Injection device with suspended parenteral interface

Abstract

Systems and methods for drug delivery are disclosed, wherein the injection device includes a parenteral interface comprising a support and a needle assembly suspended within a cavity of a housing of the device, such that the parenteral interface is movably mounted relative to the housing when the needle assembly is in the injection position. The parenteral interface can be configured to allow movement of the housing of the device relative to the skin without displacement of the needle assembly. The device can be configured to passively or actively compensate for movement of the housing relative to the injection site to ensure proper delivery depth is maintained during the duration of device wear. This can be achieved, for example, by mounting the support of the parenteral interface on a deformable mount, hinge, or rotatable component.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 008,007, filed April 10, 2020, the disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to systems and methods for drug delivery, including a “floating” parenteral interface. More specifically, this disclosure relates to drug delivery devices and methods in which the parenteral interface is movably mounted relative to a housing. Background Technology

[0004] Many acute and chronic medical conditions can be managed or treated by delivering medications to patients parenterally. Parenterally delivery methods include subcutaneous injection to administer therapeutic agents into the body, such as intradermal, subcutaneous, or intramuscular injection using a needle or cannula.

[0005] Wearable devices and autoinjectors offer convenient and safe methods for delivering therapeutic agents. These are designed for user and / or caregiver convenience and comfort, ensuring adherence to desired dosing regimens. Many devices can be configured to reduce visibility or manual processes associated with conventional delivery methods. They can also provide precise dose control to ensure consistent delivery and improve patient compliance.

[0006] One of the challenges associated with wearable devices and autoinjectors throughout the entire drug delivery process is maintaining proper contact and depth between the needle and the injection site. Dislocation of the device during injection can cause pain and result in incomplete drug delivery if the needle dislodges from the injection site.

[0007] In addition to conventional subcutaneous injection, therapeutic agents can also be delivered through the skin via hollow microneedle arrays. Microneedle arrays typically consist of an arrangement of multiple short, sharp structures that penetrate only the upper layers of the skin. Due to the reduced insertion depth (and the smaller diameter of individual needles), microneedling tends to result in lower levels of pain compared to conventional subcutaneous injection needles. However, the adoption of microneedling technology has been limited in some applications because the microneedle array must be applied to the skin with precise force and appropriate impact velocity to achieve consistent microneedle depth and leak-free drug delivery. It is also essential to prevent the microneedle array from detaching from the injection site to prevent drug leakage through the microneedle array.

[0008] Therefore, a drug delivery device is needed that ensures contact between the needle or microneedle array and the injection site throughout the entire duration of therapeutic delivery. This is crucial given the amount of wearable drug delivery devices users may wear for extended periods and in many different situations, whether active, dressed, resting, or sleeping, as the device housing could be knocked off when the needle array is in the skin. Summary of the Invention

[0009] This disclosure addresses some of the drawbacks associated with known injection devices, and specifically, the manner in which the needle assembly of the injection device is attached and supported relative to the housing.

[0010] Various aspects of this disclosure provide various injection devices, including a gastrointestinal interface of a support and needle assembly suspended within a cavity in the housing of the device, such that the gastrointestinal interface is movably mounted relative to the housing when the needle assembly is in the injection position. The device can be a wearable device configured to be fixed against the skin. The gastrointestinal interface can be configured to allow movement of the device housing relative to the skin without displacing the needle assembly.

[0011] The device described herein can be configured to passively compensate for movement of the housing relative to the injection site (e.g., by mounting a support for the extra-gastric interface onto a deformable mount, hinge, or rotatable component). Alternatively or additionally, the device described herein may include active compensation for housing movement, which may include a system configured to control the position of the needle assembly relative to the housing in response to sensed displacement of the housing or extra-gastric interface from the skin. In some embodiments, active needle assembly positioning control may be configured to maintain contact force between the needle assembly (e.g., a cannula or microneedle array) and the injection site.

[0012] In at least some embodiments, the external gastrointestinal interface can be configured to bias the needle assembly in a proximal direction (towards the injection site) such that the external gastrointestinal interface remains in contact with the injection site when the housing is displaced in a distal direction away from the injection site. In these and other embodiments, the external gastrointestinal interface can be configured to allow lateral movement of the needle assembly relative to the housing in response to lateral displacement of the housing relative to the injection site. Alternatively or additionally, the external gastrointestinal interface can be configured to be tilted within the lumen relative to the housing. Thus, an injection device according to this disclosure can generally be considered to include: a housing configured to receive a drug container; and an external gastrointestinal interface including a needle assembly and a support disposed within a lumen in the housing. The support is mounted within the lumen such that the support can be displaced (e.g., tilted, rotated, or translated) relative to the housing while the external gastrointestinal interface is in the injection position.

[0013] By allowing the needle assembly to move relative to the housing when it is in the injection position, various embodiments of this disclosure can help reduce pain and irritation for the user, reduce drug leakage from the injection site, and help maintain the needle insertion depth within the desired range throughout the entire duration of use of the device.

[0014] In a first aspect, an injection device is provided, comprising a housing configured to receive a drug container; and a parenteral interface including a support disposed within a cavity in the housing. A needle assembly is mounted to the support and configured to deliver a dose of drug to an injection site. A flexible catheter is configured to deliver drug from the drug container to the needle assembly. The support is mounted on a plurality of springs coupled to a spring base disposed in the housing. Each spring has a longitudinal axis, and the longitudinal axes of the springs do not coincide.

[0015] The spring base can be part of the housing, i.e., a component fixedly mounted within the housing or needle insertion mechanism, which is configured to advance the needle assembly relative to the housing so that the needle assembly contacts the injection site to deliver the injection.

[0016] By mounting the external gastrointestinal interface on multiple springs, the external gastrointestinal interface can be configured to tilt, rotate, or translate relative to the housing so as to maintain (or assist in maintaining) contact between the external gastrointestinal interface and the injection site even during device displacement.

[0017] In a second aspect, an injection device is provided, comprising: a housing configured to receive a drug container; and a gastrointestinal interface including a support disposed within a cavity in the housing and a needle assembly mounted to the support and configured to deliver a dose of drug to an injection site. A flexible catheter is configured to deliver the drug from the drug container to the needle assembly. The support is movably mounted within the cavity, and a plurality of motors are configured to move the support relative to the housing to maintain contact between the gastrointestinal interface and the injection site.

[0018] By mounting the external gastrointestinal interface on multiple motor-driven actuators, the external gastrointestinal interface can be configured to tilt, rotate, or translate relative to the housing so as to maintain (or assist in maintaining) contact between the external gastrointestinal interface and the injection site even during device displacement.

[0019] In a third aspect, an injection device is provided, comprising a housing configured to receive a drug container and a parenteral interface. The parenteral interface includes a support and a needle assembly mounted to the support and configured to deliver a dose of drug to an injection site, the support being disposed within a lumen within the housing. A flexible catheter is configured to deliver drug from the drug container to the needle assembly. The support is rotatably mounted relative to the housing to allow rotation of the support within the lumen.

[0020] The swivel mount for the support can be configured to allow rotation about at least one of an axis substantially perpendicular to the surface of the injection site (thereby allowing the support to twist relative to the housing). The swivel mount for the support can also be configured to allow rotation about multiple axes. For example, the swivel mount can allow twisting relative to the housing and tilting of the support within the cavity.

[0021] By mounting the external gastrointestinal interface on a rotating mount, the external gastrointestinal interface can be configured to tilt, rotate, or translate relative to the housing so as to maintain (or assist in maintaining) contact between the external gastrointestinal interface and the injection site even during device displacement.

[0022] In a fourth aspect, an injection device is provided, comprising a housing configured to receive a drug container and a gastrointestinal interface. The gastrointestinal interface includes a support and a needle assembly mounted to the support and configured to deliver a dose of drug to an injection site, the support being disposed in a cavity within the housing. A flexible catheter is configured to deliver drug from the drug container to the needle assembly. The support is mounted on an elastically deformable mount connected within the cavity to the housing. The support includes an outer sidewall, the cavity includes an inner sidewall, and the outer sidewall of the support is separated from the inner sidewall of the cavity by a circumferential space extending around the outer sidewall of the support.

[0023] In any of the foregoing aspects, the needle assembly may include a hollow injection needle. Alternatively (or in addition), the needle assembly may include a microneedle array.

[0024] The housing may include a skin-contact surface comprising an adhesive portion configured to attach the device to a user's skin. Additionally or alternatively, further adhesive portions may be provided on the skin-facing surface of the support. In at least some embodiments, the injection device is a wearable injection device and includes a securing mechanism for attaching the device to the user's body.

