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EP-4262929-B1 - FLUID DELIVERY SYSTEM WITH NEEDLE ASSEMBLY

EP4262929B1EP 4262929 B1EP4262929 B1EP 4262929B1EP-4262929-B1

Inventors

  • GUNAY, Murat
  • JUDSON, JARED ALDEN
  • PERKINS, RUSSELL WAYNE
  • SCHAFF, ANTHONY LAWRENCE

Dates

Publication Date
20260506
Application Date
20211214

Claims (12)

  1. A drug delivery device (11, 12, 13, 126, 1000) comprising: a container comprising a medication; a needle assembly (50, 132, 300, 400, 500, 600) coupled to the container, the needle assembly (50, 132, 300, 400, 500, 600) comprising: a housing (310, 410, 510, 610) with a first end (392) and a second end (394) configured to interface with the container; a first needle support (320, 420, 520, 620) and a second needle support (340, 440, 540, 640) positioned within the housing (310, 410, 510, 610); a first needle (51, 330, 430, 530, 630) coupled to the first needle support (320, 420, 520, 620), a second needle (53, 350, 450, 550, 650) coupled to the second needle support (340, 440, 540, 640), a movable connector (360, 460, 560, 660) in fluid communication between the first and second needles; and a driving mechanism configured to move the needle assembly (50, 132, 300, 400, 500, 600) from a first configuration to a second configuration, wherein in the first configuration the first needle (51, 330, 430, 530, 630) and the second needle (53, 350, 450, 550, 650) are positioned completely within the housing (310, 410, 510, 610), and in the second configuration the first needle (51, 330, 430, 530, 630) extends beyond the first end (392) of the housing (310, 410, 510, 610) and the second needle (53, 350, 450, 550, 650) extends beyond the second end of the housing (310, 410, 510, 610), wherein the first end (392) of the housing (310, 410, 510, 610) comprises a seal (230) and the container comprises a septum (35, 226) proximate the second end of the housing (310, 410, 510, 610), and when moving from the first configuration to the second configuration, the first needle (51, 330, 430, 530, 630) pierces the seal (230), and the second needle (53, 350, 450, 550, 650) pierces the septum (35, 226); and a delivery mechanism coupled to the container and configured to drive the medication through the second needle (53, 350, 450, 550, 650) and the first needle (51, 330, 430, 530, 630) when the needle assembly (50, 132, 300, 400, 500, 600) is in the second configuration, characterized in that : the first needle support (320, 420, 520, 620) and the second needle support (340, 440, 540, 640) are positioned along a common plane and are slidably coupled to one another through the driving mechanism, and activation of the driving mechanism allows for movement of the first needle support (320, 420, 520, 620) and the second needle support (340, 440, 540, 640) in order for the needle assembly to move to the second configuration.
  2. The drug delivery device (11, 12, 13, 126, 1000) of claim 1, wherein the container is configured to be decoupled from the needle assembly (50, 132, 300, 400, 500, 600).
  3. The drug delivery device (11, 12, 13, 126, 1000) of any one of claims 1-2, wherein the movable connector (360, 460, 560, 660) is flexible.
  4. The drug delivery device (11, 12, 13, 126, 1000) of claim 3, wherein the movable connector (360, 460, 560, 660) is a flexible tube.
  5. The drug delivery device (11, 12, 13, 126, 1000) of any one of claims 1-4, wherein the driving mechanism is configured to operate at multiple different operating speeds.
  6. The drug delivery device (11, 12, 13, 126, 1000) of any one of claims 1-5, wherein each of the first needle support (320, 420, 520, 620) and the second needle support (340, 440, 540, 640) comprise a rack, and the driving mechanism is a pinion gear configured to drivably engage with the rack of the first needle support (320, 420, 520, 620) and the second needle support (340, 440, 540, 640), respectively.
  7. The drug delivery device (11, 12, 13, 126, 1000) of any one of claims 1-6, the driving mechanism comprises a drive screw in threaded engagement with the first needle support (320, 420, 520, 620) and the second needle support (340, 440, 540, 640).
  8. The drug delivery device (11, 12, 13, 126, 1000) of any one of claims 1-7, wherein the driving mechanism is further configured to move the needle assembly (50, 132, 300, 400, 500, 600) from the second configuration back to the first configuration.
  9. The drug delivery device (11, 12, 13, 126, 1000) of any one of claims 1-8 further comprising an electric motor, the electric motor configured to activate at least one of the delivery mechanism and the driving mechanism.
  10. The drug delivery device (11, 12, 13, 126, 1000) of any one of claims 1-9, further comprising a communication device (780) configured to send and receive signals related to operation of the drug delivery device to and from a computing device.
  11. The drug delivery device (11, 12, 13, 126, 1000) of any one of claims 1-10, wherein during movement of the needle assembly (50, 132, 300, 400, 500, 600) from the first configuration to the second configuration, the first needle (51, 330, 430, 530, 630) moves along an axis in a first direction and the second needle (53, 350, 450, 550, 650) moves along an axis in a second direction opposite the first direction.
  12. The drug delivery device (11, 12, 13, 126, 1000) of any one of claims 1-10, wherein during movement of the needle assembly (50, 132, 300, 400, 500, 600) from the first configuration to the second configuration, the first needle (51, 330, 430, 530, 630) moves along an axis in a first direction and the second needle (53, 350, 450, 550, 650) moves along an axis in a second direction orthogonal to the first direction.

