an O-ring P1150a, P1150b, P2150a, P2150b in place. In some embodiments, the O-ring P1150a, P1150b, P2150a, P2150b is configured to seal against and / or engage two drive nuts P1142, P1144, P2142, P2144 (e.g., piston shafts). In some embodiments, the fully retracted drive nut P1142, P1144, P2142, P2144, together with the circumferentially inwardly extending saddle P1132, P1134, P2132, P2134 of the pump, provides a distal end of the pump P1000, P2000 against which the drug cartridge abuts when the drug cartridge is placed in the pump P1000, P2000 (e.g., Fig.2I and Figure 4E ).
[0245] As in Figure 2A , Figure 2B , Figure 2D , Figure 2G , Figure 2H and Figure 4B-Figure 4EAs shown, although the display is removed, when fully assembled, the pump chambers P1100, P1110, P2100, P2110 are isolated and / or separated from the interior regions P1008, P2008 of the pumps P1000, P2000, the saddles P1132, P1134, P2132, P2134, the O-rings P1150a, P1150b, P2150a, P2150b, and the drive nuts P1142, P1144, P2142, P2144. In some embodiments, as Figure 2D-Figure 2I and Figure 4B-Figure 4E As shown, the drive nut P1142, P1144, P2142, P2144 enters the pump container P1100, P1110, P2100, P2110 via the container aperture P1100a, P1110a, P2100a, P2110a. In some embodiments, as disclosed elsewhere herein, an O-ring engages the drive nut P1142, P1144, P2142, P2144 to prevent dirt, grime, water, and / or air from entering the pump interior region P1008, P2008 from the drug cartridge container P1100, P1110, P2100, P2110. In some embodiments, the seal between the O-ring 1150a, P1150b, P2150a, P2150b and the drive nut P1142, P1144, P2142, P2144 is air-tight and / or water-tight as disclosed elsewhere herein. In some embodiments, the seal between the O-ring 1150a, P1150b, P2150a, P2150b and the drive nut P1142, P1144, P2142, P2144 seals the interior area of the pump from the pump chamber in an air-tight and / or water-tight manner.
[0246] In some embodiments, as in Figure 2D-Figure 2I and Figure 4A-4E As shown in , the drive nut P1142, P1144, P2142, P2144 engages and / or interacts with a longitudinally extending and / or internally embedded lead screw P1152, P1154, P2152, P2154. In some embodiments, the lead screw P1152, P1153 is threadedly engaged with a threaded insert P1172, P1174, P2172, P2174, as shown in Figure 2D In some embodiments, as discussed elsewhere herein, the drive nut and threaded insert are secured together (e.g., the threaded insert is sonic welded, glued, or otherwise secured within the drive nut). In some embodiments, as discussed elsewhere herein, the drive nut and threaded insert are secured together (e.g., the threaded insert is sonic welded, glued, or otherwise secured within the drive nut). Fig.2I and Figure 4BAs shown in FIG. 1 , the gears of the motor P1160a, P1160b, P2160a, P2160b drive the gear assembly P1070, P2070 to engage the lead screw P1152, P1154, P2152, P2154, which transmits rotational motion to the threaded insert P1172, P1174, P2172, P2174. In several embodiments, the threaded insert advances along the lead screw, pushing the drive nut P1142, P1144, P2142, P2144 longitudinally forward or backward (e.g., along the length of the pump). In some embodiments, when the drive nut P1142, P1144, P2142, P2144 is pushed forward or backward, the rotational movement of the lead screw P1152, P1154, P2152, P2154 does not rotate the drive nut. In some embodiments, the non-rotation of the first drive nut P1142, P1144 and the second drive nut P2142, P2144 reduces the rotational friction between the drive nut and the first O-ring P1150a, P1150b and the second O-ring P2150a, P2150b, respectively, and / or reduces the rotational friction between the drug cartridge plunger M1005, M1105, respectively.
[0247] As in Figure 2G , Figure 2H , Figure 4C , Figure 4D As shown in and disclosed elsewhere herein, in some embodiments, an O-ring 1150a, P1150b, P2150a, P2150b is received within the drug chamber via the chamber wall P1100", P1110", P2100", P2110. In some embodiments, a threaded insert P1172, P1174, P2172, P2174 is secured to a drive nut P1142, P1144, P214 2, P2144, and when the lead screw P1152, P1154, P2152, P2154 rotates, the threaded insert wrinkles longitudinally along the lead screw, causing the drive nut to extend longitudinally toward the first end of the hole in the drug chamber P1100, P1110, P2100, P2110. In some embodiments, when the drive nut is pushed forward or backward, the rotational movement of the lead screw against the threaded insert is not transmitted to the drive nut. For example, as in Figure 2H and Figure 4DAs shown in, in several embodiments, the first drive nut P1142, P1144 and the second drive nut P2142, P2144 have first tongues P1427a, P1427b and second tongues P2427a, P2427b (e.g., protrusions, tabs, etc.), respectively, which are seated in the first grooves P3128a, 3128b and the second grooves P2428a, P2428b (e.g., tracks, protrusion containers, etc.) and / or are configured to engage the first grooves P3128a, 3128b and the second grooves P2428a, P2428b (e.g., tracks, protrusion containers, etc.) to prevent the drive nuts P1142, P1144, P2142, P2144 from rotating. In some embodiments, one tongue can be larger and the other tongue can be smaller (or differently shaped) to fit into a correspondingly shaped groove of the pump housing. In some embodiments, during the movement of the drive nut and / or drug delivery, an O-ring fixed in and / or at the hole of the barrel chamber remains in place and is circumferentially disposed on the drive nut. In several embodiments, the protrusion can be located on the pump housing, and the protrusion container (e.g., groove, track, etc.) can be located on the drive nut. In some embodiments, not rotating around the drive nut reduces the rotational friction between the drive nut and the O-ring and / or the drug cartridge plunger.
[0248] In some embodiments, as described above, the protrusions P1427a, P1427a of the first drive nut can be shaped differently from the protrusions P1427b, P1427b of the second drug drive nut. In some variations, the first grooves P1428a, 1428b and the second grooves 2428a, 2428b (e.g., tracks) can be shaped differently from each other and can be configured to engage the first protrusions P1427a, P1427b and the second protrusions P2427a, P2427b of the first drive nut and the second drive nut, respectively. In some embodiments, a track can be provided on the drive nut, and a tongue (e.g., a protrusion) can be provided below the drive nut and on the housing, the tongue being in a position to engage with the track of the drive nut.
[0249] In some embodiments, as in Figure 2G As shown in , the first drive nut P1142 (e.g., an elongated cylinder, a piston shaft, etc.) may include an elongated head P1142a having one or more barbs P1142b (e.g., 1, 2, 3, 4 or more). Figure 2GIn the embodiment shown in, the second drive nut (e.g., an elongated cylinder, a piston shaft, etc.) has a flat head P1144a. In some embodiments, the plunger M1005 of the first barrel M1001 (e.g., an insulin barrel) can be threaded. In some embodiments, when the drive nut is pushed forward, the elongated head P1142a slides in the plunger M1005 of the first barrel, and the distal thread in the barb engagement plunger M1005 is fixed to the drive nut P1142. In some embodiments, the features of these barbs help prevent the plunger from lifting off the drive nut. In some embodiments, the plunger M1105 can have enough friction in the second barrel M1101 to avoid lifting off. Therefore, in some embodiments, the second drive nut has no barbs, and the second barrel has no threaded plunger. In some embodiments, the second drive nut may or may not include an elongated head with one or more barbs. In some embodiments, the plunger of the second drug cartridge (e.g., for glucagon) may or may not include threads.
[0250] In some embodiments, as in Figure 2C As shown in , one or more of the cylinders P1142, P1144 include attachment features P1142c, P1144c (e.g., tracks, towing points, handles, etc.). In some embodiments, these attachment features provide a grip for one or more drive nut attachment tools. In some embodiments, the drive nut attachment tool is used to test the pull force (during retraction) or push force (during extension) of the drive nut. In some embodiments, the attachment tool is used to pull the drive nut through the drive nut hole P1100a, P1110a of the housing during assembly, thereby allowing, for example, proper positioning of the lead screw.
[0251] For example, as in Figure 2A As shown in , in some embodiments, the motor P1060 rotates and / or moves the drive gear P1071 (e.g., pinion) in the gear assembly. Figure 2B As shown in , in some embodiments, each gear assembly P1070 (two of which are shown, the first and the second) includes four gear components P1071, P1072, P1073, P1074, and facilitates the rotation of the lead screws P1152, P1154 within the internal area of the pump. In some embodiments, the gear ratio of the gears that are laterally adjacent and / or engaged in the gear assembly can be equal to or at least about 3:1, 4:1, 5:1, 8:1, or ratios that span and / or include the above ratios. In some embodiments, as in Figure 2BAs shown in , the gear configuration in the assembly from the motor pinion to the drive pinion on the lead screw is 4:1, 5:1, 5:1 (e.g., for a total effective gear ratio of 100:1). In several embodiments, the radially adjacent and / or stacked gear configuration enables an infusion pump to have a compact design. In several embodiments, the total effective gear ratio of the gear assembly is equal to or at least about: 200:1, 100:1, 75:1, 50:1, or ratios spanning and / or including the above ratios.
[0252] In some variations, as shown, the gear assembly in the pump may include pinions P1071a, P1072a, P1073a and large gears P1072b, P1073b, P1074b. Figure 2C As shown in , the gear assembly P1070 includes one or more stepped gear components P1072, P1073. The stepped gears include larger gears P1072b, P1073b and smaller gears P1072a, P1073a on the same gear assembly. In some embodiments, the ratio of the diameters of the larger gear and the smaller gear of the stepped gear may be equal to at least about: 3:1, 4:1, 5:1, 8:1, or a ratio spanning and / or including the above ratios. In some embodiments, as disclosed elsewhere herein, a transverse traversing gear assembly with multiple gear steps advantageously allows the height of the pump to be reduced. In addition, the motor can be placed laterally adjacent to its drive nut, which increases the compactness of the design.
[0253] In some embodiments, the diameter of each large gear is similar to each other. This feature advantageously allows the height of the pump to be reduced. For example, if an effective gear ratio of 100:1 is required, three lateral steps can be used (such as in Figure 2C ) to achieve smaller diameter gears, rather than a simple single step of 100:1. In some embodiments, the diameter of each large gear is within about 20% of each other. In some embodiments, the diameters of the large gears differ by equal to or less than 40%, 30%, 20%, 10%, 5%, 0%, or a range spanning and / or including the above values. In some embodiments, the diameter of the largest gear in the gear assembly and the diameter of the second largest gear in the gear assembly differ by equal to or less than 40%, 30%, 20%, 10%, 5%, 0%, or a range spanning and / or including the above values. In some embodiments, the diameter of the largest gear in the gear assembly and the diameter of the third largest gear in the gear assembly (for example, where there are two gears that are larger than the third largest gear in the gear assembly) differ by equal to or less than 40%, 30%, 20%, 10%, 5%, 0%, or a range spanning and / or including the above values.
[0254] In some embodiments, the size of the motor housing relative to the size of the larger gear is within about 20% of each other. In some embodiments, the diameter of the larger gear and the diameter of the motor housing differ by equal to or less than 40%, 30%, 20%, 10%, 5%, 0%, or a range spanning and / or including the above values. This also advantageously reduces the height of the pump.
[0255] In some embodiments, the diameter of the pinion gear is no greater than half the diameter of the large gear. For example, the largest pinion gear will have a diameter less than or equal to half the diameter of the smallest large gear gear. In some embodiments, the diameter of each pinion gear is similar to each other. In some embodiments, the diameter of each pinion gear is within about 20% of each other. In some embodiments, the diameters of the pinion gears differ by equal to or less than 40%, 30%, 20%, 10%, 5%, 0%, or a range spanning and / or including the above values. In some embodiments, the diameter of the smallest gear in the gear assembly and the diameter of the second smallest gear in the gear assembly differ by equal to or less than 40%, 30%, 20%, 10%, 5%, 0%, or a range spanning and / or including the above values. In some embodiments, the diameter of the smallest gear in the gear assembly and the diameter of the third smallest gear in the gear assembly (for example, where there are two gears that are smaller than the third smallest gear in the gear assembly) differ by equal to or less than 40%, 30%, 20%, 10%, 5%, 0%, or a range spanning and / or including the above values.
[0256] In some embodiments, the number of gear components P1071, P1072, P1073, P1074 in the gear assembly P1070 is equal to or at least about: 2, 3, 4, 5, 6 or more. Figure 2B As shown in , each gear assembly of the pump may include 4 gear components. In some embodiments, the number of gears (e.g., gears) including a pinion attached to a lead screw and a drive gear is equal to or at least about: 2, 3, 4, 5, 6 or more. As shown in Figure 2B As shown in , there can be 6 gears in the gear assembly P1070. In some embodiments, the number of gear steps between the pinion gear attached to the lead screw and the drive gear is equal to or at least about: 2, 3, 4, 5 or more. As shown in Figure 2B As shown in FIG. 1 , there may be three gear steps in the gear assembly P1070. In some embodiments, the stepped pinion gears in the gear assembly are stacked, as shown in FIG. Figure 2C as shown in .
[0257] In some embodiments, a stacked configuration (e.g., a transverse stacked configuration) means that at least one line drawn transversely through a particular gear assembly may radially pass through each gear component in the stack (e.g., in FIG. Figure 2CIn some embodiments, as shown in line P1070' in Figure 2C As shown in , at least one line drawn transversely through the stacked gear assembly (shown as a dashed line) radially passes through at least four gears in the assembly. Figure 2C As shown in , different lines drawn transversely through the stacked gear assembly (as shown by the dashed lines) can radially pass through at least two gears in the assembly. In some embodiments, the lines drawn transversely through the stacked gear assembly radially pass through 3, 4, 5 or more gears in the assembly.
[0258] In some embodiments, the gears in the stacked configuration interact with the large gears in an alternating manner (e.g., Figure 2C In some embodiments, as shown in Figure 2C As shown in , the large gear is laterally adjacent and / or radially adjacent to the small gear. In some embodiments, the small gear of the stepped gear P1073 is laterally adjacent and / or radially adjacent to at least two large gears of the adjacent gears P1074, P1072. The drive shaft and the lead screw of the motor are each configured to be parallel to each other and to be on the same axis as the reservoir. In some embodiments, the motor shaft and the lead screw shaft are parallel and are located on the same side of the drive train. In some embodiments, the stacked configuration allows the gear to extend laterally through the motor of the pump. In some embodiments, as described elsewhere herein, the stacked configuration allows a compact height (e.g., in order to achieve the required transmission ratio, multiple gears do not require any individual gear to have a large pump length.
[0259] In some embodiments, a stacked configuration of gears engages the lead screw, threaded insert, and drive nut to provide a telescoping arrangement along the drive nut and lead screw. In some embodiments, this also facilitates a compact design of the pump system. In some embodiments, the length of the drive nut and the drug chamber together (e.g., in Fig.2I The ratio of P(1-P / C) to P(1) is equal to or at least about 5:6, 6:7, 7:8, 9:10, or a ratio that spans and / or includes the above ratios.
[0260] In some embodiments, as disclosed elsewhere herein, the pump housing P1001 houses one or more printed circuit boards (PCBs) P1080, one or more lead screws P1152, P1154, a gear assembly P1070 including one or more gears P1071, P1072, P1073, P1074 for the one or more lead screws P1152, P1154, one or more motors P1060, one or more drug cartridge containers P1100, P1101, a power source P1050, and an antenna P1200. The pump housing P1001 may also house a memory, such as firmware, to store various user settings, control schemes and algorithms, and certain instructions and / or settings related to various characteristics of the patient. For example, the memory may include instructions and / or settings regarding when and how much to dose the patient, as well as other aspects. The pump P1000 can be configured so that a patient or physician can modify (e.g., update, program, or otherwise) the memory, such as by connecting the pump to a computer (e.g., a smart phone, laptop, etc.) equipped with software or "app" configured to enable the computer and / or pump to perform any of the functions, tasks, and / or steps described and / or illustrated herein.