[0025] The device may also include a mounting member connected to the support. The mounting member may take the form of a spring base, a deformable mounting member, or a rotatable mounting member as described above. The mounting member may be movably mounted within the housing to travel in a proximal direction to advance the support and thus the needle assembly from a retracted position to an extended position from the device housing toward the skin.

[0026] The device may also include an insertion mechanism configured to move a support and / or mount (e.g., a spring base, a deformable mount, or a rotatable mount) between a first position relative to the housing in which the needle assembly does not extend from the housing and a second position relative to the housing in which the needle assembly extends from the housing to be inserted into an injection site. The support and / or mount may be mounted within the housing to travel in a proximal direction to advance the needle assembly from a retracted position to an extended position from the device housing toward the skin.

[0027] Optionally, the injection device further includes a releasable locking mechanism configured to: (i) when the locking mechanism is active, hold the mounting member and / or support member in a first position relative to the housing in which the needle assembly does not extend from the housing; and when the locking mechanism is inactive, allow the support member and / or mounting member to move relative to the housing.

[0028] In one configuration, the releasable locking mechanism can be configured to: (i) when the locking mechanism is active, hold the support member in a first position relative to the mounting member in which a plurality of springs (or deformable materials) are compressed and the pin assembly does not extend from the housing; and (ii) when the locking mechanism is inactive, allow the support member to move relative to the mounting member in a second position in which the pin assembly extends from the housing under the influence of the plurality of springs (or deformable materials).

[0029] In some embodiments, the device further includes a deployment mechanism coupled to a support member, wherein the deployment mechanism is configured to move the support member between a first position in which the pin assembly does not extend from the housing and a second position in which the pin assembly extends from the housing. Optionally, the deployment mechanism may be removably coupled to the housing.

[0030] In any of the foregoing aspects and embodiments, the device may include one or more of the following mounting elements: multiple springs, resiliently deformable mounting elements, rotatably or pivotally mounted supports, motor-actuated supports, or any combination thereof. For example, a pivotally mounted support may be mounted on multiple springs to allow the support to twist relative to the housing (with minimal resistance), while the multiple springs bias the external gastrointestinal interface in a proximal direction to maintain contact between the needle assembly and the injection site. In another example, a motor-actuated support may be combined with a deformable mounting element to provide additional comfort to the user and help maintain uniform pressure at the injection site.

[0031] Therefore, the plurality of springs may include at least one helical spring. The plurality of springs may be fixed to a spring base. The spring base may be movably mounted in the housing. The spring base may be rotatably mounted in the housing. Alternatively or otherwise, the spring base may be pivotally mounted on the housing. In yet another embodiment, in combination with or as an alternative to rotatably and pivotally mounted components, the spring base may be movably mounted within the housing to travel in a proximal direction to advance the needle assembly from a retracted position to an extended position from the device housing toward the skin. In any embodiment, the plurality of springs may be configured to bias the support at a position where the needle extends beyond the skin contact surface of the housing.

[0032] The resiliently deformable mounting element may include a foam layer. The foam layer may be secured to a base. The base may be movable relative to the housing to travel in a proximal direction to advance the needle assembly from a retracted position to an extended position from the device housing toward the skin. Alternatively, the foam layer may be fixedly mounted within the housing. A spring base may be rotatably mounted within the housing. Alternatively or otherwise, the spring base may be pivotally mounted on the housing.

[0033] Any of the above embodiments may include a motor (or multiple motors) and at least one corresponding actuator configured to move the support relative to the housing to maintain contact between the extra-gastric interface and the skin at the injection site. The motor may be a servo motor. Each motor may be in communication with at least one sensor configured to sense detachment of the extra-gastric interface from the injection site. Optionally, at least one sensor is a microneedle electrode sensor. The sensor may be disposed on the skin-contact surface of the housing. Additionally or alternatively, at least one sensor may be disposed on the skin-facing surface of the support. The motor may be mounted to a motor base movably mounted within the housing. For example, the motor base may be rotatably mounted within the housing and / or pivotally mounted within the housing. In some configurations, the base may be movably mounted within the housing to travel in a distal direction to advance the needle assembly from a retracted position to an extended position toward the skin. In any of the above configurations, multiple motors may be configured to hold the support in a position where the needle extends beyond the skin-contact surface of the housing.

[0034] In any of the foregoing aspects and embodiments, the support member may be rotatably mounted relative to the housing. The support member may be rotatably mounted to a fixed component, such as the housing or a mounting member, or the support member may be fixedly mounted to a mounting member that is rotatably mounted relative to the housing.

[0035] Any of the above embodiments may further include a rotary joint configured to allow the support to rotate within the housing about an axis extending proximally from the device housing toward the skin. The support may be configured to pivot about a pivot point. In some embodiments, the support may be mounted relative to the housing via a ball joint. The support may be rotatably mounted to a support base movably mounted within the housing to travel distally to advance the needle assembly from a retracted position to an extended position. The aforementioned rotatable support may also include a plurality of springs (or other biasing devices) configured to bias the support to a position where the needle extends beyond the skin contact surface of the housing.

[0036] The support member can be positioned within a cavity of the housing to allow at least one of lateral, proximal, rotational, or pivotal movement of the support member relative to the housing. In some configurations, the cavity can be configured to allow lateral displacement of the support member relative to the housing. In such embodiments, the support member may include an outer sidewall, the cavity may include an inner sidewall, and the outer sidewall of the support member can be separated from the inner sidewall of the cavity by a circumferential space extending around the outer sidewall of the support member. For example, a foam layer can be separated from the inner sidewall of the cavity by a circumferential space.

[0037] This disclosure also provides associated methods for supporting the needle of an injection device at an injection site, and methods for manufacturing an injection device according to any aspect or embodiment of the foregoing.

[0038] Therefore, in a fifth aspect, a method for manufacturing an injection device is provided, the method comprising the steps of: providing a housing configured to receive a drug container, the housing further comprising a cavity having an opening on a skin-contact surface of the housing; providing an extragastric interface within the cavity of the housing, the extragastric interface including a support and a needle assembly mounted to the support and configured to deliver a dose of drug to an injection site, the extragastric support being disposed within the cavity of the housing; providing a flexible conduit configured to deliver drug from the drug container to the needle assembly; and mounting the support on a plurality of motors within the cavity, the plurality of motors being configured to maintain contact between the extragastric interface and the injection site.

[0039] In a sixth aspect, a method of manufacturing an injection device is provided, the method comprising the steps of: providing a housing configured to receive a drug container, the housing further comprising a cavity having an opening on a skin-contact surface of the housing; providing an extragastric interface within the cavity of the housing, the extragastric interface comprising a support and a needle assembly mounted to the support and configured to deliver a dose of drug to an injection site, the extragastric support being disposed within the cavity of the housing; providing a flexible conduit configured to deliver drug from the drug container to the needle assembly; and mounting the support to a plurality of springs coupled to a spring base disposed in the housing, each spring having a longitudinal axis and wherein the longitudinal axes do not coincide.

[0040] In a seventh aspect, a method of manufacturing an injection device is provided, the method comprising the steps of: providing a housing configured to receive a drug container, the housing further comprising a cavity having an opening on a skin-contact surface of the housing; providing an extragastric interface within the cavity of the housing, the extragastric interface comprising a support and a needle assembly mounted to the support and configured to deliver a dose of drug to an injection site, the extragastric support being disposed within the cavity of the housing; providing a flexible conduit configured to deliver drug from the drug container to the needle assembly; and mounting the support within the cavity, wherein the support is rotatably mounted relative to the housing to allow the support to rotate relative to the housing about at least one axis.

[0041] In an eighth aspect, a method of manufacturing an injection device is provided, the method comprising the steps of: providing a housing configured to receive a drug container, the housing further comprising a cavity having an opening on a skin-contact surface of the housing; providing an external gastrointestinal interface within the cavity of the housing, the external gastrointestinal interface comprising a support and a needle assembly mounted to the support and configured to deliver a dose of drug to an injection site, the external gastrointestinal support being disposed within the cavity of the housing; providing a flexible conduit configured to deliver drug from the drug container to the needle assembly; and mounting the support within the cavity to an elastically deformable mounting member connected to the housing, wherein the support includes an outer sidewall, the cavity includes an inner sidewall, and the outer sidewall of the support is separated from the inner sidewall of the cavity by a circumferential space extending around the outer sidewall of the support.

[0042] The methods in aspects five, six, seven and eight may also include the step of providing any of the features described above with reference to aspects one through four.

