Syringe with a hanging parenteral contact part

Abstract

A dispensing device is provided that ensures contact between the needle or microneedle array and the injection site during administration of the therapeutic agent. [Solution] A medication delivery system and method are disclosed, including a syringe with a parenteral interface portion. The parenteral interface portion includes a support portion and a needle portion, the needle portion suspended in a cavity within the housing of the syringe when placed at an injection site for movement relative to the housing. The parenteral interface portion may be configured to move the housing without displacing the needle portion relative to the skin. The syringe may be configured to passively or actively counteract movement of the housing relative to the injection site while the syringe is worn to maintain accurate medication delivery depth. This may be achieved, for example, by attaching the support portion to a deformable platform, articulated components, or rotatable components.

Description

[Technical Field]

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 008,007, filed April 10, 2020, the disclosure of which is incorporated herein by reference.

[0002] The present invention relates generally to systems and methods for administering medication that include a "floating" parenteral interface, and more particularly to a medication administration device and method in which the parenteral interface is movably mounted relative to a housing. [Background technology]

[0003] Many diseases, both acute and chronic, can be treated or cured by parenteral administration of medication to patients. Parenteral administration methods include administering a therapeutic agent to the body by injection, such as intradermal, subcutaneous, or intramuscular, using a needle or cannula.

[0004] Wearable injectors and auto-injectors can provide a convenient and safe method of administering therapeutic medications. They are designed to be convenient and comfortable for users and / or healthcare professionals, and to ensure compliance with required dosing regimens. Many devices may be configured to reduce visibility or manual handling relative to traditional administration methods. They can also precisely control dosing, ensuring consistent administration and facilitating patient compliance.

[0005] One of the problems with wearable injectors and auto-injectors is maintaining proper contact and depth between the needle and the injection site throughout the entire administration of medication. If the injector is removed during an injection, it can cause pain if the needle is removed from the injection site and can lead to an incomplete administration of the medication.

[0006] In addition to traditional hypodermic injections, therapeutic agents may also be administered through the skin using hollow microneedle arrays. Microneedle arrays generally contain an array of multiple short, sharp structures that penetrate only the upper layers of the skin. Due to their shallow penetration (and the small diameter of each individual needle), microneedles tend to cause less pain than traditional hypodermic needles. However, some applications are limited by the application of microneedles because microneedle arrays must apply a precise force into the skin at an appropriate impact velocity to achieve consistent microneedle depth and deliver the drug without leakage. To prevent drug leakage from a microneedle array, the microneedle array must also avoid displacement of the injection site.

[0007] As a result, there is a need for a medication delivery device that ensures contact between the needle or microneedle array and the injection site during administration of the therapeutic agent. This is paramount in providing a wearable medication delivery device that may be worn by the user for longer periods of time and under a variety of conditions, such as while exercising, getting dressed, resting, or sleeping, where the casing of the device may be impacted while the needle array is within the skin. [Prior art documents] [Non-patent literature]

[0008] [Non-Patent Document 1] “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. Summary of the Invention

[0009] The present invention addresses several of the disadvantages associated with known syringes, particularly the manner in which the needle of the syringe is mounted and supported relative to the housing.

[0010] According to one aspect of the present invention, various syringes are disclosed. In these syringes, a parenteral contact portion includes a support portion and a needle portion. The parenteral contact portion is suspended within a cavity in the housing so that the needle portion is movably attached to the housing when the syringe is at the injection site. The syringe may be a wearable type configured to be fixed to the skin. The parenteral contact portion may be configured to move the housing without displacing the needle portion relative to the skin.

[0011] The syringes described below may be configured to passively counteract movement of the housing relative to the injection site (e.g., by attaching the support of the parenteral interface to a deformable platform, articulated component, or rotatable component). Alternatively, or in addition, the syringes described below may include an element that actively counteracts movement of the housing. This element may include a system configured to control the position of the needle relative to the housing in response to sensed displacement of the housing or parenteral interface from the skin. In some embodiments, the control that actively aligns the needle may be configured to maintain contact force between the needle (e.g., cannula or microneedle array) and the injection site.

