Walking device and its components

Abstract

Certain embodiments provide a multiple drug or single drug infusion system for preventing cross-channeling or improper delivery of drugs. The system can include one or more of an infusion pump, a drug cartridge, a cartridge connector, a multi-channel fluid conduit, and an infusion set. The drug cartridges can be differently sized and shaped so that drug reservoirs can only be inserted into the pump in selected configurations.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. Provisional Patent Application No. 63 / 037,472, filed June 10, 2020, U.S. Provisional Patent Application No. 62 / 987,842, filed March 10, 2020, U.S. Provisional Patent Application No. 62 / 874,928, filed July 16, 2019, U.S. Provisional Patent Application No. 62 / 874,954, filed July 16, 2019, U.S. Provisional Patent Application No. 62 / 874,959, filed July 16, 2019, and U.S. Provisional Patent Application No. 62 / 874,960, filed July 16, 2019. This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 874,964, filed July 16, 2019, U.S. Provisional Patent Application No. 62 / 874,972, filed July 16, 2019, U.S. Provisional Patent Application No. 62 / 874,975, filed July 16, 2019, and U.S. Provisional Patent Application No. 62 / 874,977, filed July 16, 2019, the disclosures of each of which are incorporated herein by reference in their entireties.

[0002] The present disclosure relates generally 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 above, and methods of using each of the above. [Background technology]

[0003] Sustained delivery pump-driven medication injection devices generally include a delivery cannula that is subcutaneously attached through the patient's skin at an injection site. The pump draws the medical agent from a reservoir and delivers it to the patient through the cannula. The injection device typically includes a channel that conveys the agent from an inlet port to a delivery cannula that provides delivery to the subcutaneous tissue layer where the delivery cannula terminates. Some infusion devices are configured to deliver one agent to a patient, while others are configured to deliver multiple agents to a patient. Summary of the Invention

[0004] Some embodiments provide 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 above, and methods of using each of the above.

[0005] Some embodiments relate to an infusion pump for delivering a medication to a patient. In some embodiments, the infusion pump comprises a pump housing. In some embodiments, the pump housing comprises a first receptacle port configured to engage with a first cartridge connector. In some embodiments, the pump housing comprises a second receptacle port configured to engage with a second cartridge connector. In some embodiments, the pump housing comprises a first medication cartridge receptacle extending longitudinally from the first receptacle port along a first side of the infusion pump to a first cartridge receptacle aperture. In some embodiments, the pump housing comprises a second medication cartridge receptacle extending longitudinally from the second receptacle port along a second side of the infusion pump to a second cartridge receptacle aperture. In some embodiments, the pump comprises an interior section. In some embodiments, the interior section comprises a power source disposed between the first medication cartridge receptacle and the second medication cartridge receptacle. In some embodiments, the interior section includes a first motor in electronic communication with the power source. In some embodiments, the interior section includes a second motor in electronic communication with the power source. In some embodiments, the interior section includes a first stacked gear assembly. In some embodiments, the internal section comprises a second stacked gear assembly. In some embodiments, the internal section comprises a first lead screw. In some embodiments, the internal section comprises a second lead screw. In some embodiments, the first motor and the second motor (if present) comprise a first pinion gear and a second pinion gear (if present), respectively, the first pinion gear being a member of the first stacked gear assembly and the second pinion gear being a member of the second stacked gear assembly (if present). In some embodiments, the first gear assembly extends laterally towards a first side of the infusion pump. In some embodiments, the second gear assembly extends laterally towards a second side of the infusion pump. In some embodiments, the first lead screw is in rotational communication with the first pinion gear via the first gear assembly. In some embodiments, the second lead screw is in rotational communication with the second pinion gear via the second gear assembly. In some embodiments, the pump comprises a first drive nut having a length extending longitudinally along the pump housing and configured to move through a first aperture into a first drug cartridge receptacle, the first drive nut in communication with the first lead screw and configured to urge forward or rearward in response to a first rotational direction and a second rotational direction, respectively, of the first lead screw. In some embodiments, the pump comprises a second drive nut having a length extending longitudinally along the pump housing and configured to move through a second aperture into a second drug cartridge receptacle, the second drive nut in communication with the second lead screw and configured to urge forward or rearward in response to a first rotational direction and a second rotational direction, respectively, of the second lead screw.

[0006] Any of the embodiments described above, or elsewhere herein, can include one or more of the following features.

[0007] In some embodiments, the first receptacle port has one or more recognition features configured to engage with matching recognition features of the first cartridge connector. In some embodiments, the second receptacle port has one or more recognition features configured to engage with matching recognition features of the second cartridge connector. In some embodiments, the recognition features of the first receptacle port are different from the recognition features of the second receptacle port. In some embodiments, the first receptacle port is configured to not allow engagement of the second cartridge connector and the second receptacle port is configured to not allow engagement of the first cartridge connector.

[0008] In some embodiments, the pump comprises 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 receptacle. In some embodiments, the second seal provides a water-resistant barrier between an interior area of ​​the infusion pump and the second drug cartridge receptacle. In some embodiments, the first seal is a first O-ring circumferentially surrounding at least a portion of the first drive nut. In some embodiments, the second seal is a second O-ring circumferentially surrounding at least a portion of the second drive nut. In some embodiments, the pump housing comprises a first saddle. In some embodiments, the pump housing comprises a second saddle. In some embodiments, the first saddle is configured to hold the first O-ring. In some embodiments, the second saddle is configured to hold the second O-ring. In some embodiments, the first saddle is positioned adjacent to the first cartridge receptacle aperture. In some embodiments, the second saddle is positioned adjacent to the second cartridge receptacle aperture.

[0009] In some embodiments, the first drive nut is a first cartridge receptacle. In some embodiments, the pump housing includes a protrusion on a proximal portion of the first drive nut that remains within the interior region while extending into the pump housing. In some embodiments, the pump housing includes a groove configured to receive the protrusion of the first drive nut. In some embodiments, the protrusion of the first drive nut engages the groove, thereby preventing rotation of the first drive nut. In some embodiments, the groove is provided within or within a portion of the pump backing portion of the housing.

[0010] In some embodiments, the housing comprises 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 comprises an integrated circuit configured to measure the capacitance of the circuit. In some embodiments, the conductive foam fills the gap between the surface and the integrated circuit.

[0011] In some embodiments, the housing comprises a lower metal portion and a bezel attachable to the metal portion. In some embodiments, at least a portion of the sidewall of the ambulatory medical device is covered only by the bezel. In some embodiments, the circuit board is positioned adjacent to an inner surface of the bezel. In some embodiments, the wireless antenna is secured to the circuit board such that it is positioned toward the portion of the sidewall of the ambulatory medical device that is covered only by the bezel.

[0012] In some embodiments, the bezel allows wireless signals to pass through and the metal portion does not interfere with signals from the antenna. In some embodiments, the circuit board is configured to process wireless signals received by the antenna. In some embodiments, the first magnet is coaxially mounted to a gear in the first gear assembly and a first rotational position sensor that measures an angular position of the first magnet.

[0013] In some embodiments, the first receptacle port comprises a snap arm recess extending longitudinally into the first drug cartridge receptacle, the snap arm recess of the first drug cartridge receptacle configured to receive a snap arm of the first cartridge connector when the snap arm extends over the first drug cartridge cap during engagement of the first drug cartridge while the first drug cartridge is housed in the first drug cartridge receptacle. In some embodiments, the second receptacle port comprises a snap arm recess extending longitudinally into the second drug cartridge receptacle, the snap arm recess of the second drug cartridge receptacle configured to receive a snap arm of the second cartridge connector when the snap arm extends over the second drug cartridge cap during engagement of the second drug cartridge while the second drug cartridge is housed in the second drug cartridge receptacle. In some embodiments, the snap arm recess of the first receptacle port is configured not to receive a snap arm of the second cartridge connector.

[0014] In some embodiments, the first receptacle port comprises a lug opening and a radially extending lug track configured to receive lugs of the first cartridge connector when the first cartridge connector is inserted into the first receptacle port and rotated into position. In some embodiments, the second receptacle port comprises a lug opening and a radially extending lug track configured to receive lugs of the second cartridge connector when the second cartridge connector is inserted into the second receptacle port and rotated into position.

[0015] In some embodiments, the first receptacle port includes a detent opening and a detent track, the detent track having a detent cam with a shallow first transition and a steep second transition, the detent opening and the detent track being adapted to engage the first cartridge connector. The infusion pump is configured to receive a detent of the first cartridge connector when the infusion pump is inserted into the first receptacle port and rotated into position, and the shallow first transition portion is configured to allow the detent of the first cartridge connector to be rotated into position within the infusion pump with less force than the force required to remove the first cartridge connector from the first receptacle port along the direction of the steeper second transition portion. In some embodiments, the second receptacle port includes a detent opening and a detent track having a detent cam having a shallow first transition portion and a steep second transition portion, the detent opening and the detent track configured to receive a detent of the second cartridge connector when the second cartridge connector is inserted into the second receptacle port and rotated into position, and the shallow first transition portion configured to allow the detent of the second cartridge connector to be rotated into position within the infusion pump with less force than the force required to remove the second cartridge connector from the second receptacle port along the direction of the steep second transition portion.

[0016] In some embodiments, the pump housing comprises a bezel and a display screen, the bezel configured to engage a lower portion of the pump housing configured to hold the display screen.

[0017] Some embodiments provide an infusion pump comprising a housing having an interior space. In some embodiments, the pump housing comprises a bore extending therethrough, the bore having a first end and a second end, the bore configured to receive a drug cartridge. In some embodiments, the first end defines an opening to the housing, and the second end is disposed in the interior space of the housing. In some embodiments, an elongate shaft is disposed within the bore and configured to engage the drug cartridge. In some embodiments, an O-ring is circumferentially disposed on the elongate shaft adjacent the second end of the bore.

[0018] Some embodiments provide an infusion pump for providing a therapy change. In some embodiments, the pump comprises a button that generates a wake signal after being pressed. In some embodiments, the pump comprises a touchscreen display that activates after receiving the wake signal. In some embodiments, the pump comprises a therapy change user interface that unlocks after receiving a first gesture on the touchscreen display. In some embodiments, the therapy change user interface is capable of receiving a therapy change selection from the touchscreen display. In some embodiments, the drug infusion component delivers a drug after receiving a second gesture on the touchscreen display.

[0019] Some embodiments provide the infusion pump with a capacitance sensor that detects when a finger touches the surface. In some embodiments, the surface has a curved depression. In some embodiments, the capacitance sensor comprises one or more of an integrated circuit that measures the capacitance of a circuit and / or conductive foam between the surface and the integrated circuit.

[0020] Some embodiments provide an infusion pump comprising one or more of a metal housing, a bezel attachable to the metal housing, at least a portion of a sidewall of the ambulatory medical device being covered only by the bezel, a circuit board positioned adjacent to an inner surface of the bezel, and / or a wireless antenna secured to the circuit board such that the wireless antenna is positioned toward a portion of the sidewall of the ambulatory medical device that is covered only by the bezel.

[0021] Some embodiments include an electric motor that rotates a shaft, a gear assembly that rotates a In one embodiment, the infusion pump includes one or more of a gear secured to the end of a shaft that is attached to the rotor, a magnet coaxially mounted to one of the gears in the gear assembly, and / or a rotational position sensor that measures the angular position of the magnet.

[0022] Some embodiments provide an infusion pump for delivering a medication to a patient. In some embodiments, the infusion pump comprises a pump housing. In some embodiments, the infusion pump comprises a first receptacle port comprising a snap arm extension recess configured to receive a first cartridge connector. In some embodiments, the infusion pump comprises a first medication cartridge receptacle extending longitudinally along a first side of the infusion pump from the first receptacle port to a first cartridge receptacle aperture. In some embodiments, the infusion pump comprises an interior region. In some embodiments, the infusion pump comprises a power source. In some embodiments, the infusion pump comprises a first motor in electronic communication with the power source. In some embodiments, the infusion pump comprises a first gear assembly. In some embodiments, the infusion pump comprises a first lead screw. In some embodiments, the first motor comprises a first pinion gear, the first pinion gear being a member of the first gear assembly. In some embodiments, the first lead screw is in rotational communication with the first pinion gear via 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 receptacle through a first aperture and communicates with the first lead screw. In some embodiments, the first drive nut is configured to bias forward or rearward in response to a first rotational direction and a second rotational direction, respectively, of the first lead screw.

[0023] Some embodiments provide an infusion pump for delivering a medication to a patient. In some embodiments, the infusion pump comprises a pump housing. In some embodiments, the infusion pump comprises a first receptacle port configured to receive a first cartridge connector. In some embodiments, the infusion pump comprises a first medication cartridge receptacle extending longitudinally along a first side of the infusion pump from the first receptacle port to a first cartridge receptacle aperture. In some embodiments, the infusion pump comprises an interior section. In some embodiments, the infusion pump comprises a power source. In some embodiments, the infusion pump comprises a first motor in electronic communication with the power source. In some embodiments, the infusion pump comprises a first stacked gear assembly. In some embodiments, the infusion pump comprises a first lead screw. In some embodiments, the first motor comprises a first pinion gear, the first pinion gear being 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 in rotational communication with the first pinion gear via 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 receptacle via the first aperture and is in communication with the first lead screw. In some embodiments, the first drive nut is configured to bias forward or rearward in response to a first rotational direction and a second rotational direction, respectively, of the first lead screw.

[0024] Any of the embodiments described above, or elsewhere herein, can include one or more of the following features.

[0025] In some embodiments, the first receptacle port has one or more recognition features configured to engage with matching recognition features of the first cartridge connector.

[0026] In some embodiments, the infusion pump comprises a second receptacle port having one or more features configured to engage with matching features of the second cartridge connector.

[0027] In some embodiments, the infusion pump includes a first seal, the first seal providing a water-resistant barrier between an interior region of the infusion pump and the first drug cartridge receptacle. 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, the first saddle 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, the protrusion engaging the groove and preventing rotation of the first drive nut.

[0028] In some embodiments, the infusion pump includes a magnet coaxially mounted on a gear of the first gear assembly and a rotational position sensor that measures the angular position of the magnet.

[0029] Some embodiments provide a cartridge connector. In some embodiments, the cartridge connector comprises a knob. In some embodiments, the knob is in the shape of a cam and has a flat portion. In some embodiments, the cartridge connector comprises a body. In some embodiments, the body comprises a needle. In some embodiments, the body comprises a lower surface portion extending circumferentially from the needle. In some embodiments, the body comprises a shroud extending axially away from the lower surface portion. In some embodiments, the shroud is configured to receive and mate with a portion of the first drug cartridge. In some embodiments, the first drug cartridge is configured to hold a first drug. In some embodiments, the lower surface portion is disposed within the shroud. In some embodiments, the lower surface portion is configured to contact a cap of the first drug cartridge when the first drug cartridge is inserted into the cartridge connector within the shroud. In some embodiments, the needle extends axially within the shroud away from the lower surface portion. In some embodiments, when inserted into the first pump receptacle, the first cartridge connector is configured to be positioned within the first pump receptacle using a quarter turn that aligns a flat portion of the cam with a matching flat surface on the pump to indicate to a user that the first cartridge connector is correctly positioned within the pump.

[0030] Some embodiments provide a cartridge connector. In some embodiments, the cartridge connector comprises a body. In some embodiments, the body comprises a needle. In some embodiments, the body comprises a lower surface portion extending circumferentially from the needle. In some embodiments, the body comprises a shroud extending axially away from the lower surface portion. In some embodiments, the shroud is configured to receive and mate with a portion of a first medicament cartridge configured to hold a first medicament. In some embodiments, the lower surface portion is disposed within the shroud. In some embodiments, the lower surface portion is configured to contact a cap of the first medicament cartridge when the first medicament cartridge is inserted into the cartridge connector within the shroud. In some embodiments, the needle extends axially within the shroud away from the lower surface portion. In some embodiments, the connector comprises a knob connected to the body. In some embodiments, the knob comprises an underside extending circumferentially from the shroud of the body. In some embodiments, the knob comprises a fluid outlet configured to deliver the first medicament to a location outside of the cartridge connector. In some embodiments, the underside of the knob comprises one or more malleable nubs. In some embodiments, the malleable nub is configured to contact an upper side of the infusion pump. In some embodiments, the malleable nub is configured to deform (e.g., against an upper side of the infusion pump) when the cartridge connector is screwed into place within the infusion pump. In some embodiments, the one or more malleable nubs provide one or more contact points between the underside of the knob and the infusion pump.

[0031] Some embodiments provide a cartridge connector. In some embodiments, the cartridge connector comprises a body. In some embodiments, the body comprises a needle. In some embodiments, the body comprises a lower surface portion extending circumferentially from the needle. In some embodiments, the lower surface comprises a bowl-shaped concave surface. In some embodiments, the lower surface comprises a peripheral lip. In some embodiments, the needle protrudes from and extends away from the bowl-shaped concave surface. In some embodiments, the body comprises a shroud extending axially away from a circumference of the lower surface portion. In some embodiments, the shroud is configured to receive and mate with a portion of a first medicament cartridge configured to hold a first medicament. In some embodiments, the lower surface portion is disposed within the shroud and configured to contact a cap of the first medicament cartridge when the first medicament cartridge is inserted into the cartridge connector within the shroud. In some embodiments, the needle extends axially into the shroud from the lower surface portion. In some embodiments, the cartridge connector comprises a knob portion. In some embodiments, the cartridge connector comprises a fluid outlet configured to deliver the medicament to a location outside of the cartridge connector. In some embodiments, the knob is fixed to or integral with the body.

[0032] Some embodiments provide a cartridge connector. In some embodiments, the cartridge connector comprises a body. In some embodiments, the body comprises a needle. In some embodiments, the body comprises a lower surface portion extending circumferentially from the needle. In some embodiments, the body comprises a shroud extending axially away from the lower surface portion. In some embodiments, the shroud is configured to receive and mate with a portion of a first medicament cartridge configured to hold a first medicament. In some embodiments, the body comprises a protrusion extending axially upward from a top surface of the body. In some embodiments, the protrusion comprises a fluid outlet. In some embodiments, the lower surface portion is disposed within the shroud. In some embodiments, the lower surface portion is configured to contact a cap of the first medicament cartridge when the first medicament cartridge is inserted into the cartridge connector within the shroud. In some embodiments, the needle extends axially into the shroud from the lower surface portion. In some embodiments, the body is configured to receive the medicament through the needle and deliver the medicament out of the body through a fluid outlet of the body. In some embodiments, the needle and the fluid outlet of the body are in fluid communication to provide a fluid path through the body. In some embodiments, the cartridge connector comprises a knob portion. In some embodiments, the knob portion is configured to engage with the body. In some embodiments, the knob portion comprises a receptacle portion. In some embodiments, the receptacle portion extends over and is configured to receive at least a portion of the projection of the body. In some embodiments, a fluid inlet is disposed within the receptacle portion, the fluid inlet configured to receive the medicament. In some embodiments, the knob comprises a fluid outlet configured to deliver the medicament to a location exterior to the cartridge connector. In some embodiments, the connector comprises an interstitial space (or area) disposed between the projection of the body and the receptacle portion of the knob. In some embodiments, a flexible membrane is disposed within the interstitial space. In some embodiments, the flexible membrane extends over at least a portion of the projection of the body.In some embodiments, the flexible membrane is configured to allow fluid to enter the knob inlet from the body outlet only after a threshold fluid pressure of the agent has been reached.

[0033] Any of the embodiments described above, or elsewhere herein, can include one or more of the following features.

[0034] In some embodiments, the knob is in the shape of a cam having a flat portion. In an embodiment, when inserted into the first pump receptacle, the first cartridge connector is configured to be positioned within the first pump receptacle using a quarter turn that aligns a flat portion of the cam with a matching flat surface on the pump to indicate to a user that the first cartridge connector is correctly positioned within the pump.

[0035] In some embodiments, the knob includes an underside that extends circumferentially from the shroud of the body, the underside of the knob including one or more malleable nubs. In some embodiments, the malleable nubs contact an upper side of the infusion pump and are configured to deform when the cartridge connector is screwed into place within the infusion pump. In some embodiments, the one or more malleable nubs provide one or more contact points between the underside of the knob and the infusion pump.

[0036] In some embodiments, the lower surface portion of the body comprises a bowl-shaped concave surface and a peripheral lip, hi some embodiments, the needle protrudes from and extends away from the bowl-shaped concave surface.

[0037] In some embodiments, the body comprises a protrusion extending axially upward from a top surface of the body. In some embodiments, the protrusion comprises a fluid outlet. In some embodiments, the body is configured to receive the medicament through the needle and deliver the medicament out of the body through the fluid outlet of the body. In some embodiments, the needle and the fluid outlet of the body are in fluid communication and provide a fluid path through the body. In some embodiments, the knob comprises a receptacle portion. In some embodiments, the receptacle portion extends across and is configured to receive at least a portion of the protrusion of the body. In some embodiments, a fluid inlet is disposed within the receptacle portion, the fluid inlet configured to receive the medicament. In some embodiments, the fluid outlet is configured to deliver the medicament to a location exterior to the cartridge connector. In some embodiments, the connector comprises an interstitial space disposed between the protrusion of the body and the receptacle portion of the knob. In some embodiments, the connector comprises a flexible membrane disposed within the interstitial space and extending across at least a portion of the protrusion of the body. In some embodiments, the flexible membrane is configured to allow fluid to enter the knob inlet from the body outlet only after a threshold fluid pressure of the medicament is reached.

[0038] In some embodiments, the cartridge connector is also configured to engage with a first port of the infusion pump.

[0039] In some embodiments, the needle of the cartridge connector is configured to pierce a septum of the cap of the first medication cartridge.

[0040] In some embodiments, the knob is fixed to and / or integral with the body.

[0041] In some embodiments, the shroud comprises one or more of a snap arm, a detent, and / or a lug configured to engage with the cap of the first drug cartridge.

[0042] Some embodiments relate to a medication connector set for delivering single or multiple medications to a patient, the medication connector set comprising a first cartridge connector as disclosed herein and a first fluid conduit configured to receive a first medication from the first cartridge connector, In some embodiments, the connector set further comprises a first infusion connector in fluid communication with the first fluid conduit (e.g., secured and / or connected to the fluid conduit).

[0043] Some embodiments relate to a drug connector set for delivering single or multiple drugs to a patient, comprising a first cartridge connector configured to engage a second drug cartridge and a cartridge connector disclosed elsewhere herein as a second cartridge connector. In some embodiments, the second drug cartridge comprises a body. In some embodiments, the second drug cartridge comprises a needle. In some embodiments, the second drug cartridge comprises a lower surface portion extending circumferentially from the needle. In some embodiments, the second drug cartridge comprises a shroud extending axially away from the lower surface portion and configured to receive and mate with a portion of the second drug cartridge configured to hold the second drug. In some embodiments, the lower surface portion is disposed within the shroud and configured to contact a cap of the second drug cartridge when the second drug cartridge is inserted into the cartridge connector within the shroud. In some embodiments, the second drug cartridge comprises a bowl-shaped concave surface. In some embodiments, the needle extends axially within the shroud away from the lower surface portion. In some embodiments, the second drug cartridge comprises a knob connected to the body. In some embodiments, the knob comprises an underside extending circumferentially from a shroud of the body, the knob comprising a fluid outlet configured to deliver the first medicament to a location exterior to the cartridge connector. In some embodiments, the second medicament cartridge is configured to engage with a second port of the infusion pump. In some embodiments, the shroud of the second cartridge connector comprises one or more of a snap arm, a detent, and / or a lug configured to engage with a cap of the second medicament cartridge.

[0044] In some embodiments, one or more of the snap arms, detents, and / or lugs of the first cartridge connector are different from the snap arms, detents, and / or lugs of the second cartridge connector. In some embodiments, the first cartridge connector is configured not to engage with the second drug cartridge, and / or the second cartridge connector is configured not to engage with the first drug cartridge. In some embodiments, the first cartridge connector is configured not to engage with the second port of the infusion pump, and / or the second cartridge connector is configured not to engage with the first port of the infusion pump.

[0045] Some embodiments relate to an infusion system, hi some embodiments, the system comprises a connector or connector set, as disclosed elsewhere herein, and an infusion pump.

[0046] Some embodiments disclosed herein relate to an infusion pump for delivering a plurality of fluids to a patient. In some embodiments, the infusion pump comprises a pump housing. In some embodiments, the housing comprises a first receptacle port and a second receptacle port. In some embodiments, the infusion pump comprises a first drug cartridge receptacle. In some embodiments, the receptacle extends longitudinally from the first receptacle port along a first side of the infusion pump to a first cartridge receptacle aperture. In some embodiments, the infusion pump comprises a second drug cartridge receptacle extending longitudinally from the second receptacle port along a second side of the infusion pump to a second cartridge receptacle aperture. In some embodiments, the infusion pump comprises an interior section comprising one or more of a power source, a first motor, and a second motor. In some embodiments, the motor comprises a first pinion gear that is part of a first stacked gear assembly. In some embodiments, the pump includes a first gear assembly extending laterally toward a first side of the infusion pump. In some embodiments, the pump includes a first drive nut in rotational communication with a first pinion gear through the first gear assembly. In some embodiments, the pump includes a first drive nut in rotational communication with the first drive nut, the first piston being in communication with the first drive nut when fully retracted. The first drive nut is configured to reside within an interior region of the infusion pump and extend outwardly from the interior region of the pump through the first receptacle aperture when not fully retracted, and the first drive nut is configured to urge a plunger of the first drug cartridge forward to dispense a 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.

[0047] In some embodiments, the housing comprises a capacitance sensor configured to detect when a finger touches the surface. In some embodiments, the surface is a curved indentation on the housing, and the capacitance sensor comprises an integrated circuit configured to measure the capacitance of the circuit. In some embodiments, a conductive foam is provided that fills the gap between the surface and the integrated circuit. In some embodiments, the capacitance sensor generates a wake signal after being pressed. In some embodiments, a touchscreen display of the pump wakes up after receiving the wake signal. In some embodiments, the therapy change user interface unlocks after receiving a first gesture on the touchscreen display. In some embodiments, the therapy change user interface can receive a therapy change selection from the touchscreen display. In some embodiments, the drug infusion component delivers the drug after receiving a second gesture on the touchscreen display.

[0048] In some embodiments, the housing comprises a metal portion and a bezel attachable to the metal portion. In some embodiments, at least a portion of a sidewall of the ambulatory medical device is covered by the bezel and not the metal housing. In some embodiments, the circuit board is positioned adjacent to an inner surface of the bezel. In some embodiments, the wireless antenna is secured to the circuit board such that it is positioned toward a portion of the sidewall of the ambulatory medical device that is only covered by the bezel.

[0049] In some embodiments, the first motor rotates a shaft. In some embodiments, the pump includes a gear fixed to an end of the shaft that rotates a gear assembly. In some embodiments, the pump includes a magnet coaxially mounted 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.

[0050] In some embodiments, the housing comprises an interior space. In some embodiments, the housing comprises a bore extending therethrough, the bore having a first end and a second end, the bore configured to receive a drug cartridge. In some embodiments, the first end defines an opening to the housing, and the second end is disposed in the interior space of the housing. In some embodiments, the housing comprises an elongate shaft disposed within the bore and configured to engage the drug cartridge. In some embodiments, the housing comprises an O-ring circumferentially disposed on the elongate shaft adjacent the second end of the bore.

[0051] Some embodiments relate to a drug infusion system for delivering single or multiple medicaments to a patient. In some embodiments, the drug infusion system comprises a first cartridge connector configured to engage a first drug cartridge and an infusion pump. In some embodiments, the first cartridge connector comprises a needle configured to allow access to a first drug in the first drug cartridge. In some embodiments, the first cartridge connector comprises a knob in the shape of a cam and having a flat portion. In some embodiments, the knob comprises at least one detent. In some embodiments, the knob comprises a snap arm. In some embodiments, the knob comprises a skirt. In some embodiments, the knob comprises a gripping rib. In some embodiments, the first cartridge connector is configured to engage with a first pump receptacle of the pump. In some embodiments, the first pump receptacle has a receiving track that matches the location and shape of the at least one detent. In some embodiments, when inserted into the first pump receptacle, the first cartridge connector is configured to be positioned within the first pump receptacle using a quarter turn that aligns a flat portion of the cam with a matching flat surface of the pump (e.g., to indicate to a user that the first cartridge connector is correctly positioned within the pump).