[0043] In a ninth aspect, a method is provided for supporting an injection device needle to prepare for injecting a drug, the method comprising: placing a device against an injection site, the device comprising: a housing having a cavity; an extragastric interface disposed within the cavity, wherein the extragastric interface includes a support and a needle assembly mounted to the support and configured to deliver a dose of drug to the injection site; a flexible catheter configured to deliver drug from a drug container to the needle assembly, wherein the support is movably mounted on a plurality of motors within the cavity, the plurality of motors being configured to maintain contact between the extragastric interface and the injection site; securing the injection device to the injection site using an adhesive disposed on the housing; and maintaining contact between the extragastric interface and the injection site by actuating at least one motor. Optionally, the plurality of motors are in communication with at least one sensor configured to detect detachment of the extragastric interface from the injection site, and wherein the motors are configured to actuate in response to the sensed detachment of the extragastric interface from the injection site.

[0044] In a tenth aspect, a method is provided for supporting a needle of an injection device to prepare for injection of a drug, the method comprising: placing a device against an injection site, the device comprising: a housing having a cavity; an external gastrointestinal interface disposed within the cavity, wherein the external gastrointestinal interface includes a support member and a needle assembly mounted to the support member and configured to deliver a dose of drug to the injection site, wherein the support member is mounted on a plurality of springs extending from a spring base within the housing, the plurality of springs having non-coincident longitudinal axes; securing the injection device to the injection site using an adhesive disposed on the housing; and compressing the springs between the support member and the spring base.

[0045] In an eleventh aspect, a method is provided for supporting an injection device needle to prepare for injection of a drug, the method comprising: placing a device against an injection site, the device comprising: a housing having a cavity; an external gastrointestinal interface disposed within the cavity, wherein the external gastrointestinal interface includes a support member and a needle assembly mounted to the support member and configured to deliver a dose of drug to the injection site, wherein a flexible conduit is configured to be in fluid communication with a drug container and the needle assembly, and wherein the support member is rotatably mounted relative to the housing to allow the support member to rotate within the cavity; securing the injection device to the injection site using an adhesive disposed on the housing; and contacting the external gastrointestinal interface with the injection site.

[0046] In a twelfth aspect, a method is provided for supporting a needle of an injection device to prepare for injection of a drug, the method comprising: placing a device against an injection site, the device comprising: a housing having a cavity; an external gastrointestinal interface disposed within the cavity, wherein the external gastrointestinal interface includes a support member and a needle assembly mounted to the support member and configured to deliver a dose of drug to the injection site, wherein the support member is mounted on an elastically deformable mounting member connected within the cavity to the housing, and wherein: the support member includes an outer sidewall; the cavity includes an inner sidewall, and the outer sidewall of the support member is connected to the inner sidewall of the cavity through a circumferential space extending around the outer sidewall of the support member; securing the injection device to the injection site using an adhesive disposed on the housing; and compressing an elastically deformable material between the support member and the housing.

[0047] Further advantages and additional embodiments will become apparent from the following detailed description and accompanying drawings. Attached Figure Description

[0048] The invention will be described in more detail with reference to a number of non-limiting exemplary embodiments shown in the following figures, wherein:

[0049] Figure 1A A schematic side view of a wearable injection device placed against the injection site is shown;

[0050] Figure 1B A side view of an autoinjector positioned against the injection site is shown;

[0051] Figure 1C A schematic top view of a wearable injection device placed against the injection site is shown;

[0052] Figure 2A A cross-sectional side view of the injection device according to the first embodiment is shown;

[0053] Figure 2B It shows during the impact Figure 2A Injection device;

[0054] Figure 3A A cross-sectional side view of the injection device according to the second embodiment is shown;

[0055] Figure 3B It shows during the impact Figure 3A Injection device;

[0056] Figure 4A A cross-sectional side view of the injection device according to the third embodiment is shown;

[0057] Figure 4B It shows during the impact Figure 4A Injection device;

[0058] Figure 5A A cross-sectional side view of the injection device according to the fourth embodiment is shown;

[0059] Figure 5B It shows during the impact Figure 5A Injection device;

[0060] Figure 6A A cross-sectional side view of the injection device according to the fifth embodiment is shown;

[0061] Figure 6B It shows during the impact Figure 6A Injection device;

[0062] Figure 7A A cross-sectional side view of the injection device according to the sixth embodiment is shown;

[0063] Figure 7B It shows during the impact Figure 7A Injection device;

[0064] Figure 8 A cross-sectional side view of the injection device according to the seventh embodiment is shown;

[0065] Figure 9 A cross-sectional side view of the injection device according to the eighth embodiment is shown;

[0066] Figure 10A A cross-sectional side view of the injection device according to the ninth embodiment is shown, wherein the needle assembly is in the retracted position;

[0067] Figure 10B It shows Figure 10A A cross-sectional side view of the injection device, in which the needle assembly is in the extended position;

[0068] Figure 11A A cross-sectional side view of the injection device according to a tenth embodiment is shown, wherein the needle assembly is in the retracted position;

[0069] Figure 11B It shows Figure 11A A cross-sectional side view of the injection device, in which the needle assembly is in the extended position.

[0070] Throughout the accompanying drawings, the same reference numerals are used for the same parts. Detailed Implementation

[0071] This disclosure generally relates to systems and methods for supporting a parenteral interface at an injection site. Specifically, the systems and methods described herein are configured to maintain the position and depth of the needle assembly on the skin surface in the event of displacement of the housing of the injection device.

[0072] Figure 1A A schematic side view of a wearable injection device placed against an injection site is shown. The injection device 110 is placed against skin 112 and secured in place with adhesive or other attachment means. A needle 114 extends from the housing 116 of the injection device and penetrates the skin to deliver a therapeutic agent to the patient. Typically (though not always), the housing 116 of the device 110 also includes a container 118 for storing medication and a conduit 120 providing fluid communication between the container 118 and the needle 114. A drive system (not shown) is also typically housed in the housing 116 and configured to drive medication through the conduit 120 from the container 118 for delivery via the needle 114. The drive system may include a mechanical actuator (e.g., a spring or clock mechanism) and / or an electrical actuator (e.g., a motor) configured to deliver medication. An actuator, such as a button 122, may be provided on the housing 116 so that a user can trigger the initiation of the injection. However, those skilled in the art will understand that a mechanical actuator is not required, and the device can be controlled and actuated electronically, for example, using a remote device that communicates wirelessly with the drive system.

[0073] exist Figure 1A In the illustrated device, needle 114 is fixedly mounted relative to housing 116, typically at least for the duration of injection. This means that if housing 116 is struck, causing lateral displacement of housing 116 relative to skin 112, needle 114 will also displace laterally, potentially causing pain and irritation to the user. Lateral displacement of housing 116 (in the xy plane) may impair the connection between needle 114 and catheter 120 or dislodge needle 114 from the injection site, potentially leading to drug leakage from the device and poor dosage control.

[0074] Despite Figure 1A Not shown, but it should also be understood that axial displacement of the housing 116 (in the z-direction) may also alter the depth of needle insertion. This, in turn, may adversely affect the device's ability to properly deliver medication to the patient.

[0075] Figure 1B This illustrates how a similar problem might occur with a conventional autoinjector. Figure 1B An autoinjector 180 is shown placed against the skin 112 at the injection site during injection. Figure 1B As shown, the autoinjector 180 includes a housing 186 and a needle 184. Because the needle 184 is fixed in position relative to the housing 186 during injection, movement of the housing 186 relative to the injection side during injection causes movement of the needle 184, which may result in pain or suboptimal drug delivery. However, since drug delivery via an autoinjector typically takes 10-120 seconds and is patient-controlled, self-aligning the needle can be used to make delivery more comfortable and / or result in severe knocking when withdrawing the needle.

[0076] Figure 1C It shows something similar to Figure 1A Another wearable injection device 190 of the device 110. However, although Figure 1A The device 110 includes a conventional cannula for delivering medication to the injection site, but Figure 1C The device 190 includes a hollow microneedle array (MNA) 194. The microneedle array 194 is arranged within a cavity on the lower side of the housing 116 (similar to...). Figure 1A The cavity shown is configured to be in fluid communication with the container 118 via the conduit 120.

[0077] exist Figure 1C In this device, the microneedle array 194 is fixedly mounted relative to the device housing 116 (during injection), and any impact that causes the housing 116 to rotate relative to the skin at the injection site (e.g., in the xy plane) may cause the microneedle array 194 to twist relative to the skin. This rotational displacement may cause pain and irritation to the user, but may also cause the microneedle array 194 to detach from the injection site at the correct depth, resulting in drug leakage and poor dosage control.