[0261] As in Figure 3A and Figure 3B As shown in , display screen P1007 can have a length P(d1) and a width P(dw). In some embodiments, as shown in Figures P1(Q) and P1(R), the area A(d) of display screen P1007 (measured by multiplying the length P(d1) by the width P(dw)) constitutes a majority of the area A(f) of a face of pump P1002 (measured by multiplying the length of face P(f1) by the width of face P(f1)) and / or substantially all of face P1002 of pump 1000. The area of face A(f) is as shown in Figure 3B As shown in , the area of display A(d) is bounded by the dashed line. In some embodiments, the ratio of the area of the display to the area of the face is equal to or at least about: 4:5, 17:20, 9:10, 19:20, or a ratio spanning and / or including the above values. In some embodiments, the ratio of the length to the width of the display (e.g., aspect ratio) is greater than or equal to about: 4:3, 25:16, 16:9, 21:9, or a ratio spanning and / or including the above values. In some embodiments, the ratio of the length to the width of the pump (e.g., aspect ratio) is equal to or approximately equal to the aspect ratio of the display. In some embodiments, the ratio of the length to the width of the pump (e.g., aspect ratio) is greater than or equal to about: 4:3, 25:16, 16:9, 21:9, or a ratio spanning and / or including the above values.
[0262] As in Figure 3C and Figure 3DAs shown in , the pump housing can have one or more rounded corners when viewed from the bottom P1001b or from the front P1001f. In some embodiments, these rounded corners provide a transition from the side surface of the pump to the underside surface of the pump. It has been noted that corners having a particular radius of curvature impart additional strength to the pump housing. This feature is particularly important when the pump has a large display as disclosed elsewhere herein (e.g., a display that makes up a large portion of the face of the pump). In some embodiments, the pump housing has more than one radius of curvature (e.g., two or more) when viewed from different angles. For example, the pump housing can have a radius of curvature P(r)b as viewed from the bottom of the pump (as shown in Figure 3C As shown in, for example, the radius of curvature P1001b) and the radius of curvature P(r)f as viewed from the front of the pump (as shown in Figure 3D In some embodiments, P(r)b is less than P(r)f. In some embodiments, the ratio of the radius of curvature P(r)b of the fillet as viewed from the bottom to the width of the pump P(w) is equal to or at least about 1:9, 1:6, 1:4, or includes and / or spans the range of the above values. In some embodiments, the ratio of the radius of curvature of the fillet P(r)f as viewed from the front to the height of the pump P(h) is equal to or at least about 1:2, 5:9, 2:3, or includes and / or spans the range of the above values.
[0263] In some embodiments, as in Figure 5A As shown in Figure 1A The bottom P1001"b of the lower portion P1001" of the pump housing P1001 of the embodiment has a radius of curvature P(r)f that is consistent with a circle (as shown by the dashed line). In some embodiments, the bottom P1001"b is defined by the lower half of the height P(h) of the pump 1000. In some embodiments, as in Figure 5A As shown in Figure 4A The bottom P2001"b of the lower portion P2001" of the pump housing P2001 of the embodiment has a plurality of curvature radii P(r)fa, P(r)fb, which are consistent with the elliptical shape of the pump housing P2001, as shown by the dotted lines. It has been noted that by including an elliptical shape (such as Figure 4A In some embodiments, this increased housing strength can advantageously protect the pump and its components from breaking during an accidental drop (e.g., a broken or shattered display, etc.).
[0264] In some variations, increased shell strength is achieved using an elliptical shape characterized by a lower radius of curvature P(r)fb and an upper radius of curvature P(r)fa. In some embodiments, increased shell strength is achieved when the lower radius of curvature P(r)fb is less than the upper radius of curvature P(r)fa. In some embodiments, the ratio of the lower radius of curvature P(r)fb to the upper radius of curvature P(r)fa is equal to or at least approximately: 1:2, 2:3, 4:5, 9:10, or a ratio spanning and / or including the above values. In some embodiments, the elliptical configuration adds shell material (e.g., between the container inlet port P2100' and the perimeter of the pump P2001) Figure 5A denoted by the double arrows).
[0265] Capacitive touch sensor
[0266] As disclosed elsewhere herein, Figure 1A Embodiments of a mobile pump P1000 are described. In some embodiments, the finger pad P1010 is a curved indentation and provides access to a capacitive sensor wake-up feature. In several embodiments, the wake-up feature is activated by touching a fingerprint recognition pad, a tactile sensor, and / or by pressing a button provided by the curved indentation P1010. In several embodiments, the capacitive sensor of the finger pad P1010 can be located close to the curved indentation so that it can sense changes in capacitance that occur when a finger is placed in the curved indentation P1010. In several implementations, the surface of the curved indentation P1010 is closer to the internal electronics of the mobile medical device than the surface surrounding the curved indentation P1010 (e.g., the lower surface P1005). The capacitive sensor can be placed so that the capacitive sensor is only activated when the curved indentation P1010 is pressed or touched by a user. As in Figure 1A As shown in FIG. , the curved indentation P1010 can be shaped in a concave manner and / or fit a finger (or shaped to fit a different body part, such as a thumb).
[0267] As shown, the curved indentation P1010 can be formed in the bezel P1001' of the pump P1000. One advantage of having the curved indentation P1010 formed as the bezel P1001' is that the curved indentation P1010 for the wake button does not add a water entry point to the pump P1000. In some embodiments, as shown, the curved indentation P1010 is placed on the lower portion P1005 of the pump 1000, although it can be located on any other surface P1002, P1003, P1004, P1006', P1006" of the pump 1000.
[0268] In several implementations, as described elsewhere herein, the pump can be made in a variety of shapes. Figure 1AAs shown in , the pump can have a flat brick-like shape with six faces. When the curved indentation P1010 is placed on the end faces P1004, P1005 or the side faces P1006', P1006" of the pump 1000, the curved indentation P1010 does not occupy the space of one of the larger faces P1002, P1003, leaving more space for a display screen and / or an inductive charging plate.
[0269] Figure 5B A cross-sectional view of an embodiment of the pump P1000, pump P2000, cut by a plane extending along the length and height of the pump and through the width. Figure 5B As shown in , the bending indentations P1010 and P2010 are equally divided, and the electronic devices behind the bending indentations P1010 and P2010 are visible. Figure 5B-Figure 6B As shown in FIG, capacitive sensor plates 1020, 2020 contact at least a portion of an interior portion of finger pads P1010, P2010 (e.g., within the pump housing and the interior of the pump) through an intermediate material P1021. In several embodiments, capacitive signals are received by finger pads P1010, P2010, transmitted to capacitive sensor plates P1020, P2020, and sent to plates P1030, P2030 that are in electronic communication with PCBs P1080, P2080.
[0270] In several embodiments, the capacitive sensor plate P1020, P2020 may be any conductive metal plate that provides a conductive path from the finger pad P1010, P2010 to the plate P1030, P2030. In some embodiments, the capacitive sensor plate P1020, P2020 is a copper plate. In several embodiments, the close proximity of the capacitive sensor plate P1020, P2020 to the curved indentations of the finger pads P1010, P2010 allows the capacitive sensor plate P1020, P2020 to detect changes in capacitance caused by a user placing a finger on the curved indentations P1010, P2010. In several embodiments, the logic level of the capacitive signal is reversible.
[0271] In some embodiments, a conductive foam (eg, an intermediate material) is placed between the capacitive sensor plates P1020, P2020 and the curved indentations P1010, P2010. One embodiment of the conductive foam P1021 is a foam such as Fig. 6A As shown in the figure, the conductive foam P1021 is crushed and / or deformed between the bending indentation P1010 and the capacitive touch pad P1020, thereby forming a large amount of contact between the bending indentation P1010 and the capacitive touch pad P1020. Figure 6BAnother view of the conductive foam is shown, which is sandwiched between the frame and the plate P1030. Various conductive foam materials can be placed between the capacitive sensor plates P1020, P2020 and the bending indentations P1010, P2010. In several embodiments, the conductive foam material is a polyurethane foam coated with nickel and copper. In several embodiments, the foam is a sponge-like material. In some embodiments, when installed, the foam deforms and / or crushes to provide contact between the finger pads P1010, P2010 and the capacitive sensor plates P1020, P2020. The conductive foam can be used for a variety of purposes. In several embodiments, the conductive foam is configured to allow the capacitive sensor plates P1020, P2020 to be placed further away from the bending indentations P1010, P2010. In several embodiments, this feature creates a larger space tolerance in the device. In some variations, the conductive foam is configured to reduce the sensitivity of the capacitive sensor plates P1020 , P2020 and / or tune the sensitivity of the capacitive sensor plates P1020 , P2020 .
[0272] In several variations, the capacitive signal is transmitted to the board P1030, P2030 via the capacitive sensor board P1020, P2020. In several implementations, the board P1030, P2030 is configured to transmit the signal to an integrated circuit. In some embodiments, the integrated circuit has a programmable threshold configured to compare the capacitance change. In some implementations, when the programmable threshold is met, the integrated circuit can transmit a signal corresponding to the satisfied programmable threshold to the signal processing component of the pump 1000, 2000. In some implementations, the signal processing component can be configured to generate a wake-up signal when the signal processing component receives the signal from the integrated circuit. The signal processing component can also be configured to generate a wake-up signal only when the integrated circuit meets a specific programmable threshold.
[0273] In certain variations, the curved indentations P1010, P2010 as disclosed elsewhere herein are shaped to fit a user's fingers. The curved indentations P1010, P2010 may be shaped to various sizes to fit various sized fingers of different users. In some implementations, the increased surface area of the curved indentations P1010, P2010 may achieve the purpose of increasing the potential change in capacitance generated by the user's fingers. Thus, in some embodiments, the indentations may be configured to typically interact with adult-sized fingers or child-sized fingers. In some implementations, the curved indentations are configured to recognize a user's fingerprint. In certain implementations, fingerprint recognition is used as a security feature and may ensure that only certain users are allowed to access specific functions of the pump and / or wake up the system (e.g., to set specific pump and / or control parameters).
[0274] In some embodiments, as disclosed elsewhere herein, the curved indentations P1010, P2010 of the pumps 1000, 2000 prevent accidental activation of the mobile medical device by allowing only shapes that match the curved indentations P1010, P2010 to press against the surface of the curved indentations. In some embodiments, because the curved indentations are relatively narrow, a user's appendages, such as the user's arms or elbows, are less likely to penetrate the curved indentations (e.g., preventing or minimizing accidental activation) in addition to the user's fingers. In some embodiments, the concave shape of the curved indentations P1010, P2010 can have a size that prevents accidental contact with the surface of the curved indentations because objects larger than the curved indentations are unlikely to enter the curved indentations. In some embodiments, as described above, the curved indentations P1010, P2010 can be configured to identify a particular user with the aid of a fingerprint. In some embodiments, fingerprint recognition can also prevent users from accidentally activating the system.
[0275] Fig. 6A is an illustration of a pump 1000 with a capacitive sensor wake-up button, which is shown with a transparent bezel. Bezel P1001' connects the display to the pump 1000. In some embodiments, where the bezel is non-metallic, a change in capacitance can be measured when a finger presses on the bezel. Fig. 6A A transparent border in provides a view of the components beneath the border. Fig. 6A In some embodiments, the capacitive sensor plate P1020 can detect the change in capacitance generated by the user's finger when the user's finger is pressed into the curved indentation of the finger pad P1010. In some embodiments, the capacitive sensor plate P1020 is mounted on the plate P1030. In some variations, the signal generated at the capacitive sensor plate is transmitted to the plate and then transmitted to the integrated circuit. Several variations of integrated circuits configured to detect capacitance changes are publicly available. In some embodiments, the integrated circuit detects the capacitance change of the signal transmitted to the integrated circuit, entering the mobile medical device (e.g., a pump). The integrated circuit can detect the capacitance change by measuring the change in voltage on the measuring circuit.
[0276] In various embodiments, the conductive foam P1021 can be located on the capacitive sensor plate P1020. As described elsewhere herein, the conductive foam P1021 can effectively expand the range of the capacitive sensor plate P1020 by approximately the size of the conductive foam P1021. In some embodiments, the conductive foam P1021 can be used to reduce the sensitivity of the capacitive sensor plate P1020 and / or the conductive foam P1021 can be used to tune the sensitivity of the capacitive sensor plate P1020.
[0277] Figure 6C is a schematic diagram showing components of an embodiment of a capacitive sensor in a pump. The capacitive sensor may include one or more of a curved indentation P1010, a conductive foam P1021, a metal conductor plate P1020, a board P1030, and an integrated circuit board P1035. In some embodiments, as shown, the curved indentation P1010 may be a circular depression in the surface of the frame of the pump. In some embodiments, the curved indentation P1010 is incorporated into the frame so that the curved indentation P1010 is seamless with no entry points for liquid. In some embodiments, the curved indentation P1010 may be shaped to fit with the tip of a user's finger when the user's finger is pressed into the curved indentation.
[0278] In some embodiments, the conductive foam P1021 is located on top of the metal conductor plate P1020. In some implementations, the capacitance is measured at the metal conductor plate P1020. In several variations, the conductive foam P1021 is located on top of the metal conductor plate P1020 and effectively expands the capacitance sensing range of the metal conductor plate P1020 to the length of the conductive foam P1021 extending from the metal conductor plate P1020. In several variations, the conductive foam P1021 can be used to reduce the sensitivity of the capacitance measured at the metal conductor plate P1020. In several embodiments, because the conductive foam P1021 can be used to reduce the sensitivity of the capacitance measured at the metal conductor plate P1020, the sensitivity of the capacitance can be tuned by adjusting the size of the conductive foam P1021. In several embodiments, the metal conductor plate P1020 can be made of and / or include a conductive metal such as copper. In several embodiments, the conductive foam P1021 can be made of a conductive foam material. In some embodiments, the conductive foam is a polyurethane material coated with copper and / or nickel. In various embodiments, the conductive foam P1021 is a polyurethane foam surrounded by conductive fabric.
[0279] In several embodiments, as described elsewhere herein, the signal generated at the metallic conductor plate P1020 is transmitted to the plate P1030. In some variations, the plate P1030 may connect the metallic conductor plate P1020 to an integrated circuit P1035. In some variations, the integrated circuit P1035 may be configured to determine that the signal generated by the metallic conductor plate P1020 represents a change in capacitance. The integrated circuit P1035 may detect a change in capacitance by measuring a change in voltage in a circuit that connects the integrated circuit P1025 to the metallic conductor plate P1020 and the conductive foam P1021 through the plate P1030.
[0280] Fig.6Dis a schematic diagram showing the components of a pump 1000 with a capacitive sensor. The pump with a capacitive sensor includes a frame P1001' having a curved indentation P1010, a conductive foam P1021, a metal conductor plate P1020, a secondary PCB board P1030, and a capacitive sensor P1020. In some embodiments, the frame P1001' partially covers the outside of the pump 1000. In several embodiments, the curved indentation P1010 in the frame P1001' is where the user's finger can be pressed to generate a wake-up signal. As shown in the figure, in some embodiments, the conductive foam is located on top of the metal conductor plate. In some embodiments, a change in capacitance can be detected at the metal conductor plate. In some embodiments, the conductive foam can expand the range of capacitance that can be measured at the metal conductor plate P1022 through the size of the conductive foam P1021. In some embodiments, if the conductive foam P1021 is moved closer to the vicinity of the bending indentation P1010, the metal conductor plate P1022 will detect a stronger change in capacitance by pressing a finger into the bending indentation P1010. Therefore, in several embodiments, the distance to the bottom of the bending indentation P1011 is small to increase the detectable capacitance change. In some embodiments, the capacitance signal detected by the metal conductor plate P1022 can be transmitted through the PCB board to the capacitance sensor P1020, where the signal is converted into computer-readable data. In some embodiments, the capacitance sensor P1021 can generate computer-readable data of the capacitance measured at the metal conductor plate P1021 by measuring the voltage change on the circuit passing through the metal conductor plate P1022. In some embodiments, the capacitance sensor P1020 can be programmed to send an activation signal at a variable capacitance level.