[0052] Some embodiments relate to a cartridge connector. In some embodiments, the cartridge connector comprises a body. In some embodiments, the body comprises a needle. In some embodiments, the body comprises a lower surface portion extending circumferentially from the needle. In some embodiments, the body comprises a shroud extending axially away from the lower surface portion and configured to receive and mate with a portion of a first medicament cartridge (e.g., configured to hold a first medicament). In some embodiments, the body comprises a protrusion extending axially upward from a top surface of the body. In some embodiments, the protrusion comprises a fluid outlet. In some embodiments, the lower surface portion is disposed within the shroud and configured to contact a cap of the medicament cartridge when the medicament cartridge is inserted into the cartridge connector through the shroud. In some embodiments, the needle extends axially from the lower surface portion into the shroud. In some embodiments, the body is configured to receive the medicament through the needle and deliver the medicament out of the body through the fluid outlet of the body. In some embodiments, the needle and the fluid outlet of the body are in fluid communication. In some embodiments, the needle and the fluid outlet of the body provide a fluid path through the body. In some embodiments, the connector comprises a knob portion configured to engage with the body. In some embodiments, the knob comprises a receptacle portion. In some embodiments, the receptacle portion is configured to extend over and receive at least a portion of the body projection. In some embodiments, it is within the receptacle portion that a fluid inlet is disposed, the fluid inlet being configured to receive the medicament. In some embodiments, the fluid outlet of the knob is configured to deliver the medicament to a location exterior to the cartridge connector. In some embodiments, the connector comprises an interstitial space disposed between the body projection and the receptacle portion of the knob. In some embodiments, a flexible membrane is disposed within the interstitial space and extends over at least a portion of the body projection. In some embodiments, the flexible membrane is configured to allow fluid to enter the knob inlet from the body outlet only after a threshold fluid pressure of the medicament is reached.

[0053] Some embodiments provide an infusion system comprising a connector set and any pump disclosed above or elsewhere herein. Some embodiments provide an infusion system comprising any connector and any pump disclosed above or elsewhere herein. In some embodiments, the infusion system further comprises an infusion system.

[0054] Some embodiments provide an infusion pump. In some embodiments, the infusion pump comprises a housing comprising a capacitance 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 capacitance sensor comprises an integrated circuit configured to measure the capacitance of the circuit. In some embodiments, the infusion pump comprises a conductive foam filling a gap between the surface and the integrated circuit.

[0055] In some embodiments, the surface having the curved indentation is incorporated into a frame of the medical device. In some embodiments, the curved indentation is shaped to fit the dimensions of a user's finger. In some embodiments, the curved indentation has tactile feedback. In some embodiments, the tactile feedback is provided by a capacitive sensor detecting a finger touching the surface. In some embodiments, the tactile feedback indicates when the capacitance sensor detects a finger for more than about 0.5 seconds continuously. In some embodiments, the infusion pump includes a light source under the curved recess. In some embodiments, the output of the light source is responsive based on the input received from the capacitance sensor. In some embodiments, the infusion pump includes a pump chamber that delivers one or more hormones to the user. In some embodiments, the infusion pump is activated when the capacitance sensor detects a finger for more than about 0.5 seconds continuously.

[0056] Some embodiments provide an infusion pump that includes a button that generates a wake signal after being pressed. In some embodiments, the infusion pump includes a touchscreen display that activates after receiving the wake signal. In some embodiments, the infusion pump includes a therapy change user interface that unlocks after receiving a first gesture on the touchscreen display (e.g., after unlocking). In some embodiments, the therapy change user interface can receive a therapy change selection from the touchscreen display. In some embodiments, the drug infusion component delivers a drug after receiving a second gesture on the touchscreen display.

[0057] In some embodiments, the therapy change selection includes receiving a selection between one or more hormones that regulate the user's blood glucose level. In some embodiments, the therapy change selection includes an amount of one or more hormones that regulate the user's blood glucose level. In some embodiments, the button does not generate a wake signal if pressed for less than about 0.5 seconds before being pressed. In some embodiments, the first gesture on the touch screen display further includes a predetermined sequence of inputs. In some embodiments, the button does not generate a wake signal after the button is pressed until the button is released. In some embodiments, the button does not generate a wake signal if the button is released more than about 1.5 seconds after it is pressed.

[0058] Some embodiments provide a method for preventing inadvertent therapy changes on a medical device. In some embodiments, the method includes generating a wake signal after a button is pressed. In some embodiments, the method includes activating a touch screen display after receiving the wake 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 prior to delivering medication based on the therapy change selection.

[0059] In some embodiments, the method includes receiving a therapy change selection, further including receiving a selection between one or more hormones that regulate the user's blood glucose level. In some embodiments, the method includes receiving a therapy change selection, further including receiving an amount of one or more hormones that regulate the user's blood glucose level. In some aspects, the therapy change selection further includes one or more hormones including a choice between insulin or glucagon. In some embodiments, receiving the second gesture is based on the therapy change selection. In some embodiments, the method includes receiving a predetermined series of numerical inputs to deliver the therapy change selection. In some embodiments, the first gesture further includes completing the predetermined series of inputs. In some embodiments, generating the wake signal further includes the button being pressed for at least about 0.5 seconds. In some embodiments, generating the wake signal further includes releasing the button after the button is pressed. In some embodiments, the button is released less than about 1.5 seconds after the button is pressed.

[0060] Some embodiments provide a medical device for providing a therapy change. In some embodiments, the medical device comprises a button that generates a wake signal after being pressed. In some embodiments, the medical device comprises a touch screen display that activates after receiving the wake signal. In some embodiments, the medical device comprises a therapy change user interface that unlocks after receiving a first gesture on the touch screen display. In some embodiments, the therapy change user interface can receive 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. In some embodiments, the therapy change selection includes receiving a selection between one or more hormones that regulate the user's blood glucose level. In some embodiments, the therapy change selection includes an amount of one or more hormones that regulate the user's blood glucose level. In some embodiments, the button does not generate a wake signal if pressed for less than about 0.5 seconds before being pressed. In some embodiments, the first gesture on the touch screen display further includes a predetermined sequence of inputs. In some embodiments, the button does not generate a wake signal after the button is pressed until the button is released. In some embodiments, the button does not generate a wake signal if the button is pressed and released more than about 1.5 seconds later.

[0061] Some embodiments provide a method for preventing inadvertent therapy changes on a medical device. In some embodiments, the method includes activating a touch screen display after receiving a signal from a wake button. 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 administering the therapy. In some embodiments, the method includes receiving a therapy change selection and further includes receiving a selection between one or more hormones that regulate the user's blood glucose level. In some embodiments, receiving the therapy change selection includes receiving an amount of the one or more hormones that regulate the user's blood glucose level. In some embodiments, the second gesture corresponds to the therapy change selection. In some embodiments, receiving the second gesture further includes receiving a selection of an indicator box corresponding to either insulin or glucagon. In some embodiments, the method includes receiving a predetermined series of numeric inputs to deliver the therapy change selection. In some embodiments, the method further includes receiving the second gesture confirming that the selection of the indicator box is in accordance with the therapy change selection. In some embodiments, receiving the first gesture further includes completing a predetermined sequence of inputs to unlock the therapy change user interface. In some embodiments, administering the therapy further includes receiving, by the therapy delivery device, a wireless signal from a touch screen display. In some embodiments, the touch screen display comprises at least one of an OLED, LCD, or electronic ink display, and the wake button comprises at least one of a single input button in capacitive or mechanical form.

[0062] Some embodiments provide an infusion pump. In some embodiments, the infusion pump comprises a capacitance sensor that detects when a finger touches a surface. In some embodiments, the infusion pump comprises a surface having a curved indentation. In some embodiments, the capacitance sensor comprises 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.

[0063] In some embodiments, the surface having the curved indentation is incorporated into the bezel of the medical device. In some embodiments, the size of the curved indentation is adapted to the shape of a user's finger. In some embodiments, the curved indentation has tactile feedback. In some embodiments, the tactile feedback indicates when the capacitive sensor detects a finger touching the surface. In some embodiments, the tactile feedback indicates when the capacitive sensor detects a finger continuously for about 0.5 seconds.

[0064] In some embodiments, the infusion pump includes a light source beneath the curved recess, hi some embodiments, the output of the light source is responsive based on detection of a finger by the capacitive sensor.

[0065] In some embodiments, the infusion pump delivers one or more hormones to the user. In some embodiments, the infusion pump is activated when the capacitance sensor detects a finger for more than about 0.5 continuous seconds.

[0066] Some embodiments provide a method for preventing inadvertent therapy changes on a medical device. In some embodiments, the method includes generating a wake signal after a capacitive sensor detects a user's touch within a curved recess of the medical device. In some embodiments, the method includes activating a touchscreen display after receiving the wake signal. In some embodiments, the method includes unlocking a therapy change user interface after receiving a first gesture on the touchscreen display. In some embodiments, the method includes receiving a therapy change selection on the touchscreen display. In some embodiments, the method includes receiving a second gesture prior to delivering medication based on the therapy change selection.

[0067] Some embodiments provide an infusion pump. In some embodiments, the infusion pump comprises a housing having a lower portion that is metal. In some embodiments, the infusion pump comprises a bezel attachable to the metal portion of the housing. In some embodiments, at least a portion of a sidewall of the ambulatory medical device is covered only by the bezel. In some embodiments, a circuit board is positioned adjacent to an inner surface of the bezel. In some embodiments, a wireless antenna is secured to the circuit board such that it is positioned toward a portion of the sidewall of the ambulatory medical device that is covered only by the bezel.

[0068] Some embodiments include an ambulatory medical device. In some embodiments, the device comprises a metal housing. In some embodiments, the device comprises a bezel attachable to the metal housing. In some embodiments, at least a portion of a sidewall of the ambulatory medical device is covered only by the bezel. In some embodiments, the device comprises a circuit board positioned adjacent to an inner surface of the bezel. In some embodiments, the device comprises a wireless antenna secured to the circuit board such that the wireless antenna is positioned toward a portion of the sidewall of the ambulatory medical device that is covered only by the bezel. In some embodiments, the conductive layer of the circuit board is detached from a portion of the circuit board secured to the wireless antenna. In some embodiments, a portion of the circuit board is positioned inside a portion of the sidewall of the ambulatory medical device that is covered only by the bezel. In some embodiments, the wireless antenna extends toward a portion of a side of the ambulatory medical device that is covered only by the bezel. In some embodiments, the metal housing covers the length and width of the ambulatory medical device on at least one side of the ambulatory medical device. In some embodiments, the metal housing covers the height of at least one side of the ambulatory medical device. In some embodiments, the metal housing is aluminum. In some embodiments, the bezel is plastic.

[0069] In some embodiments, the ambulatory device comprises a capacitive sensor fixed to the circuit board. In some embodiments, the ambulatory device comprises a curved recess on the outside of the bezel opposite the capacitive sensor. In some embodiments, the ambulatory device comprises a main and a display connected to the circuit board. In some embodiments, the ambulatory device includes a circuit board positioned orthogonal to the main circuit board.

[0070] Some embodiments provide an infusion pump. In some embodiments, the infusion pump comprises an antenna secured to a circuit board. In some embodiments, the infusion pump comprises a bezel surrounding the antenna. In some embodiments, a metal housing is attached to the bezel. In some embodiments, the antenna transmits and receives wireless signals. In some embodiments, the bezel allows the wireless signals to pass through. In some embodiments, the bezel 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.

[0071] Some embodiments provide a method for detecting touch on an ambulatory medical device. In some embodiments, the method includes receiving a finger touch on a bezel. In some embodiments, the method includes measuring a change in capacitance with a capacitive touch pad positioned adjacent to the bezel. In some embodiments, the method includes detecting the presence of a finger. In some embodiments, the bezel has a curved indentation. In some embodiments, the method includes detecting a capacitance that changes when the finger is removed from the bezel. In some embodiments, the method includes generating a wake-up signal in response to detecting the finger.

[0072] Some embodiments provide a method for receiving input on an ambulatory medical device. In some embodiments, the method includes receiving a finger touch on a bezel. In some embodiments, the method includes measuring a change in capacitance with a capacitive touch pad positioned adjacent to the bezel. In some embodiments, the method includes detecting the presence of a finger. In some embodiments, the bezel has a curved indentation. In some embodiments, the method includes detecting a capacitance that changes when the finger is removed from the bezel. In some embodiments, the method includes generating a wake-up signal in response to detecting the finger.

[0073] Some embodiments provide an ambulatory medical device (e.g., an infusion pump). In some embodiments, the infusion pump includes an electric 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 mounted 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.

[0074] In some embodiments, the pump comprises a circuit board positioned orthogonal to the rotation angle of the gear to which the magnet is fixed. In some embodiments, the rotational position sensor is attached to the circuit board. In some embodiments, the pump comprises a sensor that measures the rotation of the shaft. In some embodiments, the pump comprises 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 rotational position sensor are synchronized. In some embodiments, the pump comprises a first drive nut that is operated by rotating the gear assembly. In some embodiments, the pump delivers a medication to a user of the ambulatory medical device. In some embodiments, if the data from the sensor and the rotational position sensor are not synchronized, the computer generates an error signal. In some embodiments, the computer determines an amount of medication to be delivered to the user based on the data from the rotational position sensor.

[0075] In some embodiments, the pump comprises a second electric motor that operates a second drive nut. In some embodiments, the pump comprises a housing for the first drug cartridge and a housing for the second drug cartridge. In some embodiments, the first infusion drive nut delivers the drug from the first drug cartridge. In some embodiments, the second drive nut delivers the drug from the second drug cartridge. In some embodiments, the housing for the first drug cartridge does not receive the second drug cartridge. In some embodiments, the housing for the second drug cartridge does not receive the first drug cartridge. In some embodiments, the computer determines an amount of drug delivered from the second infusion pump based on verifying that data from the sensor and data from the rotational position sensor are synchronized.

[0076] Some embodiments provide a method of error detection in an ambulatory medical device. In some embodiments, the method includes receiving, by one or more sensors, a rotational position of a motor. In some embodiments, the method includes receiving, by a rotational position sensor, a rotational position of an output shaft. In some embodiments, the method includes determining that the motor and the output shaft are not rotating in sync. In some embodiments, the method includes notifying a user that the motor and the output shaft are not rotating in sync.

[0077] Some embodiments provide a method of error detection in an ambulatory medical device. In some embodiments, the method includes receiving, by one or more sensors, a rotational position of a first motor. In some embodiments, the method includes receiving, by a rotational position sensor, a rotational position of an output shaft. In some embodiments, the method includes determining that the first motor and the output shaft are not rotating in sync. In some embodiments, the method includes switching operation of the ambulatory medical device to a second motor based on determining that the first motor and the output shaft are not rotating in sync.

[0078] Some embodiments provide a method of error detection in an ambulatory medical device. In some embodiments, the method includes providing an electric motor configured to rotate a shaft. In some embodiments, the method includes providing a gear secured to an end of the shaft that rotates a gear assembly. In some embodiments, the method includes providing a magnet coaxially mounted to one of the gears in the gear assembly. In some embodiments, the method includes measuring an angular position of the magnet using a rotational position sensor.

[0079] In some embodiments, the method includes positioning the circuit board orthogonal to a rotational angle of the gear to which the magnet is attached. In some embodiments, the method includes attaching a rotational position sensor to the circuit board. In some embodiments, the method includes measuring rotation of the shaft using the sensor. In some embodiments, the method includes receiving, by a computer, computer data from the sensor and the rotational position sensor. 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 actuate a first drive nut. In some embodiments, the method includes delivering the medicament to a user using actuation of the first drive nut. In some embodiments, the method includes generating, by a computer, an error signal in response to the data from the sensor and the data from the rotational position sensor being out of sync. In some embodiments, the computer determines an amount of medicament to be delivered to a user based on the data from the rotational position sensor. In some embodiments, there is a second electric motor that actuates a second drive nut. In some embodiments, there is a handheld device for the first medicament cartridge. A housing for the second drug cartridge and a drive nut for the first drug cartridge are provided. In some embodiments, the first drive nut delivers the drug from the first drug cartridge. In some embodiments, the second drive nut delivers the drug from the second drug cartridge. In some embodiments, the housing for the first drug cartridge (e.g., cartridge chamber) does not receive the second drug cartridge and / or the housing for the second drug cartridge (e.g., cartridge chamber) does not receive the first drug cartridge. In some embodiments, the computer determines an amount of drug delivered from the second infusion drug cartridge based on verifying that data from the sensor and data from the rotational position sensor are synchronized.

[0080] Some embodiments provide an infusion pump. In some embodiments, the infusion pump comprises a housing having an interior space. In some embodiments, the infusion pump comprises a bore extending through said housing, the bore having a first end and a second end, the bore configured to receive a drug cartridge. In some embodiments, the first end defines an opening into said housing, and the second end is disposed in the interior space of the housing. In some embodiments, an elongated shaft is disposed within the bore and configured to engage the drug cartridge. In some embodiments, the infusion pump comprises an O-ring circumferentially disposed on the elongated shaft adjacent the second end of the bore.

[0081] In some embodiments, the O-ring forms a barrier that prevents water and debris from entering the interior space of the housing. In some embodiments, the position of the O-ring is configured to allow for the movement of water or air around the drug cartridge. In some embodiments, the O-ring is configured to allow for pressure differential equalization between the infusion site and the drug cartridge. In some embodiments, when the O-ring is circumferentially disposed on the elongated shaft, the O-ring exerts pressure on the elongated shaft. In some embodiments, the O-ring includes a lubricant for lubricating the elongated shaft to reduce circumferential friction between the O-ring and the elongated shaft. In some embodiments, the O-ring is configured to maintain a pressure differential between the ambient pressure and the interior space of the housing. In some embodiments, the O-ring is configured to maintain a pressure differential between the interior space of the housing and the interior of the bore. In some embodiments, the bore is configured to be exposed to ambient pressure and equalize to ambient pressure. In some embodiments, the bore is configured to be exposed to ambient pressure and equalize to ambient pressure around the drug cartridge. In some embodiments, the O-ring is a compression fit on the elongated shaft and is configured to create a barrier against the ingress of water and air into the interior space of the housing.

[0082] Some embodiments provide a method. In some embodiments, the method includes implementing a seal between an interface of a drug cartridge receiving chamber and a drug cartridge, the drug cartridge receiving chamber configured to mate with the drug cartridge in an abutting relationship. In some embodiments, the method includes disposing an O-ring adjacent a first end of the elongated shaft opposite a second end of the elongated shaft and engaging a lead screw of the elongated shaft connected to a lead screw nut. In some embodiments, the method includes driving a gear engaging the lead screw to longitudinally translate the lead screw nut toward the first end of the elongated shaft during drug delivery.

[0083] In some embodiments, the O-ring is circumferentially disposed on the lead screw nut while remaining fixed within the drug cartridge receiving chamber. In some embodiments, when the O-ring is circumferentially disposed on the elongate shaft, the O-ring exerts pressure on the elongate shaft. In some embodiments, a lubricant is used to lubricate the elongate shaft to reduce friction between the O-ring and the elongate shaft. In some embodiments, the drug cartridge is a glucagon cartridge. In some embodiments, the drug cartridge is an insulin cartridge. In some embodiments, the O-ring is a phosphorus cartridge. In some embodiments, the drive train assembly and the spur gear act to mechanically actuate the elongated shaft. In some embodiments, the O-ring helps maintain a pressure differential between the ambient pressure and the interior of the drug cartridge receiving chamber. In some embodiments, the position of the O-ring is configured to allow movement of water or air around the drug cartridge. In some embodiments, the O-ring comprises a polymeric material.

[0084] Some embodiments provide a cartridge connector set. In some embodiments, the cartridge connector set comprises a first cartridge connector configured to engage a first drug cartridge and an infusion pump. In some embodiments, the first cartridge connector comprises a needle configured to allow access to a first drug in the first drug cartridge. In some embodiments, the first cartridge connector comprises a knob in the shape of a cam and having a flat portion. In some embodiments, the body of the connector comprises the knob and one or more of a detent, a snap arm, a skirt, and / or a grip rib. In some embodiments, the first cartridge connector is configured to engage a first pump receptacle of a pump, the first pump receptacle having a receiving track that matches the location and shape of the at least one detent. In some embodiments, the first cartridge connector is configured to be positioned within the first pump receptacle using a quarter turn that aligns a flat portion of the cam with a matching flat surface of the pump to indicate to a user that the first cartridge connector is correctly positioned within the pump when inserted into the first pump receptacle.

[0085] Some embodiments provide an infusion pump. In some embodiments, the infusion pump comprises a housing having an interior space. In some embodiments, the infusion pump comprises a bore extending through said housing, the bore having a first end and a second end, the bore configured to receive a drug cartridge. In some embodiments, the first end defines an opening into said housing, and the second end is disposed in the interior space of the housing. In some embodiments, an elongated shaft is disposed within the bore and configured to engage the drug cartridge. In some embodiments, the infusion pump comprises an O-ring circumferentially disposed on the elongated shaft adjacent the second end of the bore.

[0086] Some embodiments provide a method for preventing damage to an infusion pump. In some embodiments, the method includes implementing a seal between an interface of a drug cartridge receiving chamber and a drug cartridge, the drug cartridge receiving chamber configured to mate with the drug cartridge in an abutting relationship. In some embodiments, the method includes disposing an O-ring adjacent a first end of the elongated shaft opposite a second end of the elongated shaft and engaging a lead screw of the elongated shaft connected to a lead screw nut. In some embodiments, the method includes driving a gear engaging the lead screw to longitudinally translate the lead screw nut toward the first end of the elongated shaft during drug delivery.

[0087] Some embodiments relate to a cartridge connector. In some embodiments, the cartridge includes a body. In some embodiments, the body comprises a needle. In some embodiments, the body comprises a lower surface portion extending circumferentially from the needle. In some embodiments, the body comprises a shroud extending axially away from the lower surface portion and configured to receive and mate with a portion of a first medicament cartridge configured to hold a first medicament. In some embodiments, the body comprises a protrusion extending axially upward from a top surface of the body, the protrusion comprising a fluid outlet. In some embodiments, the lower surface portion is disposed within the shroud and configured to protrude outward when the medicament cartridge is inserted into the cartridge connector within the shroud. The needle is configured to contact a cap of the medicament cartridge. In some embodiments, the needle extends axially into the shroud from the lower surface portion. In some embodiments, the body is configured to receive the medicament through the needle and deliver the medicament out of the body through a fluid outlet of the body, the needle and the fluid outlet of the body being in fluid communication to provide a fluid path through the body. In some embodiments, the cartridge comprises a knob portion configured to engage with the body. In some embodiments, the knob comprises a receptacle portion, the receptacle portion extending over and configured to receive at least a portion of the protrusion of the body. In some embodiments, the knob comprises a fluid inlet disposed within the receptacle portion, the fluid inlet configured to receive the medicament. In some embodiments, the cartridge comprises a fluid outlet configured to deliver the medicament to a location exterior to the cartridge connector. In some embodiments, the cartridge comprises a gap space located between the protrusion of the body and the receptacle portion of the knob. In some embodiments, the cartridge comprises a flexible membrane disposed within the interstitial space and extending over at least a portion of the body protrusion, the flexible membrane configured to allow fluid to pass from the body outlet to the knob inlet only after a threshold fluid pressure of the medication is reached.

[0088] Some embodiments provide a drug infusion system for delivering single or multiple medicaments to a patient. In some embodiments, the infusion system comprises a first cartridge connector configured to engage a first drug cartridge and an infusion pump. In some embodiments, the first cartridge connector comprises a needle configured to allow access to the first drug in the first drug cartridge. In some embodiments, the first cartridge connector comprises a knob in the shape of a cam and having a flat portion. In some embodiments, the first cartridge connector comprises at least one detent. In some embodiments, the first cartridge connector comprises a snap arm. In some embodiments, the first cartridge connector comprises a skirt. In some embodiments, the skirt comprises one or more snap arms, detents, and / or lugs. In some embodiments, the knob comprises a grip rib. In some embodiments, the first cartridge connector is configured to engage a first pump receptacle of a pump, the first pump receptacle having a receiving track that matches a position and shape of the at least one detent. In some embodiments, the first cartridge connector is configured to be positioned within the first pump receptacle using a quarter turn that aligns a flat portion of the cam with a matching flat surface on the pump when inserted into the first pump receptacle to indicate to a user that the first cartridge connector is correctly positioned within the pump.

[0089] In some embodiments, the connector set (or infusion system disclosed herein) comprises a second cartridge connector configured to engage with a second drug cartridge and an infusion pump. In some embodiments, the second cartridge connector comprises a needle configured to allow access to a second drug in the second drug cartridge. In some embodiments, the second cartridge connector comprises a knob in the shape of a cam and having a flat portion. In some embodiments, the second cartridge connector comprises at least one detent. In some embodiments, the second cartridge connector comprises a snap arm. In some embodiments, the second cartridge connector comprises a skirt (e.g., a shroud). In some embodiments, the skirt comprises one or more snap arms, detents, and / or lugs. In some embodiments, the knob of the second cartridge connector comprises a grip rib.

[0090] In some embodiments, the second cartridge connector is configured to engage the pump with a second receptacle of the pump. In some embodiments, the second pump receptacle has a receiving track that matches the location and shape of the at least one detent. In some embodiments, the second cartridge connector is configured to be positioned within the second pump receptacle using a quarter turn that aligns a flat portion of the cam with a second matching flat surface of the pump when inserted into the second pump receptacle to indicate to a user that the second cartridge connector is correctly positioned within the pump.

[0091] In some embodiments, the infusion system comprises a first connector and a second connector (e.g., a connector set) and further comprises a pump. In some embodiments, the connector set comprises the first and second connectors. In some embodiments, the infusion system further comprises a first drug cartridge and / or a second drug cartridge.

[0092] 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 attachment of the second cartridge connector to the first drug cartridge.

[0093] In some embodiments, the recognition feature of the second cartridge connector is configured to prevent installation of the second cartridge connector in the first pump receptacle. In some embodiments, the recognition feature of the first cartridge connector is configured to prevent installation of the first cartridge connector in the second pump receptacle.

[0094] In some embodiments, the first medication is insulin and the second medication is glucagon. In some embodiments, the direction of a quarter turn that aligns the flat portion of the cam of the first cartridge connector with the first matching flat surface of the pump is opposite to the direction of a quarter turn that aligns the flat portion of the cam of the second cartridge connector with the second matching flat surface of the pump. In some embodiments, the quarter turn that aligns the flat portion of the cam of the first cartridge connector with the first matching flat surface of the pump is clockwise and the quarter turn that aligns the flat portion of the cam of the second cartridge connector with the second matching flat surface of the pump is counterclockwise. In some embodiments, the first medication and the second medication are both insulin. In some embodiments, the first cartridge connector includes a first check valve that allows fluid flow from the first reservoir after a first threshold pressure is reached.

[0095] In some embodiments, a pump (e.g., of an infusion system) comprises a pump housing having a first inlet port configured to engage with a first cartridge connector. In some embodiments, the pump comprises a power source disposed within the pump housing. In some embodiments, the pump comprises a first pump receptacle configured to receive a first drug cartridge when inserted through the first inlet port. In some embodiments, the pump comprises a second inlet port configured to engage with a second cartridge connector and a second pump receptacle configured to receive a second drug cartridge when inserted through the second inlet port. In some embodiments, the first receptacle and the second receptacle are disposed within the pump housing and are laterally spaced apart from one another. In some embodiments, the power source is disposed within the pump housing at a location between the first receptacle and the second receptacle. In some embodiments, the first inlet port is configured to mate with the first cartridge connector and the second inlet port is configured to mate with the second cartridge connector. In some embodiments, the pump comprises a pumping mechanism configured to deliver a first agent from a first agent cartridge.

[0096] In some embodiments, the first receptacle accommodates a second drug capsule within the first chamber. In some embodiments, the infusion pump comprises a first recognition mechanism that prevents proper docking of the first medication cartridge in the second receptacle. In some embodiments, the second receptacle comprises a second recognition mechanism that prevents proper docking of the first medication cartridge in the second receptacle. In some embodiments, the power source is an inductively rechargeable battery. In some embodiments, the infusion pump is waterproof or water resistant.

[0097] Some embodiments provide an infusion pump comprising a housing having an interior space. In some embodiments, the infusion pump comprises a bore through said housing, the bore having a first end and a second end, the bore configured to receive a drug cartridge. In some embodiments, the first end defines an opening to said housing, and the second end is disposed in the interior space of the housing. In some embodiments, the infusion pump comprises an elongated shaft disposed within the bore and configured to engage the drug cartridge. In some embodiments, the infusion pump comprises an O-ring disposed circumferentially on the elongated shaft adjacent the second end of the bore. In some embodiments, the O-ring forms a barrier to prevent 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 movement around the drug cartridge. In some embodiments, the O-ring is configured to allow pressure differential equalization between the infusion site and the drug cartridge. In some embodiments, when the O-ring is disposed circumferentially on the elongated shaft, the O-ring exerts pressure on the elongated shaft, and further comprises a lubricant for lubricating between the elongated shaft to reduce circumferential friction between the O-ring and the elongated shaft. In some embodiments, the O-ring is configured to maintain a pressure differential between the ambient pressure and the interior space of the housing. In some embodiments, the O-ring is configured to maintain a pressure differential between the interior space of the housing and the interior of the bore. In some embodiments, the bore is exposed to ambient pressure and configured to equalize with the ambient pressure. In some embodiments, the bore is exposed to ambient pressure and configured to equalize with the ambient pressure around the drug cartridge. In some embodiments, the O-ring is a compression fit on the elongate shaft and is configured to create a barrier against ingress of water and air into the interior space of the housing.