[0078] In each of the above configurations, the displacement of the injection device housing relative to the injection site also causes displacement of the needle assembly relative to the injection site, resulting in user pain and discomfort, irritation or damage to the injection site over time, and the risk of suboptimal drug delivery. Now turning to... Figures 2A to 9At least some of the disadvantages described above can be addressed or reduced by embodiments of this disclosure. Typically, each embodiment described below includes an injection device with a parenteral interface, the parenteral interface including a needle assembly configured to deliver a drug to an injection site and a position configured to support the needle assembly therein, placing the needle assembly in an injection-ready position. A support is movably mounted relative to the housing to allow the parenteral interface to move relative to the housing during injection to isolate (or insulate) the parenteral interface from impacts to the housing. The support may be movably mounted or a deformable or flexible material coupling the support to the housing, or its position may be actively controlled using an actuator configured to move the support relative to the housing in response to sensed or detected movement of the housing relative to the injection site. In some embodiments, the device may be configured to actively control the position of the support relative to the housing in response to sensed dislocation (or reduced contact pressure) of the housing or needle assembly. In other embodiments, the external gastrointestinal interface may include a resiliently deformable support member configured to deform upon displacement of the injection portion associated with the housing, thereby isolating the external gastrointestinal interface from the housing and allowing the external gastrointestinal interface to maintain its position at the injection site. Allowing movement of the external gastrointestinal interface relative to the housing of the injection device can allow maintaining needle penetration depth throughout the injection process, even if the housing of the device shifts relative to the skin (e.g., by tapping a wearable device or by an unstable grip on a handheld device). Allowing the external gastrointestinal interface to suspend or float independently of the housing relative to the delivery system can mitigate discomfort caused by dislocation of the device from its original position on the body surface.

[0079] Figure 2A and Figure 2B A first embodiment of the injection device according to the present disclosure is shown. Figure 2A An injection device is shown in an undisturbed position positioned against the injection site. (Example) Figure 2A As shown, the injection device 210 includes a housing 216 configured to rest against the skin 212 at the injection site. The device also includes a needle assembly, here in the form of a hollow injection needle 214 configured to deliver medication from a container (not shown) to the injection site via a conduit 220. An adhesive layer 222 is provided to secure the injection device 210 to the skin 212. The adhesive layer 222 is disposed on the lower surface of the housing 216 (i.e., the surface facing the skin). The housing 216 includes a cavity 224 in which the needle assembly is disposed. The needle assembly forms part of a gastrointestinal interface configured to deliver medication from a medication container (not shown) to the needle 214. The gastrointestinal interface includes the needle 214 and a support 226 on which the needle 214 is mounted. The support 226 is mounted relative to the housing 216 on a resiliently deformable mounting member 228. Figure 2A In the illustrated embodiment, the elastically deformable mounting element 228 includes a flexible foam layer.

[0080] The conduit 220, which connects the container (not shown) to the needle 214, is flexible along at least a portion of its length. The flexibility of the conduit is configured to allow movement of the needle 214 relative to the housing 216, as will now be referred to. Figure 2B To describe in more detail.

[0081] Figure 2B This illustrates the impact during which the housing 216 is laterally displaced relative to the injection site. Figure 2A Device 210. Displacement of housing 216 relative to skin 212 is indicated by arrow A. When housing 216 is displaced, adhesive layer 222 attaching device 210 to skin 212 is stretched. Detachment of housing 216 from skin 212 may also occur if housing 216 is detached from skin 212 (e.g., at the point indicated by arrow D).

[0082] like Figure 2B As shown, the flexible foam layer 228 is configured to deform to allow the housing 216 to move relative to the injection site without displacing the needle 214. The flexible catheter 220 also allows the needle 214 and the support 226 to move relative to the housing, thereby allowing the catheter to adapt to the movement of the needle 214 relative to the housing without interrupting the drug supply through the catheter 220.

[0083] Because the external gastrointestinal interface (including support 226 and needle 214) is not rigidly connected to the housing 216, displacement of the housing 216 relative to the injection site will not (or to a lesser extent) cause displacement of the needle 214. Instead, the flexible foam layer 228 and the flexible catheter 220 allow the external gastrointestinal interface to remain attached to the injection site while the housing 216 is displaced (laterally or otherwise).

[0084] exist Figure 2A and Figure 2B In the illustrated embodiment, the housing 216 is secured to the skin 212, with an adhesive layer 222 disposed on the underside of the housing 216. During injection, the gastrointestinal interface remains in contact with the skin 212 due to its position relative to the housing 216. In at least some embodiments, the support 226 may also include an adhesive layer configured to maintain contact between the gastrointestinal interface and the injection site. Figure 2A and Figure 2B (Not shown in the image). This adhesive layer can be disposed on the support 226 of the external gastrointestinal interface, on the skin-facing surface of the support 226. Although in some embodiments, the adhesive layer disposed on the external gastrointestinal interface may be advantageous, this feature is optional. Inserting the needle 214 into the skin serves to prevent lateral displacement of the needle 214 relative to the injection site.

[0085] Despite Figure 2A and Figure 2B Although not indicated by arrows, the flexible foam layer 228 also serves to prevent variations in needle penetration depth at the injection site. This is likely due to the flexible nature of the foam layer, which can be configured to compress and expand in the z-direction (the direction along the axis of needle 214). The compression or expansion of the flexible foam layer can also be configured to assist in biasing needle 214 into the injection position. For example, the flexible foam layer 228 can be configured to bias support 226 in a position where the skin contact surface of support 226 protrudes beyond the underside of housing 216. Placement of injection device 210 against skin 212 can compress the flexible foam layer 228. By configuring injection device 210 such that the flexible foam layer... Figure 2A The position shown is slightly compressed by the device, and the flexible foam layer can be configured to expand when the housing 216 is pulled away from the injection site, thereby maintaining the insertion depth of the needle 214, or at least providing cushioning to prevent the needle 214 from being withdrawn from the injection site.

[0086] To allow lateral displacement of the external gastrointestinal interface (including support 226 and needle 214) relative to housing 216 (e.g.) Figure 2B As shown, a circumferential space 230 is provided between the support 226 and the sidewall 224a of the cavity 224. It should be understood that the circumferential space 230 allows the rigid support 226 to move laterally within the cavity 224, which has rigid walls. However, in some embodiments, the circumferential space 230 may be omitted, for example, where the diameter of the support is smaller than the diameter of the flexible foam layer, or where the support is also formed of a flexible material.

[0087] Figure 3A and Figure 3B A second embodiment of the injection device according to this disclosure is shown. Figure 3A and Figure 3B The injection device 310 shown is similar to Figure 2A and Figure 2B The injection device 210 shown is similar to... Figure 2A , Figure 3A The device 310 is shown in a stationary position (non-displaced position). Figure 3B The device 310 is shown during an impact that displaces the device 310 relative to the skin 212 at the injection site.

[0088] Device 310 includes a housing 316 configured to be secured in place against the skin using an adhesive layer 322 or an adhesive patch. Housing 316 includes a cavity 324 accommodating a gastrointestinal external interface comprising a support 326 (or another suitable resiliently deformable mount) mounted on a flexible foam layer 228. The cavity includes sidewalls 324a separated from the support 326 by an optional circumferential space 330. In device 310 and... Figure 2A and Figure 2B In different cases, the device 210 takes the form of a needle assembly. (Refer to...) Figure 2A and Figure 2B In the described implementation, the external gastrointestinal interface includes a single needle 214 mounted on a support 226. However, in Figure 3A and Figure 3B In the illustrated embodiment, the needle assembly takes the form of a microneedle array 294, which includes multiple microneedles configured to deliver drug to the injection site. Therefore, the flexible catheter 320 is configured to supply the microneedle array 394 to a location connected to a single hollow injection needle, such as... Figure 2A and Figure 2B As shown.

[0089] Similar to Figure 2A and Figure 2B In the embodiment shown, when the housing 316 is displaced relative to the injection site, the flexible foam layer deforms to allow the housing 316 to move relative to the injection site, while allowing the microneedle array 394 to remain in place.