Description

FIELD OF THE DISCLOSURE The present disclosure relates to a needle assembly to deliver a fluid. More specifically, the present disclosure relates to an extendable and retractable needle assembly configured to deliver a fluid through a surface. BACKGROUND OF THE DISCLOSURE Conventional injection devices are often used to drive a needle through a surface, for example in the injection of a drug, removing a fluid from a sealed container such as a vial, sampling within chemical instrumentation, and so on. Considering the example of injecting a patient with a drug, it is sometimes advantageous for the drug to be administered without the presence of a medical professional (e.g. when taken frequently). It may be a challenge to ensure that the needle is maintained in a sterile environment prior to injection, as well to ensure that the drug is administered safely and efficiently. Furthermore, some patients are uncomfortable with seeing or directly handling needles. US 2013/006213 A1 discloses a method for removing a fluid medium from a container. The method comprises providing a removal device with a closed-off, sterilizable interior, with a needle element being held in the interior, the interior being closed off by a perforable sealing element; providing the container which contains the fluid medium, the container having a container wall with a perforable section; connecting the removal device and the container, the perforable section and the perforable sealing element being interconnected such that a protected region is created between the perforable section and the perforable sealing element, the protected region being closed off with respect to the surroundings in a substantially germ-free fashion as a result of the connection; and perforating the perforable sealing element and the perforable section by means of the needle element, the needle element penetrating the protected region. US 2019/328973 A1 discloses a medicament delivery device for delivery of medicament from a cartridge into an injection site, through a cannula. The cartridge has a medicament chamber with an outlet, and a sealing element for closing the outlet. The device has a housing for receiving the cartridge, and a drive mechanism to expel the medicament from the device upon activation of the drive mechanism. The device has a connection arrangement comprising a hub and spring means for driving relative movement between the hub and the cartridge upon operation of an operating member. The operating member switches the connection arrangement from an unconnected configuration to a connected configuration, in which the hub cooperates with the cartridge to open the outlet. When connected, fluid may flow between the chamber and the cannula. US 2014/228804 A1 discloses a syringe for retracting and storing of the needles for transferring fluids. The syringe includes a hollow rotatable and retractable syringe plunger body, a hollow syringe barrel slidably disposed inside the hollow rotatable and retractable syringe plunger body, a plunger slidably disposed in the hollow syringe barrel, a syringe adapter attached to the front end of the hollow syringe barrel, a syringe plunger adapter attached to the syringe adapter, a hollow retractable barrel body attached to the hollow rotatable and retractable syringe plunger body. The syringe further includes plurality of springs, a first needle and a second needle for injecting and ejecting fluid, on using the first needle, the first needle is retracted and then the second needle stored in the syringe barrel is pushed out the hollow retractable barrel. EP 3 041 550 A1 discloses a drive mechanism for a needle insertion arrangement, the drive mechanism comprising: an actuator, a rotatable drive pulley directly or indirectly coupled to the actuator, and a belt adapted to engage the drive pulley and adapted to be fixed to a needle retainer. SUMMARY The scope of the invention is defined in the appended claims. Any "aspect", "example" and "embodiment" of the description not falling within the scope of the claims does not form part of the invention and is provided for illustrative purposes only. A needle assembly configured to be part of a drug delivery device comprises a plurality of extendable and retractable needles. The needles are fluidly coupled by a flexible connector, which is configured to maintain fluid connection between the needles throughout their movement. When the needles are extended, a first needle pierces a patient's skin, and a second needle pierces a septum of a drug container. Once the drug has been delivered, the needles may then retract within a needle assembly housing. The needle assembly may also be part of a partially disposable drug delivery device and may be used with multiple different drug containers. Multiple embodiments of the needle assembly are disclosed. According to the invention, disclosed is a drug delivery device that includes a container containing a medication, and a needle assembly