[0281] Fig. 6EFlowchart of a process for preventing accidental treatment on a mobile infusion system (e.g., a system including an infusion pump and / or the pump itself as described elsewhere herein). The pump includes a curved indentation and a capacitive sensor. In step P0605, the pump may generate a wake-up signal after the capacitive sensor detects a user's touch in the curved indentation of the medical device. The curved indentation is a recessed indentation in the frame of the mobile system. The user's finger may be pressed into the curved indentation to generate a wake-up signal. The capacitive sensor may detect a change in capacitance generated by the user's finger. Once the capacitive sensor detects the change in capacitance, the mobile medical device may generate a wake-up signal. In step P0610, the pump may activate the touch screen display after receiving the wake-up signal. In some embodiments, the touch screen display may prompt the user to enter a first gesture after the pump generates the wake-up signal. The first gesture may be a series of inputs that the user may enter on the touch screen display of the pump. In step P0615, the pump (and / or the infusion system) may unlock the treatment change user interface after receiving the first gesture on the touch screen display. In some embodiments, the first gesture is a series of inputs entered on the touch screen display. In various embodiments, the touch screen display shows an alphanumeric keyboard where the user may enter a password. In step P0620, the pump can receive a request for a therapeutic change on the touch screen display. The request for a therapeutic change can be made by the user selecting a therapeutic change. The therapeutic change can be used for a variety of medications. In some embodiments, the therapeutic change is a hormone that the pump (and / or infusion system) can deliver to the user. In step P0625, the pump (and / or another component of the infusion system) can receive a second gesture before delivering the medication based on the therapeutic change. The second gesture can be a series of inputs. In some embodiments, the second gesture includes detecting a change in capacitance by the user pressing a curved indentation. Optionally, in various embodiments, pressing the curved indentation after receiving the request for a therapeutic change and before receiving the second gesture can cancel the therapeutic change and lock the mobile medical device.
[0282] Fig. 6Fis another schematic diagram showing components of a pump P1000 having a capacitive sensor activated by a user. In some embodiments, a user's finger can press into the curved indentation P1010 to activate a mobile medical device (e.g., a pump and / or an infusion system of an infusion system). In some embodiments, the curved indentation P1010 portion of the bezel P1001' has a larger surface area than the uncurved portion of the bezel P1001'. In some embodiments, when the user's finger presses into the curved indentation P1010, the increased surface area of the curved indentation P1010 allows a higher capacitance to be detected. In some embodiments, when the user presses the curved indentation P1010, the metal conductor plate P1022 can detect the capacitance of the finger. In some embodiments, space requirements in the mobile medical device may prohibit close placement of the metal conductor plate P1022 with the curved indentation P1010. In some embodiments, the conductive foam P1021 may be placed between the bending indentation P1010 and the metal conductor plate P1022 to expand the capacitance measurement range of the metal conductor plate P1022. In some embodiments, the conductive foam P1021 may be a conductive foam material. In some embodiments, polyurethane foam coated with nickel and copper is used as the conductive foam P1021. In various embodiments, the conductive foam P1021 is a polyurethane foam covered in a conductive fabric. In some embodiments, a capacitance signal initialized by a user pressing a finger into the bending indentation P1010 is detected at the metal conductor plate P1022 and transmitted to the capacitance sensor P1020 through the PCB board P1030. The capacitance sensor P1020 may be programmed to transmit an activation signal when it detects various capacitance measurements. In some embodiments, the capacitance sensor may be programmed to transmit an activation signal from a capacitance signal generated when the bending indentation P1010 is substantially covered by human skin.
[0283] Figure 6G is an illustration of a capacitive sensing plate P1020 on a PCB P1030. In some embodiments, the capacitive sensing plate P1020 may be made of various conductive metal or metal alloy materials. In some embodiments, the capacitive sensing plate P1020 is copper. In some embodiments, the capacitive sensing plate P1020 may be connected to an integrated circuit that may convert a capacitive signal into machine-readable data through the bottom of the PCB P1030. In some embodiments, the capacitive sensing plate P1022 may detect a change in capacitance when the surface of a user's finger presses close to the surface of the capacitive sensing plate. The PCB P1030 may have a square GND opening P1024 surrounding the capacitive sensing plate P1020. In some embodiments, the GND opening P1024 is a square pattern of copper on the PCB P1030 that may be used to isolate the capacitive sensing plate P1020 from other sensors and traces in the PCB P1030.
[0284] In some embodiments, in order to prevent accidental activation of a treatment change of the pump (e.g., a change in the setting of a drug delivery schedule, etc.), it is desirable to strike a balance between ease of use and complexity to avoid accidental actions. In several embodiments, the subject matter prevents accidental activation of a treatment change by requiring a series of activations. In several embodiments, the activations must be combined in a specific order to activate the treatment change. In several embodiments, the pump includes a wake-up button (e.g., a finger pad P1010) and a touch screen display (e.g., a display screen P1007). In several embodiments, the wake-up button can be any type of button that registers a single input to generate a wake-up signal. An example of a wake-up button can be a capacitive button. Another example of a wake-up button is a mechanical button. In various embodiments, the wake-up signal is generated by a sensor. In some variations, the wake-up signal can be generated by a biometric sensor such as a fingerprint reader or a retinal scanner. The wake-up signal can also be generated by a proximity sensor. The wake-up signal can be generated by an accelerometer or a gyroscope or a combination of an accelerometer and a gyroscope. The wake-up signal can also be generated by an optical sensor. In various embodiments, the wake-up signal is generated by entering a password into an alphanumeric keyboard. In various embodiments, the wake-up signal is generated by using facial recognition. In various implementations, the wake-up signal may be generated by a wireless signal such as RFID and Bluetooth.
[0285] In some variations, the touch screen display can be any input surface that displays graphic images and text and registers the location of a touch on the input surface. The graphic images and text can be displayed by any display technology, including but not limited to OLED, LCD, or electronic ink. The touch can be registered by any type of technology. An example of a touch screen display that registers a touch is a capacitive display. Another example of a touch screen display that registers a touch is a resistive display.
[0286] In some embodiments, the wake-up button is a capacitive touch sensor. The capacitive touch sensor is located within a curved indentation. In some embodiments, the curved indentation is a convex indentation that is unlikely to be accidentally pressed by sliding the mobile medical device. The capacitive touch sensor may include a copper plate on a circuit board as close as possible to the surface touched by the finger. The capacitive sensing control integrated circuit measures the capacitance of the copper plate by applying a voltage to the circuit. In some embodiments, when a finger is present, the finger will add capacitance to the circuit, and the capacitive sensing control integrated circuit will detect the change in voltage. The capacitive sensing control integrated circuit has a programmable threshold that is used to compare the capacitance change and determine when a finger appears on the wake-up button. In some embodiments, the logic level of the capacitive signal is reversible and will return to a low capacitance measurement when the finger is removed from the wake-up button.
[0287] In some embodiments, in order to obtain high capacitance (maximum signal-to-noise ratio) when a finger is placed on a capacitive touch sensor, the design includes a scalloped indentation or a curved indentation to shrink the gap between the touchable surface and the capacitive sensing surface. In some embodiments, the touchable surface is the outer wall of the device. In some variations, the outer wall of the device is in a plastic housing or frame. In some embodiments, the capacitive sensing surface is a copper plate. In some embodiments, the curved indentation also provides visual and tactile cues that guide the finger to the optimal position to add capacitance to the sensor. In addition, in order to increase the maximum signal-to-noise ratio, the surface area of the copper plate is maximized, wherein when the finger is pressed into the curved indentation, the copper plate will be placed almost parallel to the finger. In some embodiments, in order to increase the maximum signal-to-noise ratio, the circuit board with the copper plate is moved as close to the curved indentation as possible while maintaining the tolerances and mechanical requirements of the mobile medical device. In some embodiments, in order to increase the signal-to-noise ratio, a conductive foam is added to the copper plate (as disclosed elsewhere herein), which effectively lifts the capacitive sensing surface of the copper plate to a position closer to the curved indentation and the finger.
[0288] In some embodiments, pressing the wake-up button is sufficient to engage the display screen to change the device setting. In other embodiments, a series of activations is required. In some embodiments, the series of activations begins by pressing the wake-up button for a set amount of time to unlock the medical device. In various embodiments, the wake-up button must be pressed for at least 0.5 seconds and less than 1.5 seconds to unlock the device. In some embodiments, the device can provide tactile feedback to indicate the time period required for the wake-up button to be held.
[0289] In some embodiments, after the wake button is pressed (and / or, as the case may be, if held for the correct period of time), the touch screen display activates. In various embodiments, a touch on the touch screen display is not registered until the wake button unlocks the touch screen display. In some embodiments, the touch screen display remains locked from accepting any user input until a gesture is performed on the display. In some embodiments, a gesture (e.g., a finger swipe, a series of swipes, touching a specific area of the screen, etc.) unlocks the device setting.
[0290] In some embodiments, after the display is activated, the next activation is a gesture (e.g., a complex gesture) for unlocking the treatment change user interface. In some embodiments, the complex gesture can be any series of inputs on the touch screen display. An example of a complex gesture is a swipe. Another example of a complex gesture is inputting a predetermined touch sequence (e.g., a combination of swiping, swiping to form a shape, pressing a code in an alphanumeric manner, etc.). Once the treatment change user interface is unlocked by the correct complex gesture, the treatment change interaction can be initiated using the touch screen display. In some embodiments, the treatment change interaction will allow the user to select a treatment change. In some embodiments, once a treatment change is selected, another final activation can be performed to deliver the treatment change. In an exemplary embodiment, the final activation is a second complex gesture. The second complex gesture can be a swipe, a predetermined touch sequence, or any other touch sequence on the touch screen display. In some embodiments, once the second complex gesture is successfully completed, the treatment change will take effect.
[0291] In some embodiments, the initial or final activation is performed by a sensor. In some embodiments, the initial or final activation is performed by a biometric sensor (such as a fingerprint or retinal scanner). In another example, the initial or final activation is performed by a proximity sensor. In some embodiments, the initial or final activation is performed by an accelerometer, a gyroscope, or a combination of an accelerometer and a gyroscope. In some embodiments, the initial or final activation is performed by an optical sensor such as a visible light sensor or an IR sensor. In addition, in an exemplary embodiment, the initial or final activation is performed by positive facial recognition. In addition, in an exemplary embodiment, the initial or final activation can be performed by entering a password on an alphanumeric keypad. In addition, in an exemplary embodiment, the initial or final activation can be performed by a wireless signal such as an RFID or Bluetooth.
[0292] In some embodiments, the pump and / or system can have a timeout such that if no interaction occurs within a set period of time, the screen will turn off and the therapy change request process must be restarted (e.g., to make the change). In some embodiments of the timeout, if no interaction occurs for more than 10 seconds, 15 seconds, 30 seconds, or longer after activation of the wake button and before the second gesture, the touch screen display is deactivated. In some embodiments, if no interaction occurs for more than 30 seconds after activation of the wake button and before the first gesture, the touch screen display is deactivated. In some embodiments, if no interaction occurs for more than 30 seconds after the first gesture and before the second gesture, the touch screen display is deactivated. Additionally, in some embodiments, pressing the wake button while the touch screen display is activated will deactivate the touch screen display.
[0293] Pump housing frame and antenna
[0294] As stated elsewhere in this article, Figure 1C A view of a pump is provided that can be part of a mobile infusion system. In some embodiments, a portion of the housing can be metal, molded plastic, or other suitable material (e.g., a lower portion P1006', etc.). In some embodiments, the metal housing forms an exterior portion of the pump P1000 or at least a portion of an exterior portion (e.g., a lower portion P1001"). In some embodiments, the metal housing is the lower portion P1001" of the pump and forms at least the bottom and sides of the pump P1000. In some embodiments, a bezel is attached to the lower portion of the housing so that together they form a watertight seal (as disclosed elsewhere herein). In some embodiments, the bezel P1001' is made of a plastic material or a non-metallic material, although in other embodiments, the bezel can be metal. In some embodiments, the bezel includes a curved indentation P1010 for activating a capacitive touch interface (as disclosed elsewhere herein). In some embodiments, the bezel holds a display P1007 (e.g., a touch screen display). In some embodiments, as disclosed elsewhere herein, the finger pad P1010 provides a depression (e.g., a concave portion, a curved indentation, etc.) to accommodate a user's finger. In other embodiments, the finger pad is elevated, protruding, and / or flush with the surrounding bezel (but referred to as a traction pad, a dimple, an indentation extending around the perimeter of the touch pad, etc.). In some embodiments, as disclosed elsewhere herein, the curved indentation P1010 can detect a finger touch by sensing a change in capacitance using a capacitive sensor on a circuit board located below the bezel.
[0295] Fig. 7A is an illustration of another pump P3000 embodiment. As noted above, for the sake of brevity, not all features of each pump embodiment are mentioned, although any pump 1000, 2000, 3000 may have each feature described with respect to another pump embodiment (except for features that are explicitly distinguished). In addition, as noted above, it should be recognized that throughout this disclosure, similar and / or identical features for separate embodiments of devices or system components (e.g., pumps, connectors, etc.), while not described for each different embodiment, are only offset by a factor of 1000 in the figures (although they share hundreds, tens, and a few values). For example, Fig. 7A The pump P3000 and the container P3100 and P3110 can be characterized with Figure 1A The characteristics of the pump P1000 and the containers P1100 and P1110 are the same (or vice versa), although Fig. 7A The features of the pump P3000 may not be specifically described in detail where they are redundant. Fig. 7AThe pump P3000 and the container P3100 and P3110 can be characterized with Figure 4A The pump P2000 has the same characteristics as the containers P2100, P2110 (or vice versa), although Fig. 7A Features of the pump P3000 may not be specifically described in detail where they are redundant. In addition, even where specific features are not highlighted with numerical callouts in the drawings, they may be present as will be apparent from the drawings themselves.
[0296] As shown, the pump P3000 is provided with the display removed. The lower portion P3001″ of the housing P3001 forms the exterior of the mobile medical device. A bezel P3001' (which provides the upper portion of the housing) is attached to the top of the lower portion P3001″ of the housing. In several embodiments, the circuit board P1030 is attached to the inner side of the bezel P3001'. In some embodiments, as disclosed elsewhere herein, the circuit board P3030 has a capacitive sensor consistent with a curved indentation for capacitive touch. In several variations, the circuit board P3030 is perpendicular to the metal housing, the lower surface of the housing, and parallel to a portion of the bezel. The bezel can be made of a material that allows RF signals to pass through. The main board P3080 (e.g., main PCB board P1080) controls any function of the infusion system that is not controlled by the circuit board P1030.
[0297] Figure 7B is an illustration of an exploded view of a portion of the pump. The lower portion of the housing P3001" (e.g., the metal portion of the housing) is separated from the frame P3001' at the top. As shown, in some embodiments, an antenna P3039 is provided. In several variations, as shown, the antenna P3039 is fixed to the secondary circuit board P3030. In several embodiments, the antenna P3039 sends and receives wireless signals (e.g., radio frequency, Bluetooth, etc.). In several embodiments, the antenna P3029 is parallel to the frame to receive wireless signals and / or extends along the length of a portion of the frame. In some embodiments, the main board P3080 controls pump features that are not controlled by the secondary circuit board P3030. In several embodiments, the secondary circuit board P3030 can have a capacitive touch pad P3020, and when a user places a finger into the curved indentation for capacitive touch P3010, a change in capacitance can be sensed.
[0298] Figure 7C yes( Figure 1AAnother illustration of a pump of the type shown in FIG. 1 , wherein the frame is made transparent. In some variations, the lower portion of the housing P1001″ forms at least the bottom and sides of the pump. A transparent frame P1001′ is attached to the top of the lower portion of the housing P1001″. In some embodiments, a circuit board P1030 is parallel to the transparent frame and the lower portion of the housing. In some embodiments, an antenna chip P1039 is attached to the circuit board P1030, which extends parallel to and in line with a capacitive sensor board P1020, which is configured to receive input from the finger pad P1010. In several embodiments, the antenna chip P1039 is a protruding structure perpendicular to the frame. In several embodiments, the antenna chip P1039 can receive and send wireless signals using Bluetooth, LTE, 3G, etc. In several embodiments, the signals generated by the pump are wirelessly transmitted to a user (e.g., a practitioner, a parent of a child, a patient / wearer of the device, etc.) interface on a phone or computer, etc. In several embodiments, the lower portion of the shell is located below the antenna chip P1039 (e.g., the portion of the lower portion near and / or adjacent to the antenna chip terminates at a height below the height of the antenna chip). In some embodiments, the position of the antenna relative to the shell P1001" substantially avoids, substantially prevents, and / or prevents interference with wireless signals. In some embodiments, no metal portion of the shell will intersect with the antenna's signal. In some variations, the antenna chip P1039 is parallel to the bend indentation P1010. In several embodiments, the bend indentation P1010 is above the capacitive touch pad P1020 (at a higher height than the capacitive touch pad P1020).