[0090] It should be understood that by mounting the support member of the above-described embodiment onto a resiliently deformable mounting element (such as a flexible foam layer), the support member can be movably mounted relative to the housing to isolate the external gastrointestinal interface from the housing. Although the above-described embodiment is depicted with a flexible foam layer, other deformable materials may also be used. For example, gel-based layers or rubber-based layers may also be used. Furthermore, it is envisioned that the deformable mounting element may comprise a material layer or multiple discrete portions of a material. For example, multiple deformable portions may form a deformable mounting element placed adjacent to each other (and optionally adjacent), or spaced apart between discrete portions of a deformable material. Flexible foam may be particularly suitable for some embodiments where ease of assembly is of paramount importance. For example, the support member may be glued to appropriate locations on a flexible material layer, which itself may be glued to components within the housing.

[0091] It should also be understood that the aforementioned deformable mounting element does not need to be statically mounted relative to the housing. For example, the aforementioned feature can be implemented in an injection device including a movable needle hub configured to advance the needle from a retracted pre-injection position (where the needle does not extend from the housing) to an advanced injection position (where the needle extends from the housing to penetrate the injection site). In such embodiments, the elastically deformable mounting element can be disposed between the support member and the needle hub component.

[0092] Turn now Figure 4A and Figure 4B The third embodiment according to this disclosure will be described. Figure 4A and Figure 4B The implementation shown is largely similar to the reference. Figure 2A and Figure 2B The described implementation scheme. Similar to... Figure 2A , Figure 4A The device 410 is shown in a stationary position (non-displaced position). Figure 4B The device 410 is shown during an impact that displaces the device 410 relative to the skin 212 at the injection site.

[0093] like Figure 4A As shown, device 410 includes a housing 416 configured to be secured against the skin 212 at the injection site using an adhesive 422. Housing 416 includes a cavity 424 configured to receive a gastrointestinal external interface comprising a support 426 and a needle assembly, here in the form of a hypodermal injection needle 414. The needle 414 is configured to be positioned in fluid communication with a drug container (not shown) via a flexible conduit 420. Cavity 424 includes a sidewall 424a and a circumferential gap 430 extending between the outer surface of the support 426 and the sidewall 424a of the cavity. The circumferential gap 430 allows lateral movement of the support 426 within cavity 424 to allow displacement of the needle 414 relative to housing 416 of device 410.

[0094] Although the support 226 of the device 210 is mounted on the flexible foam layer, Figure 4A In the illustrated embodiment, the support 426 is mounted on a plurality of springs 432, which are configured to deform to allow the support 426 to move relative to the housing 416, such as Figure 4B As shown. The springs 432 are arranged such that they are not coaxial with each other. The springs 432 are further advantageously arranged symmetrically with respect to the needle 414 to ensure that force is applied uniformly to the injection site in the z-direction of the needle 414. The non-coaxial arrangement allows the support 426 to be stably mounted on a plurality of smaller diameter springs, which allows the support 426 to move laterally relative to the housing 416.

[0095] In some embodiments, the support 426 may be mounted on two springs arranged symmetrically with respect to the needle 414, such as on opposite sides. In other embodiments, one, three, four or more springs may be provided, arranged coaxially with each other to movably support the support 426 relative to the housing.

[0096] Figure 5A and Figure 5B A fourth embodiment of the injection device according to this disclosure is shown. Figure 5A and Figure 5B The injection device 510 shown is similar to Figure 4A and Figure 4B The injection device 410 shown is similar to... Figure 4A , Figure 5A The device 510 is shown in a stationary position (non-displaced position). Figure 5B The device 510 is shown during an impact that displaces the device 510 relative to the skin 212 at the injection site.

[0097] Device 510 includes a housing 516 configured to be secured in place against the skin using an adhesive layer 522 or an adhesive patch. Housing 516 includes a cavity 524 accommodating a gastrointestinal external interface, which includes a support 526 mounted on a plurality of springs 534. The cavity includes sidewalls 324a separated from the support 526 by an optional circumferential space 530. In device 510 and... Figure 4A and Figure 4B In different cases of device 510, the device takes the form of a needle assembly. (Refer to...) Figure 4A and Figure 4B In the described implementation, the external gastrointestinal interface includes a needle 414 mounted on a support 426. However, in Figure 5A and Figure 5B In the illustrated embodiment, the needle assembly takes the form of a microneedle array 594, which includes multiple microneedles configured to deliver medication to the injection site. Therefore, the flexible catheter 520 is configured to supply the microneedle array 594 to a location connected to a single hollow injection needle, such as... Figure 4A and Figure 4B As shown.

[0098] Similar to Figure 4A and Figure 4B In the illustrated embodiment, when the housing 516 is displaced relative to the injection site, the spring 534 deforms to allow the housing 516 to move relative to the injection site while allowing the microneedle array 594 to remain in place.

[0099] It should be understood that by mounting the support member of the above embodiment on multiple springs, the support member can be movably mounted relative to the housing to isolate the external gastrointestinal interface from the impact on the housing. Although the above embodiment is depicted with multiple helical springs, other springs may also be used. For example, multiple leaf springs, conical springs, or other springs may also be used. Using a spring as an elastically deformable mounting element between the support member and the housing may be particularly suitable for some embodiments where it may be desirable for the support member to be biased toward the skin-mounted needle assembly. For example, in some embodiments, the spring may be configured to bias the support member to a position where the skin-facing surface of the support member extends beyond the lower surface of the housing, such that the spring is slightly compressed as the external gastrointestinal interface comes into contact with the injection site. By configuring the device such that the spring... Figure 5A The position shown is slightly compressed by the device, and the spring can be configured to expand when the housing 516 is pulled away from the injection site, thereby maintaining the insertion depth of the needle assembly, or at least providing a buffer to prevent the needle assembly from being withdrawn from the injection site.

[0100] It should also be understood that the mounting element of the aforementioned deformable spring does not need to be statically mounted relative to the housing. For example, the aforementioned feature can be implemented in an injection device including a movable needle hub configured to advance the needle from a retracted pre-injection position (where the needle does not extend from the housing) to an advanced injection position (where the needle extends from the housing to penetrate the injection site). In such embodiments, the spring mounting element can be disposed between the support member and the needle hub component.

[0101] Figure 6A and Figure 6B Another embodiment of the injection device according to this disclosure is shown. Figure 6A and Figure 6B The illustrated embodiment shows device 610, which employs an active displacement compensation system for maintaining contact between the gastrointestinal external interface and the skin. Similar to the foregoing figures, Figure 6A A device 610 is shown in a non-displaced position relative to the injection site, while Figure 6B The device 610 is shown when the housing is displaced by an external device.

[0102] like Figure 6A As shown, device 610 is similar to devices 210, 310, 410 and 510 described above, and includes a housing 616, an adhesive layer or one or more adhesive patches 622 configured to secure device 610 against the skin 212 at the injection site.

[0103] The device 610 also includes a cavity 624 that accommodates an external gastrointestinal interface, which includes a needle assembly (in this case, a subcutaneous injection needle 614) and a support 626 that supports the needle assembly 614. The needle 614 is in fluid communication with a flexible catheter 620 configured to deliver medication from a drug container to the needle 614.

[0104] Instead of a passive external gastrointestinal interface positioning system (such as an elastically deformable layer or the aforementioned spring), device 610 includes an active external gastrointestinal interface positioning system comprising one or more actuators 636 coupled to a motor (multiple motors) and configured to actively control the positioning of support 626 within cavity 624. For example, the active external gastrointestinal interface positioning system may include one or more servo motors configured to drive one or more retractable actuators 636 configured to advance support 626 relative to housing 616 in the z-direction. The servo motors may be positioned in communication with one or more sensors 638 configured to sense detachment of housing 616 and / or the external gastrointestinal interface from skin 212. A controller (not shown) is configured to control activation of the servo motors and extension of the retractable actuators in response to the sensed detachment of device 610 from skin 212.

[0105] Sensor 638 may be disposed on the lower surface of housing 616 and configured to sense detachment of housing 616 from skin 212. Figure 6B The diagram schematically illustrates the activation of actuator 636 to correct for the sensed detachment of housing 616 from skin 212.

[0106] exist Figure 6A and Figure 6B In the illustrated embodiment, two actuators 636 are shown, each configured to be driven by an associated motor. Two sensors 638 are also provided, one sensor associated with each actuator 636. In this embodiment, the sensor on the right side senses disengagement (see [reference]). Figure 6B The detachment (indicated by arrow D) causes actuation of actuator 636 to prevent support 626 from detaching from the injection site. Actuator 636 is actuated in response to a detachment sensed on one side of housing 616, the external gastrointestinal interface, and specifically, support 626 can be configured to tilt relative to housing to compensate for asymmetrical detachment of housing 616 from the skin surface. If necessary, suitable mechanical fixation can be provided between support 626 and actuator 636 to allow support 626 to pivot relative to the telescopic actuator.