[0012] In at least some embodiments, the parenteral contact portion may be configured to direct the needle portion proximally (toward the injection site) so that the parenteral contact portion maintains contact with the injection site when the housing is moved distally away from the injection site. In these and other embodiments, the parenteral contact portion may be configured to move the needle portion laterally relative to the housing in response to lateral displacement of the housing relative to the injection site. Alternatively, or in addition, the parenteral contact portion may be configured to tilt relative to the housing within the cavity. Thus, a syringe according to the present invention may generally be considered to include the following elements: a housing configured to accommodate a medication container; a needle portion and a support portion disposed within a cavity of the housing; and the support portion mounted within the cavity such that the support portion can be displaced (e.g., tilted, rotated, translated) relative to the housing while the parenteral contact portion is at the injection site.

[0013] By moving the needle relative to the housing while it is at the injection site, embodiments of the present invention help reduce pain and irritation to the user, reduce leakage of medication from the injection site, and maintain needle penetration depth within a desired range throughout the life of the syringe.

[0014] In a first aspect, a syringe is provided. The syringe includes a housing and a parenteral contact portion. The housing is configured to accommodate a medication container. The parenteral contact portion includes a support portion disposed within a cavity in the housing. A needle portion is attached to the support portion, and the needle portion is configured to administer a dose of medication to an injection site. A flexible conduit is configured to deliver the medication from the medication container to the needle portion. The support portion is attached to a plurality of springs, which are connected to a spring mount disposed within the housing. Each spring has a major axis, and the major axes of all the springs are different.

[0015] The spring load may be part of the housing, a fixed component within the housing, or a needle penetration mechanism configured to advance the needle relative to the housing into contact with the injection site during injection.

[0016] The parenteral contact portion can be configured to tilt, rotate, or translate relative to the housing by being attached to a plurality of springs to maintain (or help maintain) contact with the injection site even during syringe displacement.

[0017] In a second aspect, a syringe is provided. The syringe includes a housing and a parenteral contact portion. The housing is configured to accommodate a medication container. The parenteral contact portion includes a support portion disposed within a cavity in the housing and a needle portion attached to the support portion. The needle portion is configured to administer a dose of medication to an injection site. A flexible conduit is configured to deliver medication from the medication container to the needle portion. The support portion is movably mounted within the cavity. A plurality of motors are configured to move the support portion relative to the housing to maintain the parenteral contact portion in contact with the injection site.

[0018] The parenteral contact portion can be configured to be attached to a plurality of motor-driven actuators so that it tilts, rotates, or translates relative to the housing to maintain (or help maintain) contact with the injection site even during syringe displacement.

[0019] In a third aspect, a syringe is provided. The syringe includes a housing and a parenteral contact portion. The housing is configured to accommodate a medication container. The parenteral contact portion includes a support portion disposed within a cavity in the housing and a needle portion attached to the support portion. The needle portion is configured to administer a dose of medication to an injection site. A flexible conduit is configured to deliver medication from the medication container to the needle portion. The support portion is mounted for rotation relative to the housing and is rotatable within the cavity.

[0020] The turntable for the support may be configured to rotate at least once about an axis substantially perpendicular to the surface of the injection site (thereby twisting the support relative to the housing). The turntable for the support may also be configured to rotate about multiple axes. For example, the turntable may twist relative to the housing or tilt the support within the cavity.

[0021] The parenteral contact portion can be configured to be mounted on a rotating platform so that it tilts, rotates, or translates relative to the housing to maintain (or help maintain) contact with the injection site even during syringe displacement.

[0022] In a fourth aspect, a syringe is provided. The syringe includes a housing and a parenteral contact portion. The housing is configured to accommodate a medication container. The parenteral contact portion includes a support portion disposed within a cavity in the housing and a needle portion attached to the support portion. The needle portion is configured to administer a dose of medication to an injection site. A flexible conduit is configured to deliver medication from the medication container to the needle portion. The support portion is attached within the cavity to an elastically deformable mount connected to the housing. The support portion has an outer wall, and the cavity has an inner wall, with the outer wall of the support portion separated from the inner wall of the cavity by a circumferential space extending around the outer wall.