[0299] Fig.7D is an illustration of the pump with the bezel removed, wherein the lower portion of the housing is shown as transparent. As described elsewhere herein, in some embodiments, the lower portion of the housing P1001" is metal. In some variations, the metal housing P1001" forms at least the lower portion of the pump. Antenna P1039 is located above the metal housing and is attached to circuit board P1030. Antenna P1039 is located above the metal housing P1001" so that antenna P1039 can receive and transmit wireless signals without interference. In some embodiments, antenna P1039 can receive and transmit wireless signals using Bluetooth, LTE, or 3G. In some implementations, the capacitive touch pad P1020 is parallel to antenna P1039.
[0300] In some embodiments, at least a portion of the side wall of the pump is covered only by the frame. In some embodiments, the circuit board is positioned adjacent to the inner surface of the frame. In some embodiments, the wireless antenna is secured to the circuit board such that the wireless antenna is positioned toward the portion of the side wall of the mobile medical device that is covered only by the frame. In some embodiments, a conductive layer of the circuit board is removed from a portion of the circuit board secured to the wireless antenna. In some embodiments, a portion of the circuit board is positioned within the portion of the side wall of the mobile medical device that is covered only by the frame. In some embodiments, the wireless antenna extends toward the portion of one side of the mobile medical device that is covered only by the frame.
[0301] Error detection system
[0302] Fig. 7E is an illustration of a portion of a pump P3000. In some embodiments, a pump P1000, P2000, P3000 as disclosed herein comprises an error detection system. In some embodiments, the error detection system is configured to determine when a calculated rate and / or amount of drug dispensed (e.g., indicated by energy input to the motor) differs from an actual rate or amount of drug dispensed (calculated by the number of revolutions of the lead screw). Fig. 7E The view of shows an embodiment of the output shaft angular position error detection system. In some implementations, the output shaft angular position error detection system determines that there is an error in delivering the drug from the pump. For example, in some embodiments, the sensor P3426 allows the pump to determine whether the rotation of the lead screw P3430 is not synchronized (and / or not properly calibrated) with the rotation of the motor P3060. In some embodiments, the pump includes more than one sensor and / or the distribution of each drug is monitored by a sensor. In some embodiments, for each motor, a sensor (e.g., a Hall sensor or a mechanical sensor) in the motor P3060 records the number of revolutions of the motor P3060. In some embodiments, the motor P3060 rotates a gear P3071 that is part of a gear assembly P3070. In some embodiments, a part of the gear assembly P3070 is an output gear P3074. In some embodiments, the output gear P3074 has a magnet P3425 attached thereto or thereon that rotates on a coaxial shaft of the output gear. In some embodiments, the rotational position sensor P3426 detects the rotation of the magnet P3425 to determine the actual rotation of the lead screw P3430.
[0303] For example, the motor P3060 is controlled and monitored by itself by Hall counts. However, the lead screw extension dispenses the medication. The rotational position sensor P3426 provides an independent and precise understanding of the precise movement of the lead screw. In some embodiments, it is a redundant encoder that monitors the lead screw. This monitoring allows the user to diagnose any problems between the motor and the lead screw (e.g., broken gears, etc.). For example, if the gear train is sticking, disconnected, etc., such problems will not be recorded without this sensor system. The encoder also provides real-time monitoring of the lead screw movement. In some embodiments, any delay between communication from the display (or elsewhere) to the motor can be noted with a magnetic encoder.
[0304] In some embodiments, the output gear P3074 rotates an output shaft P3430 (e.g., a lead screw) that operates to deliver medication to a user. In several embodiments, the magnet P3425 measures the angular position of the output gear P3074 by determining the angle of the magnet on the output gear P3074. In some embodiments, a rotational position sensor P3426 is attached to the circuit board P3418. In some embodiments, data from the rotational position sensor P3426 and data from a sensor in the motor P3060 are transmitted to a computer in the pump (e.g., in a wired manner or wirelessly using an antenna, etc.). In several embodiments, the computer can determine that the output shaft P3430 does not rotate synchronously with the motor P3060, and an error is generated based on this determination. In several embodiments, the computer can also determine the amount of medication that the mobile medical device has injected into the user based on data from the rotational position sensor P3426 and the sensor in the motor P3060. The computer can determine the amount of drug that has been injected into the user by multiplying the number of revolutions of the motor P3060 by the predetermined amount of drug per revolution of the motor P3060. The computer can also determine the amount of drug that has been injected into the user by multiplying the number of revolutions of the output shaft P3430 by the predetermined amount of drug per revolution of the output shaft. The number of revolutions of the motor P3060 can be determined based on data from a sensor in the motor P3060. The number of revolutions of the output shaft can be determined by data from a rotational position sensor P3426. In some embodiments, in response to an error determination, the computer can adjust the rotation of the motor pinion to provide a corrected drug administration rate.
[0305] Figure 7FA flow chart of a process for determining that there is an error in drug delivery in a pump is provided. In step P510, the pump may receive the rotational position of a motor in a mobile medical device through one or more sensors. The motor operates to deliver drugs to a user. The sensor in the motor may be a Hall sensor that measures the number of revolutions of the motor. In step P520, the mobile medical device may receive the rotational position of an output shaft through a rotational position sensor. In several embodiments, the output shaft is connected to the motor through a gear assembly. In some variations, the gear assembly may generate a mechanical advantage that causes the output shaft to rotate at a slower rate than the motor. In step P530, the mobile medical device may determine that the motor and the output shaft rotate synchronously based on the mechanical advantage generated by the gear assembly. In step P540, the pump may notify the user that the motor and the output shaft do not rotate synchronously. In some embodiments, the pump may stop delivering drugs to the user, or may be recalibrated to provide correct drug distribution. Optionally, the pump may display an error to the user while the system continues to deliver drugs to the user. In various embodiments, the pump may deactivate the motor that generates the error and activate a second motor in the mobile medical device. In some embodiments, when one type of drug is being delivered using two drug chambers, if an error is noted, the motor in the infusion line where the error occurred can be disabled in favor of the other motor (where no error occurred).
[0306] Figure 7Gis a diagram of a portion of a pump showing an output shaft angular position error detection system. In several embodiments, as disclosed elsewhere herein, the pump may include a motor P3060, a gear P3071 attached to the motor, a gear assembly P3070, a magnet (e.g., a sheath, a retractable shaft, etc.) attached to an output shaft assembly P3430 having a piston P3142. In certain implementations, the motor P3060 has a sensor that determines the number of revolutions of the motor P3060. In several embodiments, the sensor is a Hall sensor. In some embodiments, the motor rotates the gear P3071 in the gear assembly P3070 and transmits the rotation to the fourth gear in the gear assembly P3074. In several embodiments, the gear assembly P3070 can generate a mechanical advantage that operates to rotate the output shaft P3430 (e.g., a lead screw) at a slower rate than the motor P3060. When the output shaft rotates, the drug is pushed out of the drug cartridge and delivered into the user's body. In some embodiments, the magnet attached to the output shaft rotates with the output shaft P3430. The rotational position sensor measures the angular position of the output shaft. Data from the angular position of the output shaft and the number of revolutions of the motor P3060 are compared by a computer in the pump. If the computer determines that the output shaft P3430 and the motor P3060 are not rotating synchronously, the computer may generate an error. When the computer determines that the output shaft and the motor P3060 are not rotating synchronously, the computer may take into account the mechanical advantage generated by the gear assembly P3070. Data from the angular position of the output shaft can also be used to determine the amount of drug that has been delivered to the user.
[0307] Figure 7H is an illustration of a portion of a pump showing two drive nuts configured to engage with two or more drug cartridges. In some embodiments, the pump includes a first drug piston P3142, a second piston P3144, a first motor P3060a, and a second motor P3060b. In some embodiments, a magnet used by a first rotation sensor for a first drug chamber P3100 interacts with another magnet on the drive nut. In some embodiments, a magnet for a second drug chamber P3110a interacts with a second rotating magnet. In some embodiments, the first drug cartridge may contain a drug that can be infused into a user. In some embodiments, the drug in the first drug cartridge is infused by rotation of the first motor P3060a. Similarly, the drug may be contained in a second drug cartridge. In some embodiments, the drug in the second drug cartridge may be infused into a user by rotation of the second motor P3060b.
[0308] In some embodiments, the cartridge slot of the housing of the mobile medical device can be shaped to exclude one or more drug cartridges from being inserted into the cartridge slot. For example, a first cartridge slot (e.g., cartridge receiver) in the housing of the pump can be shaped to exclude the insertion of a second drug cartridge into the first cartridge slot. The first cartridge slot of the housing can be shaped to receive the alignment protrusion of the first drug cartridge when the first drug cartridge 2710 is inserted into the housing. Similarly, the second cartridge slot of the housing can be shaped to receive the alignment protrusion of the second drug cartridge when the second drug cartridge is inserted into the housing.
[0309] Fig.7I is a diagram of components of a pump having an output shaft angular position error detection system. In some embodiments, the pump includes a first motor P3060a, a second motor P3060b, a first rotational position sensor P3426a, and a second rotational position sensor P3426b. In several embodiments, a sensor in the first motor P3426a can determine the rotational speed of the first motor P3060a. In several embodiments, the first rotational position sensor P3426a can determine the rotational speed of the first output shaft. In several embodiments, the computer can determine that the first motor P3060a and the first output shaft do not rotate synchronously based on data from the sensor in the first motor P3060a and data from the first rotational position sensor P3426a. In several embodiments, the computer can switch the operating motor of the mobile medical device from the first motor P3060a to the second motor P3060b based on the determination. For example, the computer can deactivate the first motor P3060a and activate the second motor P3060b based on the determination that the first motor P3060a does not rotate synchronously with the first output shaft. Likewise, the computer can determine that the second motor P3060b and the second output shaft do not rotate synchronously based on data from the sensor in the second motor P3060b and data from the second rotational position sensor P3426b. The computer can similarly deactivate the second motor P3060b and activate the first motor P3060a based on a determination that the second motor does not rotate synchronously with the second output shaft.
[0310] O-Rings and Chambers
[0311] Various embodiments include one or more boundary sealing O-rings in the pump housing. In some embodiments, the placement of the O-ring seals the medicine chamber with the interior of the pump. However, in several embodiments, the O-ring does not seal the cartridge container with the environment outside the pump. Therefore, in several embodiments, the internal area of the cartridge container can be balanced with any atmospheric pressure outside and / or outside the pump. On the other hand, the area inside the pump housing is sealed with the atmosphere (e.g., in an airtight and / or watertight manner) to prevent harmful contaminants from entering the pump. Some embodiments have been designed to allow the atmospheric pressure of the drug cartridge to match that of the patient's tubing and infusion site.
[0312] The difference in atmospheric pressure felt between the infusion site (e.g., the area outside the pump) and the sealed drug barrel in the infusion pump can lead to insufficient / excessive delivery of the drug. For example, in an embodiment where the pump barrel chamber is sealed with the external atmosphere in the pump, the sealing of the barrel chamber can occur at atmospheric pressure, which is ultimately different from the atmospheric pressure of the external environment. If the patient seals the chamber under a high atmospheric pressure environment and moves to a lower pressure environment, a pressure difference may occur. In some embodiments, when the pressure in the pump attempts to balance with the external pressure, the pressure difference between the high chamber pressure and the low external pressure may force the distribution of additional drugs from the barrel. For example, if the patient loads the barrel into the infusion pump at sea level (higher atmospheric pressure), and then boards an airplane to a cruising altitude, the pressure in the barrel chamber may be higher than the pressure outside the pump at high altitude (causing drug escape and / or uncontrolled administration). Alternatively, if the patient seals the cartridge chamber at a lower atmospheric pressure (e.g., at high altitude, during a low pressure weather event, in an airplane, above sea level, in the mountains, etc.) and travels to a higher atmospheric pressure (e.g., at or below sea level, during a high pressure weather event, etc.), a partial vacuum may be created within the cartridge container (and pump) which impedes movement of the plunger within the drug cartridge, potentially resulting in less drug being delivered than desired.
[0313] By providing a pump in which the cartridge container can be pressure balanced with the pump exterior, these or other problems can be avoided. As described elsewhere herein, some implementations provide a water-resistant or waterproof infusion pump (and / or infusion system). Thus, in several embodiments, the cartridge chamber and the drug cartridge itself do not have to be sealed from the environment (and / or allowed to balance with the external ambient pressure), and because the cartridge chamber in the infusion pump can allow air and water to pass freely around the drug cartridge, the drug cartridge chamber and the drug cartridge can be made airtight and / or watertight (or not affected by the environment or substantially not affected by the environment).
[0314] In some embodiments, the drug cartridge chamber can be substantially sealed to prevent water ingress (e.g., having a sealing mechanism that prevents water from penetrating into the cartridge area), but can still allow air or gas to move through the seal to equalize the pressure difference between the infusion site and the drug cartridge. In certain embodiments, the seal can be watertight, but not airtight. In some embodiments, the seal provides a hole between the cartridge connector that is small enough so that the surface tension of water prevents its ingress, but does not prevent the ingress (or egress) of air (or other gases).
[0315] In some embodiments, the quality of the seal between the drug chamber and the internal area of the pump is represented by an IP code (or inlet protection code, IEC standard 60529, sometimes interpreted as an international protection code). The IP code classifies and rates the degree of protection of the mechanical housing against intrusion, dust, accidental contact, and water. The IP code provides two numbers, one as a measure of solid particle barrier protection and the other as a measure of liquid barrier protection. The first number after "IP" in the IP code represents solid particle protection and the second number represents liquid barrier protection. Therefore, an IP code of IP 34 has a solid particle protection level of 3 and a liquid ingress protection of 4. For solid particles, level 4 provides a seal for most silk threads, slender screws, large ants, etc. Level 5 indicates that dust is not completely prevented from entering, but dust must not enter in sufficient quantity to interfere with the satisfactory operation of the device. Level 6 indicates no dust ingress; complete protection from contact (dustproof). A vacuum must be applied. The test duration based on airflow is up to 8 hours. For liquids, Level 1 indicates that dripping water (vertically falling drops) has no detrimental effect on the specimen when mounted on a turntable in an upright position and rotated at 1 RPM. Level 2 indicates that vertical dripping water has no detrimental effect when the housing is tilted at an angle of 15° from its normal position. A total of four positions are tested in both axes. Level 3 indicates that water falling in the form of a spray at any angle up to 60° from the vertical has no detrimental effect, using: a) a swinging fixture, or b) a nozzle with an offset shield (Test "a" is conducted for 5 minutes and then the sample is rotated 90° horizontally and repeated for a second 5-minute test; Test "b" is conducted (with shield in place) for a minimum of 5 minutes). Level 4 indicates that water splashed onto the housing from any direction has no detrimental effect, using: a) a swinging fixture, or b) a nozzle without a shield. Test a) is conducted for 10 minutes. b) is conducted (without shield) for a minimum of 5 minutes. Level 5 indicates that water projected onto the housing from any direction by a nozzle (6.3 mm (0.25 in)) has no detrimental effect. Grade 6 indicates that powerful jets of water (12.5 mm (0.49 in)) projected onto the housing from any direction have no harmful effects. Grade 7 indicates that ingress of harmful quantities of water is not possible when the housing is immersed in water under defined conditions of pressure and time (up to 1 m (3 ft 3 in) immersion). Grade 8 indicates that the device is suitable for continuous immersion in water under conditions (1 m (3 ft 3 in) or more). Grade 9 indicates protection against powerful high temperature water jets.