[0107] exist Figure 6A and Figure 6BIn the illustrated embodiment, sensor 638 is configured as a microneedle sensor. Each sensor 638 is configured as a microneedle array attached to a housing 616 of device 610. The microneedle array may be configured to characterize skin-electrode contact force. A method for determining the skin-electrode contact force between the microneedle array sensor 638 and the skin (e.g., skin 212 at the injection site) can be achieved by analyzing the signal-to-noise ratio of an ECG signal sensed using the microneedle array as a “dry electrode,” which depends on the contact force between the skin and the microneedle array. An exemplary technique for contact force analysis is described in “Design, fabrication, and skin-electrode contact analysis of polymer microneedle-based ECG electrodes,” Journal of Micromechanics and Microengineering, Vol. 26 (2016), O’Mahony, Conor, et al., the entire contents of which are incorporated herein by reference.

[0108] Those skilled in the art will understand that other sensors can be used to determine the correct placement of the needle assembly relative to the injection site. For example, in addition to (or as an alternative to) microneedle sensors configured as ECG electrodes, capacitive or “touch” sensors can be used to detect contact between the support and the injection site. Displacement sensors can also be used to detect whether the support has shifted from its correct position of contact with the injection site. Microneedle sensors configured to detect contact with interstitial fluid in the skin can also be used. Other suitable sensors suitable for use in conjunction with this invention, based on this disclosure, will be apparent to those skilled in the art.

[0109] It should also be understood that, although Figure 6A and Figure 6B The illustrated implementation includes two sensors, two motors, and two actuators, but other combinations are possible. For example, one sensor, one actuator, and one motor can be configured. Alternatively, one, two, three, or more sensors, motors, and actuators can be configured. Those skilled in the art will also understand that the sensors, actuators, and motors do not need to be configured in a 1:1:1 ratio. Instead, multiple sensors can provide feedback to the controller to actuate one or more actuators. Similarly, multiple actuators can be driven (selectively) by a single motor.

[0110] Furthermore, despite Figure 6A and Figure 6B The illustrated embodiment includes a circumferential space 630 between the outer edge of the support 626 and the inner wall 624a of the cavity 624, but this arrangement is not required in all configurations, as described above.

[0111] As an alternative to (or as an addition to) sensors mounted on the housing, sensors 638 may be mounted on the support 626 (and optionally as part of a drug delivery microneedle array) such that they are configured to detect disengagement of the support 626 from the skin 212 and to advance the support 626 to prevent disengagement from the skin 212, thereby maintaining the needle insertion depth at the injection site.

[0112] Figure 7A and Figure 7B Another embodiment of the injection device according to this disclosure is shown. Figure 7A and Figure 7B The injection device 710 shown is similar to Figure 6A and Figure 6B The injection device 610 shown is similar to... Figure 6A , Figure 7A The device 710 is shown in a stationary position (non-displaced position). Figure 7B The device 710 is shown during an impact that displaces the device 710 relative to the skin 212 at the injection site.

[0113] Device 710 includes a housing 716 configured to be held in place against the skin using an adhesive layer 722 or an adhesive patch. The housing 716 includes a cavity 724 accommodating a gastrointestinal external interface, which includes a support 726 mounted on at least one actuator 736, the actuator being motor-driven in response to detachment of the housing 716 from the skin 212 sensed by a sensor 738. The cavity includes sidewalls 724a separated from the support 726 by an optional circumferential space 730. In device 710 and... Figure 6A and Figure 6B In different cases of device 710, the device takes the form of a needle assembly. (Refer to...) Figure 6A and Figure 6B In the described implementation, the external gastrointestinal interface includes a needle 614 mounted on a support 726. However, in Figure 7A and Figure 7B In the illustrated embodiment, the needle assembly takes the form of a microneedle array 794, which includes multiple microneedles configured to deliver drug to the injection site. Therefore, the flexible catheter 720 is configured to supply the microneedle array 794 to a location connected to a single hollow injection needle, such as... Figure 6A and Figure 6B As shown.

[0114] Similar to Figure 6A and Figure 6BIn the embodiment shown, when the housing 716 is displaced relative to the injection site, the actuator 736 is configured to actively reposition the support 726 relative to the housing in response to the detachment of the housing 716 from the skin 212 sensed by the sensor 738.

[0115] exist Figures 6A to 7B In the illustrated embodiment, the sensor is positioned on the underside of the housing and configured to sense the housing's detachment from the skin, allowing the actuator to compensate for the sensed displacement of the housing by advancing (or retracting) the external enteral interface relative to the skin, thereby maintaining the desired contact pressure and / or insertion depth between the needle assembly and the skin at the injection site. Alternatively or additionally, the sensor may be disposed on a support of the external enteral interface to directly sense the contact pressure of the external enteral interface against the skin, and the aforementioned actuator may be used to actively compensate for the sensed displacement.

[0116] It should be understood that by mounting the support of the above embodiment on one or more actuators driven by one or more motors configured to reposition the extracorporeal interface relative to the housing in response to disengagement of the device from the injection site, the support is movably mounted relative to the housing to isolate the extracorporeal interface from impacts on the housing. Although the above embodiment has been described with reference to a telescopic actuator driven by an associated servo motor, other configurations may also be used. The use of an active extracorporeal interface positioning system that allows positioning of the extracorporeal interface relative to the housing may be particularly suitable for some embodiments, such as those in which it is desirable to maintain a constant contact pressure between the extracorporeal interface and the injection site. This may be particularly advantageous in the context of wearable devices in which the needle assembly includes a microneedle array, as the penetration depth of the microneedles can be ideally and tightly controlled throughout the injection duration to prevent leakage. By configuring the device such that the contact force between the extracorporeal interface and the injection site is actively maintained, the insertion depth of the needle assembly can be maintained even if the housing is pulled away from the injection site.

[0117] It should also be understood that the aforementioned active extragastric positioning system does not need to be statically mounted relative to the housing. For example, the aforementioned features can be implemented in an injection device including a movable needle hub configured to advance the needle from a retracted pre-injection position (where the needle does not extend from the housing) to an advanced injection position (where the needle extends from the housing to penetrate the injection site). In such embodiments, an actuator 636 can be disposed between the support and the needle hub assembly. Alternatively, the actuator 636 can be configured to control the insertion of the needle assembly prior to injection.

[0118] Turn now Figure 8 and Figure 9 The paper describes an alternative embodiment that allows the external gastrointestinal interface to move relative to the housing.

[0119] Figure 8 A device 810 similar to the devices 210, 310, 410, 510, 610, and 710 described above is shown. However, instead of using springs, deformable materials, or actuators to maintain the position of the external gastrointestinal interface relative to the injection site, Figure 8 The implementation scheme includes a support for the rotational mounting of the needle assembly.

[0120] like Figure 8 As shown, device 810 includes a housing 816 configured to be secured in place against skin 212 using an adhesive layer 822 or adhesive patch. Housing 816 includes a cavity 824 accommodating a gastrointestinal external interface, which includes a support 826 rotatably mounted relative to housing 816. The pivoting mount can be provided by a universal joint 840 or a ball joint. Other rotary joint configurations are possible, and smaller rotational degrees of freedom than ball joints or universal joints can be provided. For example, a simple torsion joint can be provided to allow support 826 to rotate about a single axis relative to housing 816.

[0121] The support 826 is configured to rotate about at least one axis, such as the z-axis. Rotating the support 826 relative to the housing 816 about the z-axis ensures that rotation of the housing 816 relative to the skin in the xy-plane does not cause the needle 814 to twist within the injection site. In at least some embodiments, the support 826 may be configured to rotate about all three axes (x, y, z) to allow the support to pivot within the cavity 824, thereby maintaining contact between the external gastrointestinal interface and the skin even if the housing 816 of the device is twisted or removed from the injection site.

[0122] like Figure 8 As shown, cavity 624 includes sidewalls 824a that are separated from support 826 by an optional circumferential space 830. The circumferential space allows the external gastrointestinal interface to tilt and pivot within cavity 824 to maintain contact with the skin 212 at the injection site.

[0123] Figure 9 A device 910 similar to the device 810 described above is shown. In device 910 and... Figure 8 In different cases of device 810, the device takes the form of a needle assembly. (Refer to...) Figure 8 In the described implementation, the external gastrointestinal interface includes a needle 814 mounted on a support 826. However, in Figure 9 In the illustrated embodiment, the needle assembly takes the form of a microneedle array 994, which includes multiple microneedles configured to deliver medication to the injection site. Therefore, the flexible catheter 920 is configured to supply the microneedle array 994 to a location connected to a single hollow injection needle, such as... Figure 8 As shown.