[0098] Some embodiments provide a battery charging station that includes a docking area for inductive charging, in some embodiments the docking area is configured to receive an infusion pump as disclosed elsewhere herein.

[0099] Some embodiments provide a method that includes implementing a seal between an interface of a drug cartridge receiving chamber and a drug cartridge. In some embodiments of the method, the drug cartridge receiving chamber is configured to mate with the drug cartridge in an abutting relationship. In some embodiments, the method includes disposing an O-ring adjacent a first end of the elongated shaft opposite a second end of the elongated shaft and engaging a lead screw of the elongated shaft connected to a lead screw nut. In some embodiments, the method includes driving a gear that engages the lead screw to translate the lead screw nut longitudinally toward the first end of the elongated shaft during drug delivery. In some embodiments, the O-ring is circumferentially disposed on the lead screw nut while remaining fixed within the drug cartridge receiving chamber.

[0100] Some embodiments provide a cartridge connector. In some embodiments, the cartridge connector comprises a body. In some embodiments, the body comprises a needle. In some embodiments, the body comprises a lower surface portion extending circumferentially from the needle. In some embodiments, the body comprises a shroud extending axially away from the lower surface portion and configured to receive and mate with a portion of a first medicament cartridge configured to hold a first medicament. In some embodiments, the body comprises a protrusion extending axially upward from a top surface of the body, the protrusion comprising a fluid outlet. In some embodiments, the lower surface portion comprises a shroud. The needle is disposed within the shroud and configured to contact a cap of the medicament cartridge when the medicament cartridge is inserted into the cartridge connector in the shroud. In some embodiments, the needle extends axially into the shroud from the lower surface portion. In some embodiments, the body is configured to receive the medicament through the needle and deliver the medicament out of the body from a fluid outlet of the body, the needle and the fluid outlet of the body being in fluid communication to provide a fluid path through the body. In some embodiments, the cartridge connector comprises a knob portion configured to engage with the body. In some embodiments, the knob comprises a receptacle portion, the receptacle portion extending over and configured to receive at least a portion of the protrusion of the body. In some embodiments, the knob comprises a fluid inlet disposed within the receptacle portion, the fluid inlet configured to receive the medicament. In some embodiments, the knob comprises a fluid outlet configured to deliver the medicament to a location exterior to the cartridge connector. In some embodiments, the gap space is disposed between the protrusion of the body and the receptacle portion of the knob. In some embodiments, the flexible membrane is disposed within the gap and extending over 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 to the knob inlet only after a threshold fluid pressure of the agent has been reached.

[0101] In some embodiments, the knob is in the shape of a cam and has a flat portion. In some embodiments, the knob comprises a gripping rib configured to facilitate manipulation and / or twisting of the cartridge connector. In some embodiments, the gripping rib is configured to fit between a user's index finger and thumb. In some embodiments, the body comprises at least one detent. In some embodiments, the cartridge connector is configured to engage with a first pump receptacle of the pump. In some embodiments, the first pump receptacle has a receiving track that matches the location and shape of the at least one detent. In some embodiments, the cartridge connector is configured to lock within the first pump receptacle when inserted into the first pump receptacle through a quarter turn that aligns a flat portion of the cam with a matching flat surface of the pump. In some embodiments, the alignment of the flat portion of the cam indicates to a user that the cartridge connector is correctly positioned within the pump. In some embodiments, the cartridge connector comprises at least one snap arm configured to deform outwardly from the shroud when a cap of the first drug cartridge is inserted into the shroud, the snap arm comprising a protruding fit. In some embodiments, the snap arm is configured to snap back into place after the cap abuts against the top surface of the body of the cartridge connector, thereby engaging the cap via the protruding fitting. In some embodiments, the shroud abuts against the top surface of the cap of the drug cartridge. In some embodiments, the body and the knob portion are unitary.

[0102] Some embodiments provide a drug infusion set comprising one or more cartridge connectors disclosed above or elsewhere herein. In some embodiments, the infusion set further comprises a second cartridge connector configured to engage with a second drug cartridge and an infusion pump. In some embodiments, the second cartridge connector comprises a needle configured to allow access to a second drug in the second drug cartridge. In some embodiments, the second cartridge connector comprises a knob in the shape of a cam and having a flat portion. In some embodiments, the second cartridge connector comprises at least one detent. In some embodiments, the second cartridge connector comprises a snap arm. In some embodiments, the second cartridge connector comprises a shroud. In some embodiments, the knob of the second cartridge connector comprises a grip rib. In some embodiments, the second cartridge connector is configured to engage with a second receptacle of a pump, the second pump receptacle conforming to a position and shape of the at least one detent of the second cartridge connector. In some embodiments, the second cartridge connector is configured to be positioned in the second pump receptacle using a quarter turn that aligns a flat portion of the cam with a second matching flat surface of the pump to indicate to a user that the second cartridge connector is correctly positioned in the pump when inserted into the second pump receptacle. In some embodiments, the shroud of the second cartridge connector is longer than the shroud of the first cartridge connector. In some embodiments, the shroud of the second cartridge connector is configured to prevent attachment of the second cartridge connector to the first drug cartridge. In some embodiments, the recognition mechanism of the second cartridge connector is configured to prevent attachment of the second cartridge connector in the first pump receptacle. In some embodiments, the second cartridge connector comprises a recognition mechanism of the first cartridge connector configured to prevent attachment of the first cartridge connector in the second pump receptacle.

[0103] In some embodiments, the first medication is insulin and the second medication is glucagon. In some embodiments, the direction of a quarter turn that aligns the flat portion of the cam of the first cartridge connector with the first matching flat surface of the pump is opposite to the direction of a quarter turn that aligns the flat portion of the cam of the second cartridge connector with the second matching flat surface of the pump. In some embodiments, the quarter turn that aligns the flat portion of the cam of the first cartridge connector with the first matching flat surface of the pump is clockwise and the quarter turn that aligns the flat portion of the cam of the second cartridge connector with the second matching flat surface of the pump is counterclockwise. In some embodiments, the direction of a quarter turn that aligns the flat portion of the cam of the first cartridge connector with the first matching flat surface of the pump is the same as the direction of a quarter turn that aligns the flat portion of the cam of the second cartridge connector with the second matching flat surface of the pump.

[0104] Various embodiments are shown in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of the embodiments in any way. Any feature, structure, component, material, and / or step of any embodiment can be combined or substituted with any feature, structure, component, material, and / or step of any other embodiment to form additional embodiments that are part of this disclosure. The illustrated embodiments are intended to illustrate, but not limit, the disclosure. The proportions, relative dimensions and sizes of each component shown in these drawings form part of the disclosure supporting this specification, but do not limit the scope of this specification, except to the extent that such proportions, dimensions, or sizes are included in the scope of the individual claims. [Brief description of the drawings]

[0105] [Figure 1A] FIG. 1 illustrates a perspective view of one embodiment of a pump system engaged with a cartridge connector set and fluid channels, showing the underside of the pump. [Figure 1B] FIG. 1B is a second perspective view of the embodiment of FIG. 1A, now showing the top side of the pump. [Figure 1C] 1B is another perspective view of the embodiment of FIG. 1A showing a top view of the pump device with the connector set removed. [Figure 1D] FIG. 1B is another perspective view of the embodiment of FIG. 1A showing the top surface of the pump. [Figure 1E] FIG. 1B is another perspective view of the embodiment of FIG. 1A showing the underside of the pump. [Figure 1F] 1B is another perspective view of the embodiment of FIG. 1A, showing the underside of the pump and the cartridge receptacle. [Figure 1G] FIG. 1B is a diagram of the embodiment of FIG. 1A showing the cartridge receptacle of the pump. [Figure 1H] 1B is another view of the embodiment of FIG. 1A showing the cartridge receptacle of the pump. [Figure 1I] 1B is another view of the embodiment of FIG. 1A showing the cartridge receptacle of the pump. [Figure 1J]FIG. 1B is a top side view of the embodiment of FIG. 1A showing the cartridge receptacle of the pump. [Figure 2A] 1A with its display screen and / or pump face and other portions of the housing removed, revealing various internal components of the pump. FIG. 1A with its display screen and pump face removed, revealing various internal components of the pump. [Figure 2B] 1B shows a view of the embodiment of FIG. 1A with its display screen and / or pump face and other portions of the housing removed, revealing various internal components of the pump; FIG. 1C shows another view of the embodiment of FIG. 1A with the display screen and pump face removed, revealing various internal components of the pump; [Figure 2C] 1B shows a view of the embodiment of FIG. 1A with its display screen and / or pump face and other portions of the housing removed to reveal various internal components of the pump. FIG. 1C shows a portion of the cartridge drive assembly of the pump of FIG. [Figure 2D] 1B shows a view of the embodiment of FIG. 1A bisected by a plane along the length and width of the pump. [Figure 2E] 1B shows a cross-sectional view of the embodiment of FIG. 1A in a plane along the length and height of the pump, cutting through the first cartridge receptacle and the second cartridge receptacle. [Figure 2F] 1B shows a cross-sectional view of the embodiment of FIG. 1A in a plane along the length and height of the pump, cutting through the first cartridge receptacle and the second cartridge receptacle. [Figure 2G] 1B illustrates a partially exploded view of the embodiment of FIG. 1A with the display and bezel removed. [Figure 2H] 2H shows a partially exploded view of the embodiment of FIG. 1A with the display and bezel removed. As shown in FIG. 2H, the pump includes a lead screw, a threaded insert, and a drive nut. [Figure 2I]1B shows a view of the embodiment of FIG. 1A bisected by a plane along the length and width of the pump, where a drug cartridge set and a cartridge connector set are present and / or engaged to the pump. [Figure 3A] FIG. 1B shows a top view of the embodiment of FIG. 1A. [Figure 3B] FIG. 1B shows a perspective view of the embodiment of FIG. 1A. [Figure 3C] FIG. 1B shows a bottom view of the embodiment of FIG. 1A. [Figure 3D] FIG. 1B shows a top side view of the embodiment of FIG. 1A. [Figure 4A] FIG. 13 illustrates a perspective view of another embodiment of a pump showing the upper side of the pump. [Figure 4B] 4B shows a perspective view of the embodiment of FIG. 4A with the display removed. [Figure 4C] 4B shows a perspective view of the lower part of the housing of the embodiment of FIG. 4A. [Figure 4D] 4B shows a partially exploded perspective view of the lower part of the housing and the drive nut of the embodiment of FIG. [Figure 4E] 4B shows a view of the embodiment of FIG. 4A bisected by a plane along the length and width of the pump, where a drug cartridge set and cartridge connector set are present and / or engaged to the pump (with corresponding fluid conduits). [Figure 5A] 1A and 4A, respectively, show top side views of the embodiments. [Figure 5B] FIG. 4B is a bisected side view of a portion of the pump of FIGS. 1A and 4A. [Figure 6A] 1B shows a view of the pump of FIG. 1A with the bezel shown transparent or in cross section along the width of the pump. [Figure 6B] 1B shows a view of the pump of FIG. 1A with the bezel shown transparent or in cross section along the width of the pump. [Figure 6C] FIG. 1 is a schematic diagram showing components of a capacitive sensor in an ambulatory medical device. [Figure 6D] FIG. 1 is a schematic diagram showing components of an ambulatory medical device having a capacitance sensor. [Figure 6E] 1 is a flow diagram of a process for preventing inadvertent treatment with an ambulatory device. [Figure 6F] FIG. 1 is a schematic diagram illustrating components of an ambulatory medical device having a capacitive sensor being activated by a user. [Figure 6G] FIG. 2 is a diagram of capacitive sensing pads on a PCB board. [Figure 7A] FIG. 13 is another embodiment of the pump, shown without a display. [Figure 7B] FIG. 7B is an exploded view of the pump of FIG. 7A. [Figure 7C] FIG. 1B is a diagram of the pump of FIG. 1A with a transparent bezel. [Figure 7D] FIG. 1B is a view of the pump of FIG. 1A with the transparent metal housing and bezel removed. [Figure 7E] FIG. 7B is a diagram of the pump of FIG. 7A having an output shaft angular position error detection system. [Figure 7F] 1 is a flow diagram of a process for determining that there is an error in the delivery of a medication in an ambulatory medical device. [Figure 7G] FIG. 1 is a diagram of a pump having an output shaft angular position error detection system. [Figure 7H] FIG. 1 is a diagram of a pump having two or more drug cartridges. [Figure 7I] FIG. 1 is a diagram of an ambulatory medical device having an output shaft angular position error detection system. [Figure 7J] 1 is a perspective view of an interior space of an infusion pump housing according to an exemplary embodiment. [Figure 7K] 1 is a cross-sectional view including an interior space of an infusion pump housing according to an exemplary embodiment. [Figure 7L] FIG. 2 is a top view of components within an infusion pump, according to an exemplary embodiment. [Figure 7M] FIG. 2 is a perspective view of an elongated shaft member of an infusion pump, according to an exemplary embodiment. [Figure 7N] FIG. 2 is a perspective view of two O-rings of an infusion pump, according to an exemplary embodiment. [Figure 7O] 1 is a cross-sectional view of an elongated shaft member of an infusion pump according to an exemplary embodiment. [Figure 7P] 1 is a top cross-sectional view of components of an infusion pump according to an exemplary embodiment. [Figure 7Q] 1 is an exploded view of components of an infusion pump according to an exemplary embodiment. [Figure 8] FIG. 1 is a perspective view of one embodiment of an induction charger. [Figure 9A] 1A and 1B are diagrams of a cartridge connector set with two cartridge connectors and matching fluid conduits (tubes). [Figure 9B] 1A and 1B are diagrams of a cartridge connector set with two cartridge connectors and matching fluid conduits (tubes); [Figure 9C] 13 illustrates an embodiment of a cartridge connector that provides a visual indication when a connector from a connector set is unlocked or locked, respectively, within a pump chamber. [Figure 9D] 9B shows a cross-sectional view of the connector of FIG. 9A. [Figure 9E] 9B shows a view of the connectors of FIG. 9A with the body of one connector separated from its knob. [Figure 9F] 9B shows a view of one of the connectors of FIG. 9A, with the body of the connector separated from its knob. [Figure 9G] 9B shows a view of one of the connectors of FIG. 9A, with the body of the connector separated from its knob. [Figure 9H] 9B shows a cross-sectional view of one of the connectors of FIG. 9A. [Figure 9I] 9B shows an additional cross-sectional view of the connector of FIG. 9A. [Figure 10A] FIG. 13 is a diagram of another embodiment of a cartridge connector set comprising two cartridge connectors. [Figure 10B] 10B shows a cross-sectional view of the connector of FIG. 10A. [Figure 10C] 10B shows a bottom view of the connector of FIG. 10A. [Figure 10D] 9A and 10A show diagrams of the connector. [Figure 10E] 9A and 10A show diagrams of the connector. [Figure 10F] 1 illustrates a cross-sectional view of one embodiment of a connector set engaged with a drug cartridge. [Figure 10G] A diagram of a connector having a check valve is shown. [Figure 10H] A diagram of a connector having a check valve is shown. [Figure 11A] 1 illustrates a cross-sectional view of an embodiment of a connector set engaged with a drug cartridge in a pump. [Figure 11B] 1 illustrates a cross-sectional view of an embodiment of a connector set engaged with a drug cartridge in a pump. [Figure 11C] 1 illustrates a cross-sectional view of an embodiment of a connector set engaged with a drug cartridge. [Figure 11D] 1 illustrates a cross-sectional view of an embodiment of a connector set engaged with a drug cartridge. [Figure 11E] 1A-1C show diagrams of an embodiment of a connector set engaged with a drug cartridge. [Figure 12A] 1 illustrates an embodiment of a dual lumen portion of a multi-channel lumen assembly. [Figure 13A] 1 illustrates components and steps for filling or refilling a drug cartridge. [Figure 13B] 1 illustrates additional components and steps for filling or refilling a drug cartridge. [Figure 13C] 1 illustrates additional components and steps for filling or refilling a drug cartridge. [Figure 13D] 1 illustrates additional components and steps for filling or refilling a drug cartridge. [Figure 13E] 1 illustrates additional components and steps for filling or refilling a drug cartridge. [Figure 14A] 1 shows a perspective view of a dual infusion set base, also showing an insertion tool. [Figure 14B]1 shows a perspective view of a dual infusion set base. [Figure 15A] 15A shows a perspective view of the dual drug dispensing connector, also showing the cover of the dispensing connector. [Figure 15B] FIG. 1 shows a perspective view of a dual drug dispensing connector. [Figure 16A] A diagram of a dual drug infusion set is shown. [Figure 16B] 1 shows a top cross-sectional view of a dual drug infusion set. [Figure 17A] 1 shows a single drug infusion housing set base with an insertion tool attached. [Figure 17B] 1 shows a single drug infusion housing set base with the insertion tool removed. [Figure 18A] FIG. 1 shows a perspective view of a single drug dispensing connector, also showing a cover for the dispensing connector. [Figure 18B] FIG. 1 shows a perspective view of a single drug dispensing connector. [Figure 19A] A diagram of a single drug infusion based set is shown. [Figure 19B] FIG. 1 shows a top cross-sectional view of a single drug infusion base set. [Figure 20A] 1 illustrates various configurations of a dual drug infusion set base, connector, and cover;FIG. 1 illustrates an embodiment having a right site base connected to a right site base cover. [Figure 20B] 1 illustrates various configurations of a dual drug infusion set base, connector, and cover;FIG. 2 illustrates a second site base connected to a second site base cover; [Figure 20C] 1 illustrates various configurations of a dual drug infusion set base, connector, and cover;1 shows a first site connector connected to a first site connector cover; [Figure 20D] 1 illustrates various configurations of a dual drug infusion set base, connector, and cover. 2 shows a second (left) site connector connected to a second (left) site connector cover. [Figure 20E]1 illustrates various configurations of a dual drug infusion set base, connector, and cover;FIG. 2 illustrates a dual drug infusion site base connected to a dual drug site base cover; [Figure 21A] 1 shows a perspective view of a drug dispensing connector. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0106] Some embodiments described herein relate to drug infusion systems and components of such systems (e.g., infusion pumps, drug cartridges, cartridge connectors, lumen assemblies, infusion connectors, infusion sets, etc.) for one or more drugs. Some embodiments relate to drug refill systems. Some embodiments relate to methods of manufacturing the infusion systems and components thereof. Some embodiments relate to methods of using any of the aforementioned systems or components for infusing one or more drugs into a patient. Some embodiments disclosed herein ensure proper flow-path formation of a drug to a patient. While multiple recognition mechanisms can be used for the various components disclosed herein to reduce the chance of erroneous flow-path formation, no single component or collection of components is required or essential. For example, some embodiments may include each recognition mechanism and / or component disclosed herein, while other embodiments may not include or may lack one or more mechanisms or components disclosed herein while still achieving proper flow-path formation. As an exemplary illustration, an infusion system may include an infusion pump but not include a drug cartridge. An infusion system may include a drug cartridge and a cartridge connector but not include a pump. The infusion system may include a cartridge connector and an infusion pump, but may not include a drug cartridge. The infusion system may include an infusion connector, a lumen assembly, a cartridge connector, an infusion pump, but may not include a drug cartridge or an infusion set. Any feature, structure, component, material, step, or method described and / or illustrated in any embodiment herein may be used with or in place of any feature, structure, component, material, step, or method described and / or illustrated in any other embodiment herein. Additionally, any feature, structure, component, material, step, or method described and / or illustrated in one embodiment may not be present in another embodiment.

[0107] Introduction As disclosed elsewhere herein, a sustained delivery pump-driven medication injection device generally includes a delivery cannula attached in a subcutaneous manner through the patient's skin at an injection site. The pump draws medical medication from a reservoir and delivers it to the patient through the cannula. The injection device may include a channel that transmits the medication and receives it through an inlet port and provides a fluid path to the delivery cannula. The medication may be delivered to the patient through the cannula, which delivers the medication to a subcutaneous tissue layer where the delivery cannula terminates. The infusion device may be configured to deliver one medication to the patient or multiple medications to the patient.

[0108] Although multiple drug delivery systems exist, a drawback is that a patient or physician may accidentally load and therefore administer or have administered the wrong drug (e.g., medicine, hormone). For example, in a multiple drug infusion device, a user may load a drug into the wrong pump receptacle, which may lead the user to mistakenly believe they are administering one drug when in fact they are delivering a different drug. Accidental administration of the wrong drug to a patient can have serious and potentially fatal consequences.

[0109] For example, standard of care insulin therapy for regulating blood glucose in diabetic patients may include subcutaneous infusion of insulin via an insulin pump. If the insulin dose is excessive, it may lead to a situation of hypoglycemia or impending hypoglycemia. To counteract and / or reverse such adverse conditions, the individual typically consumes additional carbohydrates (e.g., sweet juice or glucose tablets). The individual may alternatively and / or additionally administer a counterregulatory agent, a so-called "rescue dose," such as glucagon. The counterregulatory agent counteracts the effects of an excess regulator dose (e.g., excess insulin) that mitigates or substantially prevents the side effects associated with excess doses. However, if the patient is given additional insulin instead of the intended rescue dose of glucagon, the results may be devastating and may lead to death. Similarly, during the onset of diabetes, if the patient requires insulin but is instead administered glucagon, the administration may worsen symptoms, have devastating effects, or be fatal.

[0110] Therefore, proper channeling in drug administration is important, 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 automated system, if a drug is accidentally loaded into the wrong cartridge or the wrong cartridge chamber of the pump, the automated system may deliver an ineffective (and / or potentially harmful) drug to the patient. This phenomenon of incorrect drug loading and / or administration in an automated system is called cross-channeling (or incorrect channeling). As exemplified above, cross-channeling is dangerous not only because the wrong drug may not provide the intended therapeutic effect, but also because the wrong drug may have the opposite effect (or some other side effect) to the intended effect. Also, as mentioned above, improper channeling may not only fail to alleviate the patient's condition, but may worsen the patient's condition or cause a new problem condition to the patient. Improper flow channeling (e.g., incorrect flow channeling) can cause a negative feedback loop, where the control system attempts to regulate the patient's condition in one direction, but the delivery of the incorrect medication either worsens the condition or has no effect on the condition. Sensing this, the control system can trigger further dosing of the incorrect medication in an attempt to control the patient's condition, actually making the patient's condition worse (or causing an overdose of the incorrect medication).

[0111] Additionally, in certain situations or circumstances, commercially available diabetes drug infusion systems may be insufficient to prevent improper dosing, even when the proper drug is being administered, e.g., runaway dosing may occur in some situations and improper dosing in others.

[0112] Although diabetes drugs (e.g., insulin and glucagon) are used above and elsewhere herein as exemplary drugs, improper channeling (or dosing) can have deleterious effects in many multi-drug regimens, as drugs are not administered to the patient when needed (and / or at the required levels), or the wrong drug is administered at dangerous levels. Incorrect channeling can be harmful with other drug combinations that regulate pancreatic enzymes, other combinations of drugs intended to maintain the body's balance in one direction or the other, or simply when a patient requires multiple drugs regardless of the relationship between the drugs or the general disease state (e.g., when one drug treats one medical condition and another completely unrelated medical condition). Thus, the embodiments and discussion provided herein can be applied to any drug combination. Additionally, while cross-channeling can refer to a system with two drugs, the term cross-channeling as used herein can also refer to a system in which more than two drugs are used, and / or where a single drug is used (e.g., when a single drug is improperly placed in the distribution system).

[0113] Some embodiments disclosed herein address one or more of the problems associated with these issues (e.g., incorrect routing, runaway, or improper administration, etc.) or other problems. Described herein are infusion systems for single or multiple medications, and various connectors, tubing, cartridges, pumps, infusion sets, and / or systems including any one or more of the foregoing that ensure, aid in ensuring, and / or substantially assist in providing proper routing and / or administration of each medication to a patient. Certain embodiments of the infusion systems and components thereof described herein are configured to help minimize, mitigate, and / or otherwise avoid the occurrence of cross-channeling and / or improper administration of medications. In some embodiments, when medications are delivered by the infusion systems disclosed herein, components including the recognition mechanisms described herein are configured to hinder, prevent, minimize the occurrence, or otherwise inhibit the opportunity for a user to inadvertently place a medication in a wrong location and / or deliver the wrong medication (and / or an improper amount of the right medication).

[0114] Cross-channeling can be avoided by providing a recognition mechanism (e.g., a uniquely distinguishable recognition element) that allows mating between only certain shaped components in the infusion system. In some embodiments, the infusion system includes an infusion pump having one, two, or more infusion chambers (or pump chambers) and one or more recognition mechanisms. In some embodiments, the system further includes cartridges filled with different medicaments and connectors and tubing having recognition mechanisms that connect the cartridges to the infusion pump to prevent erroneous channeling or cross-channeling of the medicaments. In certain variations, each type of cartridge for each type of medicament has one or more uniquely distinguishable mechanisms (either as an integral part of the cartridge or as an attached or fixed component to the cartridge). The recognition mechanisms can include, for example, geometric or shape-based features that allow for unique coupling between components of the system. One type of connector with a uniquely distinguishable mechanism can engage with a corresponding mechanism in the pump housing to allow the appropriate cartridge to be inserted into the appropriate infusion chamber. A cartridge with a unique mechanism can interact with a pump infusion pump having a corresponding mechanism (e.g., a drive shaft or pump chamber having a corresponding mechanism). Improper dosing can be avoided by certain design features disclosed herein, including seals, valves, and other devices incorporated into the components disclosed herein.

[0115] The following disclosure provides additional details regarding the configuration of systems and components to avoid cross-channeling. The following description provides context and examples, but should not be construed as limiting the scope of the inventions covered by the claims that follow this specification.

[0116] Injection System Some embodiments disclosed herein relate to an infusion system configured to deliver one or more medications without cross-channeling and / or configured to prevent improper administration of medication. In certain variations, the system comprises one or more of an infusion pump (configured to receive one or more medication cartridges in one or more cartridge receptacles), one or more cartridge connectors (configured to simultaneously engage one or more medication cartridges, an infusion pump, and / or both), one or more medication cartridges, an infusion set (configured to deliver medication to a patient via a piercing element that may include a cannula or needle that penetrates the patient's skin), one or more infusion connectors configured to engage the infusion set, and one or more fluid conduits in fluid communication with the one or more cartridge connectors and / or the one or more infusion connectors. In some embodiments, the infusion system (or components thereof) includes one or more design features that make it compact. In some variations, the infusion system ( or components thereof) are particularly suited to be ambulatory and / or wearable by the patient, allowing the patient freedom of movement (e.g., daily activities including, but not limited to, working, engaging in exercise, swimming, air travel, etc.).

[0117] In some implementations, if the infusion system is configured to deliver multiple medicaments (rather than just one), the infusion system may be adapted to receive multiple medicaments from multiple medicament cartridges. By way of example, in a two medicament infusion system, the system may comprise multiple different configurations of components including or lacking one or more components selected from two medicament cartridges, an infusion pump configured to receive the two cartridges (e.g., in different cartridge receptacles), a cartridge connector configured to engage with the medicament cartridges and / or the infusion pump (e.g., at or near the cartridge receptacle), an infusion set configured to deliver the medicaments to the patient (e.g., a piercing element for the first medicament and a piercing element for the second medicament), two infusion connectors configured to engage with the infusion set, and fluid conduits (e.g., providing separate flow paths), each in fluid communication with one cartridge connector and one infusion connector. In FIG. 1A, a two medicament infusion system is shown, where the system comprises two different cartridge connectors with matching fluid conduits and pumps. Additionally, if the system is configured to deliver more than two medications, additional cartridges, cartridge receptacles, cartridge connectors, infusion connectors, and piercing elements may be provided as needed (although the system may lack any one or more of these components). As disclosed elsewhere herein, more than one medication may be delivered by the infusion system, although some embodiments relate to pumps that deliver a single medication (e.g., having a pump with only one cartridge receptacle or multiple cartridge receptacles configured to receive a single type of medication cartridge, e.g., insulin).

[0118] In some embodiments, as disclosed elsewhere herein, the system and / or its components include unique mating features and design elements (recognition features). These recognition features can ensure that each part of the system can only be connected in a unique way or configuration (e.g., the appropriate way) within the system, thus preventing cross-channeling (e.g., erroneous channeling). In some embodiments, when different drugs are delivered by a single system (or its components), the drugs may remain completely separate throughout their residence within the system (or its components) and may have different fluid paths to the patient. For example, cartridge connectors and fluid conduits can be used to provide separate fluid paths that terminate at designated delivery members (e.g., needles, cannulas, etc.) within a base (e.g., an infusion set), thereby allowing independent delivery (e.g., subcutaneous or otherwise) of the drugs separately.

[0119] In certain embodiments, the design features of the disclosed systems (and / or components thereof) provide the following advantages or otherwise: (1) allowing a user to easily connect and disconnect components independent of any drug source and injection port or site; (2) mitigating the possibility of erroneous fluid flow formation occurring when a user accidentally connects the wrong components together; (3) mitigating the possibility of improper dosage levels; (4) mitigating drug loss and / or contamination; (5) allowing single or multi-step insertion of dual cannula injection sites or ports. In some embodiments, the systems and components described herein may further include visual or Braille callouts in addition to or in lieu of the various paired physical features disclosed herein. For example, in some implementations, the components may include callouts with wording indicating the appropriate medication. In some variations, different colors (red, blue, yellow, green, orange, purple, etc.) or lengths (or other colors) may be used to provide visual feedback regarding the proper medication for the appropriate component. variables).