[0316] In some embodiments, the seal between the cartridge chamber and the interior area of the pump is characterized by a solid particle protection IP code number greater than or at least 4, 5, 6, or a range across and / or including the above values. For example, the IP number for solid particle protection can be in the range of 4 to 6. In some embodiments, the seal between the cartridge chamber and the interior area of the pump is characterized by a liquid ingress protection IP code number greater than or at least: 2, 3, 4, 5, 6, 7, 8, 9, or a range across and / or including the above values. For example, the IP number for liquid ingress protection can be in the range of 2 to 6, 4 to 8, 3 to 9, etc. In addition, the IP code can be IP42 to IP69, etc.
[0317] As disclosed elsewhere herein, some embodiments provide an infusion pump comprising an outer perimeter defined by a pump face P1002, a backing P1003, a lower surface P1005, an upper surface P1004, a first side surface P1006', and a second side surface P1006" (as shown in Figure 1A-Figure 1D ). In some embodiments, the outer periphery provides a pump housing. In some embodiments, the pump includes a hole having a first end and a second end and configured to receive a first drug cartridge. In some embodiments, the first end of the first hole defines an opening (e.g., a container inlet port) in the pump housing. In some embodiments, the sidewall of the hole (e.g., the sidewall of the barrel chamber) extends longitudinally and inwardly into the housing to the second end of the hole. In some embodiments, the second end of the hole is located within the periphery of the pump. In some embodiments, as disclosed elsewhere herein, a drive nut (e.g., an elongated shaft, a piston shaft, etc.) is at least partially disposed in the hole and is configured to engage and / or contact the first drug cartridge when the first drug cartridge is inserted into the first barrel chamber. In some embodiments, the second end of the hole is an opening configured to receive one end of the drive nut. In some embodiments, in order to dispense the drug from the pump, the drive nut extends into the hole via the second end of the hole and moves longitudinally toward the first end of the hole. In this case, the piston pushes the plunger of the first drug cartridge forward, thereby dispensing the drug in the barrel.
[0318] In certain implementations, as disclosed elsewhere herein, an O-ring is disposed circumferentially around the piston and provides a barrier and / or seal between an interior region of the pump and an external environment outside the pump. In some embodiments, a saddle for an O-ring abutment defines a bottom wall of the barrel chamber at the second end of the hole. In some embodiments, the O-ring is positioned adjacent the second end of the first hole, but outside the hole. In some embodiments, as disclosed elsewhere herein, the drive nut is configured to extend into the hole via rotation of a lead screw of the pump. In some embodiments, when the lead screw is rotated in one direction, the drive nut extends into the barrel chamber along the hole. When the lead screw is rotated in the opposite direction, the drive nut is retracted from the barrel chamber along the hole. The O-ring can be fixed at a position adjacent the second end of the hole, and during movement of the drive nut.
[0319] In some embodiments, the pump also includes a second hole having a first end and a second end. In some embodiments, the second hole shares one or more or all features of the first hole, but the second hole is configured to distribute the medicine from the second barrel. For example, the second hole can be configured to receive the second drug cartridge. In some embodiments, the second hole is configured to receive the second drive nut. In some embodiments, the internal area of the pump is sealed with the external area of the pump by a second O-ring, which forms a barrier that blocks water and debris from entering the internal space of the pump. In the case of providing additional drug chambers, additional O-rings and drive nuts can be provided in a manner similar to that disclosed above.
[0320] In some embodiments, as disclosed herein, the O-ring can be configured to allow water or air to move around the drug cartridge. In some embodiments, the O-ring is configured to allow the pressure difference between the infusion site and the drug cartridge to be balanced. In some embodiments, when the O-ring is circumferentially arranged on the elongated shaft, the O-ring applies pressure on the elongated shaft. In some embodiments, a lubricant is provided to lubricate the elongated shaft to reduce the friction between the O-ring and the elongated shaft. In some embodiments, the O-ring is configured to maintain the pressure difference between the ambient pressure and the internal space of the housing. In some embodiments, the O-ring is configured to maintain the pressure difference between the internal space of the housing and the inside of the hole. In some embodiments, the hole is configured to be exposed to ambient pressure and balance ambient pressure. In some embodiments, the hole is configured to be exposed to ambient pressure and balance the ambient pressure around the drug cartridge. In some embodiments, the O-ring is compression-fitted on the elongated shaft, and the O-ring is configured to form a barrier that blocks water and air from entering the internal space of the housing.
[0321] As described elsewhere herein, the infusion pump device includes a housing for various components. The housing can take substantially any shape suitable for receiving a drug cartridge and incorporating components for dispensing the drug from the cartridge. Figure 7JThe housing is shown with the upper portion P3001' of the housing removed (e.g., the bezel and display P3007). The interior of the pump P3008 may be designed to hold or receive certain components. Figure 7J In the example shown, the pump has an interior space P3008 and opposite top and bottom ends (eg, lower surface P3005 ) that form a portion of the upper surface P3004 .
[0322] The infusion pump device of the exemplary embodiment can have one or more holes configured to receive the drug cartridge. Typically, the hole is cylindrical, but can have any shape or modified features, such as grooves or slots, to receive the features of the drug cartridge and other components of the device. Figure 7J A device having a first hole P3106 and a second hole P3116 is depicted, respectively. Each hole has a first end (P3126, P3128) and a second end (not shown), wherein the first end defines an opening into the housing and the second end is located in the interior space of the housing. The first opening is located at the first end P3126 and P3128 of each hole P3122 and P3124, respectively. Each hole has a longitudinal axis P3130 along which other components translate (as further described below).
[0323] As in Figure 7K As shown in , an O-ring (not shown) can be received by an O-ring groove P3132 and P3134 (e.g., a saddle, a frame, etc.) located at the second end P3127 and P3129 of the adjacent hole, respectively. Generally, the groove can take any shape that allows the O-ring to be fixed and form a seal. For example, the groove can be cylindrical and include a boundary that prevents the O-ring from moving when the elongated shaft travels longitudinally in the hole. In some embodiments, the grooves P3132 and P3134 can have raised surfaces P3131, P3133 on both sides of the O-ring to fix the O-ring.
[0324] As in Figure 7L As shown in, in some embodiments, the elongated shafts P3142 and P3144 disposed in the hole (not shown) can be driven by the gears of the motor P3060 and the gear assembly P3070 to translate longitudinally in the hole. The motor can be powered by a battery P3050. In an exemplary embodiment, each elongated shaft includes a lead screw engaged with a drive nut (described further below), which engages with a drug cartridge (not shown). In addition, as shown in the figure, an elongated shaft can also include an identification portion P3146 (e.g., a thread, a small block, an opening, a groove, etc.) or the other end feature for identifying a consistent drug cartridge. When different barrels (e.g., glucagon and insulin) are simultaneously disposed in the device, this feature advantageously allows the user to determine which hole holds a specific drug cartridge. In addition, an O-ring P3150 circumferentially disposed on each elongated shaft is shown.
[0325] In several embodiments, the O-ring can be formed of any material suitable for achieving sealing, and has different shapes or thicknesses. In an exemplary embodiment, the O-ring for the elongated shaft includes a polymeric material. In some embodiments, the O-ring is composed of a synthetic rubber, a thermoplastic, or a combination thereof. In some embodiments, the synthetic rubber includes one or more of the following or is composed of the following: butadiene rubber (BR), butyl rubber (IIR), chlorosulfonated polyethylene (CSM), epichlorohydrin rubber (ECH, ECO), ethylene propylene diene monomer (EPDM), ethylene propylene rubber (EPR), fluoroelastomer (FKM), nitrile rubber, perfluoroelastomer (FFKM), polyacrylate rubber (ACM), polychloroprene (CR), polyisoprene (IR), polysulfide rubber (PSR), polytetrafluoroethylene (PTFE), tetrafluoroethylene and propylene copolymer (FEPM), silicone rubber and / or styrene-butadiene rubber. In some embodiments, the thermoplastic comprises or consists of one or more of the following: thermoplastic elastomers (TPE) styrenics, thermoplastic polyolefins (TPO) LDPE, HDPE, LLDPE, ULDPE thermoplastic polyurethanes (TPU) polyethers, polyesters: thermoplastic ether ester elastomers (TEEEs) copolyesters, thermoplastic polyamides (PEBA) polyamides, melt processable rubbers (MPR) and / or thermoplastic vulcanizates (TPV).
[0326] In addition, the O-rings can have different sizes, such as Figure 7N . In some embodiments, O-rings of different sizes engage drive nuts of different sizes, which are configured to engage drug cartridges of different sizes (e.g., cartridges with different circumferences). In addition, the O-rings can be compression-fitted on the elongated shaft to form a barrier that blocks water and air from entering the interior space of the housing. For the seal, there are variations in cross-sectional design that are different from circular. In some embodiments, the cross-section of the O-ring is an X-shaped profile, square, or circular. In some embodiments, square (or square O-rings) are used, and when squeezed during installation, they seal with multiple (1, 2, 3, or 4) contact surfaces (e.g., 2 small contact surfaces on the top and bottom, one on each side of the saddle).
[0327] As in Figure 7M As shown in , in some embodiments, when the shaft is fully retracted in the pump and opposite the second ends P3156 and P3158, respectively, the O-ring P3150 is adjacent to the first ends P3157 and P3159 of the two elongated shafts P3142 and P3144. In some embodiments, as in Fig.7OAs shown in FIG. 1 , each of the elongated shafts P3142 and P3144 includes a lead screw P3152, P3154 threadedly engaged with a drive nut P3142, P3144 and / or with a threaded insert P3172, P3174. In some embodiments, the drive nut serves as a lead screw nut for the lead screw. In some embodiments, the lead screws P3152, P3154 are threadedly engaged with the drive nut P3142, P3144 and / or with the threaded insert P3172, P3174. Figure 7N The threaded inserts P3172, P3174 shown in FIG. engage drive nuts P3142, P3144. A piston assembly P3040 for a second piston P3144 is shown. In some embodiments, such as in 7M, Figure 7N and Figure 7P , motors P3160a, P3160b drive gear P3070 that engages lead screw P3154. In some embodiments, movement of lead screws P3152, P3154 transfers rotational energy to threaded inserts P3172, P3174. In some embodiments, threaded inserts P3172, P3174 are fixed within drive nuts P3142, P3144, and as lead screws P3152, P3154 rotate, threaded inserts P3172, P3174 wrinkle longitudinally along lead screws P3152, P154, thereby extending drive nuts P3142, P3144 longitudinally toward the first end of the hole within the drug chamber (not shown). In some embodiments, as discussed elsewhere herein, the engagement between the drive nut and the threaded insert is fixed together (e.g., the threaded insert is sonic welded, glued, or otherwise fixed within the drive nut). In some embodiments, when the drive nut P3142, P3144 is pushed forward or backward, the rotational movement of the lead screw P3152, P3154 against the threaded insert P3174 does not rotate the drive nut P3144. Figure 7M As shown in , in several embodiments, the first drive nut P3142 and the second drive nut P3144 have a first tongue P3427a and a second tongue P3427b, respectively, which are seated in a first groove P3428a and a second groove 3428b (e.g., a track) to prevent the drive nuts P3142, P3144 from rotating. In some embodiments, during drug delivery, the O-ring fixed in the hole remains in place, but is still circumferentially disposed on the lead screw nut P3172 portion of the elongated shaft. In some embodiments, the lack of rotation around the drive nut P3142, P3144 reduces the rotational friction between the drive nut P3142, P3144 and the O-ring and / or the drug cartridge plunger.
[0328] In some embodiments, the shape of the protrusion P3427a of the first drive nut can be different from the shape of the protrusion P3427b of the second drug drive nut. In some variations, the first groove P3428a and the second groove 3428b (e.g., tracks) can be shaped differently from each other and can be configured to engage the first protrusion P3427a and the second protrusion P3427b of the first drive nut P3142 and the second drive nut P3144, respectively. In some variations, the first groove P3428a and the second groove 3428b (e.g., tracks) can be configured not to engage with the first protrusion P3427a and the second protrusion P3427b, respectively.
[0329] In an exemplary embodiment, when the O-ring is disposed circumferentially on the elongated shaft, the O-ring seal exerts pressure on the elongated shaft. A lubricant may be included to lubricate the elongated shaft to reduce friction between the O-ring and the elongated shaft.
[0330] exist Figure 7Q A non-limiting example of an embodiment is provided in FIG. As shown, the bottom portion of the housing 1 is engaged with the top portion of the housing 18 including the display. A rear cover 5 is included to completely enclose the housing. A battery 9 powers the PCBA motherboard and the vibrator 12. O-rings 8 are placed on the lead screw nuts 2 and 3. The lead screw nut 2 is attached to the lead screw 4 via a threaded insert 7. The piston 2 engages with the glucagon cartridge, while the other piston 3 engages with the insulin cartridge. The drive train assembly 15 and the spur gear 10 are used to mechanically actuate the elongated shaft.
[0331] The features of the exemplary embodiments described in this disclosure provide various advantages. First, the O-ring seal around the elongated shaft forms a barrier to water and debris that enter the interior space of the housing. This can prevent interference with the mechanical action of the pump and can avoid potentially dispensing an incorrect amount of medication.
[0332] Additionally, the location of the O-ring near the second end of the elongated shaft allows water or air to move around the barrel, thereby equalizing pressure differences between the infusion site and the drug barrel.
[0333] Another advantage of the exemplary embodiment is that the infusion pump does not utilize an O-ring to seal the connection between the infusion set and the top of the drug cartridge. In particular, the O-ring is not placed adjacent to the opening of the pump housing. This allows for a design that does not require a hydrophobic filter, as such a filter can become clogged, thereby affecting the pressure inside the pump housing. In addition, a permanently installed hydrophobic filter is unlikely to last the entire warranty period of the device, forcing the filter and complexity to be added to the disposable device, which increases the cost and complexity of the disposable device.
[0334] The use of an O-ring as described above can result in a pump device configured to maintain a pressure differential between the ambient pressure and the interior of the housing. In addition, the pump device can be configured to maintain a pressure differential between the interior of the housing and the interior of the bore. Yet another advantage is that the bore is configured to be exposed to the ambient pressure and to equalize the ambient pressure around the drug cartridge. Thus, no sealing is required at the first opening of the bore. In addition, the wiping action of the O-ring on the lead screw nut prevents water and dust from entering the housing and provides a durable seal.
[0335] Other designs may include features that use an O-ring to seal a disposable cartridge or connector to seal the pump surface to a flat surface on the disposable. One disadvantage of the aforementioned design is that the sealing surface of the O-ring is exposed to the environment during setting changes and contaminants may be allowed to accumulate on the sealing surface of the O-ring, resulting in failure of the O-ring to provide adequate IPX sealing for the device. This can result in seal failure and water and fluid entering the drug cartridge. The advantage of choosing not to include an IPX sealing boundary allows the hydrophobic filter mechanism to be removed because it is no longer required. Water and air can move freely around the cartridge to equalize pressure. Therefore, the O-ring seal provides an IPX seal to the device, preventing water and dirt from entering the electronics and motor / gear train housing. The application of an O-ring around the lead screw nut provides a smooth, continuous surface for sealing and prevents exposure of the sealing surface to environmental contaminants. The wiping action of the O-ring on the lead screw nut prevents water and dust from entering the housing and provides a durable seal.
[0336] As disclosed elsewhere in this article, in optional embodiments, a seal (e.g., by an O-ring, polymer sealing features, etc.) is disposed between the tube connector and the pump to seal the tube chamber from the external environment. In such embodiments, a pressure difference may occur between the tube chamber and the external environment. In some embodiments, the seal between the tube chamber and the external atmosphere (external pump) is characterized by being greater than or at least 4,5,6, or spanning and / or including the solid particle protection IP code number of the range of the above values. For example, the IP number for solid particle protection can be in the range of 4 to 6. In some embodiments, the seal between the tube chamber and the external atmosphere is characterized by being greater than or at least: 2,3,4,5,6,7,8,9, or spanning and / or including the range of the above values. For example, the IP number for liquid entry protection can be in the range of 2 to 7,5 to 8,4 to 9, etc.
