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CN-115666683-B - Injection device with suspended parenteral interface

CN115666683BCN 115666683 BCN115666683 BCN 115666683BCN-115666683-B

Abstract

Systems and methods for drug delivery are disclosed in which an injection device includes a parenteral interface including a support and a needle assembly suspended within a cavity in a housing of the device such that the parenteral interface is movably mounted relative to the housing when the needle assembly is in an injection position. The parenteral interface may be configured to allow the housing of the device to move relative to the skin without displacing the needle assembly. The device may be configured to passively or actively compensate for movement of the housing relative to the injection site to ensure that the correct delivery depth is maintained during the time the device is worn. For example by mounting the support of the parenteral interface on a deformable mount or a hinge or rotatable member.

Inventors

  • A. Linnes
  • G.T. Luin
  • B. Costello

Assignees

  • 西医药服务有限公司

Dates

Publication Date
20260505
Application Date
20210323
Priority Date
20200410

Claims (17)

  1. 1. An injection device, the injection device comprising: A housing having a cavity and configured to receive a drug container; A parenteral interface comprising a support having a skin-facing surface and a needle assembly mounted to the support, wherein the needle assembly is configured to deliver a dose of medicament to an injection site, and the support is disposed in the cavity and is configured to contact skin at the injection site; a flexible catheter configured to deliver the drug dose from the drug container to the needle assembly; a spring base rotatably mounted in the housing, and A plurality of springs mounted to the support and coupled with the spring base, wherein the plurality of springs bias the skin-facing surface into contact with the skin at the injection site, each spring having a longitudinal axis, and the longitudinal axes being non-coincident, Wherein the inner side wall of the cavity forms a circumferential gap with the outer side wall of the support to allow the support to move and tilt laterally within the cavity during delivery of the medicament dose.
  2. 2. The injection device of claim 1, wherein the needle assembly comprises a hollow injection needle.
  3. 3. The injection device of claim 1 or 2, wherein the needle assembly comprises a microneedle array.
  4. 4. The injection device of claim 1 or 2, wherein the plurality of springs comprises at least one coil spring.
  5. 5. The injection device of claim 1 or 2, wherein the circumferential gap extends around the outer sidewall of the support.
  6. 6. An injection device according to claim 1 or 2, wherein the spring base is pivotally mounted within the housing.
  7. 7. The injection device of claim 1 or 2, wherein the spring base is configured to be movably mounted within the housing for travel in a distal direction to advance the needle assembly from a retracted position to an extended position from the housing toward the skin.
  8. 8. The injection device of claim 1 or 2, wherein the plurality of springs are configured to bias the support to a position in which the needle assembly extends beyond a skin contacting surface of the housing.
  9. 9. The injection device of claim 1 or 2, wherein the device further comprises an insertion mechanism configured to move the spring base between: A first position relative to the housing in which the needle assembly does not extend from the housing, and Wherein the needle assembly extends from the housing for insertion into a second position of the injection site relative to the housing.
  10. 10. The injection device of claim 9, further comprising a releasable locking mechanism, the releasable locking mechanism is configured to: Maintaining the support or the spring base in the first position relative to the housing when the locking mechanism is in an active state, and The support or the spring base is allowed to move to the second position when the locking mechanism is in an inactive state.
  11. 11. The injection device of claim 10, wherein the releasable locking mechanism is configured to: holding the support in the first position relative to the spring base in which the plurality of springs are compressed, and The support is allowed to move to the second position relative to the spring base under the influence of the plurality of springs.
  12. 12. The injection device of claim 1 or 2, further comprising a deployment mechanism coupled to the support, wherein the deployment mechanism is configured to move the support between a first position and a second position.
  13. 13. The injection device of claim 12, wherein the deployment mechanism is removably coupled to the housing.
  14. 14. The injection device of claim 1 or 2, wherein the housing comprises a skin contact surface comprising an adhesive portion configured to attach the device to the skin of a user.
  15. 15. The injection device according to claim 1 or 2, further comprising an adhesive portion provided on a skin facing surface of the support.
  16. 16. A method of supporting a needle of an injection device in preparation for injecting a dose of a medicament, the method comprising: placing the device of claim 1 or 2 against an injection site; contacting the support with skin at the injection site; Fixing the injection device to the injection site using an adhesive disposed on the housing, and Compressing the spring between the support and the spring base.
  17. 17. A method of manufacturing the injection device of claim 1, the method comprising the steps of: providing a housing configured to receive a medicament container, the housing further comprising a cavity having an opening on a skin contacting surface of the housing; Providing a parenteral interface within the cavity of the housing, the parenteral interface comprising a support and a needle assembly mounted to the support and configured to deliver a dose of medicament to an injection site; Providing a flexible catheter configured to deliver a drug from the drug container to the needle assembly, and The support is mounted on a plurality of springs coupled to a spring base disposed in the housing, each spring having a longitudinal axis such that the longitudinal axes do not coincide, and a circumferential gap between an outer sidewall of the support and an inner sidewall of the cavity allows the support to move laterally within the cavity.