[0120] In some embodiments, as described elsewhere herein, an infusion system can be used to provide separate fluid pathways for various agents (e.g., drugs, hormones, proteins, pharmaceuticals, biologics, etc.) dissolved in various liquid carriers (and / or liquid drugs). In certain embodiments, different liquid vehicles may be preferred based on the solubility, stability, or sensitivity of the agent in a particular carrier. In some embodiments, an aqueous solution (such as a buffer) is used as a delivery vehicle for the agent. In certain variations, a solvent such as DMSO is used to dissolve the agent. In some embodiments, a solvent / aqueous mixture is used.

[0121] In some implementations, a dual medication system is provided that is configured to receive an insulin cartridge and a glucagon cartridge. In another embodiment, the system may include a pump having multiple cartridge receptacles (e.g., chambers) configured to receive medication cartridges containing the same medication (but not different medications) and / or configured to interact with multiple identical cartridge connectors. For example, in some embodiments, an infusion pump can have two medication receptacles that are identical and include identical recognition mechanisms. Both of these receptacles may be configured to receive the same medication cartridge and / or may be configured to engage with the same cartridge connector (e.g., two cartridges include insulin and / or two cartridge connectors both configured to engage with insulin cartridges). In such a configuration, the system and its components (e.g., medication cartridges, infusion pump, cartridge connector, infusion set, infusion connector, and fluid conduits) are configured to receive two (or more) medication cartridges containing a particular medication (e.g., insulin) and not a medication cartridge containing a different medication (e.g., glucagon). By providing a system that accommodates two or more cartridges of the same medicament (and prevents or inhibits the insertion or connection of cartridges having other medicaments), the system operates for longer periods of time without the need to refill or add additional cartridges. Furthermore, a consumed single cartridge (e.g., one that is empty or near empty) can be replaced in situ by a user without interrupting and / or delaying the flow of medical drug from a second cartridge that is providing the medicament to the patient. In some embodiments, the pump is configured to receive a single medicament cartridge and the system includes a single component that enables delivery of a single medicament cartridge (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 medicament cartridge, etc.).

[0122] The following sections provide additional information regarding the individual components of the infusion system disclosed herein. Although these components may be described as being part of the infusion system, it should be understood that each of these components (e.g., the infusion pump, cartridge connector, medication cartridge, infusion set, infusion connector, and fluid conduit) may be individually separate from the system. Similarly, when a component is described alone, it may be part of the infusion system disclosed herein. Any combination of recognition mechanisms within the infusion system may be mixed and matched to address the problem of erroneous fluid flow formation, just as any dosing safety recognition mechanism may be mixed and matched to address the problem of improper dosing. In some implementations, it is not necessary that all recognition mechanisms or safety mechanisms disclosed herein be used in a particular embodiment. For example, as disclosed elsewhere herein, the cartridge connector may be uniquely shaped to allow it to only engage with one medication vial (and not others) and uniquely threaded to only engage with a matching cartridge receptacle in the pump. In such embodiments, such features may be sufficient to avoid erroneous fluid flow formation. By way of example, in such a configuration, the cartridge receptacle of the pump may lack a recognition mechanism configured to prevent insertion of a cartridge, and instead the connector is configured to engage with a particular drug cartridge and a particular cartridge port within the pump.

[0123] Pump System As disclosed elsewhere herein, some embodiments relate to infusion pumps (e.g., pump systems). In some implementations, the infusion pumps disclosed herein are part and / or components of an ambulatory infusion system.

[0124] In some embodiments, as shown in Figures 1A, 1B, and 1E, the pump can include a face P1002, a backing P1003, a bottom side P1005 (e.g., a lower side), an upper side P1004 (e.g., an upper side), a first side P1006' (e.g., a right side), and a second side P1006" (a left side). As shown in Figures 1A and 1B, the pump face P1002 and pump backing P1003 may extend (e.g., laterally as a plane) along the upper side P1004 and lower side P1005, respectively, of the pump P1000, which provide a pump width P(w). The pump face P1002 and the pump backing P1003 may extend between the lower side P1005 and the upper side P1004 in a direction along the first side P1006' and the second side P1006" of the pump P1000, respectively (e.g., longitudinally as a plane), to provide a pump length P(l). As shown in FIG. 1A, the pump P1000 may also have a height P(h) extending between the pump face P1002 and the pump backing P1003 in a direction along the first side P1006' (and / or along the second side P1006"). In some embodiments, the pump face P1002, the backing P1003, the lower side P1005, the upper side P1004, the first side P1006', and the second side P1006" provide a pump perimeter.

[0125] In some variations, the infusion pump P1000 includes a pump housing P1001 that houses and / or accommodates one or more internal components of the infusion pump. As shown in FIG. 1C (also seen in FIG. 1A, FIG. 1B, and FIG. 1D-FIG. 1F), in certain implementations, the pump housing P1001 can include a bezel P1001′ and a lower portion P1001″. In some embodiments, the lower portion P1001″ provides a frame to which the bezel fits and / or connects. As shown in FIG. 1C, 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 extend to the face of the pump to provide an upper side P1004 of the pump P1000. In some embodiments, the upper and lower portions of the housing can be ultrasonically welded, snap-fit, glued, or otherwise secured to one another. In some embodiments, the connection between the bezel 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 1 m for a period of time equal to or at least about 5 minutes, 10 minutes, 15 minutes, 30 minutes, or ranging and / or including the foregoing values. In some embodiments, the upper and lower portions of the housing may 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 polymeric and / or plastic. In some embodiments, both the lower portion and the upper portion are independently a polymeric material (e.g., plastic) or metal.

[0126] In some embodiments, the generally cuboid-shaped configuration of the pump P1000 (as shown) has been found to advantageously house the internal pump components in a compact (e.g., wearable) manner. The compact nature of the cuboid configuration, together with one or more other design features disclosed, reduces volume and allows the disclosed infusion system to be worn and / or used. In some embodiments, the compact nature of the design enhances user adaptability and convenience. While a rectangular parallelepiped offers certain advantages with regard to the configuration of the pump's internal components, in other embodiments, other shapes (e.g., generally cuboid, oval, cylindrical, oval 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 resistance to cracking when impacted (e.g., by being dropped, etc.).

[0127] In certain implementations, the ratio of the pump P1000's length to its width is equal to or at least about 3:1, 5:2, 2:1, 5:3, 4:3, or ranges ranging and / or including the aforementioned ratios. For example, in some embodiments, the ratio of the pump's length to its width can range between 3:1 and 2:1, between 5:2 and 5:3, etc. In some configurations, the ratio of the pump P1000's width to its height is equal to or at least about 7:1, 5:1, 4:1, 3:1, 5:2, or ranges ranging and / or including the aforementioned ratios. For example, in some embodiments, the ratio of the pump's width to its height can range between 7:1 and 4:1, etc.

[0128] In certain embodiments, as shown in FIG. 1A, the pump P1000 includes a display area P1007. In some embodiments, the display area P1007 is a display screen and / or a touch screen, as disclosed elsewhere herein. In some variations, the display area P1007 may be configured to provide data (e.g., alphanumeric, image-based, etc.) to the user regarding drug levels, drug administration rates, information regarding blood glucose levels, and / or other diagnostic information. In certain configurations, the display screen allows the user to adjust drug dispensing or other pump and delivery settings (including one or more control features disclosed herein), as disclosed elsewhere herein. In some embodiments, the bezel supports and / or engages the display screen while holding the display screen in place.

[0129] 1A and 1B, the underside P1005 of the pump P1000 can include a touchpad P1010. In some embodiments, the touchpad P1010 is a fingerpad having a curved indentation configured to receive a user's finger. In some variations, a capacitive touch sensor may be disposed beneath and / or in electronic communication with the fingerpad P1010, as disclosed elsewhere herein. In other embodiments, additional capacitive touch sensors can be in communication with different sides of the pump (e.g., elsewhere on the pump surface, the pump backing, the upper side, the first side, or the second side).

[0130] In certain variations, the display P1007 may additionally or alternatively be a capacitive touch sensor and / or the capacitive touch sensor may be located on 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 designated 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 disposed within the pump. For example, in some embodiments, , the user can swipe (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 capability (e.g., speed, etc.).

[0131] Pump Cartridge Receptacle 1A and 1B show a plurality of drug pumps P1000 engaged with two cartridge connectors C1001, C1101 (e.g., first and second cartridge connectors). These cartridge connectors can be configured to mount different drug cartridges and simultaneously engage the pumps via cartridge receptacles (e.g., first and second cartridge receptacles). As shown, first and second fluid conduits T1001, T1101 are engaged with the first and second cartridge connectors C1001, C1101, respectively. Although not visible in FIGS. 1A and 1B, the drug cartridges may be housed within chambers that are engaged with the cartridge connectors C1001, C1101. Also visible in FIGS. 1A and 1B are a first tube T4001 and a second tube T4002 configured to provide a fluid path to an infusion set and / or infusion connector (not shown).

[0132] As shown in FIGS. 1C and 1D, the pump 1000 includes cartridge receptacles P1100, P1110 (e.g., cartridge holders, cartridge chambers, and / or cartridge repositories). As shown, the cartridge receptacles include drug receptacle inlet ports P1100′, P1110″. In FIGS. 1C-1F, the cartridge connectors C1001, C1002 shown in FIGS. 1A and 1B (with matching drug cartridges M1001, M1101, visible in FIG. 2I) have been disengaged and removed from the pump P1000, revealing the cartridge receptacles P1100, P1110 and inlet ports P1100′, P1110″. In some embodiments, these cartridge receptacles are configured to accommodate (e.g., receive, secure in place, hold, etc.) the drug cartridges M1001, M1101 (as shown in FIG. 2I).

[0133] As shown in Figures 1A, 1B, and 1D-1F, the pump P1000 may include a first drug chamber P1100 that is distinct from the second drug chamber P1110. In some variations, one or more design features (e.g., recognition features) of the inlet port P1100', P1110' and / or other features in the cartridge receptacle P1100, P1110 prevent proper engagement of the cartridge connector and / or prevent insertion of an improper cartridge into an incorrect chamber. For example, as shown in Figures 1E-1J, these chambers P1100, P1110 or inlet ports P1100', P1110' may include one or more recognition features P1101, P1102, P1103, P1111, P1112, P1113 that prevent or inhibit coupling to an improper component.

[0134] In some embodiments, the cartridge receptacles are configured to receive certain drug vials and not others. For example, a given receptacle can be configured not to receive the wrong drug cartridge (e.g., by diameter, length, size, or shape of the drug cartridge). In other embodiments, the cartridge receptacle may be configured to indiscriminately accept different types of cartridges. In such embodiments, even if a given cartridge receptacle can receive drug cartridges of different shapes and / or cartridges for different drugs (e.g., a first receptacle can receive either a glucagon cartridge or an insulin cartridge), incorrect flow path formation can still be avoided by the cartridge connector and inlet ports P1100', P1110''.

[0135] For example, as disclosed elsewhere herein, the first cartridge connector C1001 can be configured to engage only with a particular drug cartridge M1001 (e.g., a first drug cartridge), and the second cartridge connector C1101 can be configured to engage only with a matching particular drug cartridge M1101 (e.g., a second drug cartridge). The pump receptacles P1100, P1110 themselves may not be configured to prevent insertion of an incorrect drug cartridge, but the inlet ports P1100', P1110'' can include unique mating features (e.g., recognition features) that only allow them to engage with mating features that match a particular drug cartridge connector. By way of example, the first receptacle can be configured to engage with the first cartridge connector but not the second cartridge connector. The second receptacle can be configured to engage with the second cartridge connector but not the first cartridge connector.

[0136] In other embodiments, a given receptacle can be configured not to receive an incorrect drug cartridge (eg, by drug cartridge shape) and not to mate with an incorrect cartridge connector.

[0137] In some embodiments, the pump is configured to receive a drug cartridge that is already connected to the connector. Illustratively, the drug cartridge can be connected to the cartridge connector, and then the pump can receive the cartridge and connector simultaneously (allowing only the appropriate connector and / or cartridge to engage). Alternatively or additionally, in some embodiments, the pump can receive a drug cartridge (e.g., loose, without a cartridge connector, and / or with the cartridge connector disconnected). The pump may then be configured to receive the cartridge connector in a cartridge receptacle on the cartridge, and the connector can be locked into place in the pump (e.g., screwed into place). In such embodiments, the connector can be configured to simultaneously engage both the vial and the pump. If the connector or drug cartridge is inappropriate for a given receptacle, a specific recognition mechanism can prevent the connector from engaging. For example, if the cartridge and connector are not paired, the cartridge is of insufficient diameter to receive the cartridge, preventing engagement of the cartridge connector to the cartridge and holding the cartridge connector in a position too far from the pump to engage the inlet port. Alternatively, the connector may receive the incorrect vial, but travel too deep within the receptacle and fail to engage the inlet recognition mechanism of the pump.

[0138] As shown in FIG. 2I , the inlet port P1100′ of the first drug chamber P1100 may be configured to engage with the first cartridge connector C1001 and / or receive the first cartridge M1001. In some embodiments, as shown, the inlet port P1110″ of the second drug chamber P1110 is configured to engage with the second cartridge connector C1101 and / or receive the second cartridge M1101. In some embodiments, the inlet port P1100′ of the first drug chamber P1100 is configured not to engage with a cartridge connector (e.g., the second cartridge connector C1101) that engages with the second inlet port P1110″. In some embodiments, additionally or alternatively, the inlet port P1110″ of the second drug chamber P1110 is configured not to engage with a cartridge connector (the first cartridge connector C1001) that engages with the first inlet port P1100′. In the embodiment shown in FIG. 1D, the first receptacle P1100 is configured to house or receive a cartridge and cartridge connector for a modulator (e.g., insulin), and the second drug chamber P1110 is configured to house or receive a cartridge and cartridge connector for a counterregulatory drug (e.g., glucagon).

[0139] As shown in Figures 1D-1I, each of the pump chambers P1100, P1110 includes one or more recognition features P1101, P1102, P1103, P1111, P1112, P1113 configured to prevent or inhibit erroneous flow channel formation. As shown, the features may be protrusion-shaped openings (e.g., divots, apertures, through spaces, detent slots, lug slots, radial lug or detent shaped notches, cutouts, etc.) configured and / or shaped to receive corresponding protrusion features (e.g., protrusions, tabs, lugs, detents) of the cartridge connector mating with the pump chamber. These mating features facilitate attachment of the appropriate components and / or prevent connection of the appropriate components. In the illustrated embodiment, radial depots (e.g., divots or notches shaped to receive matching protrusion features) are distributed circumferentially around the inlet ports P1100', P1110'', although in other embodiments, protrusions (e.g., tabs, lugs, detents) and / or a mixture of protrusions and depots may be provided on or within the inlet ports to prevent or inhibit erroneous flow passage formation (not shown). In such embodiments, matching radial divots and / or protrusions may be provided on the corresponding cartridge connector.

[0140] In some embodiments, as shown, features of pump receptacles P1100, P1110 may be located proximate to the inlets of the receptacles (e.g., at inlet ports P1100′, P1110″) to enable interaction with corresponding cartridge connectors. As shown in FIGS. 9A-9B, cartridge connectors C1001, C1101 corresponding to pump receptacles P1100, P1110, respectively, include matching protrusions (e.g., tabs, lugs, detents). In some embodiments, these protrusions include lugs C1010, C1011, C1110, C1111 and / or detents C1012, C1112. In some embodiments, the protrusions (e.g., projections) are configured to mate (e.g., slide) with matching openings configured to receive such protrusions, as described elsewhere herein. As shown in Figures 1D-1J and 9B, each cartridge chamber may have a number of recognition features configured to mate with corresponding recognition features of a cartridge connector. In the illustrated embodiment of Figures 1D-1J, each pump chamber P1100, P1110 includes three radial notches configured to engage matching shaped lugs and detents, respectively, of a corresponding cartridge connector C1001, C1101, shown in Figure 9B. These recognition features may be configured to engage with a suitable connector and prevent or inhibit engagement of an inappropriate cartridge connector (e.g., not corresponding and lacking one or more matching protrusions), or both.

[0141] In the embodiment shown in Figures 1D-1J, each inlet port 1100', 1110' has three radial divots as recognition features, but in some embodiments, each pump chamber can independently have one, two, three, forty-five, or more recognition features (e.g., divots and / or protrusions) configured to receive matching recognition features (e.g., protrusions and / or divots) from a corresponding cartridge connector. Additionally, as will be apparent herein, while the cartridge receptacle has been described as having divots and the cartridge connector has been described as having protrusions, the opposite configuration is possible (divots on the cartridge connector and protrusions on the receptacle). Similarly, in some embodiments, several types of recognition features can be mixed and matched on a particular receptacle or cartridge connector (so that the receptacle has both protrusions and divots and the corresponding cartridge connector has matching divots and protrusions). In yet another variation, the cartridge receptacle can include only divots and different cartridge receptacles in the same pump can only have protrusions. In such an embodiment, the corresponding cartridge connector set includes: Each may include a connector with matching protrusions and a connector with matching divots. As an exemplary embodiment, if the first cartridge connector includes a five protrusion feature (e.g., three lugs and two detents, not shown), the corresponding first receptacle (e.g., first inlet port) includes five divots for receiving those protrusions (e.g., three lug openings and two detent openings). The second cartridge connector may include four divots (e.g., two lug openings and two detent openings) configured to engage with a corresponding second receptacle with four protrusions (e.g., two lugs and two detents) that are received within those divots.

[0142] In some embodiments, as shown in FIGS. 1D-1J, the lug openings and detent openings may be of various different sizes (e.g., circumferential length, radial height, etc.). For example, as shown in FIG. 1J, the lug openings of one cartridge receptacle may be of one length lug (l') and the second may be of a second length lug (l''), which may differ from each other and / or from the lug length of the second cartridge receptacle lug (l'''), lug (l''''). As shown, the detent openings of one cartridge receptacle may be of one length det (l') that is different from the length det (l'') of the detent openings of the other cartridge receptacle. In some embodiments, these openings are configured to receive correspondingly sized lugs and detents (e.g., of matching lengths) disposed on a corresponding cartridge connector (e.g., as shown in FIG. 9B).

[0143] As shown in FIG. 1J, the detents and lug openings of two different medication receptacles P1100, P1110 can have corresponding positions. For example, the detent openings P1103, P1113 of both inlets P1100′, P1110″ are located at the 12 o'clock position of the receptacle P1100, P1110, the first lug opening P1101, P1111 is at the 9 o'clock position, and the second lug opening P1102, P1112 is at the 3 o'clock position. In some variations, the lugs and detents are not at corresponding positions, or only a portion of the lugs and detents are at corresponding positions. In some embodiments, even if the lug openings and detent openings are at corresponding positions on separate inlets (or separate connectors), installation of an incorrect cartridge connector can be prevented and / or substantially hindered by providing different sizes of their comparably positioned features. It has been found that erroneous flow channel formation can be prevented and / or substantially reduced by providing a feature on a first receptacle (e.g., a lug opening, a detent opening, a lug, a detent, etc.) having a size difference of at least 15% (e.g., 15% larger or smaller) than an equivalent feature on a second receptacle (e.g., a feature in the same relative position). In certain implementations, the ratio of the length of a feature on one receptacle compared to the length of an equivalent feature on a different receptacle is equal to or is at least about 3:1, 5:2, 2:1, 5:3, 4:3, 20:17, or ranges spanning and / or including the foregoing ratios.

[0144] In certain embodiments, as shown in FIGS. 3D and 9B, one or more recognition features (e.g., lugs, detents, openings configured to receive lugs or detents, etc.) may be distributed around the circumference of the inlets P1100′, P1110″ or cartridge connectors C1001, C1101. For example, as shown in FIG. 1J, the midpoint of one recognition feature may be located at the 9 o'clock position and an adjacent recognition feature may have a midpoint at 12 o'clock, thereby being separated by 90°. In some embodiments, adjacent recognition features of the inlets P1100′, P1110″ or connectors C1001, C1101 may be spaced apart from each other at a value independently selected from about 180°, 160°, 140°, 120°, 100°, 90°, 80°, 70°, 60°, 50°, 40°, 30°, 20°, 10° or less, values ​​between the aforementioned values, or otherwise. 1J and 9B, in some embodiments, non-adjacent recognition features of inlets P1100′, P1110″ or connectors C1001, C1101 may be separated by a value independently selected from about 180°, 160°, 140°, 120°, 100°, 90°, 80°, 70°, 60°, 50°, 40°, 30°, 20°, 10° or less, a value between the aforementioned values, or otherwise.

[0145] It should be understood that for any divot, any dimension of that divot, location of that divot, or relationship of that divot to another divot (e.g., a second divot) described herein also applies to the protrusion or relationship between the protrusions. For purposes of brevity, such relationships have been shortened or omitted as will be readily understood in light of this disclosure. Similarly, any recognition features (e.g., notches, protrusions, etc.) described with respect to the cartridge receptacle apply to the recognition features of the cartridge connector, as disclosed elsewhere herein.

[0146] As shown in FIGS. 1D-1I, in some embodiments, divots (e.g., notches, protrusion-shaped openings, etc.) can be opened into tracks P1101′, P1103′, P1111′, P1113′ (e.g., slots, pathways, etc.). In some embodiments, these pathways move and / or are positioned circumferentially within the drug receptacle P1100, P1110. In certain variations, once the cartridge connector is inserted into the pump chamber opening, the connector rotates to lock the cartridge connector into the receptacle. For example, in the embodiment shown in FIGS. 1A-1J, the connectors can each be rotated a quarter turn to lock each into position within the pump chamber. As shown, in some embodiments, the lugs of the cartridge connectors are initially inserted through the lug openings P1101 and then rotated a quarter turn to position under the other detent openings P1102 of the pump chamber P1100. The lugs move along the lug pathways to their locked positions. In other embodiments, the larger lug can be positioned under the opening for the smaller lug. In some embodiments, alignment of the lug under the smaller detent or smaller lug opening inhibits removal of the cartridge connector from the pump chamber when locked because the larger lug cannot pass through the smaller detent or lug opening. As mentioned above, if the receptacle inlet includes a protrusion (not shown), a matching divot and track are placed on the corresponding cartridge connector.

[0147] As can be seen from Figures 1E-1J where different drugs are used, the cartridge connectors may be configured to require clockwise rotation to lock one cartridge connector (and cartridge) into place in its corresponding receptacle, and counterclockwise rotation to lock the other cartridge connector (and cartridge) into place in its corresponding receptacle. Thus, the direction of twist is another optional indicator that allows the user to avoid erroneous fluid flow formation. In another embodiment not shown, the cartridge connector and cartridge receptacle may both be configured to allow clockwise rotation to lock the cartridge into place. In another embodiment not shown, the cartridge connector and cartridge receptacle may both be configured to allow counterclockwise rotation to lock the cartridge into place.

[0148] In some embodiments, as shown in Figures 1G and 1H, the cartridge receptacle P1100, P1110 can include a first "shallow" detent cam P1103', P1113' that includes a smaller transition angle than a second "step" detent cam P1103", P1113" that includes a larger transition angle. In some embodiments, the cartridge connector (and corresponding detent lug) is inserted into the opening of the corresponding pump chamber. Once the cartridge connector is rotated in a first direction to lock the connector into the pump chamber. In some embodiments, while the connector is rotating in the receptacle, the detents can abut against a first "shallow" detent cam and then travel over the first "shallow" detent cam until the detents reach the transition P1103'", P1113'". As rotation continues, the detents travel over the transition P1103'", P1113'" and pass a second steep detent cam P1103", P1113" that reaches a detent clearance configured to receive the detent. At the same time, the lugs reach the end of their tracks and stop or prevent further twisting of the cartridge connector. The detent clearance may be bounded on one side by a second "steep" detent cam P1103", P1113", which requires a greater rotational force in the opposite direction to allow the detent to overcome the second cam and remove the detent from the clearance. Thus, in some embodiments, the combination of different detent cams causes the cartridge connector, once locked to the pump, to require a greater amount of force to remove and / or unlock the cartridge connector from the pump chamber than the amount of initial force required to lock the cartridge connector to the pump chamber. In certain implementations, the ratio of the steep cam angle compared to the shallow cam angle is equal to or is at least about 5:1, 3:1, 5:2, 2:1, 5:3, 4:3, or ranges spanning and / or including the aforementioned ratios. In other embodiments, steep and shallow cams can be configured to lock the lugs in place (instead of or in addition to detents). As mentioned above, if the receptacle entrance includes a protrusion (not shown), a matching cam and track are placed on the corresponding cartridge connector.

[0149] In some embodiments, as shown in Figures 1F and 1G, the receptacles P1100, P1110 can include one or more snap arm clearance recesses P1105a, P1105b, P1115a, P1115b (e.g., snap arm extension recesses). In some embodiments, the snap arm clearance recesses extend downward (e.g., axially) through one or more portions of the medication receptacle. In some embodiments, these recesses are configured to allow and / or provide space for the expansion of the snap arms C1105a, C1105b, C1115a, C1115b (shown in Figure 9D) on the cartridge connectors C1001, C1101 to engage a medication cartridge present in the cartridge receptacle P1100, P1110. In other words, in some embodiments, one or more cartridges are first placed in the pump via pump receptacles P1100, P1110 to secure the drug cartridges in the pump, as disclosed elsewhere herein. In some embodiments, a cartridge connector can be inserted into the receptacle, as disclosed elsewhere herein. When a suitable cartridge connector receives a corresponding cartridge via the cartridge connector shroud, the snap arms expand as they pass over the circumference of the drug cartridge cap. The snap arm recess allows this expansion for properly positioned connectors and / or cartridges. Once the cap has passed the snap arms, the snap arms snap back into place where the lip (e.g., teeth, edges, steps, or other cap locking mechanism) engages with the drug cartridge cap. Without the snap arm clearance, the snap arms would not be able to expand over the cartridge cap, preventing and / or impeding improper drug connection.

[0150] In certain variations, as described elsewhere herein, the receptacles themselves may be different shapes or sizes to accept one type of drug cartridge but not another. For example, the chambers may have different diameters, shapes, or lengths to be able to accept and / or engage one drug but not another. In some embodiments, the diameters of the chambers may be different, for example as shown in FIG. 2D. As disclosed elsewhere herein, the glucagon chamber may have a lip that transitions from one diameter moving distally from the inlet to another smaller diameter. In such embodiments, the insulin cartridge may not be insertable into the glucagon chamber. In some embodiments, the glucagon cartridge (smaller diameter) can enter the insulin chamber. However, in some embodiments, a stop rib at the bottom of the chamber prevents full insertion of the glucagon cartridge. Similarly, it will be appreciated that the glucagon cartridge may 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 seating low enough to allow connection in the insulin chamber. In other embodiments, the cartridges are the same diameter, and other aspects disclosed herein may be implemented to avoid erroneous flow channel formation.

[0151] Pump housing configuration In certain variations, as shown in Figures 2D-2I, the cartridge receptacles P1100, P1110 are laterally spaced apart within the housing P1001. As shown elsewhere herein, in some embodiments in which the pump is configured to deliver different medicaments (as shown in Figures 1A-2I), each medicament cartridge receptacle (and / or its inlet) may differ depending on the medicament it is configured to accept. Each different receptacle may be configured to accept only a particular medicament cartridge and / or cartridge connector and not another incorrect medicament cartridge and / or cartridge connector. Alternatively, in a pump configured to accept multiple medicament cartridges having the same medicament (not shown), the pump may have identical or substantially identical medicament receptacles (albeit located at different locations within the pump housing).

[0152] In some embodiments, cross-channeling is avoided by providing design features and / or mating connectors or adapters to certain components of the infusion system, as described elsewhere herein. For example, in some embodiments, the infusion system includes an infusion pump having one, two, or more infusion chambers (or pump chambers). In some variations, the system further includes cartridges filled with different medicaments, and cartridge connectors and tubing that connect the cartridges to the infusion pump to prevent erroneous channeling or cross-channeling of the medicaments. In certain variations, for example, each type of cartridge for each type of medicament has one or more unique distinguishing features (either as an integral part of the cartridge or as an attached or fixed component to the cartridge), e.g., geometric or shape-based features (e.g., protrusions, detents, tabs, apertures, feature receptacles, slots, etc.) that engage with corresponding features in the pump housing and enable unique mating with a type of connector that has its own unique distinguishing feature (e.g., apertures, feature receptacles, slots, protrusions, detents, tabs, etc.) that enables the appropriate cartridge to be inserted into the appropriate 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, e.g., geometric or shape-based features (e.g., protrusions, detents, tabs, apertures, feature receptacles, slots, protrusions, detents, tabs, etc.) (either as an integral part of the cartridge or as an attached or fixed component to the cartridge) that enable unique coupling with a cartridge receptacle having a unique distinguishing feature (e.g., apertures, feature receptacles, slots, protrusions, detents, tabs, etc.).