[0124] Similar to Figure 8 In the embodiment shown, when the housing 916 is displaced relative to the injection portion, the support 926 is configured to tilt and / or rotate relative to the housing to maintain contact between the support 926 and the skin 212.

[0125] It should be understood that the support of the embodiment is installed rotatably, for example around a pivot point, universal joint, or ball joint, as described above, so as to isolate the external gastrointestinal interface from the impact on the housing.

[0126] It should also be understood that the universal joint mount (or other swivel mount for supporting the aforementioned needle support) does not need to be statically mounted relative to the housing. For example, the aforementioned features can be implemented in an injection device including a movable needle hub configured to advance the needle from a retracted pre-injection position (where the needle does not extend from the housing) to an advanced injection position (where the needle extends from the housing to penetrate the injection site). In such embodiments, the swivel mount can be positioned between the support and the needle hub assembly.

[0127] Turn now Figure 10A and Figure 10B This describes yet another implementation scheme including an insertion mechanism. Figure 10A and Figure 10B A device 1010 similar to the devices 210, 310, 410, 510, 610, 710, 810, and 910 described above is shown. Device 1010 differs from the aforementioned devices because it includes an insertion mechanism configured to withdraw the needle assembly (here, the microneedle array 1094) from a retracted position in which the needle assembly does not extend from the housing 1016 of device 1010. Figure 10A As shown, the needle assembly is advanced to an extension position where it extends from the housing 1016 to contact the skin at the injection site. Figure 10B (As shown).

[0128] The insertion mechanism includes a support base 1052, which is movably mounted relative to the housing 1016 and configured in a first position. Figure 10A (as shown) to the second position ( Figure 10B The device moves between (shown) a first position and a second position; and an actuator 1050 configured to move a support base 1052 between a first position and a second position. The actuator 1050 is any suitable mechanism for advancing the needle assembly to the injection position. It may include a power source, such as a mechanical spring or a motor-driven actuator configured to move the support base 1052 to the second position.

[0129] Support base 1052 Figure 10A and Figure 10BIn the configuration shown, the connection to the external gastrointestinal interface 1026 is via multiple springs 1032. However, those skilled in the art will recognize that, as referenced... Figure 10A and Figure 10B The described insertion mechanism can be constructed to include the components described in Figures 1 to 14 above. Figure 9 Any gastrointestinal external interface support arrangement described.

[0130] The insertion mechanism can be configured to advance the support 1026 to a position where the gastrointestinal external interface extends beyond the lower surface of the housing when the spring 1032 is not compressed (e.g., Figure 10B (As shown). This configuration advantageously ensures that when the device is fixed against the skin at the injection site, the spring 1032 is slightly compressed, thereby biasing the gastrointestinal external interface toward the skin to maintain contact with the injection site, even if the device will undergo temporary or prolonged dislocation relative to the injection site.

[0131] Figure 10A and Figure 10B Also shown is a releasable locking mechanism 1054, which is configured to hold the insertion mechanism in the active position as an optional additional feature. Figure 10A (As shown). The releasable locking mechanism 1054 is shown here as a latch arm, which is configured to engage the support base 1052 to prevent the support base 1052 from advancing to the second position.

[0132] like Figure 10B As shown, the latch arm of the releasable locking mechanism 1054 forming this configuration can be deflected to an inactive position (see...). Figure 10B This allows the support base 1052 to advance relative to the housing 1016, thereby allowing the external gastrointestinal interface and needle assembly to extend to the injection site. Although Figure 10A and Figure 10B The image shows a flexible latch arm, but those skilled in the art will understand that other releasable locking arrangements are possible.

[0133] Now refer to Figure 11A and Figure 11B Another embodiment of the invention is described below. Figure 11A and Figure 11B A device 1110 similar to the devices 210, 310, 410, 510, 610, 710, 810, and 910 described above is shown. Device 1110 differs from the aforementioned devices because it includes a deployment mechanism 1160 configured to deploy a needle assembly (here, a microneedle array 1194) to the injection site. Figure 11A and Figure 11B As shown, the deployment mechanism is configured to move the needle assembly from a retracted position in which the needle assembly does not extend from the housing 1116 of the device 1110 (see [reference]). Figure 11AThe needle assembly extends from the housing 1016 to contact the skin at the injection site (see [link]). Figure 11B The extended position of ).

[0134] The deployment mechanism 1160 here takes the form of a manually deployed actuator configured to allow a user to advance a parenteral interface, including a needle assembly (here, the microneedle array 1194), to the injection site. The deployment mechanism 1160 at its first end 1162 takes the form of a key engaging a support 1126 for the parenteral interface. The key extends through a channel in the housing 1116 to a second end, which includes an actuating member 1164 or handle. The deployment mechanism 1160 is capable of operating within the housing in a first position ( Figure 11A (as shown) to the second position ( Figure 11B Slide between (as shown). Because the first end 1162 of the key engages with the support 1126, the actuating member 1164 moves to Figure 11B The position shown allows the needle assembly (here, the microneedle array 1194) to contact the injection site.

[0135] exist Figure 11A and Figure 11B In the configuration shown, the support member 1126 is mounted within a housing on the support base 1152 by a plurality of springs 1132. However, those skilled in the art will understand that, referring to... Figure 11A and Figure 11B The described deployment mechanism 1060 can be implemented in any of the above implementation schemes.

[0136] Furthermore, it should be understood that the deployment mechanism 1160 can be configured to hold the support 1126 in place. Figure 11A The retracted position is shown, where spring 1132 is compressed between support 1126 and support base 1152. Figure 11B At the position shown, spring 1132 is still compressed, although in Figure 11A The compression at the indicated location is minimal, thus maintaining skin contact between the gastrointestinal inlet and the injection site.

[0137] To prevent the extragastric interface from accidentally retracting from the injection site after the needle assembly has been deployed into the injection position, the deployment mechanism 1160 can be configured to be removed from the device 110. For example, a user can slide the first end 1162 of the key out of engagement with the support 1126 and remove the key from the housing 1116 once the extragastric interface has been deployed.

[0138] Although reference Figure 11A and Figure 11BThe described deployment mechanism is in the form of a manually actuated key configured to move the support 1126 from a first position to a second position; however, those skilled in the art will understand that other configurations are possible. For example, instead of a manually actuated deployment mechanism, an automatic deployment mechanism may include a power source (mechanical or electric drive) to advance the support 1126 to... Figure 11B The injection location is shown. In the above embodiments, each of devices 210, 310, 410, 510, 610, 710, 810, 910, 1010, and 1110 includes a configuration that allows the external gastrointestinal interface to move relative to the housing in response to movement of the device relative to the injection site. However, it should be understood that the above-described movable external gastrointestinal mounts can be combined in some embodiments. For example, a passively compensated external gastrointestinal mount (e.g., a support mount including deformable material, multiple springs, or pivot mounts) can be combined with the above-described active compensation mechanism. For example, a rotary-mounted support configured to rotate about at least the z-axis can be combined with the above-described actively motor-driven external gastrointestinal interface support. Since telescopic actuators cannot compensate for rotational movement of the housing about the z-axis (e.g., due to torsion such as...), Figure 1C The result of the device shown), active compensation mechanism (such as Figures 6A to 7B The active compensation agency shown can be with Figure 8 or Figure 9 The type of rotary-mounted support assembly shown.

[0139] In each of the above embodiments, an adhesive layer or adhesive patch has been described disposed on the underside of the housing for securing the device to the skin. However, it should be understood that the wearable device can be attached to the skin in different ways. For example, a separate adhesive can be used to secure the device in place. The adhesive can also be disposed on a parenteral interface to hold the interface in position relative to the injection site. This can be provided as a complement to the feature secured to the housing of the wearable device.

[0140] In any of the embodiments described above that include sensors configured to detect displacement of the device, the controller may be further configured to collect data on the placement and positioning of the microneedles, or the drug delivery pattern through the device.

[0141] For simplicity, the above embodiments have been described in the context of a wearable drug delivery device configured as a self-contained unit, comprising a drug container and a drive system for delivering the drug from the container through a catheter to a needle assembly. However, it should be understood that the advantages associated with the above embodiments also apply to wearable devices configured for use with an external drug container, and also to handheld autoinjectors, particularly those designed to remain against the skin to deliver a dose of drug over an extended injection period (e.g., 10-120 seconds).