[0023] In any of the above aspects, the needle portion may comprise a hollow syringe needle. Alternatively (or in addition), the needle portion may comprise an array of microneedles.

[0024] The housing may include a skin-contacting surface. The skin-contacting surface may include an adhesive portion configured to attach the syringe to the skin of a user. Additionally or alternatively, a further adhesive portion may be provided on the skin-contacting surface of the support. In at least some embodiments, the syringe is wearable and includes a fastening means for fastening the syringe to the body of a user.

[0025] The syringe may further include a platform coupled to the support, which may form a spring-based, deformable, or rotating platform in accordance with the above aspects, and which may be movably mounted within the housing and move proximally to advance the support, and thus the needle, from a retracted position to a position extending from the housing toward the skin.

[0026] The syringe may further include an insertion mechanism configured to move the support and / or the platform relative to the housing between a first position and a second position. In the first position, the needle does not extend from the housing. In the second position, the needle extends from the housing and is inserted into the injection site. The support and / or platform may be mounted within the housing for proximal movement to advance the needle from a retracted position to a position where it extends from the housing toward the skin.

[0027] Optionally, the syringe may further include a releasable locking mechanism that (i) in an activated state maintains the support and / or platform in a first position relative to the housing, preventing the needle from extending from the housing, and (ii) in an inactivated state allows the support and / or platform to move relative to the housing.

[0028] In one embodiment, the locking mechanism may be configured such that (i) in an activated state, the support is maintained in a first position relative to the platform in which a plurality of springs (or deformable material) are compressed to prevent the needle from extending from the housing, and (ii) in a non-activated state, the force of the plurality of springs moves the support to a second position relative to the platform, allowing the needle to extend from the housing.

[0029] In some embodiments, the syringe may further include a deployment mechanism coupled to the support and configured to move the support between a first position in which the needle does not extend from the housing and a second position in which the needle extends from the housing. Optionally, the deployment mechanism may be removably coupled to the housing.

[0030] In any of the above aspects and embodiments, the syringe may include one or more of the following mounts: a plurality of springs, a resiliently deformable mount, a rotating mount, a swivel mount, a motorized mount, or combinations thereof. For example, a pivotally mounted support may be attached to a plurality of springs such that the support twists (with minimal resistance) relative to the housing while the springs exert a proximal force on the parenteral contact portion to maintain contact between the needle and the injection site. In another example, a motorized support may be combined with a deformable mount to provide additional user comfort and help maintain uniform pressure on the injection site.

[0031] Thus, the plurality of springs may include at least one coil spring. The springs may be fixed to a spring base. The spring base may be movably mounted within the housing. The spring base may be rotatably mounted within the housing. Alternatively, or in addition, the spring base may be pivotally mounted to the housing. In yet another embodiment, the spring base may be movably mounted within the housing, in combination with or separate from the rotating or pivoting mounting components, and may move proximally to advance the needle from a retracted position to a position extending from the housing toward the skin. In any embodiment, the spring may be configured to urge the support toward a position where the needle extends beyond the skin-contacting surface of the housing.

[0032] The elastically deformable platform may include a foam layer. The foam layer may be secured to the base. The base may be movable relative to the housing and may move proximally to advance the needle from a retracted position to a position extending from the housing toward the skin. Alternatively, the foam layer may be secured within the housing. A spring base may be rotatably mounted within the housing. Alternatively, or in addition, the spring base may be pivotally mounted to the housing.

[0033] Any of the above embodiments may include one or more motors and at least one actuator. The actuator is configured to move the support portion relative to the housing to maintain contact between the parenteral contact portion and the skin at the injection site. The motors may be servomotors. Each motor may be in communication with at least one sensor configured to detect when the parenteral contact portion is removed from the injection site. Optionally, the sensor may be a microneedle electrode sensor. The sensor may be located on the skin-contacting surface of the housing. Additionally or alternatively, at least one sensor may be located on the skin-contacting surface of the support portion. The motor may be attached to a motor base that is movably mounted within the housing. For example, the motor base may be rotatably and / or pivotably mounted within the housing. In some aspects, the base may be movably mounted within the housing and move proximally to advance the needle portion from a retracted position to a position extending toward the skin. In any of the above embodiments, multiple motors may be configured to maintain the support portion in a position where the needle extends beyond the skin-contacting surface of the housing.