[0153] As described elsewhere herein, for multiple drugs and multiple connectors The improved infusion system comprising the infusion pump P1000 ensures, aids in and / or substantially assists in ensuring that each medication is provided with proper flow-through to the patient. In other words, when multiple medications are delivered by the infusion system, the features and / or components described herein are configured to prevent, minimize or otherwise inhibit the opportunity for a user to inadvertently place a medication in the wrong cartridge or place a cartridge in the wrong pump chamber. In some embodiments, alternatively, when more than one cartridge is present, both cartridges may contain a single medication (e.g., insulin).

[0154] In some embodiments, as shown in FIGS. 2A-2I, the PCB P1080 (e.g., the primary PCB) may be disposed in the pump housing P1001 at a position between the cartridge receptacles P1100, P1110. The pump P1001 has an interior zone P1008 shown in FIG. 2A. As shown in FIG. 2A, the pump chamber is at least partially isolated from the interior zone by chamber walls P1100″, P1110″. In some embodiments, the power source P1050 may be disposed in the pump housing P1001 at a position between the cartridge receptacles P1100, P1110 (as shown in FIGS. 2B and 2D). In certain variations, the power source P1050 is an inductively rechargeable battery and may be disposed in a position below the PCB (as shown in FIGS. 2B and 2D). In some embodiments, the pump 1000 includes an inductive charging pad P1003′ (as shown in FIG. 1E) configured to enable charging of the inductively rechargeable battery P1050. In certain variations, as disclosed elsewhere herein, the infusion pump configuration is low profile to facilitate transport of the infusion pump in a pocket, on a belt, or under clothing. For example, as shown in FIG. 2A, a flex cable P1055 provides input to a motor P1060 of the infusion pump P1000. In some embodiments, the motor P1060 moves a drive gear P1071 (e.g., a pinion gear) in a gear assembly comprising four gear components P1071, P1072, P1073, P1074, facilitating the movement of the lead screws P1152, P1154. The drive accesses of the motor and the lead screws are configured to be parallel to each other and in the same axis as the reservoir, respectively. In certain implementations, this configuration provides a compact design for the infusion pump.

[0155] FIG. 2D provides a cross-sectional view of the pump cut through its height by a plane extending along the length and width of the pump. In some embodiments, as shown in FIG. 2D, the first drug receptacle P1100 can have a substantially equal inner diameter from the inlet port P1100′ to the end of the bore. Also, as shown in FIG. 2D, in some embodiments, the second drug receptacle P1110 may have a lip or transition where the receptacle transitions from the first inner diameter to a second, smaller inner diameter. In some embodiments, the second, smaller inner diameter of the second receptacle P1110 is configured to receive the first drug vial but not the second drug vial. In some embodiments, the first drug receptacle may be configured to receive either the first or second drug vial. In some embodiments, the smaller inner diameter is a diameter smaller than the diameter of a drug vial that is not configured to be dispensed from the second drug receptacle.

[0156] Figure 2E shows a cross-sectional view through the second cartridge receptacle P1110 (with the bezel and display removed). Figure 2F shows a cross-sectional view through the first cartridge receptacle P1100 (with the bezel and display removed). Figure 2I provides another cross-sectional view of the pump, this time with the cartridges M1001, M1101 and cartridge connectors C1001, C1101 engaged, cut through its height by a plane extending along its length and width.

[0157] FIG. 4A shows another embodiment of the pump P2000. For simplicity, the pump in FIG. Although not all of the features of the embodiments of the pumps may be mentioned, pump 2000 may have each of the features described with respect to the embodiment of FIG. 1A, except where such features are explicitly distinguished. Additionally, it should be recognized that throughout this disclosure, similar and / or identical features of separate embodiments of devices or system components (e.g., pumps, connectors, etc.) are not described in separate embodiments, but are merely numerically offset in the drawings by thousands (although they share the hundreds, tens, and ones digits). For example, features of receptacle inlet ports P2100', P2110' of pump P2000 of FIG. 4A may be common to features of receptacle inlet ports P1100', P1110' of pump P1000 of FIG. 1A, although features of either of these inlet ports may not be specifically detailed if they overlap with descriptions elsewhere in this disclosure. For convenience, certain features shown or annotated with reference numbers in some figures and embodiments are not shown or annotated with reference numbers in other figures and embodiments. Unless the context clearly requires otherwise, these omissions should not be construed to mean that features omitted from one figure drawing cannot be equally incorporated or implemented in the configuration of the disclosed methods, apparatus, and systems associated with or embodied in other figures. Conversely, unless the context clearly requires otherwise, the presence of particular features in several figures of the present disclosure should not be assumed to mean that the disclosed methods, apparatus, and systems associated with or embodied in such figures must necessarily include those features.

[0158] FIG. 4B shows a perspective view of the embodiment of 4A with the display removed. FIG. 4C shows a perspective view of the bottom of the housing of the embodiment of 4A. FIG. 4D shows a perspective view of the bottom of the housing and drive nut (e.g., piston shaft, etc.) of the embodiment of 4A. FIG. 4E shows the pump P2000 of FIG. 4A bisected at the height of the pump 2000. As shown, the pump 2000 is engaged to the connector sets C2001, C2101 via first and second cartridge receptacle inlets P2100', P2110', respectively. As shown, the first and second fluid conduits T2001, T2101 are engaged to the first and second cartridge connectors C2001, C2101, respectively.

[0159] As shown in Figures 2D-2I and 4E, in some embodiments, O-rings P1150a, P1150b, P2150a, P2150b are disposed within the saddles P1132, P1134, P2132, P2134. In some 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 regions P1008, P2008 of the pump. In some embodiments, the saddles are molded into the bottom of the pump housing P1001'', P2001'', and / or are an integral part of the bottom of the housing. In some embodiments, the saddles are disposed at the bottom of the pump chambers P1100, P1110, P2100, P2110 and / or form part of the bottom of the pump chambers. In some embodiments, the saddles P1032, P1034, P2032, P2034 provide a circumferentially inwardly extending bottom of the pump chambers P1100, P1110, P2100, P2110. In some embodiments, the saddles P1132, P1134, P2132, P2134 are configured to engage and / or hold the O-rings P1150a, P1150b, P2150a, P2150b in place. In some embodiments, the O-rings P1150a, P1150b, P2150a, P2150b are configured to seal and / or engage against the two drive nuts P1142, P1144, P2142, P2144 (e.g., piston shafts). In some embodiments, the fully retracted drive nuts P1142, P1144, P2142, P2144 together with the saddles P1132, P1134, P2132, P2134 extending circumferentially inward of the pump provide a distal end of the pump P1000, P2000 against which the drug cartridge abuts when positioned inside the pump P1000, P2000 (as shown in FIGS. 2I and 4E). do.

[0160] As can be seen from Figures 2A, 2B, 2D, 2G, 2H and 4B-4E, the display is removed but 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 by the chamber walls P1100'', P1110'', P2100'', P2110'', saddles P1132, P1134, P2132, P2134, O-rings P1150a, P1150b, P2150a, P2150b and drive nuts P1142, P1144, P2142, P2144. In some embodiments, as seen in Figures 2D-2I and 4B-4E, the drive nuts P1142, P1144, P2142, P2144 enter the pump receptacles P1100, P1110, P2100, P2110 via receptacle apertures P1100a, P1110a, P2100a, P2110a. In some embodiments, as disclosed elsewhere herein, O-rings engage the drive nuts P1142, P1144, P2142, P2144 to prevent ingress of mud, dirt, water, and / or air from the drug cartridge receptacle P1100, P1110, P2100, P2110 into the pump interior regions P1008, P2008. 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 O-ring 1150a, P1150b, P2150a, P2150b and the drive nut P1142, P1144, P2142, P2144 are air-tight and / or water-tight and seal the interior area of ​​the pump from the pump chamber.

[0161] In some embodiments, the drive nuts P1142, P1144, P2142, P2144 engage and / or interact with longitudinally extending and / or internally embedded lead screws P1152, P1154, P2152, P2154, as shown in Figures 2D-2I and 4A-4E. In some embodiments, the lead screws P1152, P1153 threadably engage with threaded inserts P1172, P1174, P2172, P2174, as shown in Figure 2D. In some embodiments, the drive nut and threaded insert are secured together (e.g., the threaded insert is ultrasonically welded, glued, or otherwise secured within the drive nut), as described elsewhere herein. In some embodiments, as shown in Figures 2I and 4B, the motors P1160a, P1160b, P2160a, P2160b drive gears of gear assemblies P1070, P2070 that engage lead screws P1152, P1154, P2152, P2154 that transfer rotational motion to threaded inserts P1172, P1174, P2172, P2174. In some embodiments, the threaded inserts advance along the lead screws, urging the drive nuts P1142, P1144, P2142, P2144 longitudinally forward or backward (e.g., along the length of the pump). In some embodiments, when the drive nuts P1142, P1144, P2142, P2144 are biased forward or rearward, the rotational movement of the lead screws P1152, P1154, P2152, P2154 does not rotate the drive nuts. In some embodiments, the lack of rotation of the first and second drive nuts P1142, P1144, P2142, P2144 reduces rotational friction between the drive nuts and the first and second O-rings P1150a, P1150b, P2150a, P2150b, respectively, and / or the drug cartridge plungers M1005, M1105, respectively.

[0162] As shown in Figures 2G, 2H, 4C, 4D, and disclosed elsewhere herein, in some embodiments, O-rings 1150a, P1150b, P2150a, P2150b are received within the drug chamber via chamber walls P1100'', P1110'', P2100'', P2110''. In some embodiments, threaded inserts P1172, P1174, P2172, P2174 are secured to drive nut P1100'', P1110'', P2100'', P21 ... 42, P1144, P2142, P2144, and as the lead screw P1152, P1154, P2152, P2154 rotates, the threaded insert slowly advances longitudinally along the lead screw, causing the drive nut to extend longitudinally within the drug chamber P1100, P1110, P2100, P2110 toward the first end of the bore. In some embodiments, when the drive nut is biased forward or rearward, rotational motion of the lead screw relative to the threaded insert is not transmitted to the drive nut. 2H and 4D, in some embodiments, the first and second drive nuts P1142, P1144, P2142, P2144 have first and second tongues P1427a, P1427b, P2427a, P2427b (e.g., protrusions, tabs, etc.) respectively configured to seat in and / or engage with first and second grooves P3128a, 3128b, P2428a, P2428b (e.g., tracks, protrusion receptacles, etc.) that prevent rotation of the drive nuts P1142, P1144, P2142, P2144. In some embodiments, one tongue is larger and the other smaller (or of a different shape) and can fit into a correspondingly shaped trough in the pump housing. In some embodiments, an O-ring secured within the cartridge chamber and / or at an opening in the cartridge chamber remains in place and is circumferentially disposed on the drive nut during movement of the drive nut and / or drug delivery. In some embodiments, a protrusion may be disposed on the pump housing and a protrusion receptacle (e.g., groove, track, etc.) may be disposed on the drive nut. In some embodiments, the lack of rotation about the drive nut reduces rotational friction between the drive nut and the O-ring and / or drug cartridge plunger.

[0163] In some embodiments, as described above, the projections P1427a, P1427a of the first drive nut may be shaped differently from the projections P1427b, P1427b of the second drug drive nut. In some variations, the first and second grooves P1428a, 1428b, 21428a, 2428b (e.g., tracks) may be shaped differently from one another and configured to engage the first and second projections P1427a, P1427b, P2427a, P2427b of the first and second drive nuts, respectively. In some embodiments, a track may be provided on the drive nut, and a tongue (e.g., projection) may be provided below the drive nut and on the housing at a location that engages the track of the drive nut.

[0164] In some embodiments, as shown in FIG. 2G, the first drive nut P1142 (e.g., an elongated cylinder, a piston shaft, etc.) can include an elongated head P1142a with one or more barbs P1142b (e.g., 1, 2, 3, 4, or more). In the embodiment shown in FIG. 2G, 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 cartridge M1001 (e.g., an insulin cartridge) can be threaded. In some embodiments, when the drive nut is biased forward, the elongated head P1142a slides within the plunger M1005 of the first cartridge, and the barbs engage the distal threads in the plunger M1005, locking the plunger to the drive nut P1142. In some embodiments, these barbed features help prevent disengagement of the plunger from the drive nut. In some embodiments, the plunger M1105 may have sufficient friction within the second cartridge M1101 to avoid disengagement. Thus, in some embodiments, the second drive nut lacks a barb and the second cartridge lacks a 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 a thread.

[0165] In some embodiments, as shown in FIG. 2C, the sacs of cylinders P1142 and P1144 One or more of these comprise attachment features P1142c, P1144c (e.g., tracks, pull points, grips, etc.). In some embodiments, these attachment features provide grips for one or more drive nut installation tools. In some embodiments, the drive nut installation tools are used to test the tension (during retraction) or compression (during extension) force of the drive nut. In some embodiments, the installation tools are used to pull the drive nut through the drive nut apertures P1100a, P1110a of the housing during assembly, allowing for proper positioning of the lead screw, for example.

[0166] For example, as shown in FIG. 2A, in some embodiments, the motor P1060 rotates and / or moves a drive gear P1071 (e.g., a pinion gear) in a gear assembly. As shown in FIG. 2B, in some embodiments, each gear assembly P1070 (of which a first and second two are depicted) comprises four gear components P1071, P1072, P1073, P1074 to facilitate rotation of the lead screw P1152, P1154 within the interior region of the pump. In some embodiments, the gear ratio of laterally adjacent and / or engaged gear wheels in a gear assembly may be equal to or at least about 3:1, 4:1, 5:1, 8:1, or a ratio ranging and / or including the aforementioned ratios. In some embodiments, 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), as shown in FIG. 2B. In some embodiments, the radially adjacent and / or stacked gear configuration provides a compact design for the infusion pump. In some 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 a ratio ranging from and / or including the above ratios.

[0167] In some variations, as shown, the gear assembly in the pump may include both small gear wheels P1071a, P1072a, P1073a and large gear wheels P1072b, P1073b, P1074b. In some embodiments, as shown in FIG. 2C, the gear assembly P1070 includes one or more stepped gear components P1072, P1073. The stepped gear includes larger gears P1072b, P1073b and smaller gears P1072a, P1073a on the same gear component. In some embodiments, the ratio of the diameters of the larger and smaller gears of the stepped gears may be equal to or at least about 3:1, 4:1, 5:1, 8:1, or a range spanning and / or including the aforementioned ratios. In some embodiments, as disclosed elsewhere herein, a laterally traversing gear assembly having multiple gear stages advantageously allows the height of the pump to be reduced. Additionally, the motors can be located laterally adjacent to their drive nuts, increasing the compactness of the design.

[0168] In some embodiments, the diameter of each of the gears is similar to one another. This feature advantageously allows the height of the pump to be reduced. For example, if an effective gear ratio of 100:1 is desired, three lateral stages (as in FIG. 2C) can be used to achieve a smaller diameter gear rather than a simple single stage of 100:1. In some embodiments, the diameter of each of the gears is within about 20% of one another. In some embodiments, the diameters of the gears differ by no more than 40%, 30%, 20%, 10%, 5%, 0%, or ranges ranging from and / or including the aforementioned 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 no more than 40%, 30%, 20%, 10%, 5%, 0%, or ranges ranging from and / or including the aforementioned values. In some embodiments, the diameter of the largest gear in the gear assembly and the diameter of the gear assembly differ by no more than 40%, 30%, 20%, 10%, 5%, 0%, or ranges ranging from and / or including the aforementioned values. The diameter of the third largest gear wheel in the assembly (e.g., if there are two larger gear wheels in the gear assembly) differs by less than 40%, 30%, 20%, 10%, 5%, 0%, or a range ranging up to and / or including the foregoing values.

[0169] In some embodiments, the size of the motor casing relative to the size of the larger gear is within about 20% of each other. In some embodiments, the diameter of the large gear and the diameter of the motor casing differ by less than 40%, 30%, 20%, 10%, 5%, 0%, or ranges ranging from and / or including the aforementioned values. This also advantageously reduces the height of the pump.

[0170] In some embodiments, the pinion gears have a diameter less than or equal to half the diameter of the gears. For example, the largest of the pinion gears has a diameter less than or equal to half the diameter of the smallest gear. In some embodiments, the diameters of each of the pinion gears are similar to each other. In some embodiments, the diameters of each of the pinion gears are within about 20% of each other. In some embodiments, the diameters of the pinion gears differ by no more than 40%, 30%, 20%, 10%, 5%, 0%, or ranges ranging from and / or including the aforementioned values. In some embodiments, the diameters of the smallest gear in the gear assembly and the diameters of the second smallest gear in the gear assembly differ by no more than 40%, 30%, 20%, 10%, 5%, 0%, or ranges ranging from and / or including the aforementioned 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 (e.g., if there are two smaller gears in the gear assembly) differ by less than 40%, 30%, 20%, 10%, 5%, 0%, or a range ranging up to and / or including the aforementioned values.

[0171] 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. In some embodiments, as shown in FIG. 2B, the pump may include four gear components per gear assembly. In some embodiments, the number of gears (e.g., cogwheels), including the pinion gear and the drive gear attached to the lead screw, is equal to or at least about 2, 3, 4, 5, 6, or more. As shown in FIG. 2B, there may be six gears in the gear assembly P1070. In some embodiments, the number of gear stages between the pinion gear and the drive gear attached to the lead screw is equal to or at least about 2, 3, 4, 5, or more. As shown in FIG. 2B, there may be three gear stages in the gear assembly P1070. In some implementations, the stepped pinion gears in the gear assembly are stacked, as shown in FIG. 2C.

[0172] 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 can pass radially through each stacked gear component (as shown by line P1070' in FIG. 2C). In some embodiments, as shown in FIG. 2C, at least one line drawn transversely through a stacked gear assembly (shown as a dashed line) passes radially through at least four gears in the assembly. In some embodiments, as shown in FIG. 2C, a different line drawn transversely through a stacked gear assembly (shown as a dotted line) can pass radially through at least two gears in the assembly. In some embodiments, a line drawn transversely through a stacked gear assembly passes radially through three, four, five, or more gears in the assembly.

[0173] In some embodiments, the gears in the stacked configuration interact in alternating fashion from small gear to large gear (as shown in FIG. 2C). In some embodiments, the large gear is laterally adjacent and / or radially adjacent to the small gear, as shown in FIG. 2C. In some embodiments, the stepped The pinion of the gear P1073 is laterally and / or radially adjacent to at least two of the gears of the adjacent gears P1074, P1072. The motor drive shaft and the lead screw are configured parallel to each other and coaxial with the reservoir. In some embodiments, the motor shaft and the lead screw shaft are parallel and on the same side of the drive train. In some embodiments, the stacked configuration allows the gears to extend laterally beyond the motor of the pump. In some embodiments, as discussed elsewhere herein, the stacked configuration allows for a compact height (e.g., multiple gears to achieve a desired gear ratio do not require individual gears to have a large length of the pump).

[0174] In some embodiments, the gear stacking engages the lead screw, threaded insert, and drive nut to provide a telescopic arrangement of the drive nut and lead screw. In some embodiments, this also contributes to a compact design of the pump system. In some embodiments, the length of the drive nut and drug chamber (e.g., collectively shown as P(lP / C) in FIG. 2I) together constitute a majority (and / or substantially all) of the overall length P(l) of the pump. In some embodiments, the ratio of P(lP / C) to P(l) is equal to or at least about 5:6, 6:7, 7:8, 9:10, or a ratio ranging and / or including the aforementioned ratios.

[0175] In some embodiments, as disclosed elsewhere herein, the pump housing P1001 houses one or more of a printed circuit board (PCB) P1080, one or more lead screws P1152, P1154, a gear assembly P1070 comprising 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 receptacles P1100, P1101, a power source P1050, and an antenna P1200. The pump housing P1001 can also house various user settings, control schemes, and algorithms, as well as a memory such as firmware for storing specific instructions and / or settings related to various characteristics of the patient. For example, the memory can include instructions and / or settings related to when and how much to administer to the patient, and so forth. The Pump P1000 may be configured so that the memory can be modified (e.g., updated, programmed, or otherwise) by a patient or physician, such as by connecting the pump to a computer (e.g., a smartphone, laptop, etc.) equipped with software or "apps" configured to enable the computer and / or pump to perform any of the functions, tasks, and / or steps described and / or illustrated herein.

[0176] As shown in Figures 3A and 3B, the display screen P1007 can have a length P(dl) and a width P(dw). In some embodiments, as shown in Figures P1(Q) and P1(R), the area A(d) of the display screen P1007 (measured by multiplying the length P(dl) and the width P(dw)) constitutes a majority of the area A(f) of the face of the pump P1002 (measured by multiplying the length of the face P(fl) and the width of the face P(fl)) and / or substantially all of the face P1002 of the pump 1000. The area of ​​the face A(f) is shown in Figure 3B bounded by dashed lines, and the area of ​​the display A(d) is shown bounded by dotted lines. In some embodiments, the ratio of the area of ​​the display to the area of ​​the face is equal to or is at least about 4:5, 17:20, 9:10, 19:20, or ratios ranging and / or including the aforementioned values. In some embodiments, the ratio of the length to the width (e.g., aspect ratio) of the display is about 4:3, 25:16, 16:9, 21:9 or more, or ratios ranging and / or including the aforementioned values. In some embodiments, the ratio of the length to the width (e.g., aspect ratio) of the pump is equal to or is greater than the aspect ratio of the display. In some embodiments, the pump has a length to width ratio (e.g., aspect ratio) of about 4:3, 25:16, 16:9, 21:9 or more, or ratios ranging and / or including the foregoing values.

[0177] As shown in FIG. 3C and FIG. 3D, the pump housing can have one or more rounded corners when viewed from the bottom P1001b or the front P1001f. In some embodiments, these rounded corners provide a transition from the side of the pump to the underside of the pump. Also note that corners with a particular radius of curvature provide additional strength to the pump housing. This feature is particularly important when the pump has a large display (e.g., a display that constitutes a significant portion of the area of ​​the face of the pump) as disclosed elsewhere herein. 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 has a radius of curvature P(r) when viewed from the bottom of the pump. b (e.g., radius of curvature P(r) shown in FIG. 3C) as viewed from the front of the pump. f (e.g., the radius of curvature of P1001f shown in FIG. 3D). In some embodiments, P(r) b is P(r) f In some embodiments, the radius of curvature of the rounded corners as viewed from the bottom, P(r) b The ratio of the width P(w) of the pump to the width P(w) of the pump is equal to or at least about 1:9, 1:6, 1:4, or ranges including and / or spanning the aforementioned values. In some embodiments, the ratio of the rounded corners P(r) in front view is f The ratio of the radius of curvature of the pump to the height P(h) of the pump is equal to or at least about 1:2, 5:9, 2:3, or ranges including and / or spanning the foregoing values.

[0178] In some embodiments, as shown in FIG. 5A, the bottom P1001″b of the lower portion P1001″ of the pump housing P1001 in the embodiment of FIG. 1A has a radius of curvature P(r) that corresponds to a circle (shown in dashed line). fIn some embodiments, the bottom portion P1001″b is defined by a pump portion that is the lower half of the height P(h) of the pump 1000. In some embodiments, as shown in FIG. 5A, the bottom P2001″b of the lower portion P2001″ of the pump housing P2001 in the embodiment of FIG. 4A has multiple radii of curvature P(r) that correspond to the elliptical shape of the pump housing P2001, shown in dashed lines. fa , P(r) fb Note that increased housing strength is achieved by including an elliptical shape (similar to the embodiment of FIG. 4A) around the receptacle inlet port P2100'. In some embodiments, this increased housing strength advantageously protects the pump and its components from damage during an accidental drop (such as shattering or cracking the display).

[0179] In some variations, the increase in housing strength is achieved by a lower radius of curvature P(r) fb and higher radius of curvature P(r) fa In some embodiments, the lower radius of curvature P(r) is achieved using an elliptical shape characterized by fb has a higher radius of curvature P(r) fa In some embodiments, an increase in housing strength is realized when the radius of curvature P(r) is smaller than fb and higher radius of curvature P(r) fa to be equal to or at least about 1:2, 2:3, 4:5, 9:10, or ratios ranging and / or including the foregoing values. In some embodiments, the elliptical configuration adds housing material between the receptacle inlet port P2100' and the periphery of the pump P2001 (as indicated by the double arrow in FIG. 5A).

[0180] Capacitive Touch Sensor As disclosed elsewhere herein, FIG. 1A illustrates one embodiment of an ambulatory pump P1000. In some embodiments, the finger pad P1010 is a curved indentation that provides access to the wake function of the capacitive sensor. In some embodiments, the wake function is activated by touching a fingerprint recognition pad, a tactile sensor, and / or a curved indentation. The finger pad P1010 is activated by pressing a button provided by the indentation P1010. In some embodiments, a capacitance sensor of the finger pad P1010 may be located near the curved indentation so that it can sense a change in capacitance that occurs when a finger is placed in the curved indentation P1010. In some implementations, the surface of the curved indentation P1010 is closer to the internal electronics of the ambulatory medical device than the surface around the curved indentation (e.g., the lower surface P1005). The capacitance sensor may be located such that the capacitance sensor is activated only when the curved indentation P1010 is pressed or touched by the user. The curved indentation P1010 can be concave and / or shaped to fit a finger (or shaped to fit a different body part, such as a thumb), as shown in FIG. 1A.

[0181] As shown, the curved recess P1010 may be formed in the bezel P1001' of the pump P1000. One advantage of shaping the curved recess P1010 into the bezel P1001' is that the curved recess P1010 for the wake button does not add a water ingress point to the pump P1000. In some embodiments, as shown, the curved recess P1010 is located on the bottom P1005 of the pump 1000, but may be located on any other surface P1002, P1003, P1004, P1006', P1006'' of the pump 1000.

[0182] In some implementations, as described elsewhere herein, the pump can have various shapes. As shown in FIG. 1A, the pump can have a flat brick-like shape with six sides. When the curved recess P1010 is placed on the end faces P1004, P1005 or the side faces P1006′, P1006″ of the pump 1000, the curved recess P1010 does not occupy one of the larger faces P1002, P1003, leaving more space for a display screen and / or an inductive charging pad.

[0183] FIG. 5B includes a cross-sectional view of an embodiment of a pump P1000, P2000 cut by a plane passing through the length and height of the pump and through the width. As shown in FIG. 5B, the curved recess P1010, P2010 is bisected, and the electronics behind the curved recess P1010, P2010 are visible. In some embodiments, as shown in FIGS. 5B-6B, the capacitive sensor pad 1020, 2020 contacts at least a portion of an interior portion of the finger pad P1010, P2010 (e.g., the pump housing and the interior of the pump) through an intermediate material P1021. In some embodiments, a capacitive signal is received by the finger pad P1010, P2010 and transmitted to a substrate P1030, P2030, which is in electronic communication with the capacitive sensor pad P1020, P2020 and the PCB P1080, P2080.

[0184] In some embodiments, the capacitive sensor pads P1020, P2020 may be any conductive metal pads that provide a conductive path from the finger pads P1010, P2010 to the substrate P1030, P2030. In some embodiments, the capacitive sensor pads P1020, P2020 are copper pads. In some embodiments, the proximity of the capacitive sensor pads P1020, P2020 to the curved depressions of the finger pads P1010, P2010 allows the capacitive sensor pads P1020, P2020 to detect a change in capacitance caused by a user placing a finger on the curved depressions P1010, P2010. In some embodiments, the logic level of the capacitive signal is reversible.

[0185] In some embodiments, a conductive foam (e.g., an intermediate material) is disposed between the capacitive sensor pad P1020, P2020 and the curved depression P1010, P2010. One embodiment of the conductive foam P1021 is a foam and is shown in FIG. 6A. As shown, the conductive foam P1021 can be crushed or deformed between the curved depression P1010 and the capacitive touch pad P1020 to prevent the curved depression P1010 from collapsing or collapsing. 6B shows another view of the conductive foam sandwiched between the bezel and the substrate P1030. There are various conductive foam materials that can be placed between the capacitive sensor pad P1020, P2020 and the curved recess P1010, P2010. In some embodiments, the conductive foam material is a polyurethane foam coated with nickel and copper. In some embodiments, the foam is a sponge-like material. In some embodiments, when placed, the foam deforms and / or crushes to provide contact between the finger pad P1010, P2010 and the capacitive sensor pad P1020, P2020. The conductive foam can serve multiple purposes. In some embodiments, the conductive foam is configured to allow the capacitive sensor pad P1020, P2020 to be placed farther away from the curved recess P1010, P2010. In some embodiments, this feature creates more space tolerance within the device. In some variations, the conductive foam is configured to reduce the sensitivity of the capacitive sensor pads P1010, P2010 and / or to adjust the sensitivity of the capacitive sensor pads P1020, P2020.