[0337] Some embodiments relate to a method comprising: achieving a seal between an interface of a cartridge receiving chamber and a cartridge, the cartridge receiving chamber being configured to cooperate with the cartridge in an abutting relationship. In some embodiments, an O-ring is placed adjacent to the first end of the elongated shaft, opposite to the second end of the elongated shaft, engaging the lead screw of the elongated shaft, and connected to the lead screw nut. In some embodiments, a gear engaging the lead screw is driven so that the lead screw nut is translated longitudinally toward the first end of the elongated shaft during drug delivery. In some embodiments, the O-ring remains fixed in the cartridge receiving chamber, but is circumferentially arranged on the lead screw nut. In some embodiments, when the O-ring is circumferentially arranged on the elongated shaft, the O-ring applies pressure on the elongated shaft. In some embodiments, a lubricant is used to lubricate the elongated shaft to reduce friction between the O-ring and the elongated shaft. In some embodiments, the cartridge is a glucagon cartridge. In some embodiments, the cartridge is an insulin cartridge. In some embodiments, a transmission assembly and a spur gear are used to mechanically actuate the elongated shaft. In some embodiments, the O-ring helps maintain a pressure differential between ambient pressure and the interior of the cartridge receiving chamber. In some embodiments, the position of the O-ring is configured to allow water or air to move around the cartridge. In some embodiments, the O-ring comprises a polymeric material.
[0338] Vacuum to avoid lift-off
[0339] Drug bottles with plungers are usually designed to have little or no resistance and / or friction between the plunger and the wall of the reservoir. Therefore, the plunger can move and distribute medicine (e.g., even by moving the barrel, lifting the pump including the barrel, etc.) when very little force is applied to the plunger. This undesirable distribution is caused by the plunger lifting the drive nut of the pump. In some embodiments, the configuration described herein avoids the problem of low friction plunger and / or lifting. In some embodiments, in order to avoid lifting, a vacuum is generated in the conveying chamber, which is sufficient to limit the plunger under free flow conditions. In some embodiments, an airtight seal is used between the lead screw nut and the housing. In some embodiments, an airtight seal is used between the barrel connector and the external environment. In some embodiments, this forms a sealed chamber, which contains an exposed portion of the lead screw, a barrel, a plunger and a medicine. When the lead screw advances to distribute, a portion of the lead screw is exposed in the chamber, the plunger moves, and the medicine is moved out of the chamber. Since the lead screw is smaller than the plunger, there is a net reduction in the volume of material in the sealed chamber, resulting in a decrease in air pressure relative to ambient air pressure. This results in a force on the plunger that resists the free-flow condition.
[0340] In some embodiments, a certain amount of lead screw advancement is used to generate sufficient negative pressure to overcome free flow, so the system can be designed to take into account the total amount of air in the chamber, the relative sizes of the lead screw and plunger, and the amount of liquid displaced during the infusion to ensure that sufficient negative pressure exists after the infusion. In some embodiments, the pressure will continue to decrease during delivery, resulting in an increase in the force from the drive mechanism to overcome the pressure. In some embodiments, the system is designed to ensure that the negative pressure generated is within the ability of the drive system to overcome it. In another embodiment, a check valve can be added to allow air to enter the chamber only when the pressure exceeds the negative limit.
[0341] Docking Station
[0342] As described elsewhere herein, in some embodiments, an inductively rechargeable battery is provided. In some embodiments, the pump 1000 includes an inductive charging plate P1003' (e.g., Figure 1E ), configured to allow charging of the inductively charged battery P1050. In some embodiments, the pump battery is not replaceable. In some embodiments, an inductive charging pad / stand and a USB cable (such as in Figure 8 ) to charge the pump. In some embodiments, the bracket is magnetized to hold the pump in place. In some embodiments, as shown in the figure, the bracket includes a guide feature that helps guide the pump to the appropriate position.
[0343] In some embodiments, to recharge the pump, one or more of the following steps can be performed: connecting the wireless charging pad to a wall outlet using the provided micro USB cable and plug, placing the pump on the provided inductive charging pad, verifying that the touchscreen and charging pad indicate that the pump is charging, and charging the pump using the provided charging pad and cable.
[0344] In some embodiments, the touch screen turns on and illuminates when placed on the charger. In some embodiments, the touch screen displays the charging status and / or indicates that the pump is charging. In some embodiments, the indicator light on the charging plate is continuously illuminated when charging and flashes when the pump is detected to be present but not charging. In some embodiments, when the charging plate flashes, the pump indicates that it is not charging and is not fully charged. In some embodiments, if the pump is not charging, the user can verify that the pump is properly aligned on the charging plate. In some embodiments, the depleted battery is configured to recharge in equal to or less than about 2 hours, 4 hours, or a range including and / or spanning the above values.
[0345] In some embodiments, it may be beneficial to minimize the time when the pump is powered off. In some embodiments, when the pump is without power, it will not administer insulin or provide continuous glucose monitoring CGM values to the user. In some embodiments, when the pump is without power, the sleep / wake button will not turn the screen on or off.
[0346] In some embodiments, for optimal battery life, it is recommended to recharge the battery daily, regardless of the battery level reported on the screen. In some embodiments, a fully charged battery can run for several days for an average user, but this depends on usage, especially the backlight and the amount of insulin delivered. In some embodiments, the user should monitor the battery charge level and alarms to determine the typical battery life of the user. In some embodiments, the user should recharge the pump based on typical usage.
[0347] In some embodiments, the system includes a wireless charging interface that complies with the Qi standard. In some embodiments, wireless charging includes Rezence (from AirFuel Alliance) and Open Dots (from Open Dots Alliance).
[0348] Some implementations may include the following specifications:
[0349] Standard name specification USB socket charger, P / N Q3002-US, UL Listed E141650 enter 100 to 240 volts AC 50 / 60Hz, 0.8A max Output voltage 5VDC / 3.0A,9VDC / 2.0A,12VDC / 1.5A Output Connectors USB Type-A
[0350]
[0351] Barrel Connector
[0352] As disclosed elsewhere in this article, some embodiments relate to one or more barrel connectors and / or barrel connector groups (including barrel connectors). In some implementations, barrel connectors (or barrel connector groups) are a part of a lumen assembly (e.g., a multichannel lumen assembly), as disclosed elsewhere in this article. In some implementations, barrel connectors (or barrel connector groups) are a part of a mobile infusion system as disclosed elsewhere in this article. In some embodiments, an infusion system including a barrel connector group is provided. In some embodiments, the connector group includes a single barrel connector. In some embodiments, the connector group includes two, three, four or more barrel connectors that may be the same or different. In some embodiments, the barrel connector group includes a fluid conduit attached to the barrel connector. In some embodiments, the barrel connector group also includes an infusion connector connected to an infusion group (it includes an apparatus such as a needle, and the needle is configured to infuse one or more drugs to a subject).
[0353] Fig.9A shows a configuration for engagement Figure 1AIn some embodiments, as in Fig.9A and Fig. 9B As shown in, the barrel connector C1001, C1101 includes a body C1002, C1102. In some embodiments, the body C1002, C1102 includes a piercing element C1003, C1103 (e.g., a needle). In some embodiments, the piercing element is configured to pierce the septum of the drug cartridge and / or receive the drug from the drug cartridge (e.g., when the cartridge is inserted into the connector). In some embodiments, the barrel connector C1001, C1101 includes a lower surface portion C1004, C1104 of a skirt C1005, C1105 (e.g., an axially extending sidewall, a shield, etc.) extending circumferentially from the needle C1003, C1103 to the connector. In some embodiments, the shield extends axially away from the lower surface portion. In some embodiments, the shield is configured to receive and be assembled on a part of the drug cartridge.
[0354] In some embodiments, the lower surface portion C1004, C1104 is located in the shield C1005, C1105, and is configured to contact the cover of the drug cartridge when the drug cartridge is inserted into the cartridge connector (e.g., in the shield). In some embodiments, as shown, the needle C1003, C1103 extends axially from the lower surface portion C1004, C1104 in the shield C1005, C1105. In some embodiments, the needle does not extend through the shield. Fig.9A and Fig. 10A A view of the cartridge connector shroud and skirt is provided at the bottom of the shroud (eg, away from the lower surface portion C1004, C1104 of the connector).
[0355] In some embodiments, the shield C1005, C1105 includes a distal end away from the lower surface portion C1004, C1104 of the connector C1001, C1101. In some embodiments, as shown in the figure, the distal end of the shield C1005a, C1105a shown in emphasis is complete (e.g., without any space, gap, and is a ring) and surrounds the connector C1001A, C1101A (at Fig.9AIn some embodiments, the shield forms an uninterrupted ring around the bottom of the barrel connector. In some embodiments, as shown in the figure, the needle is recessed in the connector above the shield. In some embodiments, the complete end of the shield helps to correctly place the drug cartridge in the connector C1001, C1101. For example, if the shield is destroyed (not shown), it is easier to insert the barrel into the connector at an angle. If the drug cartridge is inserted at an angle and the drug cartridge does not advance along the axis of the barrel connector, the piercing element of the barrel may pierce the septum at a position off-center. Then, when the barrel is inserted into the point where it abuts the lower surface C1004, C1104, the cap of the bottle will be flush with the lower surface C1004, C1104, tear open and / or form a gap where the drug can flow out at the septum. In some embodiments, the skirt ring is complete and is configured to ensure that the barrel connector shield is perpendicular to the barrel before the needle penetrates the barrel seal. In some embodiments, non-vertical needle penetration has been shown to cause leakage at the seal. Additionally or alternatively, in some embodiments, the connector C1001, C1101 may include a bowl-shaped or concave surface C1004a, C1104a on or within the lower surface C1004, C1104. Fig.9D As shown in , the concave surface C1004a, C1104a can provide a portion of the lower surface C1004, C1104, while the remainder of the lower surface C1004, C1104 can include a lip C1004b, C1104b (e.g., configured to contact and / or abut a cap of an appropriate drug cartridge). In some embodiments, unlike connectors that do not have a bowl-shaped feature, the bowl-shaped feature distances the inflection point and / or bend point of the needle from the septum. In some embodiments, this small distance from the septum allows the piercing element to bend in such a way that the piercing element can accept an incoming drug vial without tearing or distorting the hole formed by the needle in the septum.
[0356] In some embodiments, connectors C1001, C1101 include knobs C1006, C1106. In some embodiments, such as in Figure 1A and Fig.9A As shown in , the knob can be an irregular shape (e.g., a partial oval with a flat portion, etc.) such that when inserted into the pump P1000, a portion of the knob overhangs the pump to provide a lip that gives tactile feedback that the knob is not properly positioned and / or not fully engaged. In some embodiments, as disclosed elsewhere herein, when twisted a quarter turn to engage the pump, the knob of the cartridge connector is aligned so that the lip is no longer present and the knob is aligned with the pump (e.g., in Figure 1A In some embodiments, the knobs C1006, C1106 are cam-shaped and have flat portions C1006', C1106'.
[0357] In some implementations, the knobs C1006, C1106 include ribs C1006", C1106" (e.g., ridges, finger holds, wings, etc.). In some embodiments, the ribs provide a handle that makes the cover easier to operate between the fingers. In some embodiments, the knob is a protrusion or ridge. In some embodiments, the knob allows the user to easily grasp the cartridge connector between the fingers in the thumb for placement in the pump chamber and for locking in the chamber. In some embodiments, the cartridge is locked and / or secured in the pump chamber by providing a quarter turn of twist to the knob as described elsewhere herein. In some embodiments, the gripping ribs help the user generate the torque required to connect the cartridge connector to the pump. In some embodiments, the stops and / or lugs provide tactile feedback when the connection is made. In some embodiments, a shallow cam within the pump chamber is used to stop when the stop is rotated to the connection position, maintaining a low connection force. In some embodiments, a steep cam for stopping is used to make the disconnection force greater than the connection force. This is intended to minimize accidental disconnection.
[0358] As disclosed elsewhere herein, some embodiments provide that each cartridge connector is shaped to provide a visual and / or tactile indication when the cartridge connector is locked with the pump chamber. For example, in some embodiments, a knob or other physical structure on the cartridge can indicate the orientation of the cartridge and whether the cartridge is in a locked position once the cartridge is inserted into the pump chamber. Fig. 9C An example of a cartridge connector that provides a visual indication when the connector is locked into a pump chamber is shown. The left figure shows the cartridge inserted into the pump chamber but not locked to the pump chamber. The right figure shows the cartridge aligned with the pump chamber after a quarter turn to indicate the locked state. In some embodiments, as in Fig. 9C As shown in , the ridges can also provide visual feedback. In some embodiments, the ridges are perpendicular to the pump face when in the locked position. Figure 1B and Figure 4A Unlike the embodiment shown in FIG, the two knobs of the connectors C3001, C3101 are rotated in a clockwise manner to lock the connectors in the pump P3000. In other embodiments, the cartridge connectors and pump openings may be configured to require a clockwise rotation to lock one cartridge connector (and cartridge) in place, and a counterclockwise rotation to lock the other cartridge connector (and cartridge) in place. Thus, another indicator may be added that allows the user to avoid miscommunication.
[0359] In some embodiments, as in Fig.9D and Fig.9E As shown in , the knob C1106 and the body C1102 of a connector C1101 can be integral (e.g., a molded integral piece). Figure 9D-10AAs shown in , the knobs C1006, C2006, C2106 and the bodies C1002, C2002, C2102 of the connectors C1001, C2001, C2101 can be individually molded and fixed together (e.g., using adhesives, sonic welding, etc.). Fig.9E As shown in , the connector set can include either or both types of connectors (integral or fixed together).
[0360] In some embodiments, as in Figure 9E-Figure 10A As shown in , the connector C1001, C2001, C2101 may include a protrusion C1007, C2007, C2107 extending axially upward from the upper surface of the body C1008, C2008, C2108. In some embodiments, the protrusion C1007, C2007, C2107 includes a fluid outlet C1007', C2007', C2107' (e.g., connected to a through hole or channel extending radially outward from a central fluid conduit, such as in the protrusion). In some embodiments, the knob C1006, C2006, C2106 includes a container portion C1006', C2006', C2106'. In some embodiments, the container portion C1006', C2006', C2106' is configured to extend over and receive at least a portion of the protrusion of the body C1007, C2007, C2107. In some embodiments, the container portion C1006', C2006', C2106' includes a knob inlet C1006", C2006", C2106", which is configured to receive a drug through a fluid outlet C1007', C2007', C2107' of the connector body C1002, C2002, C2102. In some embodiments, the interstitial space C1009, C2009, C2109 is located between the protrusion of the body C1007, C2007, C2107 and the container portion C1006', C2006', C2106' of the knob C1006, C2006, C2106. In some embodiments, the flexible membrane C1020, C2020, C2120 is located within the interstitial space C1009, C2009, C2109 and extends over at least a portion of the protrusion of the body C1007, C2007, C2107. In some embodiments, as disclosed elsewhere herein, the flexible membrane C1020, C2020, C2120 is configured to allow fluid to pass from the body outlet C1007' and enter the knob inlet C1006" only after a threshold fluid pressure of the drug is reached.
[0361] As described elsewhere in this article, the medicine bottle with plunger is usually designed to have very little resistance and / or friction or no resistance and / or friction between the wall of plunger and reservoir.Therefore, plunger can move and distribute medicine (for example, even by moving tube, lifting the pump including tube, etc.) when very little force is applied to plunger.This undesirable distribution is caused by the driving nut of pump being lifted off by plunger.In some embodiments, the configuration described in this article avoids the problem of low friction plunger and / or lifting off.In some embodiments, film C1020, C2020, C2120 are used as one-way valve and / or prevent lifting off.In some embodiments, one-way valve (for example, check valve) allows fluid to pass only after reaching the threshold pressure (for example, crack pressure) at film.In some embodiments, the threshold pressure required for allowing fluid to flow through the check valve is greater than the fluid pressure difference caused by any gravity that may be generated between patient and infusion system. For example, when the infusion system is connected to the patient via the infusion base and the patient (or user) lifts the pump (comprising one or more medicine bottles) loaded to the height above the infusion base, fluid pressure can be generated. Under the effect of gravity, the height of the bottle pushes the fluid from the bottle through the conduit and enters the patient via the infusion base group. The size of the applied fluid force is determined by the height of the medicine bottle on the infusion group. Therefore, the size of the fluid force is usually limited by the length of the fluid conduit (which eventually connects the medicine bottle to the infusion group). In some embodiments, the standard length of the fluid conduit is about 110cm or about 60cm. In some embodiments, when a bottle of medicine in the infusion system rises above the infusion group at least about 220cm, about 110cm, about 60cm, the value between the above values or the distance across the range of these values, the check valve has enough elasticity to keep closed. In some embodiments, the check valve is designed such that the threshold pressure gradient required to allow fluid to flow through the check valve is greater than any fluid pressure difference that may arise due to any other changes in fluid pressure between the patient and the infusion system (e.g., forces caused by an airplane changing altitude, a carnival, bungee jumping, sporting activities, etc.).