[0034] In any of the above aspects and embodiments, the support may be mounted so as to rotate relative to the housing. The support may be mounted so as to rotate on a fixed part such as the housing or a base, or may be fixed to a base and the base may be mounted so as to rotate relative to the housing.

[0035] Any of the above embodiments may further include a swivel joint. The swivel joint is configured to rotate the support within the housing about an axis extending proximally from the housing toward the skin. The support may be configured to pivot about a pivot point. In some embodiments, the support may be attached to the housing by a ball-and-socket joint. The support may be rotatably mounted to a support base. The base is movably mounted within the housing and moves proximally to advance the needle from the retracted position to the extended position. The rotatable support may further include a plurality of springs (or other biasing means). The springs are configured to urge the support toward a position in which the needle extends beyond the skin-contacting surface of the housing.

[0036] The support may be disposed within a cavity in the housing and may be capable of at least one of lateral movement, proximal movement, rotation, or pivoting relative to the housing. In some aspects, the cavity may be configured to allow the support to be laterally displaced relative to the housing. In such embodiments, the support may have an outer wall, the cavity may have an inner wall, and the outer wall of the support may be separated from the inner wall of the cavity by a circumferential space extending around the outer wall. For example, a foam layer may be separated from the inner wall of the cavity by a circumferential space.

[0037] The present invention also provides a method for supporting the needle of a syringe at an injection site according to any of the above aspects or embodiments, and a method for manufacturing the syringe.

[0038] In a fifth aspect, there is provided a method for manufacturing a syringe. The method includes the step of providing a housing. The housing is configured to accommodate a medication container and includes a cavity with an opening in a skin-contacting surface. The method includes the step of providing a parenteral contact portion within the cavity of the housing. The parenteral contact portion includes a support portion disposed within the cavity in the housing and a needle portion attached to the support portion. The needle portion is configured to administer a dose of medication to an injection site. The method includes the step of providing a flexible conduit. The conduit is configured to deliver medication from the medication container to the needle portion. The method includes the step of attaching the support portion to a plurality of motors within the cavity. The motors are configured to maintain contact between the parenteral contact portion and the injection site.

[0039] In a sixth aspect, there is provided a method for manufacturing a syringe. The method includes the step of providing a housing. The housing is configured to accommodate a medication container and includes a cavity with an opening in a skin-contacting surface. The method includes the step of providing a parenteral contact portion within the cavity of the housing. The parenteral contact portion includes a support portion disposed within the cavity in the housing and a needle portion attached to the support portion. The needle portion is configured to administer a dose of medication to an injection site. The method includes the step of providing a flexible conduit. The conduit is configured to deliver medication from the medication container to the needle portion. The method includes the step of attaching the support portion to a plurality of springs. The springs are connected to a spring base provided within the housing, each having a major axis, and the major axes of all the springs are different.

[0040] In a seventh aspect, there is provided a method for manufacturing a syringe. The method includes the step of providing a housing. The housing is configured to receive a medication container and includes a cavity with an opening in a skin-contacting surface. The method includes the step of providing a parenteral contact portion within the cavity of the housing. The parenteral contact portion includes a support portion disposed within the cavity in the housing and a needle portion attached to the support portion. The needle portion is configured to administer a dose of medication to an injection site. The method includes the step of providing a flexible conduit. The conduit is configured to deliver medication from the medication container to the needle portion. The method includes the step of mounting the support portion within the cavity. The support portion is mounted for rotation relative to the housing and is rotatable relative to the housing about at least one axis.

[0041] In an eighth aspect, there is provided a method for manufacturing a syringe. The method includes the step of providing a housing. The housing is configured to accommodate a medication container and includes a cavity with an opening in a skin-contacting surface. The method includes the step of providing a parenteral contact portion within the cavity of the housing. The parenteral contact portion includes a support portion disposed within the cavity in the housing and a needle portion attached to the support portion. The needle portion is configured to administer a dose of medication to an injection site. The method includes the step of providing a flexible conduit. The conduit is configured to deliver medication from the medication container to the needle portion. The method includes the step of attaching the support portion to an elastically deformable mount within the cavity. The support portion has an outer wall and the cavity has an inner wall, the outer wall of the support portion being separated from the inner wall of the cavity by a circumferential space extending around the outer wall.