[0186] In some variations, the capacitance signal is transmitted to the substrate P1030, P2030 via the capacitance sensor pad P1020, P2020. In some implementations, the substrate P1030, P2030 is configured to transmit the signal to the integrated circuit. In some embodiments, the integrated circuit has a programmable threshold configured to compare the change in capacitance. In some implementations, when the programmable threshold is met, the integrated circuit can transmit a signal corresponding to the programmable threshold being met to a signal processing component of the pump 1000, 2000. In some implementations, the signal processing component can be configured to generate a wake signal when the signal processing component receives a signal from the integrated circuit. The signal processing component can be further configured to generate a wake signal only when a certain programmable threshold is met by the integrated circuit.

[0187] In certain variations, as disclosed elsewhere herein, the curved recesses P1010, P2010 are shaped to fit a user's finger. The curved recesses P1010, P2010 can be shaped in various sizes to fit different sizes of fingers of different users. In some implementations, an increase in the surface area of ​​the curved recesses P1010, P2010 can serve the purpose of increasing the potential change in capacitance generated by the user's finger. Thus, in some embodiments, the recesses can be configured to interact with a generally adult finger size or a child's finger size. In some implementations, the curved recesses are configured to recognize a user's fingerprint. In certain implementations, fingerprint recognition can act as a safety feature, ensuring that only certain users are allowed to access certain functions of the pump (e.g., to set certain pump and / or control parameters) and / or activate the system.

[0188] In some embodiments, as disclosed elsewhere herein, the curved recess P1010, P2010 of the pump 1000, 2000 prevents inadvertent actuation of the ambulatory medical device by allowing only shapes conforming to the curved recess P1010, P2010 to press against the surface of the curved recess. In some embodiments, because the curved recess is relatively narrow, a user's appendage other than the user's finger, such as the user's arm or elbow, is unlikely to enter the curved recess (e.g., accidental actuation is prevented or minimized). In some embodiments, the concave shape of the curved recess P1010, P2010 can have dimensions that prevent inadvertent contact with the surface of the curved recess, since objects larger than the curved recess cannot enter the curved recess. In some embodiments, as described above, the curved recess P1010, P2010 can be configured to recognize a particular user by fingerprint. In some embodiments, fingerprint recognition can also prevent a user from inadvertently activating the system.

[0189] FIG. 6A is a diagram of a pump 1000 with a capacitance sensor wake button shown with a transparent bezel. The 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 is pressed into the bezel. The transparent bezel in FIG. 6A provides a view of the components below the bezel. A curved depression P1020 integrated into the bezel is also transparent in FIG. 6A. A user can press a finger into the curved depression to generate a wake signal in an ambulatory medical device (e.g., or in the pump). In some embodiments, the capacitance sensor pad P1020 can detect a change in capacitance generated by a user when the user's finger is pressed into the curved depression of the finger pad P1010. In some embodiments, the capacitance sensor pad P1020 is mounted on a substrate P1030. In some variations, the signal generated in the capacitance sensor pad is transmitted to the substrate and then to the integrated circuit. Several variations of integrated circuits configured to detect capacitance changes are commercially available. In some embodiments, the integrated circuit detects the change in capacitance of a signal sent to the integrated circuit in an ambulatory medical device (e.g., a pump). The integrated circuit can detect the change in capacitance by measuring a change in a measured voltage on the circuit.

[0190] In various embodiments, the conductive foam P1021 may be positioned on the capacitive sensor pad P1020. As described elsewhere herein, the conductive foam P1021 may effectively extend the range of the capacitive sensor pad P1020 by approximately the size of the conductive foam P1021. In some embodiments, the conductive foam P1021 may be used to reduce the sensitivity of the capacitive sensor pad P1020 and / or the conductive foam P1021 may be used to fine-tune the sensitivity of the capacitive sensor pad P1020.

[0191] 6C is a schematic diagram showing components of one embodiment of a capacitance sensor in a pump. The capacitance sensor can include one or more of a curved recess P1010, a conductive foam P1021, a metal conductor pad P1020, a substrate P1030, and an integrated circuit substrate P1035. In some embodiments, as shown, the curved recess P1010 can be a rounded depression in the surface of the pump's bezel. In some embodiments, the curved recess P1010 is integrated into the bezel such that the curved recess P1010 is seamless without any liquid ingress points. In some embodiments, the curved recess P1010 can be shaped to fit the tip of a user's finger when the user's finger is pressed into the curved recess.

[0192] In some embodiments, the conductive foam P1021 is located on the metal conductor pad P1020. In some implementations, the capacitance is measured at the metal conductor pad P1020. In some variations, the conductive foam P1021 is located on the metal conductor pad P1020, effectively extending the capacitance sensing range of the metal conductor pad P1020 to the length of the conductive foam P1021 extending from the metal conductor pad P1020. In some variations, the conductive foam P1021 can be used to reduce the sensitivity of the capacitance measured at the metal conductor pad P1020. In some embodiments, the conductive foam P1021 can be used to reduce the sensitivity of the capacitance measured at the metal conductor pad P1020, so that the sensitivity of the capacitance can be adjusted by adjusting the size of the conductive foam P1021. In some embodiments, the metal conductor pad P1020 may be made of and / or include a conductive metal, such as copper. In some embodiments, the conductive foam P1021 may be made of a foam material that is conductive. In some embodiments, the conductive foam is a polyurethane material coated with copper and / or nickel. In various embodiments, the conductive foam P1021 is surrounded by a conductive cloth. It is a polyurethane foam.

[0193] In some embodiments, the signal generated at the metal conductor pad P1020 is transmitted to the substrate P1030, as described elsewhere herein. In some variations, the substrate P1030 can connect the metal conductor pad P1020 to an integrated circuit P1035. In some variations, the integrated circuit P1035 can be configured to determine that the signal generated by the metal conductor pad P1020 represents a change in capacitance. The integrated circuit P1035 may detect the change in capacitance by measuring a change in voltage in a circuit connecting the integrated circuit P1025 to the metal conductor pad P1020 and the conductive foam P1021 through the substrate P1030.

[0194] FIG. 6D is a schematic diagram showing components of a pump 1000 with a capacitance sensor. The pump with a capacitance sensor includes a bezel P1001′ with a curved recess P1010, a conductive foam P1021, a metal conductor pad P1020, a secondary PCB substrate P1030, and a capacitance sensor P1020. In some embodiments, the bezel P1001′ partially covers the outside of the pump 1000. In some embodiments, the curved recess P1010 in the bezel P1001′ is where a user's finger can be pressed to generate a wake signal. As shown, in some embodiments, the conductive foam is located above the metal conductor pad. In some embodiments, a change in capacitance can be detected at the metal conductor pad. In some embodiments, the conductive foam can extend the range over which the capacitance can be measured at the metal conductor pad P1022 depending on the size of the conductive foam P1021. In some embodiments, the metal conductor pad P1022 detects a stronger change in capacitance by pressing a finger into the curved indentation P1010 when the conductive foam P1021 approaches close to the curved indentation P1010. Thus, in some embodiments, the distance from the bottom of the curved indentation P1011 is small, increasing the detectable change in capacitance. In some embodiments, the capacitance signal detected by the metal conductor pad P1022 may 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 may create computer-readable data of the capacitance measured at the metal conductor pad P1021 by measuring the change in voltage on the circuit passing through the metal conductor pad P1022. In some embodiments, the capacitance sensor P1020 may be programmed to transmit an activation signal at a variable level of capacitance.

[0195] FIG. 6E is a flow diagram of a process for preventing inadvertent therapy on an ambulatory infusion system (e.g., a system including an infusion pump described elsewhere herein and / or the pump itself). The pump includes a curved recess and a capacitance sensor. In step P0605, the pump can generate a wake signal after the capacitance sensor detects a user's contact in the curved recess of the medical device. The curved recess is a concave recess in the bezel of the ambulatory system. The user's finger can press into the curved recess to generate the wake signal. The capacitance sensor can detect a change in capacitance generated by the user's finger. When the capacitance sensor detects a change in capacitance, the ambulatory medical device can generate a wake signal. In step P0610, the pump can activate a touchscreen display after receiving the wake signal. In some embodiments, the touchscreen display can prompt the user to input a first gesture after the pump generates the wake signal. The first gesture can be a series of inputs that the user can input on the touchscreen display of the pump. In step P0615, the pump (and / or infusion system) may unlock the change therapy user interface after receiving a first gesture on the touchscreen display. In some embodiments, the first gesture is a series of inputs entered on the touchscreen display. Various embodiments In step P0620, the touchscreen display shows an alphanumeric pad where the user can enter a passkey. In step P0620, the pump can receive a request for a therapy change on the touchscreen display. The request for a therapy change may be made by the user selecting a therapy change. The therapy change may be for a variety of medications. In some embodiments, the therapy change is a hormone that the pump (and / or the infusion system) may deliver to the user. In step P0625, the pump (and / or another component of the infusion system) can receive a second gesture before delivering a medication based on the therapy change. The second gesture may be a series of inputs. In some embodiments, the second gesture includes detecting a change in capacitance due to the user pressing the curved indentation. Alternatively, in various embodiments, pressing the curved indentation after receiving a request for a therapy change and before the second gesture is received can cancel the therapy change and lock the ambulatory medical device.

[0196] FIG. 6F is another schematic diagram showing components of the pump P1000 with a capacitance sensor being activated by a user. In some embodiments, the user's finger can be pressed into the curved indentation P1010 to activate the ambulatory medical device (e.g., the pump and / or the infusion system of the infusion system). In some embodiments, the curved indentation P1010 portion of the bezel P1001′ has a larger surface area than the non-curved portion of the bezel P1001′. In some embodiments, the increased surface area of ​​the curved indentation P1010 results in a higher capacitance being detected when the user's finger is pressed into the curved indentation P1010. In some embodiments, the metal conductor pad P1022 can detect the finger capacitance when the user presses the curved indentation P1010. In some embodiments, the space requirements of the ambulatory medical device can prohibit the metal conductor pad P1022 from being placed close to the curved indentation P1010. In some embodiments, a conductive foam P1021 can be placed between the curved depression P1010 and the metal conductor pad P1022 to extend the capacitance measurement range of the metal conductor pad P1022. In some embodiments, the conductive foam P1021 can be a conductive foam material. In some embodiments, a 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 with a conductive cloth. In some embodiments, a capacitance signal initialized by a user pressing a finger into the curved depression P1010 is detected at the metal conductor pad P1022 and transmitted to the capacitance sensor P1020 via the PCB board P1030. The capacitance sensor P1020 can be programmed to transmit a wake-up signal upon detecting various capacitance measurements. In some embodiments, the capacitance sensor may be programmed to transmit a wake-up signal from a capacitance signal generated when the curved depression P1010 is substantially covered by human skin.

[0197] FIG. 6G is a diagram of the capacitive sensing pads P1020 on the PCB board P1030. In some embodiments, the capacitive sensing pads P1020 can be made of various conductive metal or metal alloy materials. In some embodiments, the capacitive sensing pads P1020 are copper. In some embodiments, the capacitive sensing pads P1020 can be connected through the bottom of the PCB board P1030 to an integrated circuit that can convert the capacitive signal into machine-readable data. In some embodiments, the capacitive sensing pads P1022 can detect a change in capacitance when the surface of a user's finger is pressed in close proximity to the surface of the capacitive sensing pad. The PCB board P1030 can have a square GND hatch P1024 surrounding the capacitive sensing pads P1020. In some embodiments, the GND hatch P1024 is a square pattern of copper on the PCB board P1030 that can act to isolate the capacitive sensing pads P1020 from other sensors and traces in the PCB board P1030.

[0198] In some embodiments, to prevent inadvertent activation of a therapy change (e.g., changing settings of a drug delivery schedule) of the pump, it is desirable to balance ease of use with complexity to avoid inadvertent activation. In some embodiments, the described subject matter prevents inadvertent activation of a therapy change by requiring a sequence of actuations. In some embodiments, the actuations must be combined in a specific order to activate the therapy change. In some embodiments, the pump includes a wake button (e.g., finger pad P1010) and a touch screen display (e.g., display screen P1007). In some embodiments, the wake button may be any type of button that registers a single input to generate a wake signal. One example of a wake button may be a capacitive button. Another example of a wake button is a mechanical button. In various embodiments, the wake signal is generated by a sensor. In some variations, the wake signal may be generated by a biometric sensor, such as a fingerprint reader or a retina scanner. The wake signal may also be generated by a proximity sensor. The wake signal may be generated by an accelerometer or a gyroscope, or a combination of an accelerometer and a gyroscope. The wake signal may also be generated by a light sensor. In various embodiments, the wake signal is generated by entering a passkey into an alphanumeric pad. In various embodiments, the wake signal is generated by the use of facial recognition. In various embodiments, the wake signal may be generated by a wireless signal, such as RFID and Bluetooth.

[0199] In some variations, a touch screen display may be any input surface that displays graphic images and text and registers the location of a contact on the input surface. The graphic images and text may be presented by any display technology, including but not limited to OLED, LCD, or e-ink. The contact may be registered by any type of technology. An example of a touch screen display that registers a contact is a capacitive display screen. Another example of a touch screen display that registers a contact is a resistive display screen.

[0200] In some embodiments, the wake button is a capacitive touch sensor. The capacitive touch sensor is disposed within a curved recess. In some embodiments, the curved recess is a convex recess that is unlikely to be accidentally pressed by touching the ambulatory medical device. The capacitive touch sensor may comprise a copper pad on a circuit board as close as possible to the surface that the finger contacts. The capacitance sensing control integrated circuit measures the capacitance of the copper pad by applying a voltage to the circuit. In some embodiments, when a finger is present, the finger adds capacitance to the circuit and the capacitance sensing control integrated circuit detects a change in voltage. The capacitance sensing control integrated circuit has a programmable threshold that is used to compare the change in capacitance and determine when a finger is present on the wake button. In some embodiments, the logic level of the capacitance signal is reversible and returns to a low capacitance measurement when the finger is removed from the wake button.

[0201] In some embodiments, to achieve high capacitance (maximum signal to noise) when a finger is placed on the capacitive touch sensor, the design includes scallops or curved indentations to reduce 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 a plastic housing or bezel. In some embodiments, the capacitive sensing surface is a copper pad. In some embodiments, the curved indentation also provides visual and tactile cues to guide the finger to the optimal position to add capacitance to the sensor. Also, to increase maximum signal to noise, the surface area of ​​the copper pad is maximized where it is positioned approximately parallel to the finger when the finger is pressed into the curved indentation. In some embodiments, to increase the maximum signal to noise, the circuit board with the copper pad is moved as close as possible to the curved indentation while maintaining the tolerances and mechanical requirements of the ambulatory medical device. In some embodiments, to increase the signal to noise, a conductive foam is added to the copper pad (as disclosed elsewhere herein), effectively raising the capacitive sensing surface of the copper pad closer to the curved indentation and finger location.

[0202] In some embodiments, pressing the wake button is sufficient to engage the display screen to change settings on the device. In other embodiments, a series of activations is required. In some embodiments, the series of activations begins by pressing the wake button for a set amount of time to unlock the medical device. In various embodiments, the wake 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 haptic feedback indicating that the wake button has been held for the required period.

[0203] In some embodiments, after the wake button is pressed (and / or, in some cases, held for the correct period of time), the touchscreen display is activated. In various embodiments, touches on the touchscreen display are not registered until the wake button unlocks the touchscreen display. In some embodiments, the touchscreen display remains locked from accepting user input until a gesture is performed on the display screen. In some embodiments, the gesture (e.g., a finger swipe, a series of swipes, touching a particular area of ​​the screen, etc.) unlocks the device settings.

[0204] In some embodiments, after the display is activated, the next actuation is a gesture (e.g., a complex gesture) to unlock the therapy change user interface. In some embodiments, the complex gesture may be any series of inputs on a touch screen display. One example of a complex gesture is a swipe. Another example of a complex gesture is inputting a predetermined series of touches (e.g., a combination of swipes, swipes to form shapes, pressing a code with alphanumeric characters, etc.). Once the therapy change user interface is unlocked with the correct complex gesture, a therapy change dialogue may be initiated using the touch screen display. In some embodiments, the therapy change dialogue allows the user to select a therapy change. In some embodiments, once the therapy change is selected, another final actuation may be performed to deliver the therapy change. In an exemplary embodiment, the final actuation is a second complex gesture. The second complex gesture may be a swipe, a predetermined series of touches, or any other series of touches on the touch screen display. In some embodiments, once the second complex gesture is successfully completed, the therapy change is realized.

[0205] In some embodiments, the initial or final wakeup is provided by a sensor. In some aspects, the initial or final wakeup is provided by a biometric sensor, such as a fingerprint or retina scanner. In another example, the initial or final wakeup is provided by a proximity sensor. In some embodiments, the initial or final wakeup is provided by an accelerometer, a gyroscope, or a combination of an accelerometer and a gyroscope. In some embodiments, the initial or final wakeup is provided by an optical sensor, such as a visible light sensor or an IR sensor. Also, in exemplary embodiments, the initial or final wakeup is provided by positive facial recognition. Also, in exemplary embodiments, the initial or final wakeup may be provided by entering a passkey on an alphanumeric keypad. Also, in exemplary embodiments, the initial or final wakeup may be provided by a wireless signal, such as RFID or Bluetooth.

[0206] In some embodiments, the pump and / or system may have a timeout where if no interaction occurs for a set period of time, the screen turns off and the therapy change request process must be restarted (e.g., to make a change). In some embodiments of the timeout, the touchscreen display is deactivated if no interaction occurs for 10, 15, 30 or more seconds after activation of the wake button and before the second gesture. In some embodiments, the touchscreen display is deactivated if no interaction occurs for more than 30 seconds after activation of the wake button and before the first gesture. In some embodiments, the touchscreen display is deactivated if no interaction occurs for more than 30 seconds after the first gesture and before the second gesture. Also, in some embodiments, pressing the wake button while the touchscreen display is activated deactivates the touchscreen display.

[0207] Pump housing bezel and antenna As described elsewhere herein, FIG. 1C provides a diagram of a pump that may be part of an ambulatory infusion system. In some embodiments, a portion of the housing (e.g., lower portion P1006′, etc.) may be metal, molded plastic, or other suitable material. In some embodiments, the metal housing forms an exterior portion or at least a portion of the exterior portion of the pump P1000 (e.g., 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 such that together they form a watertight seal (as disclosed elsewhere herein). In some embodiments, the bezel P1001′ is made of a plastic or non-metallic material, while in other embodiments, the bezel may be metal. In some embodiments, the bezel includes a curved recess 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 recess, a curved indentation, etc.) for accommodating a user's finger. In other embodiments, the finger pad is raised, convex, and / or flush with the surrounding bezel (also referred to as a traction pad, dimple, indentation, etc. that extends around the perimeter of the touchpad). In some embodiments, as disclosed elsewhere herein, the curved indentation P1010 can detect finger contact by sensing a change in capacitance using a capacitive sensor located on a circuit board below the bezel.

[0208] FIG. 7A is a diagram of another embodiment of pump P3000. As mentioned above, for brevity, not all features of each pump embodiment are mentioned, but any pump 1000, 2000, 3000 can have each feature described with respect to another pump embodiment (unless the feature is explicitly distinguished). Additionally, as mentioned above, it should be recognized that throughout this disclosure, similar and / or identical features for different embodiments of devices or system components (e.g., pumps, connectors, etc.) are not described for different embodiments, but are merely numerically offset in the drawings by thousands (although they share hundreds, tens, and ones digits). For example, features of receptacles P3100, P3110 of pump P3000 of FIG. 7A may be common to features of receptacles P1100, P1110 of pump P1000 of FIG. 1A (or vice versa), but features of pump P3000 of FIG. 7A may not be specifically detailed where they overlap. Similarly, features of the receptacles P3100, P3110 of the pump P3000 of FIG. 7A may be common to features of the receptacles P2100, P2110 of the pump P2000 of FIG. 4A (or vice versa), but the features of the pump P3000 of FIG. Where they overlap, they may not be specifically detailed. Additionally, even if certain features are not numerically indicated in the figures, they may still be present as apparent from the figures themselves.

[0209] As shown, the pump P3000 is provided with the display removed. The lower part P3001″ of the housing P3001 forms the exterior portion of the ambulatory medical device. The bezel P3001′ (which provides the top of the housing) is attached to the top of the lower part P3001″ of the housing. In some embodiments, the circuit board P1030 is attached inside the bezel P3001′. In some embodiments, the circuit board P3030 has a capacitive sensor that is aligned with a curved recess for capacitive contact, as disclosed elsewhere herein. In some variations, the circuit board P3030 is perpendicular to the metal housing on the underside of the housing and parallel to a portion of the bezel. The bezel may be made of a material that passes RF signals. The main board P3080 (e.g., the primary PCB board P1080) controls any functions of the infusion system that are not controlled by the circuit board P1030.

[0210] FIG. 7B is 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 upper bezel P3001′. As shown, in some embodiments, it comprises an antenna P3039. In some variations, the antenna P3039 is fixed to the secondary circuit board P3030 as shown. In some embodiments, the antenna P3039 transmits and receives wireless signals (e.g., radio frequency, Bluetooth, etc.). In some embodiments, the antenna P3029 is parallel to the bezel and / or extends along the length of a portion of the bezel to receive wireless signals. In some embodiments, the main board P3080 controls pump mechanisms that are not controlled by the secondary circuit board P3030. In some embodiments, the secondary circuit board P3030 can have a capacitive touch pad P3020 that can sense a change in capacitance when a user places a finger on a curved indentation for capacitive touch P3010.

[0211] FIG. 7C is an additional view of the pump (of FIG. 1A) with the bezel made transparent. In some variations, the lower part of the housing P1001″ forms at least the bottom and sides of the pump. The clear bezel P1001′ is attached to the top of the lower part of the housing P1001″. In some embodiments, the circuit board P1030 is parallel to the clear bezel and the lower part of the housing. In some embodiments, the antenna chip P1039 is attached to the circuit board P1030 that runs parallel to and in line with the capacitive sensor pad P1020 configured to receive input from the finger pad P1010. In some embodiments, the antenna chip P1039 is a protruding structure perpendicular to the bezel. In some embodiments, the antenna chip P1039 can send and receive wireless signals using Bluetooth, LTE, 3G, etc. In some embodiments, the signal generated by the pump is transmitted wirelessly to a user (e.g., a medical professional, a parent of a child, a patient / wearer of the device, etc.) interface, such as a phone or computer. In some embodiments, the lower portion of the housing is disposed below the antenna chip P1039 (e.g., the portion of the lower portion proximal and / or adjacent to the antenna chip terminates at a height lower than the height of the antenna chip). In some embodiments, the position of the antenna relative to the housing P1001″ substantially avoids, substantially prevents, and / or prevents interference with wireless signals. In some implementations, the metal portions of the housing do not intersect the signals to the antenna. In some variations, the antenna chip P1039 is parallel to the curved recess P1010. In some embodiments, the curved recess P1010 is above (at a higher height than) the capacitive touch pad P1020.

[0212] Figure 7D is a view of the pump with the bezel removed, revealing the bottom of the housing. As described elsewhere herein, in some embodiments, the bottom of the housing P1001″ is metal. In some variations, the metal housing P1001″ forms at least the bottom of the pump. The antenna P1039 is disposed above the metal housing and attached to the circuit board P1030. The antenna P1039 is above the metal housing P1001″ such that the antenna P1039 can transmit and receive wireless signals without interference. In some embodiments, the antenna P1039 can transmit and receive wireless signals using Bluetooth, LTE, or 3G. In some implementations, the capacitive touch pad P1020 is parallel to the antenna P1039.

[0213] In some embodiments, at least a portion of the sidewall of the pump is covered only by the bezel. In some embodiments, the circuit board is positioned adjacent to an inner surface of the bezel. In some embodiments, the wireless antenna is secured to the circuit board such that the wireless antenna is positioned toward a portion of the sidewall of the ambulatory medical device that is covered only by the bezel. In some embodiments, the conductive layer of the circuit board is detached from the portion of the circuit board secured to the wireless antenna. In some embodiments, the portion of the circuit board is positioned inside the portion of the sidewall of the ambulatory medical device that is covered only by the bezel. In some embodiments, the wireless antenna extends toward a portion of the side of the ambulatory medical device that is covered only by the bezel.

[0214] Error Detection System FIG. 7E is a diagram of a portion of the pump P3000. In some embodiments, the pumps P1000, P2000, P3000 disclosed herein include an error detection system. In some embodiments, the error detection system is configured to determine when a calculated drug dispense rate and / or amount (e.g., as indicated by the energy input to the motor) differs from an actual drug dispense rate or amount (calculated by the number of revolutions of the lead screw). FIG. 7E illustrates an embodiment of an 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 the delivery of drug from the pump. For example, in some embodiments, the sensor P3426 enables the pump to determine if the rotation of the lead screw P3430 is not synchronized (and / or is not properly calibrated) with the rotation of the motor P3060. In some embodiments, the pump includes more than one sensor and / or each drug dispense is monitored by a sensor. In some embodiments, for each motor, a sensor (e.g., a Hall sensor or 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, part of the gear assembly P3070 is an output gear P3074. In some embodiments, the output gear P3074 is fitted with a magnet P3425 that rotates on its coaxial axis. In some embodiments, a rotational position sensor P3426 detects the rotation of the magnet P3425 to determine the actual rotation of the lead screw P3430.

[0215] For example, the motor P3060 is controlled by the hole count and monitors itself. However, the lead screw extension dispenses the drug. The rotational position sensor P3426 provides an independent and accurate understanding of the exact 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 problems between the motor and the smallest screw (e.g., broken gears, etc.). For example, without this sensor system, if the gear train was binding, disconnected, etc., such a problem would not be registered. The encoder also provides real-time monitoring of the movement of the lead screw. In some embodiments, any delay between communication from the display (or elsewhere) to the motor can be recorded with a magnetic encoder.

[0216] In certain variations, the output gear P3074 rotates the output shaft P3430 (e.g., lead screw), which operates to deliver the medication to the user. In some embodiments, the magnet P3425 measures the angular position of the output gear P3074 by determining the angle of a magnet on the output gear P3074. In certain variations, the rotational position sensor P3426 is mounted on 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 some embodiments, the computer can determine that the output shaft P3430 is not rotating in sync with the motor P3060 and generate an error based on the determination. In some embodiments, the computer can also determine the amount of medication that the ambulatory medical device has infused to the user based on the data from the rotational position sensor P3426 and the sensor in the motor P3060. The computer can determine the amount of drug infused to the user by multiplying the number of rotations of the motor P3060 by a predetermined amount of drug per rotation of the motor P3060. The computer can also determine the amount of drug infused to the user by multiplying the number of rotations of the output shaft P3430 by a predetermined amount of drug per rotation of the output shaft. The number of rotations of the motor P3060 may be determined based on data from a sensor in the motor P3060. The number of rotations of the output shaft may be determined by data from the rotational position sensor P3426. In some embodiments, in response to the error determination, the computer can adjust the rotation of the motor pinion gear to provide a corrected dosing rate.

[0217] FIG. 7F provides a flow diagram of a process for determining that there is an error in the delivery of medication in a pump. In step P510, the pump may receive a rotational position of a motor in the ambulatory medical device by one or more sensors. The motor operates to deliver medication to a user. The sensor in the motor may be a Hall sensor that measures the number of rotations of the motor. In step P520, the ambulatory medical device may receive a rotational position of an output shaft by a rotational position sensor. In some embodiments, the output shaft is connected to the motor through a gear assembly. In some variations, the gear assembly may create a mechanical advantage in which the output shaft rotates at a slower speed than the motor. In step P530, the ambulatory medical device may determine that the motor and the output shaft are rotating in sync based on the mechanical advantage created by the gear assembly. In step P540, the pump may notify the user that the motor and the output shaft are not rotating in sync. In some embodiments, the pump may stop delivering medication to the user or may recalibrate to provide a correct distribution of medication. Alternatively, the pump may display an error to the user while the system continues to deliver medication to the user. In various embodiments, the pump can shut off the motor that caused the error and start a second motor in the ambulatory medical device. In some embodiments, if one type of drug is being delivered using both drug chambers and an error is recorded, the motor in the infusion line where the error occurred can be shut off in favor of the other motor (which did not experience an error).

[0218] FIG. 7G is a diagram of a portion of a pump illustrating an output shaft angular position error detection system. In some embodiments, as disclosed elsewhere herein, the pump may include a motor P3060, a gear P3071 attached to the motor, a gear assembly P3070, and a magnet (e.g., sheath, extendable shaft, etc.) attached to the output shaft P3430 assembly having a piston P3142. In certain implementations, the motor P3060 has a sensor that determines the number of rotations of the motor P3060. In some embodiments, the sensor is a Hall sensor. In some embodiments, the motor rotates a gear P3071 in the gear assembly P3070 and a fourth gear P3074 in the gear assembly P3074. In some embodiments, the gear assembly P3070 can create a mechanical advantage that acts to rotate the output shaft P3430 (e.g., lead screw) at a slower speed than the motor P3060. As the output shaft rotates, the drug is forced out of the drug cartridge and delivered to the user. In some embodiments, a magnet attached to the output shaft rotates the P3430 along with the output shaft. A rotational position sensor measures the angular position of the output shaft. Data from both the angular position of the output shaft and the number of rotations 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 in sync, it may generate an error. If the computer determines that the output shaft and the motor P3060 are not rotating in sync, it may take into account the mechanical advantage created by the gear assembly P3070. Data from the angular position of the output shaft can also be used to determine the amount of drug delivered to the user.