[0142] In addition to the devices described above, this disclosure also provides numerous exemplary methods. Specifically, this disclosure provides methods for manufacturing devices according to any of the embodiments described above, and exemplary methods for supporting needles for injection devices. Methods for supporting needle assemblies of injection devices include methods for supporting the needle assembly at an injection site in preparation for injection, and methods for supporting the needle assembly of the injection device at the injection site between deliveries of drug doses. The latter is particularly suitable for wearable devices configured to deliver discrete bolus doses of drug spaced apart over extended time periods.

[0143] In one embodiment, a method of supporting a needle assembly of an injection device for preparing an injection drug includes: placing the injection device against an injection site, the injection device including a housing having a cavity; an external gastrointestinal interface disposed within the cavity, wherein the external gastrointestinal interface includes a support and a needle assembly mounted to the support and configured to deliver a dose of drug to the injection site, wherein the support is mounted on a plurality of springs extending from a spring base within the housing, the plurality of springs having non-coincident longitudinal axes. The method further includes securing the injection device to the injection site using an adhesive disposed on the housing; and compressing the springs between the support and the spring base.

[0144] The above method may also include the step of moving the external gastrointestinal interface relative to the housing by compressing and / or extending at least one of a plurality of springs to maintain contact between the external gastrointestinal interface and the skin.

[0145] In another embodiment, a method of supporting a needle assembly of an injection device for preparing an injection drug includes: placing a device against an injection site, the device including a housing having a cavity; an external gastrointestinal interface disposed within the cavity, wherein the external gastrointestinal interface includes a support and a needle assembly mounted to the support and configured to deliver a dose of drug to the injection site, wherein the support is mounted on an elastically deformable mount connected to the housing within the cavity, and wherein: the support includes an outer sidewall; the cavity includes an inner sidewall, and the outer sidewall of the support is separated from the inner sidewall of the cavity by a circumferential space extending around the outer sidewall of the support. The method further includes securing the injection device to the injection site using an adhesive disposed on the housing, and compressing an elastically deformable material between the support and the housing.

[0146] The above method may also include the step of moving the external gastrointestinal interface relative to the housing by compressing and / or expanding an elastically deformable mounting element to maintain contact between the external gastrointestinal interface and the skin.

[0147] In yet another embodiment, a method of supporting a needle assembly of an injection device for preparing an injection drug includes: placing the injection device against an injection site, the injection device including a housing having a cavity; an extragastric interface disposed within the cavity, wherein the extragastric interface includes a support and a needle assembly mounted to the support and configured to deliver a dose of drug to the injection site; a flexible catheter configured to deliver drug from a drug container to the needle assembly, wherein the support is movably mounted on a plurality of motors within the cavity, the plurality of motors being configured to maintain contact between the extragastric interface and the injection site. The method further includes the steps of securing the injection device to the injection site using an adhesive disposed on the housing, and maintaining contact between the extragastric interface and the injection site by actuating at least one motor.

[0148] The above method may further include sensing the contact force between the housing and the skin and / or between the gastrointestinal external interface and the skin, and actuating the actuator in response to the sensed displacement of the gastrointestinal external interface from a predetermined needle penetration depth.

[0149] In yet another embodiment, a method of supporting a needle assembly of an injection device for preparing an injection drug includes: placing a device against an injection site, the device including a housing having a cavity; and an external gastrointestinal interface disposed within the cavity, wherein the external gastrointestinal interface includes a support and a needle assembly mounted to the support and configured to deliver a dose of drug to the injection site, wherein a flexible conduit is configured to be in fluid communication with a drug container and the needle assembly, and wherein the support is rotatably mounted relative to the housing to allow the support to rotate within the cavity. The method further includes securing the injection device to the injection site using an adhesive disposed on the housing and bringing the external gastrointestinal interface into contact with the injection site.

[0150] The above method may also include the step of moving the gastrointestinal external interface relative to the housing by rotating the support about the pivot mount to maintain contact between the gastrointestinal external interface and the skin.

[0151] The foregoing detailed description describes systems and methods for supporting a parenteral interface at the injection site. However, those skilled in the art will understand that the invention is not limited to use in conjunction with the exemplary devices described herein. Rather, one or more benefits associated with the invention can be implemented in conjunction with other drug delivery systems, as will be apparent to those skilled in the art from the foregoing detailed description.

[0152] It should also be understood that, in use, the terms “proximal,” “farthest,” “front,” “back,” “side,” “top,” and “bottom” are used for the convenience of interpreting the drawings and should not be construed as restrictive. The term “including” should be interpreted as “including, but not limited to,” such that it does not exclude the presence of features not listed.

[0153] The embodiments described and illustrated in the above figures are provided as examples of how the invention can be implemented and are not intended to limit the scope of the invention. Modifications can be made without departing from this disclosure, and elements can be replaced with functionally and structurally equivalent components, and features of different embodiments can be combined.

Claims

1. An injection device, the injection device comprising: A housing having a cavity and configured to receive a drug container; An extra-gastric interface, the extra-gastric interface including a support having a skin-facing surface and a needle assembly mounted to the support, wherein the needle assembly is configured to deliver a drug dose to an injection site, and the support is disposed in the cavity and configured to contact the 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, which is rotatably mounted into the housing, and A plurality of springs are mounted to the support and connected to the spring base, wherein the plurality of springs are biased against the skin-facing surface to contact the skin at the injection site, and each spring has a longitudinal axis that does not coincide. The inner wall of the cavity forms a circumferential gap with the outer wall of the support to allow the support to move laterally and tilt within the cavity during delivery of the drug dose.

2. The injection device according to claim 1, wherein the needle assembly comprises a hollow injection needle.

3. The injection device according to claim 1 or 2, wherein the needle assembly comprises a microneedle array.

4. The injection device according to claim 1 or 2, wherein the plurality of springs comprises at least one helical spring.

5. The injection device according to claim 1 or 2, wherein the circumferential gap extends around the outer sidewall of the support.

6. The injection device according to claim 1 or 2, wherein the spring base is pivotally mounted within the housing.

7. The injection device according to claim 1 or 2, wherein the spring base is configured to be movably mounted within the housing to 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. The injection device of claim 1 or 2, wherein the plurality of springs are configured to bias the support at a location where the needle assembly extends beyond the skin contact surface of the housing.

9. The injection device according to claim 1 or 2, wherein the device further comprises an insertion mechanism configured to move the spring base between the following positions: The needle assembly does not extend from the housing at a first position relative to the housing, and The needle assembly extends from the housing to be inserted into a second position relative to the housing at the injection site.

10. The injection device of claim 9, further comprising a releasable locking mechanism, the releasable locking mechanism being configured such that: When the locking mechanism is in the active state, it holds the support member or the spring base in the first position relative to the housing; and When the locking mechanism is inactive, the support or the spring base is allowed to move to the second position.

11. The injection device of claim 10, wherein the releasable locking mechanism is configured as follows: The support is held in the first position relative to the spring base where the plurality of springs are compressed; and The support member is allowed to move relative to the spring base to the second position under the influence of the plurality of springs.

12. The injection device according to claim 1 or 2, further comprising a deployment mechanism coupled to the support member, wherein the deployment mechanism is configured to move the support member between a first position and a second position.

13. The injection device of claim 12, wherein the deployment mechanism is removably coupled to the housing.

14. The injection device of claim 1 or 2, wherein the housing includes a skin contact surface, the skin contact surface including an adhesive portion configured to attach the device to the user's skin.

15. The injection device according to claim 1 or 2, further comprising an adhesive portion disposed on the skin-facing surface of the support.

16. A method for supporting a needle of an injection device to prepare an injection dose of a drug, the method comprising: The device according to claim 1 or 2 is placed against the injection site; Make the support member contact the skin at the injection site; The injection device is secured to the injection site using an adhesive disposed on the housing; and The spring between the support member and the spring base is compressed.

17. A method for manufacturing the injection device according to claim 1, the method comprising the following steps: The housing is configured to receive a drug container, the housing further including a cavity having an opening on the skin-contact surface of the housing; An external gastrointestinal interface is provided within the cavity of the housing, the external gastrointestinal interface including a support and a needle assembly mounted to the support and configured to deliver a drug dose to the injection site; A flexible catheter is provided, the flexible catheter being configured to deliver medication from the medication container to the needle assembly; as well as The support is mounted on a plurality of springs connected to a spring base disposed in the housing, each spring having a longitudinal axis such that the longitudinal axes do not coincide, and the circumferential gap between the outer wall of the support and the inner wall of the cavity allows the support to move laterally within the cavity.

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