[0042] The methods according to the fifth, sixth, seventh and eighth aspects may further comprise the step of providing any of the above elements according to the first to fourth aspects.

[0043] In a ninth aspect, a method for supporting a syringe needle for injection of a medication is provided. The method includes the step of attaching an apparatus to an injection site. The apparatus includes a housing having a cavity, a parenteral contact portion disposed within the cavity, and a flexible conduit. The parenteral contact portion includes a support portion and a needle portion. The needle portion is attached to the support portion and configured to administer a dose of medication to the injection site. The conduit is configured to transport medication from a medication container to the needle portion. The support portion is movably attached to a plurality of motors within the cavity. The motors are configured to maintain contact between the parenteral contact portion and the injection site. The method includes the steps of securing the syringe to the injection site using an adhesive provided on the housing and maintaining contact between the parenteral contact portion and the injection site by operating at least one motor. Optionally, the plurality of motors are in communication with at least one sensor. The sensor is configured to detect detachment of the parenteral contact portion from the injection site. The motor is configured to operate in response to detection of detachment of the parenteral contact portion from the injection site.

[0044] In a tenth aspect, a method for supporting a syringe needle in preparation for injection of a medication is provided. The method includes the steps of attaching an apparatus to an injection site. The apparatus includes a housing having a cavity and a parenteral contact portion disposed within the cavity. The parenteral contact portion includes a support portion and a needle portion. The needle portion is attached to the support portion and configured to administer a dose of medication to the injection site. The support portion is attached to a plurality of springs. The springs extend from a spring base within the housing and have different longitudinal axes. The method includes the steps of securing the syringe to the injection site using an adhesive provided on the housing and compressing the springs between the support portion and the spring base.

[0045] In an eleventh aspect, a method for supporting a syringe needle in preparation for injection of a medication is provided. The method includes the step of attaching an apparatus to an injection site. The apparatus includes a housing having a cavity, a parenteral contact portion disposed within the cavity, and a flexible conduit. The parenteral contact portion includes a support portion and a needle portion. The needle portion is attached to the support portion and configured to administer a dose of medication to the injection site. The conduit communicates between the medication container and the needle portion. The support portion is rotatably mounted relative to the housing and is rotatable within the cavity. The method includes the steps of fixing the syringe to the injection site using an adhesive provided on the housing and contacting the parenteral contact portion with the injection site.

[0046] In a twelfth aspect, a method for supporting a needle of a syringe in preparation for injection of a medication is provided. The method includes the steps of attaching an apparatus to an injection site. The apparatus includes a housing having a cavity and a parenteral contact portion disposed within the cavity. The parenteral contact portion includes a support portion and a needle portion. The needle portion is attached to the support portion and configured to administer a dose of medication to the injection site. The support portion is attached within the cavity to an elastically deformable mount connected to the housing. The support portion has an outer wall, the cavity has an inner wall, and the outer wall of the support portion is separated from the inner wall of the cavity by a circumferential space extending around the outer wall. The method includes the steps of fixing the syringe to the injection site using an adhesive provided on the housing and compressing the elastically deformable mount between the support portion and the housing.

[0047] Further advantages and additional embodiments will be readily apparent from the following detailed description and accompanying drawings. [Brief explanation of the drawings]