[0219] FIG. 7H is a diagram of a portion of a pump showing two drive nuts configured to engage 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 the first drug chamber P3100 interacts with another magnet on the drive nut. In some embodiments, a magnet for the second drug chamber P3110a interacts with a second rotation magnet. In some embodiments, the first drug cartridge may contain a drug that may be infused to a user. In some embodiments, the drug in the first drug cartridge is infused by the rotation of the first motor P3060a. Similarly, a drug may be contained in a second drug cartridge. In some embodiments, the drug in the second drug cartridge may be infused to a user by the rotation of the second motor P3060b.

[0220] In some embodiments, a cartridge slot of a housing of an ambulatory medical device can be shaped to prevent one or more drug cartridges from being inserted into the cartridge slot. For example, a first cartridge slot (e.g., a cartridge receptacle) in a housing of a pump can be shaped to prevent a second drug cartridge from being inserted into the first cartridge slot. The first cartridge slot of the housing can be shaped to receive a shape of an alignment protrusion of a first drug cartridge 2710 when the first drug cartridge is inserted into the housing. Similarly, a second cartridge slot of the housing can be shaped to receive a shape of an alignment protrusion of a second drug cartridge when the second drug cartridge is inserted into the housing.

[0221] 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 some embodiments, the sensor P3426a in the first motor can determine the rotational speed of the first motor P3060a. In some embodiments, the first rotational position sensor P3426a can determine the rotational speed of the first output shaft. In some embodiments, the computer can determine that the first motor P3060a and the first output shaft are not rotating synchronously based on data from the sensor in the first motor P3060a and data from the first rotational position sensor P3426a. In some embodiments, the computer can switch the operating motor of the ambulatory medical device from the first motor P3060a to the second motor P3060b based on the determination. For example, the computer may stop the first motor P3060a and start the second motor P3060b based on a determination that the first motor P3060a is not rotating synchronously with the first output shaft. The computer may determine that the second motor P3060b and the second output shaft are not rotating in sync based on data from sensors in the first motor P3060b and data from the second rotational position sensor P3426b. The computer may similarly stop the second motor P3060b and start the first motor P3060a based on determining that the second motor is not rotating in sync with the second output shaft.

[0222] O-rings and chambers Various embodiments include one or more boundary seal O-rings within the pump housing. In some embodiments, the O-ring arrangement seals the drug chamber from the interior of the pump. However, in some embodiments, the O-ring does not seal the cartridge receptacle from the environment outside the pump. Thus, in some embodiments, the interior area of ​​the cartridge receptacle can be at any external air pressure and / or equal to the outside of the pump. Meanwhile, the interior area of ​​the pump housing is sealed from the atmosphere (e.g., air-tight and / or water-tight) to prevent harmful contaminants from entering the pump. Some embodiments are designed to allow the drug cartridge to match the air pressure of the patient line and the infusion site.

[0223] The difference in air pressure between the infusion site (e.g., an area outside the pump) and that felt at the sealed drug cartridge within the infusion pump can result in under / over-delivery of medication. For example, in embodiments where the pump cartridge chamber is sealed from the external atmosphere within the pump, sealing of the cartridge chamber may occur at air pressure, which will ultimately differ from the air pressure of the external environment. If a patient seals the chamber in a high pressure environment and moves to a low pressure environment, a pressure difference can occur. In some embodiments, the pressure difference between the high chamber pressure and the low external pressure can cause additional medication to be dispensed from the cartridge as the pressure within the pump attempts to equalize with the external pressure. To illustrate, if a patient loads a cartridge into an infusion pump at sea level (where air pressure is high) and then boards an airplane traveling to a cruising altitude, the pressure within the cartridge chamber can become higher than the pressure outside the pump at altitude (causing runaway and / or uncontrolled administration of medication). Alternatively, if a patient seals the cartridge chamber in a lower pressure atmosphere (e.g., at a higher altitude, during a low pressure weather event, in an airplane, at sea level, in a mountain, etc.) and moves to a higher pressure atmosphere (e.g., below sea level, during a high pressure weather event, etc.), a partial vacuum may be created in the cartridge receptacle (and pump) that may prevent movement of the plunger in the medication cartridge, resulting in less medication than needed to be delivered.

[0224] These and other problems can be avoided by providing a pump in which the cartridge receptacle can equalize pressure to that outside the pump. As described elsewhere herein, some implementations provide a water-resistant or waterproof infusion pump (and / or infusion system). Thus, in some embodiments, the cartridge chamber and drug cartridge itself are not necessarily sealed from the environment (and / or can be pressure-balanced with the external environment), and the cartridge chamber within the infusion pump may allow air and water to pass freely around the drug cartridge, so that the drug cartridge chamber and drug cartridge can be made air-tight and / or water-tight (or impervious or substantially impervious to environmental influences).

[0225] In some embodiments, the drug cartridge chamber may be substantially sealed from water ingress (e.g., with a sealing mechanism that prevents water from penetrating into the cartridge area), but may still allow air or gas to move through the seal to equalize the pressure differential between the injection site and the drug cartridge. In certain embodiments, the seal may be water-tight but not air-tight. In some embodiments, the seal is sufficiently sealed such that the surface tension of water prevents its ingress, but not enough to prevent the ingress (or egress) of air (or other gases). To provide a small aperture between the cartridge connectors.

[0226] In some embodiments, the quality of the seal between the drug chamber and the internal area of ​​the pump is characterized by an IP code (or Ingress Protection Code of IEC standard 60529, sometimes interpreted as the International Protection Code). The IP code classifies and rates the degree of protection provided by the mechanical casing against ingress, dust, accidental contact, and water. The IP code is two digits, one providing a measure of solid particle barrier protection and the other a measure of liquid barrier protection. The first digit following the "IP" in the IP code indicates solid particle protection and the second indicates liquid barrier protection. Thus, an IP code of IP34 has a solid particle protection level of 3 and a liquid ingress protection of 4. For solid particles, a level of 4 provides a seal against most wires, thin threads, large doves, etc. A level of 5 indicates that dust ingress is not completely prevented, but should not enter in sufficient quantities to interfere with satisfactory operation of the device. A level of 6 indicates no dust ingress, i.e. complete protection against contact (dust-proof). A vacuum must be applied. Test period up to 8 hours based on air flow. For liquids, a level of 1 indicates that dripping water (drops falling vertically) has no detrimental effect on the specimen when mounted in an upright position on a turntable and rotated at 1 RPM. A level of 2 indicates that vertically falling water has no detrimental effect when the enclosure is tilted at an angle of 15° from its normal position. A total of four positions in the two axes are tested. A level of 3 indicates that water falling as a spray at any angle up to 60° from vertical has no detrimental effect, utilizing either a) a vibration fixture, or b) a spray nozzle with a counterbalanced shield (Test "a" is performed for 5 minutes, then repeated with the specimen rotated 90° horizontally for a second 5 minute test. Test "b" is performed for a minimum of 5 minutes (with the shield in place). A level of 4 indicates that there is no detrimental effect when water is splashed on the enclosure from any direction, utilizing either a) a vibration fixture, or b) a spray nozzle without a shield. Test a) is performed for 10 minutes and b) is performed for a minimum of 5 minutes (without shielding).Level 5 indicates that water sprayed from a nozzle (6.3 mm (0.25 in)) against the enclosure from any direction will have no harmful effects. Level 6 indicates that water sprayed in a powerful jet (12.5 mm (0.49 in)) against the enclosure from any direction will have no harmful effects. Level 7 indicates that harmful amounts of water cannot enter the enclosure when the enclosure is immersed in water (up to 1 meter (3 ft 3 in) of submersion) under specified conditions of pressure and time. Level 8 indicates that the equipment is suitable for continuous immersion in water under conditions (depth of 1 meter (3 ft 3 in) or more). Level 9 indicates protection against powerful hot water jets.

[0227] 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 ranges ranging and / or including the aforementioned values. For example, the IP number for solid particle protection may be in the range of 4-6. 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 ranges ranging and / or including the aforementioned values. For example, the IP number for liquid ingress protection may be in the range of 2-6, 4-8, 3-9, etc. Additionally, the IP code may be IP42-IP69, etc.

[0228] As disclosed elsewhere herein, some embodiments provide an infusion pump with an outer periphery defined by a pump face P1002, a backing P1003, a lower side P1005, an upper side P1004, a first side P1006', and a second side P1006'' (shown in FIGS. 1A-1D). In some embodiments, this periphery is defined by a pump housing. In some embodiments, the pump comprises a bore, the bore having a first end and a second end, configured to receive a first drug cartridge. In some embodiments, the first end of the first bore defines an opening in the pump housing (e.g., a receptacle inlet port). In some embodiments, a sidewall of the bore (e.g., a sidewall of the cartridge chamber) extends longitudinally and to the second end of the bore inside the housing. In some embodiments, the second end of the bore is disposed within a periphery of the pump. In some embodiments, a drive nut (e.g., an elongated shaft, a piston shaft, etc.) is disposed at least partially within the bore and configured to engage and / or contact the first drug cartridge when the first drug cartridge is inserted into the first cartridge chamber, as disclosed elsewhere herein. In some embodiments, the second end of the bore is an opening configured to receive an end of the drive nut. In some embodiments, to dispense medicament from the pump, the drive nut extends into the bore through the second end of the bore and moves longitudinally toward the first end of the bore, whereupon the piston urges the plunger of the first medicament cartridge forward, thereby dispensing medicament into the cartridge.

[0229] In certain implementations, as disclosed elsewhere herein, an O-ring is circumferentially disposed around the piston to provide a barrier and / or seal between an interior region of the pump and an external environment outside the pump. In some embodiments, an O-ring seating saddle defines a bottom wall of the cartridge chamber at the second end of the bore. In some embodiments, the O-ring is positioned adjacent the second end of the first bore, but outside the bore. In some embodiments, as disclosed elsewhere herein, the drive nut is configured to extend into the bore via rotation of the lead screw of the pump. In some embodiments, when the lead screw rotates in one direction, the drive nut extends along the bore into the cartridge chamber. When the lead screw rotates in the opposite direction, the drive nut retracts along the bore from the cartridge chamber. The O-ring may be fixed during movement of the drive nut in a position adjacent the second end of the bore.

[0230] In some embodiments, the pump also comprises a second bore having a first end and a second end. In some embodiments, the second bore shares one or more or all of the features of the first bore, but the second bore is configured to dispense a medicament from a second cartridge. For example, the second bore may be configured to receive a second medicament cartridge. In some embodiments, the second bore is configured to receive a second drive nut. In some embodiments, the interior region of the pump is sealed from the exterior region of the pump by a second O-ring that forms a barrier that prevents water and debris from entering the interior space of the pump. If an additional medicament chamber is provided, the additional O-ring and drive nut may be provided in a manner similar to that disclosed above.

[0231] In some embodiments, the O-ring may be configured to allow for the movement of water or air around the drug cartridge as disclosed herein. In some embodiments, the O-ring is configured to allow for pressure differential equalization between the infusion site and the drug cartridge. In some embodiments, the O-ring exerts pressure on the elongated shaft when the O-ring is circumferentially disposed on the elongated shaft. In some embodiments, a lubricant is provided to lubricate between 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 differential between the ambient pressure and an interior space of the housing. In some embodiments, the O-ring is configured to maintain a pressure differential between an interior space of the housing and an interior of the bore. In some embodiments, the bore is exposed to ambient pressure and configured to equalize with ambient pressure. In some embodiments, the bore is exposed to ambient pressure and configured to equalize with ambient pressure around the drug cartridge. In some embodiments, the O-ring is configured to maintain a pressure differential between the elongated shaft and the interior space of the housing. The housing is a compression fit over the lid and is configured to create a barrier against water and air ingress into the interior space of the housing.

[0232] As described elsewhere herein, the infusion pump device comprises a housing for the various components. The housing can take essentially any shape suitable for incorporating components for receiving a drug cartridge and dispensing a drug from the cartridge. FIG. 7J shows the housing's upper portion P3001′ (e.g., with the bezel and display P3007 removed). The interior of the pump P3008 may be designed to hold or receive certain components. In the example shown in FIG. 7J, the pump has an interior space P3008, as well as opposing top and bottom ends (e.g., lower side P3005) that form part of the upper side P3004.

[0233] The infusion pump device of the exemplary embodiment may have one or more bores configured to receive a drug cartridge. Generally, the bores are cylindrical, but may have any shape or modified features, such as grooves or slots, for receiving features of the drug cartridge as well as other components of the device. FIG. 7J shows the device having first and second bores P3106 and P3116, respectively. Each bore has a first end (P3126, P3128) and a second end (not shown), the first end defining an opening into the aforementioned housing, and the second end disposed within the interior space of the housing. The first opening is disposed at the first end P3126 and P3128 of each bore P3122 and P3124, respectively. Each bore has a longitudinal axis P3130 along which other components translate (as will be further described below).

[0234] As shown in FIG. 7K, an O-ring (not shown) may be received by O-ring slots P3132 and P3134 (e.g., saddle, frame, etc.) located adjacent the second ends P3127 and P3129 of the bore, respectively. In general, the slots may be of any shape that allows for the O-ring to be secured and form a seal. For example, the slots may be cylindrical and may include a boundary that prevents the O-ring from moving as the elongated shaft moves longitudinally within the bore. In some embodiments, the slots P3132 and P3134 may have raised surfaces P3131, P3133 on either side of the O-ring to secure the O-ring.

[0235] As shown in 7L, in some embodiments, the elongated shafts P3142 and P3144 disposed within the bores (not shown) can be driven by a motor P3060 and gears of a gear assembly P3070 to translate longitudinally within the bores. The motors may be powered by a battery P3050. In an exemplary embodiment, each elongated shaft comprises a lead screw that engages with a drive nut (described further below) that engages with a drug cartridge (not shown). Additionally, as shown, one elongated shaft can further comprise a recognition portion P3146 (e.g., threads, nubs, apertures, slots, etc.) or another end feature for identifying a matching drug cartridge. This feature advantageously allows a user to determine which bore holds a particular drug cartridge when different cartridges (e.g., glucagon and insulin) are placed simultaneously within the device. Also shown is an O-ring P3150 disposed circumferentially on each elongated shaft.

[0236] In some embodiments, the O-ring can be formed from any material suitable for achieving a seal and can have different shapes or thicknesses. In an exemplary embodiment, the O-ring for the elongate shaft comprises a polymeric material. In some embodiments, the O-ring is made of synthetic rubber, thermoplastic, or a combination thereof. In some embodiments, the synthetic rubber is butadiene rubber (BR), butyl rubber (IIR), chlorosulfonated polyethylene rubber (PB), or a combination thereof. (CSM), epichlorohydrin rubber (ECH, ECO), ethylene propylene diene monomer (EPDM), ethylene propylene rubber (EPR), fluoroelastomer (FKM), nitrile rubber, perfluoroelastomer (FFKM), polyacrylate rubber (ACM), polychloroprene (neoprene) (CR), polyisoprene (IR), polysulfide rubber (PSR), polytetrafluoroethylene (PTFE), sanifluor (FEPM), silicone rubber, and / or styrene-butadiene rubber. In some embodiments, the thermoplastic resin comprises or consists of one or more of polyesters such as thermoplastic elastomers (TPE) styrenics, thermoplastic polyolefins (TPO) LDPE, HDPE, LLDPE, ULDPE thermoplastic polyurethanes (TPU) polyethers, thermoplastic ether sterlastomers (TEEE) copolyesters, thermoplastic polyamides (PEBA) polyamides, melt processable rubbers (MPRs), and / or thermoplastic vulcanizates (TPVs).

[0237] Additionally, the O-rings can be of different sizes, as exemplified by 7N. In some embodiments, the different sized O-rings engage with different sized drive nuts configured to engage with different sized drug cartridges (e.g., cartridges having different circumferences). Additionally, the O-rings can be compression fitted onto the elongated shaft to create a barrier against water and air intrusion into the interior space of the housing. There are variations in cross-sectional designs other than circular for the seal. In some embodiments, the cross-section of the O-ring is an X-shaped profile, a square profile, or a circle. In some embodiments, square (or rectangular shaped O-rings) are used such that when compressed during installation, they seal with multiple (1, 2, 3, or 4) contact surfaces (e.g., one on each side of the saddle, and two small contact surfaces at the top and bottom).

[0238] As shown in FIG. 7M, in some embodiments, the O-ring P3150 is near the first ends P3157 and P3159 of the two elongated shafts P3142 and P3144 when the shafts are fully retracted into the pump and are opposite the second ends P3156 and P3158, respectively. In some embodiments, as shown in FIG. 7O, the elongated shafts P3142 and P3144 each include a lead screw P3152, P3154 that threadably engages with the drive nut P3142, P3144 and / or the treaded insert P3172, P3174. In some embodiments, the drive nut acts as a lead screw nut for the lead screw. In some embodiments, the lead screw P3152, P3154 engages with the drive nut P3142, P3144 via a threaded insert P3172, P3174 shown in FIG. 7N. The piston assembly P3040 of the second piston P3144 is shown. In some embodiments, the motor P3160a, P3160b drives a gear P3070 that engages the lead screw P3154, as shown in 7M, 7N, and 7P. In some embodiments, the movement of the lead screw P3152, P3154 transfers rotational energy to the threaded insert P3172, P3174. In some embodiments, the threaded insert P3172, P3174 is secured within the drive nut P3142, P3144, and as the lead screw P3152, P3154 rotates, the threaded insert P3172, P3174 creeps longitudinally along the lead screw P3152, P154, causing the drive nut P3142, P3144 to extend longitudinally into the drug chamber toward a first end (not shown) of the bore. In some embodiments, the engagement between the drive nut and the threaded insert is fixed together (e.g., the threaded insert is ultrasonically welded, glued, or otherwise fixed within the drive nut), as described elsewhere herein. In some embodiments, when the drive nut P3142, P3144 is biased forward or rearward, rotational movement of the lead screw P3152, P3154 relative to the threaded insert P3174 does not rotate the drive nut P3144.For example, as shown in FIG. 7M, in some embodiments, the first and second drive nuts P3142, P3144, respectively, prevent rotation of the drive nuts P3142, P3144. The drive nut P3142, P3144 has first and second tongues P3427a, P3427b that seat within first and second grooves P3428a, 3428b (e.g., tracks) that seat the drive nut P3142, P3144 in a bore that is circumferentially fixed in position on the lead screw nut P3172 portion of the elongate shaft during drug delivery. In some embodiments, the lack of rotation about the drive nut P3142, P3144 reduces rotational friction between the drive nut P3142, P3144 and the O-ring and / or drug cartridge plunger.

[0239] In some embodiments, the protrusion P3427a of the first drive nut may be shaped differently from the protrusion P3427b of the second drug drive nut. In some variations, the first and second grooves P3428a, 3428b (e.g., tracks) may be shaped differently from each other and configured to engage with the first and second protrusions P3427a, P3427b of the first and second drive nuts P3142, P3144, respectively. In some variations, the first and second grooves P3428a, 3428b (e.g., tracks) may be configured not to engage with the second and first protrusions P3427a, P3427b, respectively.

[0240] In an exemplary embodiment, the O-ring seal applies pressure to the elongated shaft when the O-ring is circumferentially disposed 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.

[0241] A non-limiting example of an embodiment is provided in 7Q. As shown, the housing bottom 1 mates with the housing top 18, which includes the display. A back cover 5 is included to completely encase the housing. A battery 9 powers the PCBA main board and the vibrator 12. O-rings 8 are disposed 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 a glucagon cartridge and the other piston 3 engages with an insulin cartridge. A drive train assembly 15 and spur gear 10 act to mechanically actuate the elongated shaft.

[0242] The features of the exemplary embodiments described in this disclosure provide various advantages. First, an O-ring seal around the elongate shaft forms a barrier against water and debris entering the interior space of the housing, preventing interference with the mechanical action of the pump and potentially avoiding dispensing an incorrect amount of medication.

[0243] Additionally, the location of the O-ring near the second end of the elongate shaft allows for the movement of water or air around the cartridge, thereby equalizing the pressure differential between the injection site and the drug cartridge.

[0244] Yet another advantage of the exemplary embodiment is that the infusion pump does not utilize an O-ring to seal the interface between the infusion set and the top of the medication cartridge. Specifically, the O-ring is not located adjacent to an opening in the pump housing. This allows for a design that does not require a hydrophobic filter, which can clog and thereby affect the pressure within the pump housing. Additionally, a permanently installed hydrophobic filter may not last the entire warranty period of the device, which adds filters and complexity to a disposable device, increasing the cost and complexity of the disposable device.

[0245] The use of O-rings as described can result in the pump device being configured to maintain a pressure differential between the ambient pressure and the interior of the housing. , 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 exposed to ambient pressure and configured to equalize the ambient pressure around the drug cartridge. Thus, no seal is required at the first opening of the bore. Additionally, the wiping action of the O-ring against the lead screw nut prevents water and dust from entering the enclosure, providing a durable seal.

[0246] Other designs may include the feature of using an O-ring to seal against the disposable cartridge or connector to seal the pump surface to a flat surface on the disposable. One drawback of the aforementioned design is that the O-ring sealing surface is exposed to the environment during set-up changes, which can cause the O-ring to fail to provide a proper IPX seal for the device due to contamination accumulating on the O-ring sealing surface. This can result in poor sealing and water and fluid ingress into the drug cartridge. The advantage of choosing not to include an IPX seal boundary allows for the removal of the hydrophobic filter mechanism since it is no longer required. Water and air are free to move around the cartridge to equalize pressure. The O-ring seal thus provides an IPX seal to the device and prevents water and dirt from entering the electronic and motor / gear train enclosures. The O-ring application 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 against the lead screw nut prevents water and dirt from entering the enclosure and provides a durable seal.

[0247] As disclosed elsewhere herein, in alternative embodiments, a seal is provided between the cartridge connector and the pump (e.g., by an O-ring, polymeric sealing mechanism, etc.) to seal the cartridge chamber from the external environment. In such embodiments, a pressure differential may be created between the cartridge chamber and the external environment. In some embodiments, the seal between the cartridge chamber and the external atmosphere (outside the pump) is characterized by a solid particle protection IP code number greater than, or at least, 4, 5, 6, or a range extending to and / or including the aforementioned values. For example, the IP number for solid particle protection may be in the range of 4-6. In some embodiments, the seal between the cartridge chamber and the external atmosphere 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 extending to and / or including the aforementioned values. For example, the IP number for liquid ingress protection may be in the range of 2-7, 5-8, 4-9, etc.

[0248] Some embodiments relate to a method including implementing a seal between an interface of a drug cartridge receiving chamber and a drug cartridge, the drug cartridge receiving chamber configured to mate with the drug cartridge in an abutting relationship. In some embodiments, an O-ring is disposed adjacent a first end of the elongated shaft opposite a second end of the elongated shaft and engages a lead screw of the elongated shaft connected to a lead screw nut. In some embodiments, a gear engaging the lead screw is driven to translate the lead screw nut longitudinally toward the first end of the elongated shaft during drug delivery. In some embodiments, the O-ring is circumferentially disposed on the lead screw nut while remaining fixed within the drug cartridge receiving chamber. In some embodiments, the O-ring exerts pressure on the elongated shaft when the O-ring is circumferentially disposed 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 drug cartridge is a glucagon cartridge. In some embodiments, the drug cartridge is an insulin cartridge. In some embodiments, the drive train assembly and the spur gear act to mechanically actuate the elongated shaft. In some embodiments, the O-ring helps maintain a pressure differential between the ambient pressure and the interior of the drug cartridge receiving chamber. In some embodiments, the O-ring comprises a polymer material.

[0249] Vacuum prevents lift-off Drug vials with plungers are typically designed to have little or no resistance and / or friction between the plunger and the walls of the reservoir. Thus, the plunger can move and dispense the drug with little force applied to the plunger (e.g., by moving the cartridge, even lifting the pump with the cartridge, etc.). This undesired dispensing is caused by the plunger lifting the drive nut of the pump. In some embodiments, the configurations described herein avoid the problem of low friction plungers and / or lift-off. In some embodiments, to avoid lift-off, a vacuum is created in the delivery chamber sufficient to restrain the plunger under free-flowing 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 cartridge connector and the outside environment. In some embodiments, this creates a sealed chamber that contains the exposed portion of the lead screw, the cartridge, the plunger, and the drug. When the lead screw is advanced to dispense, a portion of the lead screw is exposed in the chamber, the plunger moves, and the drug moves from the chamber. Because the lead screw is smaller than the plunger, there is a net reduction in the volume of material in the enclosed chamber, reducing the air pressure relative to the ambient air pressure, which creates a force on the plunger that resists a free-flowing condition.

[0250] 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 ensure there is sufficient negative pressure after prime, taking into account the total amount of air in the chamber, the relative sizes of the lead screw and plunger, and the amount of liquid expelled during prime. In some embodiments, the pressure continues to decrease throughout delivery, and the force from the drive mechanism increases to overcome it. In some embodiments, the system is designed to ensure that the negative pressure generated is within the ability of the drive system to overcome. In an alternative embodiment, a check valve can be added to allow air to enter the chamber only if the pressure exceeds a negative limit.

[0251] Docking Station As described elsewhere herein, in some embodiments, an inductively rechargeable battery is provided. In some embodiments, the pump 1000 includes an inductive charging pad P1003' (shown in FIG. 1E) configured to allow charging of the inductively rechargeable battery P1050. In some embodiments, the pump battery is not replaceable. In some embodiments, the pump is charged using an inductive charging pad / cradle and a USB cable (as shown in FIG. 8). In some embodiments, the cradle is magnetized to hold the pump in place. In some embodiments, the cradle includes a guiding mechanism to help guide the pump into place, as shown.

[0252] In some embodiments, to recharge the pump, one or more of the following steps may 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 touch screen and charging pad indicate that the pump is charging; and charging the pump with the provided charging pad and cable.

[0253] In some embodiments, when placed on the charger, the touch screen turns on and lights up. In some embodiments, the touch screen displays the charging status and / or indicates that the pump is charging. In some embodiments, the light on the charging pad is continuously lit when charging and flashes when it detects the presence of the pump but is not charging. In some embodiments, the pump is not charging when the charging pad is flashing, indicating that it is not fully charged. In some embodiments, if the pump is not charging, the user can ensure that the pump is properly aligned on the charging pad. In some embodiments, a depleted battery is configured to recharge in approximately 2 hours, 4 hours, or ranges including and / or including the foregoing values.

[0254] In some embodiments, it may be beneficial to minimize the amount of time that the pump is unpowered. In some embodiments, if the pump is unpowered, it will not administer insulin or provide continuous glucose monitoring CGM values ​​to the user. In some embodiments, the sleep / wake button will not turn the screen on or off when the pump is powered off.

[0255] In some embodiments, for optimal battery life, it is recommended to recharge the batter daily, regardless of how the battery level is reported on the screen. In some embodiments, a fully charged battery can operate for several days for a typical user, depending especially on the amount of backlight usage and the amount of insulin delivered. In some embodiments, the user should monitor the battery charge level and alarms to determine the user's typical battery life. In some embodiments, the user should recharge the pump according to typical usage.

[0256] In some embodiments, the system includes a wireless charging interface that complies with the Qi standard, hi some embodiments, the wireless charging includes Rezence (from the AirFuel Alliance) and Open Dots (from the Open Dots Alliance).

[0257] Particular embodiments may include the following features: [Table 1] [Table 2]

[0258] Cartridge Connector As disclosed elsewhere herein, some embodiments relate to one or more cartridge connectors and / or cartridge connector sets (including cartridge connectors). In some embodiments, the cartridge connector(s) (or cartridges) In some implementations, the cartridge connector (or cartridge connector set) is part of a lumen assembly (e.g., a multi-channel lumen assembly), as disclosed elsewhere herein. In some implementations, the cartridge connector (or cartridge connector set) is part of an ambulatory infusion system, as disclosed elsewhere herein. In some embodiments, an infusion system is provided that includes a cartridge connector set. In some embodiments, the connector set comprises a single cartridge connector. In some embodiments, the connector set comprises two, three, four, or more cartridge connectors, which may be the same or different. In some embodiments, the cartridge connector set comprises a fluid conduit attached to the cartridge connector. In some embodiments, the cartridge connector set further comprises an infusion connector that connects to an infusion set (which includes an instrument, such as a needle, configured to inject one or more medications into a subject).

[0259] FIG. 9A illustrates a cartridge connector set C1000 configured to engage with the pump P1000 of FIG. 1A. In some embodiments, as shown in FIG. 9A and FIG. 9B, the cartridge connector C1001, C1101 comprises a body C1002, C1102. In some embodiments, the body C1002, C1102 comprises a piercing element C1003, C1103 (e.g., a needle). In some embodiments, the piercing element is configured to pierce a septum of the drug cartridge and / or receive a drug from the drug cartridge (e.g., when the cartridge is inserted into the connector). In some embodiments, the cartridge connector C1001, C1101 comprises a lower surface portion C1004, C1104 extending circumferentially from the needle C1003, C1103 to a skirt C1005, C1105 of the connector (e.g., an axially extending sidewall, shroud, etc.). In some embodiments, the shroud extends axially away from the lower surface portion.In some embodiments, the shroud is configured to receive and fit a portion of the drug cartridge.