[0362] In some embodiments, as in Figure 9H and Fig. 10B As shown in FIG. 1 , one or more radially extending channels C1007a, C2007a, C2007b, C2107a, C2107b (e.g., tunnels, fluid conduits, etc.) pass through a protrusion C1007 that terminates at a fluid outlet C1007'. In some embodiments, the tunnel provides a fluid path through the protrusion C1007, C2007, C2107 of the cartridge connector body C1002, C2002, C2102, which terminates at a side hole C1007' or multiple side holes C2007', C2107'. In some embodiments, the side hole is adjacent to the membrane C1020, C2020, C2120.
[0363] Figure 10G and Fig. 10H Shown is a view of another example of a barrel connector including a check valve, the check valve including a seat projection and a fluid path flowing from the concave side of the check valve, the proximal end of the check valve and toward the convex side of the check valve. In some embodiments, as shown in the figure, an improved sheath (e.g., a cover feature) is arranged above the inlet port entering the barrel connector and below the knob. The fluid moves below the sheath via the space formed between the depicted seat projections (which are distributed around the sheath), thereby providing a path to the end of the cover feature. In some embodiments, the fluid flows upward along the needle (from the drug cartridge). In some embodiments, the fluid abuts the sheath. In some embodiments, when the plunger of the barrel produces enough fluid pressure by pushing out the fluid, the periphery of the sheath opens to release pressure. In some embodiments, the fluid then flows upward to the patient along the pipe. In some embodiments, the valve provides a non-return flow, wherein if the fluid attempts to flow in another direction (i.e., flowing back to the drug cartridge from the pipe), the valve will remain closed, thereby stopping the flow. The check valve can be made of silicone or other materials.
[0364] In some embodiments, when the knob and the body are integral, the connector C1101 is configured to receive the drug through the needle C1103 and deliver the drug from the fluid outlet C1130 to the outside of the knob C1106. In some embodiments, in the connectors C1001, C2001, C2101 including the flexible membrane C1020, C2020, C2120, the connectors C1001, C2001, C2101 are configured to receive the drug through the needle C1003, C2003, C2103 and deliver the drug out of the connector through the fluid outlet of the connector C1030, C2030, C2130. In some embodiments, the fluid outlets of the needles C1003, C1103, C2003, C2103 and the connectors C1030, C1130, C2030, C2130 are in fluid communication and provide a fluid path through the connectors C1001, C1101, C2001, C2101.
[0365] In some embodiments, as in Fig. 10AAs shown in , in the case of having more than one connector C2001, C2101, each connector may include a protrusion c2007, C2107 extending axially upward from the upper surface of the body C2008, C2108, a container portion C2006', C2106', a knob inlet C2006", C2106", a gap space C2009, C2109 located between the protrusion of the body and the container portion of the knob C2006, C2106, and a flexible membrane C2020, C2120. In some embodiments, each connector and / or multiple connectors in the connector group may include a one-way valve. As shown in Fig.9I As shown in , in the case where there are more than one connector C1001, C1101, a single connector may include a one-way valve (rather than both and / or and no more than one).
[0366] In some embodiments, as in Fig. 9B and Fig. 10C As shown in , the lower side of the knob C1022, C1122, C2022, C2122 may include one or more small pieces C1021, C1121, C2021, C2121 (e.g., a crushable protrusion, a small lump, a protrusion, etc.). In some embodiments, these small pieces are crushable and / or malleable. In certain embodiments, these small pieces ensure a tight (e.g., snug, flush, no space, no vibration, and / or no noise) engagement of the connector with the pump. For example, in some embodiments, when the connector is rotated to a suitable position within the connector container, and when the lug of the connector passes along the characteristic track P1101', P1103', P1111', P1113', the longitudinally extending thread (e.g., advancing distally along the hole) secures the connector in a position closer and closer to the pump until the connector substantially abuts the upper surface P1004 of the pump. In some embodiments, these nubs ensure that at least a portion of the connector contacts the upper side surface of the pump to hold the connector tightly in place against the upper side surface. It has been noted that without the nubs and with space between the cartridge connector and the pump housing, the cartridge connector may accidentally be pushed flush against the pump housing (e.g., at the upper side surface), which in turn pushes the cartridge within the pump against the drive nut, thereby delivering a bolus. In some embodiments, the nubs allow the connector to be molded to the upper side surface of the pump (so that each attachment and reattachment of the connector provides a flush connection without space between the pump and cartridge connector).
[0367] In some embodiments, a nub in combination with a stop cam (or lug cam) provides additional stability to the system. Additionally, the manufacturing tolerances of the cartridge connector (which may be disposable) are increased by using the nub. For example, the cartridge connector does not need to be manufactured to precisely conform to a particular upper surface of the pump because the nub helps to form a snug / tight fit between the upper surface of the pump and the cartridge connector.
[0368] As in Figure 1D-Figure 1I , Figure 4A , Figure 9A-9B and Fig. 10A As shown in , identification features P1101, P1102, P1103, P1111, P1112, P1113, C1010, C1011, C1110, C1111, C1012, C1112 can be provided and can be configured to prevent or inhibit miscommunication. Figure 9A-9B As shown in , the cartridge connectors C1001, C1101 corresponding to the pump containers P1100, P1110, respectively, include protrusions C1010, C1011, C1110, C1111, C1012, C1112 (e.g., tabs, lugs, stops) that coincide with the openings of the pump chambers P1101, P1102, P1103, P1111, P1112, P1113. In some embodiments, these protrusions include lugs C1010, C1011, C1110, C1111 and / or stops C1012, C1112. Similarly, as Figure 4A The pump 2000 and Fig. 10A and Fig. 10C As shown in, the barrel connectors C2001 and C2101 corresponding to the pump containers P2100 and P2110 respectively include consistent protrusions (e.g., lugs, lugs, stoppers). In some embodiments, these protrusions include lugs C2010, C2011, C2110, C2111 and / or stoppers C2012 and C2112. In some embodiments, as disclosed elsewhere in this article, protrusions (e.g., projections) are configured to cooperate (e.g., slide into) with consistent openings configured to receive such projections. As shown in the figure, features can be protruding features (e.g., protrusions, lugs, lugs, stoppers), configured to engage the corresponding recesses (e.g., holes, through spaces, stopper grooves, lug grooves, radial notches, notches, etc.) of the container. These matching features facilitate the attachment of appropriate components and / or prevent the connection of appropriate components.
[0369] As in Fig. 9BAs shown in , each cartridge connector can have multiple identification features. In the illustrated embodiment, each connector C1001, C1101 includes three radially extending protrusions (lugs and stops) configured to engage with notches that conform to the shape of the corresponding cartridge container. These identification features can be configured to engage the appropriate container to prevent or inhibit engagement of an incorrect cartridge connector (e.g., one that does not correspond and does not have one or more conforming protrusions), or both. Although in Fig. 9B In the embodiment shown, each connector has three radially extending protrusions as identification features, but in some embodiments, each connector can independently have one, two, three, four or more identification features (e.g., recesses and / or protrusions), configured to engage and / or receive consistent identification features (e.g., protrusions and / or recesses) from corresponding pump chambers. In addition, although the barrel connector has been described as including circumferentially distributed protrusions and pump chambers including circumferentially distributed recesses, the opposite configuration is also possible (wherein protruding on the barrel connector and recesses on the container). Similarly, in some embodiments, the types of identification features can be mixed and matched on a specific barrel connector (therefore the connector includes protrusions and recesses, and the corresponding container has consistent recesses and protrusions). In another modification, the barrel connector can only include recesses, and the different barrel connectors in the same connector group can only include protrusions. In this embodiment, the corresponding barrel container can include consistent protrusions respectively, and the barrel container can include consistent recesses.
[0370] In some embodiments, as in Fig. 9B and Fig. 10C As shown in , the lugs and stops can have various different sizes (e.g., circumferential length, radial height, etc.). For example, as shown in Fig. 9B As shown in the figure, the lug of one barrel connector can have a length lug (c1') and the second can have a second length lug (c1"), and these lengths can be different from each other and / or different from the lug lengths of the second barrel connector lug (c1"'), lug (c1""). As shown in the figure, the stop of one barrel connector can have a length det(c1'), which is different from the stop length det(c1") of the other barrel connector. In some embodiments, these lugs and stops are configured to be inserted into corresponding sized (e.g., consistent length) openings located on corresponding barrel containers.
[0371] As in Fig. 9B and Fig. 10CAs shown in , the stops and lugs of two different connectors can have corresponding positions (e.g., when the intermediate feature is rotated to 12 o'clock, the first lug is at 9 o'clock, the stop is at 12 o'clock, the second lug is at 3 o'clock, etc.). In some variations, the lugs and stops are not in corresponding positions, or only a portion of the lugs and stops are in corresponding positions. In some embodiments, even if the lugs and stops are in corresponding positions on different connectors, the attachment of incorrect barrel connectors can be prevented and / or substantially hindered by providing those equivalently positioned features of different sizes. It has been found that by providing a feature on the first connector (e.g., lug opening, stop opening, lug, stop, etc.) that is at least 15% larger (e.g., 15% longer or 15% shorter) than the equivalent feature on the second connector (e.g., a feature in the same relative position), miscommunication can be prevented and / or substantially prohibited. In certain embodiments, the ratio of the length of a feature on one connector to the length of an equivalent feature on a different connector is equal to or at least approximately: 3:1, 5:2, 2:1, 5:3, 4:3, 20:17, or a range spanning and / or including the above ratios.
[0372] In certain embodiments, such as in Fig. 9B As shown in , a plurality of identification features (e.g., lugs, stops, openings configured to receive lugs or stops, etc.) can be distributed (e.g., circumferentially) around the periphery of the cartridge connectors C1001, C1101. For example, as shown in Fig. 9B As shown in , the midpoint of one identification feature C1012 can be located at the 9 o'clock position, and the adjacent identification feature can have a midpoint at 12 o'clock C1011, thereby being 90° apart. In some embodiments, adjacent identification features of connectors C1001, C1101 can be separated by values independently selected from the following: equal to or less than about: 180°, 160°, 140°, 120°, 100°, 90°, 80°, 70°, 60°, 50°, 40°, 30°, 20°, 10°, values between the above values, or other values. As shown in Fig. 9B As shown in , in some embodiments, non-adjacent identification features of connectors C1001, C1101 can be separated by values independently selected from: equal to or less than approximately: 180°, 160°, 140°, 120°, 100°, 90°, 80°, 70°, 60°, 50°, 40°, 30°, 20°, 10°, values between the above values or other values.
[0373] As disclosed elsewhere in this article, as noted elsewhere in this article, the barrel connector may include, in place of and / or in addition to protrusions, recesses (not shown). In some embodiments, the recesses may be open to tracks (e.g., grooves, paths, etc.). In some embodiments, as shown in the container entrance elsewhere in this article, these paths may travel and / or be positioned circumferentially around the connector. In some variations, once the barrel connector is inserted into the pump chamber opening, the connector is rotated to lock the barrel connector in the container (as disclosed elsewhere in this article).
[0374] In some embodiments, as in Fig. 10D , Fig.10E and Fig.11D As shown in , a separate cartridge connector shield (and / or a separate drug cartridge) can be formed to prevent an incorrect cartridge connector from being attached to an incorrect drug cartridge. Fig. 10D , Fig.10E and Fig.11D As shown in , the first cartridge connector can have a shorter skirt. In some embodiments, the second cartridge connector C1101, C2101 (e.g., a glucagon cartridge) can be formed to have a longer shield (e.g., skirt) than the first cartridge connector C1001, C2001 (e.g., an insulin cartridge connector). In some embodiments not shown, the diameter of one connector can be larger, while the diameter of the other connector can be smaller. In some embodiments, optionally, the first cartridge M1001 (e.g., an insulin cartridge) can be formed to have a wider diameter than the second cartridge M1101 (e.g., a glucagon cartridge). In this way, the longer shield C2105 of the cartridge connector C2101 will abut the larger diameter bottle of the first drug cartridge M1001; therefore, preventing the clamp arm and needle cannula of the glucagon cartridge connector from engaging and connecting with the insulin cartridge (see Fig.10F ). In other embodiments (not shown), the shroud of the insulin cartridge is longer to avoid engagement with the glucagon cartridge, which may be wider than the insulin cartridge.
[0375] In some embodiments, as in Fig.9A , Fig.9D and Fig. 10A As shown in , additional features of the connector may include one or more needles that are recessed into the connector above the shield. In some embodiments, this feature and other features prevent the bottle from being pressed into the connector and / or can prevent improper puncture of the bottle septum. In some embodiments, the needle is recessed in the shield so that the needle is contact-free, avoiding punctures of fingers or other parts of the user's body.
[0376] In some embodiments, as disclosed elsewhere herein, a connector set includes one or more connectors that connect fluid conduits (such as in Fig.11A and Fig. 11B In some variations of the system, as disclosed elsewhere herein, the reservoir is located in (and / or can be placed in) a pump device that is configured to dispense the drug from the reservoir to the catheter, thereby supplying the drug to the system. In some embodiments, the fluid conduits provide separate pathways that terminate at a designated delivery member (e.g., a needle, cannula, etc.) within the base, thereby enabling separate and independent delivery (e.g., subcutaneous or otherwise) of the drug.
[0377] As in Figures 9A-10F In some embodiments, one or more card arms C1015a, C1015b, C2015a, C2015b, C1115a, C1115b, C2115a, C2115b (for example, 1, 2, 3, 4 or more) are molded into the main body of the barrel connector. In some embodiments, these arms are...
Claims
1. An infusion pump for delivering a drug to a patient, the infusion pump comprising: Pump housing, comprising: a first container port configured to engage a first cartridge connector and a second container port configured to engage a second cartridge connector; a first drug cartridge container extending longitudinally from the first container port along a first side of the infusion pump to a first cartridge container aperture; a second drug cartridge container extending longitudinally from the second container port along a second side of the infusion pump to a second cartridge container aperture; Internal areas, including: a power source disposed between the first drug cartridge container and the second drug cartridge container; a first electric machine and a second electric machine in electronic communication with the power source; a first laminated gear assembly and a second laminated gear assembly; a first lead screw and a second lead screw; wherein the first motor and the second motor include a first pinion gear and a second pinion gear, respectively, the first pinion gear is a component of the first stacked gear assembly, and the second pinion gear is a component of the second stacked gear assembly; wherein the first laminated gear assembly extends laterally toward the first side of the infusion pump, and the second laminated gear assembly extends laterally toward the second side of the infusion pump; wherein the first lead screw is in rotational communication with the first pinion gear through the first laminated gear assembly, and the second lead screw is in rotational communication with the second pinion gear through the second laminated gear assembly; a first drive nut having a length extending longitudinally along the pump housing and configured to travel into the first drug cartridge container via a first aperture, the first drive nut being in communication with the first lead screw and configured to be urged forward or rearward in response to first and second rotational directions of the first lead screw, respectively; and A second drive nut having a length extending longitudinally along the pump housing and configured to travel into the second drug cartridge container via a second hole, the second drive nut being in communication with the second lead screw and configured to be pushed forward or rearward in response to a first rotational direction and a second rotational direction of the second lead screw, respectively.
2. The infusion pump according to claim 1, wherein: The first container port has one or more identification features configured to engage with corresponding identification features of the first cartridge connector.
3. The infusion pump according to claim 1 or 2, wherein: The second container port has one or more identification features configured to engage with corresponding identification features of the second cartridge connector.
4. The infusion pump according to claim 3, wherein: The identification feature of the first container port is different from the identification feature of the second container port.