[0048] The invention will now be explained in more detail with reference to a number of non-limiting example embodiments shown in the following drawings, in which: [Figure 1A] FIG. 1 shows a schematic side view of a wearable syringe attached to an injection site. [Figure 1B] FIG. 1 shows a side view of an auto-injector attached to an injection site. [Figure 1C] 1 shows a schematic top view of a wearable syringe attached to an injection site. [Figure 2A] 1 shows a cross-sectional side view of a syringe according to a first embodiment. [Figure 2B] 2B shows the syringe of FIG. 2A undergoing an impact. [Figure 3A] 1 shows a cross-sectional side view of a syringe according to a second embodiment. [Figure 3B] 3B shows the syringe of FIG. 3A being impacted. [Figure 4A] 10 shows a cross-sectional side view of a syringe according to a third embodiment. [Figure 4B] 4B shows the syringe of FIG. 4A undergoing an impact. [Figure 5A] 10 shows a cross-sectional side view of a syringe according to a fourth embodiment. [Figure 5B] 5B shows the syringe of FIG. 5A undergoing an impact. [Figure 6A] 10 shows a cross-sectional side view of a syringe according to a fifth embodiment. [Figure 6B] 6B shows the syringe of FIG. 6A being impacted. [Figure 7A] 13 shows a cross-sectional side view of a syringe according to a sixth embodiment. FIG. [Figure 7B] 7B shows the syringe of FIG. 7A being impacted. [Figure 8] 13 shows a cross-sectional side view of a syringe according to a seventh embodiment. FIG. [Figure 9] 13 shows a cross-sectional side view of a syringe according to an eighth embodiment. FIG. [Figure 10A] 13 shows a cross-sectional side view of a syringe according to a ninth embodiment with the needle in a retracted position. FIG. [Figure 10B] 10B shows a cross-sectional side view of the syringe of FIG. 10A with the needle in an extended position. [Figure 11A] 13 shows a cross-sectional side view of a syringe according to a tenth embodiment with the needle in a retracted position. FIG. [Figure 11B] 11B shows a cross-sectional side view of the syringe of FIG. 11A with the needle in an extended position. Like reference numerals are used throughout the drawings to refer to like elements. DETAILED DESCRIPTION OF THE INVENTION

[0049] The present invention is directed generally to systems and methods for supporting a parenteral interface at an injection site. In particular, the systems and methods described below are configured to maintain needle position and depth relative to the skin surface even when the syringe housing is displaced.

[0050] FIG. 1A shows a schematic side view of a wearable syringe attached to an injection site. The syringe 110 is attached to the skin 112 and secured in place by adhesive or other attachment means. A needle 114 extends from the syringe housing 116 and penetrates the skin, delivering a therapeutic agent to the patient. Typically (but not always), the syringe 110 housing 116 contains both a reservoir 118 for storing the agent and a conduit 120 that provides communication between the reservoir 118 and the needle 114. The housing also typically contains a drive train (not shown) that drives the agent from the reservoir 118 through the conduit 120 to the needle 114. The drive train may include a mechanical drive (e.g., a spring or clockwork) and / or an electrical drive (e.g., a motor) configured to deliver the agent. The housing 116 may include an actuator, such as a button 122, that can signal the user to begin the injection. However, those skilled in the art will appreciate that the actuator need not be mechanical and the injector may be operated electronically, for example using a remote control that communicates wirelessly with the drive train.

[0051] 1A, the needle 114 is fixed relative to the housing 116 for at least most of the injection period. This means that if the housing 116 is impacted and displaced laterally relative to the skin, the needle 114 will also displace laterally. This displacement of the needle 114 can cause pain and irritation to the user. Lateral displacement of the housing 116 (in the x-y plane) can compromise the connection between the needle 114 and the conduit 120 or dislodge the needle 114 from the injection site, causing medication to leak from the syringe and resulting in a loss of controlled dosing.

[0052] Although not shown in Figure 1A, it will be appreciated that axial (z-axis) displacement of the housing 116 can alter the needle penetration depth, and thus, this displacement may adversely affect the syringe's ability to properly administer medication to a patient.

[0053] FIG. 1B illustrates how a similar problem can arise with conventional auto-injectors. FIG. 1B shows an auto-injector 180 being placed against the skin 112 at an injection site during an injection. As shown in FIG. 1B, the auto-injector 180 includes a housing 186 and a needle 184. Because the position of the needle 184 relative to the housing 186 is fixed during an injection, any movement of the housing 186 relative to the injection site during an injection can cause the needle 184 to move, potentially causing pain or resulting in an under-dosed dose. However, because the medication delivery process with an auto-injector is typically 10-120 seconds and controlled by the patient, the needle may be automatically aligned to make medication more comfortable and / or retract if a strong shock is received.