Description

Injection device with suspended parenteral interface Cross Reference to Related Applications The present application claims priority from U.S. provisional application No. 63/008,007, filed on 10 months 4 in 2020, the disclosure of which is incorporated herein by reference. Technical Field The present disclosure relates generally to systems and methods for drug delivery that include a "floating" parenteral interface. In particular, the present disclosure relates to drug delivery devices and methods in which a parenteral interface is movably mounted relative to a housing. Background Many acute and chronic medical conditions can be managed or treated by parenteral delivery of drugs to a patient. Parenteral delivery methods include subcutaneous injections to administer the therapeutic agent into the body, such as by intradermal, subcutaneous, or intramuscular injection using a needle or cannula. The wearable device and the auto-injector may provide a convenient and safe method of delivering therapeutic agents. These designs provide convenience and comfort to the user and/or caregiver and ensure compliance with the desired dosage regimen. Many devices may be configured to reduce the visibility or manual process associated with conventional delivery methods. They may also provide accurate dose control to ensure consistent delivery and improve patient compliance. One of the challenges associated with wearable devices and auto-injectors is maintaining proper contact and depth between the injection needle and the injection site throughout the duration of drug delivery. If the needle is dislocated from the injection site, dislocation of the device during injection may result in pain and incomplete delivery of the drug. In addition to conventional subcutaneous injections, therapeutic agents can also be delivered through the skin via hollow microneedle arrays. Microneedle arrays typically include an arrangement of a plurality of short, sharp structures that penetrate only the upper layers of the skin. Due to the reduced depth of insertion (and reduced diameter of the individual needles), microneedles tend to have reduced pain levels compared to conventional hypodermic needles. However, the adoption of microneedle technology has been limited in some applications because microneedle arrays must be applied into the skin with accurate force and at the proper impact velocity to achieve consistent microneedle depth and leak-free drug delivery. Detachment of the microneedle array from the injection site must also be avoided to prevent leakage of the drug through the microneedle array. Thus, there is a need for a drug delivery device that ensures that contact is maintained between the needle or microneedle array and the injection site for the entire duration of therapeutic agent delivery. This is critical considering the amount of wearable drug delivery devices that a user may wear for an extended period of time and in many different situations, whether active, dressing, resting, sleeping, as the needle array may cause the device housing to be knocked while in the skin. Disclosure of Invention The present disclosure addresses some of the disadvantages associated with known injection devices, and in particular the manner in which the needle assembly of the injection device is attached and supported relative to the housing. Various aspects of the present disclosure provide for various injection devices in which a parenteral interface including a support and a needle assembly is suspended within a cavity in a housing of the device such that the parenteral interface is movably mounted relative to the housing when the needle assembly is in an injection position. The device may be a wearable device configured to be secured against the skin. The parenteral interface may be configured to allow the housing of the device to move relative to the skin without displacing the needle assembly. The devices described herein may be configured to passively compensate for movement of the housing relative to the injection site (e.g., by mounting the support of the parenteral interface on a deformable mount or hinge or rotatable member). Alternatively or in addition, the devices described herein may include active compensation for movement of the housing, which may include a system configured to control the position of the needle assembly relative to the housing in response to a sensed displacement of the housing or the parenteral interface from the skin. In some embodiments, the active needle assembly positioning control may be configured to maintain a contact force between the needle assembly (e.g., cannula or microneedle array) and the injection site. In at least some embodiments, the parenteral interface can be configured to bias the needle assembly in a proximal direction (toward the injection site) such that the parenteral interface remains in contact with the injection site as the housing is displaced in a distal direction away from the inje