5. The infusion pump according to claim 4, wherein: The first drug cartridge container is configured to receive an insulin cartridge and the second drug cartridge container is configured to receive a glucagon cartridge.
6. The infusion pump according to claim 1, wherein: The first drug cartridge container is configured to receive an insulin cartridge and the second drug cartridge container is configured to receive a second insulin cartridge.
7. The infusion pump according to claim 1, wherein: The first container port is configured to not permit engagement of the second cartridge connector, and the second container port is configured to not permit engagement of the first cartridge connector.
8. An infusion pump according to claim 1, further comprising a first seal and a second seal, wherein the first seal provides a water-resistant barrier between the internal area of the infusion pump and the first drug cartridge container, and the second seal provides a water-resistant barrier between the internal area of the infusion pump and the second drug cartridge container.
9. The infusion pump according to claim 8, wherein: The first seal is a first O-ring circumferentially surrounding at least a portion of the first drive nut, and wherein the second seal is a second O-ring circumferentially surrounding at least a portion of the second drive nut.
10. The infusion pump according to claim 9, wherein: The pump housing includes a first saddle configured to retain the first O-ring and a second saddle configured to retain the second O-ring.
11. The infusion pump according to claim 10, wherein: The first saddle is positioned adjacent the first cartridge container aperture, and wherein the second saddle is positioned adjacent the second cartridge container aperture.
12. The infusion pump according to claim 1, wherein: The first drive nut includes a protrusion on a proximal portion of the first drive nut, the protrusion being retained within the interior region during extension of the first drive nut into the first cartridge container; wherein the pump housing includes a recess configured to receive the protrusion of the first drive nut; and wherein the protrusion of the first drive nut engages the recess to prevent rotation of the first drive nut.
13. The infusion pump according to claim 1, wherein: The first drive nut includes one or more barbs on a distal portion of the first drive nut, wherein the distal portion of the first drive nut is located in the first cartridge container, wherein the second drive nut has no barbs on a distal portion of the second drive nut, wherein the distal portion of the second drive nut is located in the second cartridge container.
14. The infusion pump according to claim 1, wherein: The housing includes a capacitive sensor configured to detect when a finger touches a surface, the surface being a curved indentation on the housing, and the capacitive sensor includes an integrated circuit configured to measure the capacitance of a circuit; and a conductive foam fills a gap between the surface and the integrated circuit.
15. The infusion pump according to claim 1, wherein: The housing includes a lower metal portion and a frame attachable to the metal portion; at least a portion of a side wall of the mobile medical device that is covered only by the frame; a circuit board positioned adjacent to the inner surface of the frame; as well as A wireless antenna is secured to the circuit board such that the wireless antenna is positioned toward a portion of the side wall of the mobile medical device that is covered only by the frame.
16. The infusion pump according to claim 15, wherein: The frame allows wireless signals to pass through, and the metal portion does not interfere with the signal from the wireless antenna.
17. The infusion pump according to any one of claims 15 to 16, wherein: The circuit board is configured to process wireless signals received by the wireless antenna.
18. The infusion pump of claim 1, further comprising a first magnet coaxially attached to a gear in the first laminated gear assembly and a first rotational position sensor that measures an angular position of the first magnet.
19. The infusion pump according to claim 1, wherein: The first container port includes a catch arm recess extending longitudinally within the first drug cartridge container, the catch arm recess of the first drug cartridge container being configured to receive the catch arm of the first cartridge connector when the catch arm is extended over the first drug cartridge cover when the first drug cartridge is received in the first drug cartridge container during engagement of the first drug cartridge.
20. The infusion pump of claim 19, wherein: the second container port comprising a catch arm recess extending longitudinally within the second cartridge container, the catch arm recess of the second cartridge container being configured to receive a catch arm of the second cartridge connector when the catch arm is extended over the second cartridge cover when the second cartridge is received in the second cartridge container during engagement of the second cartridge; as well as Wherein the clamp arm recess of the first container port is configured not to receive the clamp arm of the second cartridge connector.
21. The infusion pump of claim 1, wherein: The first container port includes a lug opening and a radially extending lug track configured to receive a lug of the first cartridge connector when the first cartridge connector is inserted into the first container port and rotated into position.
22. The infusion pump of claim 1, wherein: The first container port includes a stop opening and a stop track, the stop track having a stop cam, the stop cam having a shallow first transition portion and a steep second transition portion, the stop opening and the stop track being configured to receive a stop of the first cartridge connector when the first cartridge connector is inserted into the first container port and rotated into place, the shallow first transition portion being configured to allow the stop of the first cartridge connector to be rotated into place within the infusion pump with less force than required to remove the first cartridge connector from the first container port in the direction of the steep second transition portion.
23. The infusion pump of claim 1, wherein: The pump housing includes a bezel configured to engage a lower portion of the pump housing and a display screen, the pump housing configured to hold the display screen.
24. An infusion pump for delivering a drug to a patient, the infusion pump comprising: A pump housing comprising: a first container port including a bayonet extension recess configured to receive a first cartridge connector; a first drug cartridge container extending longitudinally from the first container port along a first side of the infusion pump to a first cartridge container aperture; The internal area includes: power supply; a first electric machine in electronic communication with the power source; a first gear assembly; a first lead screw; wherein the first motor comprises a first pinion gear, the first pinion gear being a component of the first gear assembly; wherein the first lead screw is in rotational communication with the first pinion through the first gear assembly; and The first drive nut has a length extending longitudinally along the pump housing, the first drive nut extends into the first drug cartridge container via a first hole and is connected to the first lead screw, and the first drive nut is configured to be pushed forward or backward in response to a first rotational direction and a second rotational direction of the first lead screw, respectively.
25. An infusion pump for delivering a drug to a patient, the infusion pump comprising: A pump housing comprising: a first container port configured to receive a first cartridge connector; a first drug cartridge container extending longitudinally from the first container port along a first side of the infusion pump to a first cartridge container aperture; The internal area includes: power supply; a first electric machine in electronic communication with the power source; a first stacked gear assembly; a first lead screw; wherein the first motor includes a first pinion gear, the first pinion gear being a component of the first laminated gear assembly; wherein the first laminated gear assembly extends laterally toward the first side of the infusion pump; wherein the first lead screw is in rotational communication with the first pinion gear via the first laminated gear assembly; and The first drive nut has a length extending longitudinally along the pump housing, the first drive nut extends into the first drug cartridge container via a first hole and is connected to the first lead screw, and the first drive nut is configured to be pushed forward or backward in response to a first rotational direction and a second rotational direction of the first lead screw, respectively.
26. The infusion pump according to claim 24 or 25, wherein: The first container port has one or more identification features configured to engage with corresponding identification features of the first cartridge connector.
27. An infusion pump according to claim 24 or 25, further comprising a second container port having one or more features configured to engage with conforming features of the second barrel connector.
28. The infusion pump of claim 24 or 25, further comprising a first seal providing a water resistant barrier between the interior region of the infusion pump and the first drug cartridge container.
29. The infusion pump of claim 28, wherein: The first seal is a first O-ring surrounding at least a portion of the first drive nut.
30. The infusion pump of claim 29, wherein: The pump housing includes a first saddle configured to retain the first O-ring.
31. The infusion pump according to claim 24 or 25, wherein: The first drive nut includes a protrusion, and the pump housing includes a recess configured to receive the protrusion, wherein the protrusion engages the recess and prevents rotation of the first drive nut.
32. An infusion pump according to claim 24 or 25, further comprising a magnet coaxially attached to the gear of the first gear assembly in the infusion pump of claim 24 or the gear of the first stacked gear assembly in the infusion pump of claim 25 and a rotational position sensor for measuring the angular position of the magnet.
33. An infusion system comprising an infusion pump as claimed in any one of claims 1 to 32 and a cartridge connector, the cartridge connector comprising: a knob which is cam-shaped and has a flat portion; as well as The subject, which includes: Needle; a lower surface portion extending circumferentially from the needle; a shield extending axially away from the lower surface portion and configured to receive and fit over a portion of a first drug cartridge configured to hold a first drug; and wherein the lower surface portion is located within the shield and is configured to contact a cap of the first drug cartridge when the first drug cartridge is inserted into the cartridge connector within the shield; wherein the needle extends axially within the shield away from the lower surface portion; Wherein, once inserted into a first pump container, the first cartridge connector is configured to be positioned within the first pump container using a quarter turn, which aligns the flat portion of the cam with a consistent flat surface of the pump to indicate to a user that the first cartridge connector is properly placed in the pump.
34. An infusion system comprising an infusion pump as claimed in any one of claims 1 to 32 and a cartridge connector, the cartridge connector comprising: The subject, which includes: Needle; a lower surface portion extending circumferentially from the needle; a shield extending axially away from the lower surface portion and configured to receive and fit over a portion of a first drug cartridge configured to hold a first drug; and wherein the lower surface portion is located within the shield and is configured to contact a cap of the first drug cartridge when the first drug cartridge is inserted into the cartridge connector within the shield; wherein the needle extends axially within the shield away from the lower surface portion; a knob connected to the body, the knob including an underside extending circumferentially from the shroud of the body, the knob including a fluid outlet configured to deliver the first medicament to a location external to the cartridge connector; Wherein, the lower side of the knob includes one or more stretchable blocks, which are configured to contact the upper surface of the infusion pump and deform when the barrel connector is twisted into place in the infusion pump, and the one or more stretchable blocks provide one or more contact points between the lower surface of the knob and the infusion pump.
35. An infusion system comprising an infusion pump as claimed in any one of claims 1 to 32 and a cartridge connector, the cartridge connector comprising: The subject, which includes: Needle; a lower surface portion extending circumferentially from the needle, the lower surface portion including a bowl-shaped concave surface and a surrounding lip, wherein the needle protrudes from and extends away from the bowl-shaped concave surface; a shield extending axially away from a circumference of the lower surface portion and configured to receive and fit over a portion of a first drug cartridge configured to hold a first drug; and wherein the lower surface portion is located within the shield and is configured to contact a cap of the first drug cartridge when the first drug cartridge is inserted into the cartridge connector within the shield; wherein the needle extends axially from the lower surface portion and is within the shield; A knob includes a fluid outlet configured to deliver the first medicament to a location external to the cartridge connector, wherein the knob is fixed to or integral with the body.
36. An infusion system comprising an infusion pump as claimed in any one of claims 1 to 32 and a cartridge connector, the cartridge connector comprising: The subject, which includes: Needle; a lower surface portion extending circumferentially from the needle; a shield extending axially away from the lower surface portion and configured to receive and fit over a portion of a first drug cartridge configured to hold a first drug; and a protrusion extending axially upward from an upper surface of the body, the protrusion including a fluid outlet; wherein the lower surface portion is located within the shield and is configured to contact a cap of the first drug cartridge when the first drug cartridge is inserted into the cartridge connector within the shield; wherein the needle extends axially from the lower surface portion and is within the shield; wherein the body is configured to receive the first drug through the needle and deliver the first drug out of the body from the fluid outlet of the body, the needle and the fluid outlet of the body being in fluid communication and providing a fluid path through the body; A knob configured to engage with the body, the knob comprising: a container portion configured to extend over and receive at least a portion of the protrusion of the body; a fluid inlet located within the container portion, the fluid inlet configured to receive the first medicament; and a fluid outlet configured to deliver the first medicament to a location external to the cartridge connector; a gap space between the protrusion of the body and the receptacle portion of the knob; and A flexible membrane is positioned within the interstitial space and extends over at least a portion of the protrusion of the body, the flexible membrane being configured to allow fluid to pass from the fluid outlet of the body and into the fluid inlet of the knob only after a threshold fluid pressure of the first drug is reached.
37. An infusion system according to any one of claims 34-36, wherein: The knob is cam-shaped and has a flat portion, and wherein, once inserted into a first pump container, the first cartridge connector is configured to be positioned within the first pump container using a quarter turn that aligns the flat portion of the cam with a consistent flat surface of the pump to indicate to a user that the first cartridge connector is properly placed in the pump.
38. An infusion system according to any one of claims 33, 35 or 36, wherein: The knob includes a lower side extending circumferentially from the shield of the body, and wherein the lower side of the knob includes one or more stretchable nubs configured to contact an upper surface of an infusion pump and deform when the barrel connector is twisted into place within the infusion pump, the one or more stretchable nubs providing one or more contact points between the lower surface of the knob and the infusion pump.
39. An infusion system according to any one of claims 33, 34 or 36, wherein: The lower surface portion of the body includes a bowl-shaped concave surface and a surrounding lip, wherein the needle protrudes from the bowl-shaped concave surface and extends away from the bowl-shaped concave surface.
40. An infusion system according to any one of claims 33 to 35, wherein: The body includes a protrusion extending axially upward from an upper surface of the body, the protrusion including a fluid outlet; wherein the body is configured to receive the first drug through the needle and deliver the first drug out of the body from the fluid outlet of the body, the needle and the fluid outlet of the body being in fluid communication and providing a fluid path through the body; Wherein, the knob comprises: a container portion configured to extend over and receive at least a portion of the protrusion of the body; a fluid inlet located within the container portion, the fluid inlet configured to receive the first medicament; and a fluid outlet configured to deliver the first medicament to a location external to the cartridge connector; wherein the connector comprises a gap space between the protrusion of the body and the container portion of the knob, a flexible membrane located within the gap space and extending over at least a portion of the protrusion of the body, the flexible membrane being configured to allow fluid to pass from the fluid outlet of the body and enter the fluid inlet of the knob only after a threshold fluid pressure of the first drug is reached.
41. An infusion system according to any one of claims 33-36, wherein: The cartridge connector is also configured to engage the first port of an infusion pump.
42. An infusion system according to any one of claims 33-36, wherein: The needle of the cartridge connector is configured to pierce a septum of the cap of the first drug cartridge.
43. An infusion system according to any one of claims 33-36, wherein: The knob is fixed to the body and / or is integral with the body.
44. An infusion system according to any one of claims 33-36, wherein: The shield includes one or more latch arms configured to engage the cap, stopper and / or lug of the first drug cartridge.
45. An infusion system comprising an infusion pump as described in any one of claims 1 to 32 and a drug connector group for delivering one or more drugs to a patient, the drug connector group comprising a barrel connector in an infusion system as described in any one of claims 33 to 44 as a first barrel connector and a first fluid conduit, the first fluid conduit being configured to receive a first drug from the first barrel connector.
46. The infusion system of claim 45, wherein the drug connector set further comprises a first infusion connector in fluid communication with the first fluid conduit.
47. An infusion system comprising an infusion pump as claimed in any one of claims 1 to 32 and a drug connector set for delivering one or more drugs to a patient, the drug connector set comprising a cartridge connector in an infusion system as claimed in any one of claims 33 to 44 as a first cartridge connector, and a second cartridge connector configured to engage a second drug cartridge, the second drug cartridge comprising: The subject, which includes: Needle; a lower surface portion extending circumferentially from the needle; a shield extending axially away from the lower surface portion and configured to receive and fit over a portion of a second drug cartridge configured to hold a second drug; and wherein the lower surface portion is located within the shield and is configured to contact a cap of the second drug cartridge when the second drug cartridge is inserted into the second cartridge connector within the shield; wherein the needle extends axially within the shield away from the lower surface portion; and A knob is connected to the body, the knob including an underside extending circumferentially from the shield of the body, the knob including a fluid outlet configured to deliver the first medicament to a location external to the second cartridge connector.
48. The infusion system of claim 47, wherein: The second cartridge connector is configured to engage a second port of the infusion pump.
49. An infusion system according to claim 47 or 48, wherein The shroud of the second cartridge connector includes one or more bayonet arms configured to engage the cap, stopper and / or lug of the second drug cartridge.
50. The infusion system of claim 49, wherein: One or more of the bayonet arms, the stoppers and / or the lugs of the first barrel connector are different from the bayonet arms, the stoppers and / or the lugs of the second barrel connector.
51. The infusion system of claim 47, wherein: The first cartridge connector is configured not to engage the second drug cartridge and / or wherein the second cartridge connector is configured not to engage the first drug cartridge.
52. The infusion system of claim 48, wherein: The first cartridge connector is configured to not engage the second port of the infusion pump and / or wherein the second cartridge connector is configured to not engage the first port of the infusion pump.