[0260] In some embodiments, the lower surface portion C1004, C1104 is disposed within the shroud C1005, C1105 and configured to contact the cap of the drug cartridge when the drug cartridge is inserted into the cartridge connector (e.g., within the shroud). In some embodiments, the needle C1003, C1103 extends axially from the lower surface portion C1004, C1104 within the shroud C1005, C1105 as shown. In some embodiments, the needle does not extend through the shroud. Figures 9A and 10A provide views of the cartridge connector shroud and skirt ring at the bottom of the shroud (e.g., distal from the lower surface portion C1004, C1104 of the connector).

[0261] In some embodiments, the shroud C1005, C1105 comprises a distal end away from the underside portion C1004, C1104 of the connector C1001, C1101. In some embodiments, the distal end of the shroud C1005a, C1105a, shown highlighted as shown, is unbroken (e.g., no space, gap, is a ring) and extends circumferentially around the axis of the connector C1001A, C1101A (shown in FIG. 9A). In some variations, the shroud forms a continuous ring around the bottom of the cartridge connector. In some embodiments, the needle is recessed into the connector above the shroud, as shown. In some embodiments, the unbroken end of the shroud aids in proper placement of the drug cartridge into the connector C1001, C1101. For example, if the shroud breaks (not shown), the cartridge can be more easily inserted into the connector at an angle. If inserted at an angle and the drug cartridge does not move along the axis of the cartridge connector, the piercing element of the cartridge may pierce the septum at an off-center location. If the cartridge is then inserted to the point where it abuts the lower surface C1004, C1104, the cap of the vial will be flush with the lower surface C1004, C1104, tearing and / or creating a gap in the septum through which the drug may be released. In some embodiments, the skirt ring is not damaged and the needle is inserted into the cartridge connector before it penetrates the cartridge seal. The connector shroud is configured to ensure that the connector shroud is perpendicular to the cartridge. In some embodiments, it has been shown that non-perpendicular needle penetration causes leakage at the seal. Additionally or alternatively, in some embodiments, the connector C1001, C1101 can include a bowl-shaped or concave surface C1004a, C1104a on or within the lower surface C1004, C1104. As shown in FIG. 9D, the concave surface C1004a, C1104a can provide a portion of the lower surface C1004, C1104, and the remaining portion of the lower surface C1004, C1104 can include a lip C1004b, C1104b (e.g., configured to contact and / or abut the cap of a suitable drug cartridge). In some embodiments, unlike connectors lacking a bowl feature, this bowl feature distances the bend and / or bend point of the needle from the septum. In some embodiments, this small distance from the septum allows the piercing element to flex so as to accommodate the incoming drug vial without tearing or distorting the hole that the needle makes in the septum.

[0262] In some embodiments, the connector C1001, C1101 comprises a knob C1006, C1106. In some embodiments, as shown in FIG. 1A and FIG. 9A, the knob may be irregularly shaped (e.g., partially oval with a flat portion, etc.), and when inserted into the pump P1000, a portion of the knob hangs over the pump to provide a lip that gives tactile feedback that the knob is not positioned correctly 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 aligns such that the lip is no longer present and the knob aligns with the pump (as shown in FIG. 1A). In some implementations, the knob C1006, C1106 is in the shape of a cam and has a flat portion C1006′, C1106′.

[0263] In some implementations, the knob C1006, C1106 comprises a ribbed portion C1006″, C1106″ (e.g., ridges, finger retainers, wings, etc.). In some embodiments, the ribs provide a handle that allows the cap to be more easily manipulated between the fingers. In some embodiments, the knob is a protrusion or ridge. In some embodiments, the knob allows the user to easily grip the cartridge connector between the fingers of the thumb to facilitate placement in the pump chamber and to facilitate locking in the chamber. In some embodiments, the cartridge is locked and / or secured in the pump chamber by providing a quarter turn 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, detents and / or lugs provide tactile feedback when the connection is made. In some embodiments, shallow cams in the pump chamber are provided for detent when rotating to the connected position to keep the connection force low. In some embodiments, steep cams for the detent are used to make the disconnection force higher than the connection force. This is intended to minimize inadvertent disconnection.

[0264] As disclosed elsewhere herein, some embodiments provide each of the cartridge connectors shaped to provide a visual and / or tactile indication when the cartridge connector is locked into 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 when the cartridge is inserted into the pump chamber. FIG. 9C shows an example of a cartridge connector that provides a visual indication when the connector is locked into the pump chamber. The image on the left shows the cartridge inserted into the pump chamber but not locked. The image on the right shows the cartridge aligned with the pump chamber after a quarter turn to indicate the locked state. In some embodiments, a raised portion can also provide visual feedback, as shown in FIG. 9C. In some embodiments, the ridge is perpendicular to the pump face when in the locked position. In this embodiment, unlike the embodiment shown in Figures 1B and 4A, the knobs of both connectors C3001, C3101 are rotated clockwise to lock the connectors to 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. Therefore, another indicator may be added to allow the user to avoid erroneous flow path formation.

[0265] In some embodiments, the knob C1106 and body C1102 of one connector C1101 may be integral (e.g., a molded single piece), as shown in Figures 9D and 9E. Alternatively, in some embodiments, the knobs C1006, C2006, C2106 and bodies C1002, C2002, C2102 of connectors C1001, C2001, C2101 may be separately molded pieces secured together (e.g., using adhesive, ultrasonic welding, etc.), as seen in Figures 9D-10A. As shown in Figure 9E, a connector set can include either or both types of connectors (single or secured together).

[0266] In some embodiments, as shown in Figures 9E-10A, the connector C1001, C2001, C2101 can include a protrusion C1007, C2007, C2107 extending axially upward from a top surface of the body C1008, C2008, C2108. In some embodiments, the protrusion C1007, C2007, C2107 comprises a fluid outlet C1007', C2007'C2107' (e.g., connected to a through hole or passageway extending radially outward from, e.g., a central fluid conduit within the protrusion). In some embodiments, the knob C1006, C2006, C2106 comprises a receptacle portion C1006', C2006', C2106'. In some embodiments, the receptacle portion C1006', C2006', C2106' extends over and is configured to receive at least a portion of the projection of the body C1007, C2007, C2107. In some embodiments, the receptacle portion C1006', C2006', C2106' comprises a knob inlet C1006'', C2006'', C2106'' configured to receive a medicament passing through the fluid outlet C1007', C2007', C2107' of the connector body C1002, C2002, C2102. In some embodiments, the interstitial space C1009, C2009, C2109 is disposed between the protrusion of the body C1007, C2007, C2107 and the receptacle portion C1006', C2006', C2106' of the knob C1006, C2006, C2106. In some embodiments, the flexible membrane C1020, C2020, C2120 is disposed 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' to the knob inlet C1006'' only after a threshold fluid pressure of the agent is reached.

[0267] As described elsewhere herein, drug vials with plungers are typically designed to have little or no resistance and / or friction between the plunger and the walls of the reservoir. Thus, the plunger can move and dispense the drug with little force applied to the plunger (e.g., by moving the cartridge, even lifting a pump with the cartridge, etc.). This undesired dispensing is caused by the plunger lifting the drive nut of the pump. In some embodiments, the configurations described herein avoid the problems of low friction plungers and / or lift-off. In some embodiments, the membranes C1020, C2020, C2120 act as one-way valves and / or prevent lift-off. Some embodiments In a one-way valve (e.g., a check valve) allows fluid to pass only after a threshold pressure (e.g., a crack pressure) is reached at the membrane. In some embodiments, the threshold pressure required to allow fluid flow through the check valve is greater than the gravity-induced hydrostatic pressure difference that may occur between the patient and the infusion system. For example, when an infusion system is connected to a patient via an infusion base and the patient (or user) lifts a fill pump (containing one or more drug vials) to an elevation above the infusion base, hydrostatic pressure may occur. Gravity forces the elevation of the vial to push fluid from the vial through the conduit to the patient via the infusion base set. The amount of hydrostatic pressure applied is determined by the elevation of the drug vial above the infusion set. Thus, the amount of hydrostatic pressure is typically limited by the length of the fluid conduit (which ultimately connects the drug vial to the infusion set). In some embodiments, the standard length of the fluid conduit is about 110 cm or about 60 cm. In some embodiments, the check valve is sufficiently elastic to remain closed when a vial of medication in the infusion system is elevated above the infusion set a distance of at least about 220 cm, about 110 cm, about 60 cm, values ​​between the aforementioned values, or a range spanning those values. In some embodiments, the check valve is designed such that the threshold pressure gradient required to allow fluid flow past the check valve is greater than any hydrostatic pressure difference that may result due to any other changes in hydrostatic pressure between the patient and the infusion system (e.g., forces caused by airplane altitude changes, amusement park rides, bungee jumping, physical activity, etc.).

[0268] In some embodiments, as shown in Figures 9H and 10B, one or more radially extending passages C1007a, C2007a, C2007b, C2107a, C2107b (e.g., tunnels, fluid conduits, etc.) pass through the projection C1007 terminating in a fluid outlet C1007'. In some embodiments, the tunnel(s) provide a fluid path through the projection C1007, C2007, C2107 of the cartridge connector body C1002, C2002, C2102 terminating in a side hole C1007' or multiple side holes C2007', C2107'. In some embodiments, the side hole abuts the membrane C1020, C2020, C2120.

[0269] 10G and 10H show views of another example of a cartridge connector including a check valve with standoff bumps and a fluid path that flows from the concave side of the check valve, around the proximal end of the check valve, towards the convex side of the check valve. In some embodiments, a modified sheath (e.g., capping mechanism) is provided above the inlet port to the cartridge connector and below the knob, as shown. Fluid travels under the sheath through the spaces created between the standoff bumps (distributed around the sheath) as shown, providing a path to the end of the capping mechanism. In some embodiments, the fluid flows up the needle (from the drug cartridge). In some embodiments, the fluid abuts the sheath. In some embodiments, when sufficient fluid pressure is generated by the plunger of the cartridge pushing the fluid out, the periphery of the sheath opens to release the pressure. In some embodiments, the fluid then flows up the tube on its way to the patient. In some embodiments, the valve provides a checked flow, and if the fluid tries to flow in the other direction (i.e., from the tube back to the drug cartridge), the valve remains closed, stopping this flow. The check valve may be made of silicone or another material.

[0270] In some embodiments where the knob and body are one piece, the connector C1101 is configured to receive the medicament through the needle C1103 and deliver the medicament out of the knob C1106 through the fluid outlet C1130. In some embodiments, for connectors C1001, C2001, C2101 with flexible membranes C1020, C2020, C2120, the connectors C1001, C2001, C2101 are configured to receive the medicament through the needles C1003, C2003, C2103 and deliver the medicament out of the connector through the fluid outlets of the connectors C1030, C2030, C2130. In some embodiments, the needles C1003, C11 The fluid outlets of connectors C1001, C1101, C2001, C2101 and connectors C1030, C1130, C2030, C2130 are in fluid communication, providing a fluid path through connectors C1001, C1101, C2001, C2101.

[0271] In some embodiments, as shown in FIG. 10A, when two or more connectors C2001, C2101 are provided, each connector may include a protrusion C2007, C2107 extending axially upward from the top surface of the body C2008, C2108, a receptacle portion C2006', C2106', a knob inlet C2006'', C2106'', an interstitial space C2009, C2109 located between the protrusion of the body and the receptacle portion of the knob C2006, C2106, and a flexible membrane C2020, C2120. In some embodiments, each connector and / or multiple connectors in the connector set may include a one-way valve. When two or more connectors C1001, C1101 are provided, as shown in FIG. 9I, a single connector may include a one-way valve (but not both and / or less than one).

[0272] In some embodiments, as shown in Figures 9B and 10C, the underside of the knob C1022, C1122, C2022, C2122 may include one or more nubs C1021, C1121, C2021, C2121 (e.g., crushable protrusions, nodules, bumps, etc.). In some embodiments, the nubs are crushable and / or malleable. In certain embodiments, the nubs ensure a tight (e.g., close, snug, no gaps, no vibration, and / or no rattle) engagement of the connector to the pump. For example, in some embodiments, as the connector is rotated into place in the connector receptacle and the lugs of the connector pass along the mechanism tracks P1101′, P1103′, P1111′, P1113′, the longitudinally extending threads (e.g., progressing distally down the bore) ensure that the connector is closer to the pump until the connector substantially abuts the upper side P1004 of the pump. In some embodiments, the nubs ensure that at least a portion of the connector contacts the upper side of the pump to hold the connector firmly in place against the upper side. Note that if the nubs were not present and a space existed between the cartridge connector and the pump housing, the cartridge connector could be inadvertently pressed flush against the pump housing (e.g., at the top side), which would cause the cartridge in the pump to press against the drive nut and deliver a small bolus. In some embodiments, the nubs allow the connector to mold against the upper side of the pump (so that each installation and re-installation of the connector provides a flush connection with no space between the pump and the cartridge connector).

[0273] In some embodiments, the nubs, in combination with the detent cams (or lug cams), provide additional stability to the system. Additionally, the manufacturing tolerances of the (possibly disposable) cartridge connector are increased by the use of the nubs. For example, the cartridge connector does not need to be manufactured to precisely match the particular top surface of the pump, since the nubs help form a snug / tight fit between the top surface of the pump and the cartridge connector.

[0274] As shown in Figures 1D-1I, 4A, 9A-9B, and 10A, recognition features P1101, P1102, P1103, P1111, P1112, P1113, C1010, C1011, C1110, C1111, C1012, and C1112 can be provided and configured to prevent or inhibit erroneous flow channel formation. As shown in Figures 9A-9B, cartridge connectors C1001 and C1101 corresponding to pump receptacles P1100 and P1110, respectively, include protrusions C1010, C1011, C1110, C1111, C1012, and C1112 (e.g., tabs, lugs, detents) that match the openings of pump chambers P1101, P1102, P1103, P1111, P1112, and P1113. In some embodiments, these protrusions include lugs C1010, C1011, C1110, C1111 and / or detents C1012, C1112. Similarly, the protrusions in FIG. As shown in pump 2000 and in FIGS. 10A and 10C, cartridge connectors C2001, C2101 corresponding to pump receptacles P2100, P2110, respectively, include matching protrusions (e.g., tabs, lugs, detents). In some embodiments, these protrusions include lugs C2010, C2011, C2110, C2111 and / or detents C2012, C2112. In some embodiments, as disclosed elsewhere herein, the protrusions (e.g., projections) are configured to mate (slide into, etc.) with matching openings configured to receive such protrusions. As shown, the features can be protrusion features (e.g., projections, tabs, lugs, detents) configured to engage with corresponding divots (e.g., apertures, through spaces, detent slots, lug slots, radial notches, cutouts, etc.) in the receptacle. These mating features facilitate attachment of the appropriate components and / or prevent connection of the appropriate components.

[0275] As shown in FIG. 9B, each cartridge connector may have multiple recognition features. In the illustrated embodiment, each connector C1001, C1101 includes three radially extending protrusions (lugs and detents) configured to engage matching shaped notches in a corresponding cartridge receptacle. These recognition features may be configured to engage with an appropriate receptacle and prevent or inhibit engagement of an inappropriate cartridge connector (e.g., not corresponding and lacking one or more matching protrusions), or both. In the embodiment shown in FIG. 9B, each connector has three radially extending protrusions as recognition features, but in some embodiments, each connector may independently have one, two, three, forty-five, or more recognition features (e.g., divots and / or protrusions) configured to engage and / or receive matching recognition features (e.g., protrusions and / or divots) from a corresponding pump chamber. Additionally, while the cartridge connector has been described as having circumferentially distributed protrusions and the pump chambers as having circumferentially distributed divots, the opposite configuration (protrusions on the cartridge connector and divots on the receptacle) is also possible. Similarly, in some embodiments, it is possible to mix and match multiple types of recognition features on a particular cartridge connector (so that the connector has both protrusions and divots and the corresponding receptacle has matching divots and protrusions). In yet another variation, the cartridge connector can only have divots and different cartridge connectors in the same connector set can only have protrusions. In such an embodiment, the corresponding cartridge receptacles can have matching protrusions and the cartridge receptacles can each have matching divots.

[0276] In some embodiments, the lugs and detents may be of various different sizes (e.g., circumferential length, radial height, etc.), as shown in FIG. 9B and FIG. 10C. For example, as shown in FIG. 9B, the lugs of one cartridge connector may be of one length lugs (cl') and the second may be of a second length lugs (cl''), which may be different from each other and / or from the lug length of the lugs (cl''') and (cl'''') of the second cartridge connector. As shown, the detents of one cartridge connector may be of one length det(cl') that is different from the length det(cl'') of the detents of the other cartridge connector. In some embodiments, these lugs and detents are configured to be inserted into openings of corresponding sizes (e.g., matching lengths) disposed in corresponding cartridge receptacles.

[0277] As shown in Figures 9B and 10C, the detents and lugs of two different connectors can have corresponding positions (e.g., if the intermediate mechanism is rotated to 12 o'clock, a first lug is at 9 o'clock, a detent is at 12 o'clock, a second lug is at 3 o'clock, etc.). In some variations, the lugs and detents are not in corresponding positions, or only a portion of the lugs and detents are in corresponding positions. In some embodiments, the lugs and detents are on separate connectors. By providing different sizes of comparably positioned features, even when they are in corresponding positions on the first connector, incorrect cartridge connector attachment can be prevented and / or substantially hindered. It has been found that by providing features on a first connector (e.g., lug openings, detent openings, lugs, detents, etc.) that have a size difference of at least 15% (e.g., 15% longer or shorter) than the equivalent feature on a second connector (e.g., a feature in the same relative position), incorrect flow channel formation can be prevented and / or substantially inhibited. In certain embodiments, the ratio of the length of a feature on one connector compared to the length of an equivalent feature on a different connector is equal to or is at least about 3:1, 5:2, 2:1, 5:3, 4:3, 20:17, or ranges spanning and / or including the aforementioned ratios.

[0278] In certain embodiments, multiple recognition features (e.g., lugs, detents, openings configured to receive lugs or detents, etc.) can be distributed around (e.g., circumferentially) the cartridge connectors C1001, C1101, as shown in Figure 9B. For example, as shown in Figure 9B, the midpoint of one recognition feature C1012 may be located at the 9 o'clock position, and an adjacent recognition feature may have a midpoint at 12 o'clock C1011, thereby being separated by 90 degrees. In some embodiments, adjacent recognition features of connectors C1001, C1101 may be separated by a value equal to or less than about 180°, 160°, 140°, 120°, 100°, 90°, 80°, 70°, 60°, 50°, 40°, 30°, 20°, 10°, a value between the aforementioned values, or a value independently selected from others. As shown in FIG. 9B, in some embodiments, non-adjacent recognition features of connectors C1001, C1101 may be separated by a value independently selected from the above-mentioned values, equal to or less than about 180°, 160°, 140°, 120°, 100°, 90°, 80°, 70°, 60°, 50°, 40°, 30°, 20°, 10°, values ​​between the above-mentioned values, or others.

[0279] As disclosed elsewhere herein, the cartridge connector may include divots (not shown) instead of and / or in addition to protrusions. In some embodiments, the divots may open into tracks (e.g., slots, passages, etc.). In some embodiments, these passages may be moved and / or positioned circumferentially around the connector, as shown for the receptacle inlet elsewhere herein. In certain variations, when the cartridge connector is inserted into the pump chamber opening, the connector rotates (as disclosed elsewhere herein) to lock the cartridge connector into the receptacle.

[0280] In some embodiments, as shown in Figures 10D, 10E, and 11D, the individual cartridge connector shrouds (and / or individual drug cartridges) may be formed to prevent attachment of the wrong cartridge connector with the wrong drug cartridge. For example, as shown in Figures 10D, 10E, and 11D, the first cartridge connector may have a shorter skirt. In some embodiments, the second cartridge connector C1101, C2101 (e.g., glucagon cartridge) may be formed to have a longer shroud (e.g., skirt) than the first cartridge connector C1001, C2001 (e.g., insulin cartridge connector). In some embodiments not shown, one connector may have a wider diameter and the other a smaller diameter. In some embodiments, alternatively, the first cartridge M1001 (e.g., insulin cartridge) may be formed to have a wider diameter than the second cartridge M1101 (e.g., glucagon cartridge). Thus, the longer shroud C2105 of the cartridge connector C2101 abuts against the larger diameter vial of the first drug cartridge M1001, thus preventing the snap arms 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.

[0281] In some embodiments, as shown in Figures 9A, 9D, and 10A, an additional feature of the connector can include one or more of a needle recessed into the connector above the shroud. In some embodiments, this feature and others can prevent the vial from being forced into the connector and / or prevent improper puncture of the vial septum. In some embodiments, the needle recessed into the shroud makes the needle touch-proof, avoiding puncture of a finger or other part of the user's body.

[0282] In some embodiments, as disclosed elsewhere herein, the connector set comprises one or more cartridge connectors (shown in FIGS. 11A and 11B ) coupling the fluid conduits to the drug reservoirs. In some variations of the system, as disclosed elsewhere herein, the one or more reservoirs are (and / or can be) disposed within a pump device configured to distribute drug from the one or more reservoirs to the conduits, thereby supplying drug to the system. In some embodiments, the fluid conduits provide separate pathways that terminate at designated delivery members (e.g., needles, cannulas, etc.) within the base, thereby allowing for independent delivery (e.g., subcutaneous or otherwise) of drugs separately.

[0283] As shown in FIGS. 9A-10F, in some embodiments, there are one or more snap arms C1015a, C1015b, C2015a, C2015b, C1115a, C1115b, C2115a, C2115b (e.g., one, two, three, four, or more) molded into the body of the cartridge connector. In some embodiments, these arms snap onto (e.g., around) the cap M1002, M1102 or into the neck area M1003, M1103 of the drug cartridge when the cartridge connector is attached. In some embodiments, the snap arms comprise a lip (e.g., teeth, ridges, etc.) configured to engage with the cap and / or neck of the cartridge. In some embodiments, these snap arms are in a position that ensures that the cartridge is extracted from the pump when the cartridge connector is removed. In some embodiments, without this connection, the plunger may get stuck in the pump due to the forces on the plunger / pump connection. As shown, the longer skirt of the cartridge connector (e.g., glucagon) abuts against a larger diameter cartridge (e.g., insulin) and prevents the snap arms from snapping together. In some embodiments, the first drug cartridge is configured to receive insulin. In some embodiments, the second drug cartridge is configured to receive glucagon. In some embodiments, if the cartridge snaps are not closed, the cartridge connector cannot rotate to a locked position within the pump. In some embodiments, there are one or more snap arms (one, two, three, four, or more) molded into the body portion as shown. In some embodiments, these arms snap into the cap of the drug cartridge when the cartridge connector is attached. In some embodiments, a recognition feature of the second cartridge connector (e.g., skirt ring, snap arms, etc.) is configured to prevent attachment of the second cartridge connector into the first pump receptacle.In some embodiments, the recognition feature of the first cartridge connector is configured to prevent installation ...

Claims

1. 1. An infusion pump for delivering a medication to a patient, comprising: A pump housing comprising: a first receptacle port configured to engage with a first cartridge connector and a second receptacle port configured to engage with a second cartridge connector; a first medication cartridge receptacle extending longitudinally along a first side of the infusion pump from the first receptacle port to a first cartridge receptacle aperture; a pump housing including a second medication cartridge receptacle extending longitudinally along a second side of the infusion pump from the second receptacle port to a second cartridge receptacle aperture; An interior area, a power source disposed between the first drug cartridge receptacle and the second drug cartridge receptacle; a first motor and a second motor 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; the first motor and the second motor each include a first pinion gear and a second pinion gear, the first pinion gear being a member of the first stacked gear assembly, and the second pinion gear being a member of the second stacked gear assembly; the first gear assembly extends laterally toward the first side of the infusion pump and the second gear assembly extends laterally toward the second side of the infusion pump; an interior section, the first lead screw in rotational communication with the first pinion gear through the first gear assembly, and the second lead screw in rotational communication with the second pinion gear through the second gear assembly; a first drive nut having a length extending longitudinally along the pump housing and configured to move through the first aperture and into the first drug cartridge receptacle, the first drive nut being in communication with the first lead screw and adapted to move forward or backward in response to first and second rotational directions, respectively, of the first lead screw; a first drive nut configured to bias the first drive nut rearwardly; a second drive nut having a length extending longitudinally along the pump housing and configured to move through the second aperture and into the second drug cartridge receptacle, the second drive nut in communication with the second lead screw and configured to bias forward or rearward in response to a first rotational direction and a second rotational direction of the second lead screw, respectively; An infusion pump comprising a first seal and a second seal, the first seal providing a water-resistant barrier between the interior area of ​​the infusion pump and the first drug cartridge receptacle, and the second seal providing a water-resistant barrier between the interior area of ​​the infusion pump and the second drug cartridge receptacle.

2. The infusion pump of claim 1 , wherein the first receptacle port has one or more recognition features configured to engage with matching recognition features of the first cartridge connector.

3. The infusion pump of claim 1 or 2, wherein the second receptacle port has one or more recognition features configured to engage with matching recognition features of the second cartridge connector.

4. The infusion pump of claim 3 , wherein the recognition mechanism of the first receptacle port is different from the recognition mechanism of the second receptacle port.

5. 5. The infusion pump of claim 4, wherein the first drug cartridge receptacle is configured to receive an insulin cartridge and the second drug cartridge receptacle is configured to receive a glucagon cartridge.

6. 6. The infusion pump of claim 1, wherein the first receptacle port is configured to not allow engagement of the second cartridge connector, and the second receptacle port is configured to not allow engagement of the first cartridge connector.

7. 2. The infusion pump of claim 1, wherein the first seal is a first O-ring circumferentially surrounding at least a portion of the first drive nut and the second seal is a second O-ring circumferentially surrounding at least a portion of the second drive nut.

8. 8. The infusion pump of claim 7, wherein the pump housing comprises a first saddle and a second saddle, the first saddle configured to hold the first O-ring and the second saddle configured to hold the second O-ring.

9. 9. The infusion pump of claim 8, wherein the first saddle is positioned adjacent to the first cartridge receptacle aperture and the second saddle is positioned adjacent to the second cartridge receptacle aperture.

10. 10. The infusion pump of claim 1, wherein the first drive nut includes a protrusion on a proximal portion of the first drive nut that remains within the interior region while the drive nut extends into the first cartridge receptacle, and the pump housing includes a groove configured to receive the protrusion of the first drive nut, the protrusion of the first drive nut engaging the groove, thereby preventing rotation of the first drive nut.

11. The first drive nut has one or more barbs on a distal portion of the first drive nut.

11. The infusion pump of claim 1, wherein the distal portion of the first drive nut resides within the first cartridge receptacle, and the second drive nut does not include a barb on a distal portion of the second drive nut, and the distal portion of the second drive nut resides within the second cartridge receptacle.

12. 12. The infusion pump of claim 1, wherein the housing comprises a capacitance sensor configured to detect when a finger touches a surface, the surface being a curved recess on the housing, the capacitance sensor comprising an integrated circuit configured to measure the capacitance of a circuit, and a conductive foam filling a gap between the surface and the integrated circuit.

13. the housing includes a lower metal portion and a bezel attachable to the metal portion; at least a portion of a sidewall of the ambulatory medical device is covered only by the bezel; a circuit board positioned adjacent to an inner surface of the bezel; 13. The infusion pump of claim 1, wherein 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 ambulatory medical device that is covered only by the bezel.

14. 14. The infusion pump of claim 13, wherein the bezel allows wireless signals to pass through and the metal portion does not interfere with signals from the antenna.

15. 15. The infusion pump of claim 13 or 14, wherein the circuit board is configured to process radio signals received by the antenna.

16. 16. The infusion pump of claim 1, further comprising a first magnet coaxially mounted on a gear within the first gear assembly, and a first rotational position sensor that measures the angular position of the first magnet.

17. 17. The infusion pump of claim 1, wherein the first receptacle port comprises a snap arm recess extending longitudinally into the first drug cartridge receptacle, the snap arm recess of the first drug cartridge receptacle configured to receive the snap arm of the first cartridge connector when the snap arm extends over a first drug cartridge cap during engagement of the first drug cartridge while the first drug cartridge is housed within the first drug cartridge receptacle.

18. the second receptacle port includes a snap arm recess extending longitudinally into the second drug cartridge receptacle, the snap arm recess of the second drug cartridge receptacle configured to receive the snap arm of the second cartridge connector when the snap arm extends over a second drug cartridge cap during engagement of the second drug cartridge while the second drug cartridge is housed within the second drug cartridge receptacle; The infusion pump of claim 17 , wherein the snap arm recess of the first receptacle port is configured not to receive the snap arm of the second cartridge connector.

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