[0054] Figure 1C shows another wearable syringe 190 similar to syringe 110 of Figure 1A. However, whereas syringe 110 of Figure 1A includes a conventional cannula, syringe 190 of Figure 1C includes a hollow microneedle array (MNA) 194 for the purpose of delivering medication to an injection site. Microneedle array 194 is disposed within a cavity in the bottom of housing 116 (similar to the cavity shown in Figure 1A) and is in communication with reservoir 118 by conduit 120.

[0055] In the syringe of Figure 1C, the microneedle array 194 is fixed relative to the housing 116 (during injection). Therefore, any external force that rotates the housing 116 relative to the skin at the injection site can twist the microneedle array 194 relative to the skin. Such rotational displacement can cause pain and irritation to the user, or it can cause the microneedle array 194 to move away from the correct injection depth, potentially causing medication leakage and a loss of controlled dosing.

[0056] In each of the above configurations, displacement of the syringe housing relative to the injection site also results in displacement of the needle relative to the injection site, causing pain and discomfort to the user and, over time, irritation or damage to the injection site, potentially resulting in under-medication. However, with reference to Figures 2A-9, it can be seen that embodiments of the present invention can address or reduce at least some of the above-mentioned drawbacks. The syringes according to the following embodiments generally include a parenteral contact portion. The parenteral contact portion includes a needle portion and a support portion. The needle portion is configured to deliver medication to the injection site. The support portion is configured to support the needle portion in an injection-ready position. The support portion is movably attached to the housing, allowing the parenteral contact portion to move relative to the housing during injection, thereby isolating (or protecting) the parenteral contact portion from impact with the housing. The support portion may be movably attached to a deformable or flexible material and coupled to the housing by the material. Alternatively, the position of the support portion may be actively controlled using an actuator. The actuator is configured to move the support portion relative to the housing in response to sensing or detecting movement of the housing relative to the injection site. In some embodiments, the injector may be configured to actively control the position of the support portion relative to the housing in response to sensing displacement of the housing or needle portion (or a decrease in contact pressure). In other embodiments, the parenteral contact portion may include an elastically deformable platform that is configured to deform when the housing is displaced relative to the injection site, isolating the parenteral contact portion from displacement of the housing and maintaining its position at the injection site. The mobility of the parenteral contact portion relative to the housing allows the needle penetration depth to be maintained throughout the injection, even if the housing is displaced relative to the skin (e.g., due to impact of the wearable injector or unsteady hand holding the portable injector). Independently suspending or floating the parenteral contact portion relative to the housing can reduce discomfort caused by the injector being displaced from its original position on the body's skin.

[0057] 2A and 2B illustrate a first embodiment of a syringe according to the present invention. FIG. 2A shows the syringe attached to an injection site without any external disturbance. As shown in FIG. 2A, the syringe 210 includes a housing 216. The housing 216 is configured to be attached to the skin 212 at the injection site. The syringe 210 also includes a needle portion. In this embodiment, the needle portion is shaped as a hollow injection needle 214 and is configured to deliver a medication from a reservoir (not shown) through a conduit 220 to the injection site. An adhesive layer 222 is provided to secure the syringe 210 to the skin 212. The adhesive layer 222 is provided on the bottom surface (i.e., the skin-contacting surface) of the housing 216. The housing 216 includes a cavity 224 in which the needle portion is disposed. The needle portion forms part of a parenteral interface, which is configured to deliver a medication from a medication reservoir (not shown) to the needle 214. The parenteral interface includes needle 214 as well as a support 226 to which needle 214 is attached. Support 226 is attached to housing 216 by an elastically deformable mount 228. In the embodiment shown in Figure 2A, elastically deformable mount 228 comprises a flexible foam layer.

[0058] At least a long portion of the conduit 220 connecting the reservoir (not shown) to the needle 214 is flexible. The flexibility of the conduit allows the needle 214 to move relative to the housing, as will be described in more detail below with reference to Figure 2B.

[0059] 2B shows the syringe 210 of FIG. 2A undergoing an impact that displaces the housing 216 laterally relative to the injection site. The displacement of the housing 216 relative to the skin 212 is indicated by arrow A. As the housing 216 displaces, the adhesive layer 222 attaching the syringe to the skin 212 stretches. Detachment of the housing 216 from the skin 212 can also occur if the housing 216 is lifted from the skin 212 (e.g., at the location indicated by arrow D).

[0060] 2B, the flexible foam layer 228 is configured to allow the housing 216 to move relative to the injection site without displacing the needle 214. The flexible conduit 220 also allows the needle 214 and support 226 to move relative to the housing, such that the conduit allows movement of the needle 214 relative to the housing without interfering with the delivery of medication therethrough.

[0061] Because the parenteral interface (including the support portion 226 and needle 214) is not rigidly connected to the housing 216, displacement of the housing 216 relative to the injection site does not (or only slightly) displace the needle 214. Instead, the flexible foam layer 228 and conduit 220 allow the parenteral interface to remain attached to the injection site while the housing 216 displaces (laterally or otherwise).

[0062] In the embodiment shown in FIGS. 2A and 2B, the housing 216 is secured to the skin 212 by an adhesive layer 222 provided on the bottom surface of the housing 216. The parenteral contact portion maintains contact with the skin 212 during injection due to its position relative to the housing 216. In at least some embodiments, the support portion 226 also includes an adhesive layer (not shown in FIGS. 2A and 2B). This adhesive layer is configured to maintain contact between the parenteral contact portion and the injection site. Such an adhesive layer may be provided on the support portion 226 of the parenteral contact portion, particularly on its skin-contacting surface. While an adhesive layer on the parenteral contact portion is advantageous in some embodiments, it is also optional to provide an adhesive layer on the support portion. Once the needle 214 penetrates the skin, it acts to prevent lateral displacement relative to the injection site.

[0063] Although not indicated by the arrows in FIGS. 2A and 2B , the flexible foam layer 228 also acts to prevent the needle from varying its penetration depth within the injection site. This is possible due to the flexibility of the foam layer, which can be configured to expand and contract in the z-axis direction (along the axis of the needle 214). The expansion and contraction of the flexible foam layer can also be configured to assist in directing the needle 214 toward the injection site. For example, the flexible foam layer 228 may be configured to direct the support portion 226 toward a position where the skin-contacting surface of the support portion 226 protrudes beyond the bottom surface of the housing 216. The syringe 210 may act to compress the flexible foam layer 228 by being attached to the skin 212. The syringe 210 may be configured to slightly compress the flexible foam layer 228 in the position shown in FIG. 2, such that the foam layer expands when the housing 216 is pulled away from the injection site. This maintains the depth of penetration of the needle 214, or at least dampens movement of the needle 214 back from the injection site.

[0064] A circumferential space 230 (as shown in FIG. 2A ) is provided between the support 226 and the sidewall 224a of the cavity 224 to allow for lateral displacement of the parenteral-contacting portion (including the support 226 and needle 214) relative to the housing 216. The circumferential space 230 allows the rigid support 226 to move laterally within the rigid-walled cavity 224. However, in some embodiments, the circumferential space 230 may be omitted, for example, if the diameter of the support is narrower than the diameter of the flexible foam layer or if the support is also made of a flexible material.

[0065] Figures 3A and 3B show a second embodiment of a syringe in accordance with the present invention. The syringe 310 shown in Figures 3A and 3B is similar to the syringe 210 shown in Figures 2A and 2B. Like Figure 2A, Figure 3A shows the syringe 310 at rest (undisplaced). Figure 3B shows the syringe 310 undergoing an impact that displaces the syringe 310 against the skin 212 at the injection site.

[0066] The syringe 310 includes a housing 316. The housing 316 is configured to be secured in place on the skin using an adhesive layer 322, i.e., an adhesive patch. The housing 316 includes a cavity 324. The parenteral interface is housed therein. The parenteral interface includes a support 326 attached to a flexible foam layer 328 (or other suitable resiliently deformable mounting). The cavity includes a sidewall 324a and is optionally separated from the support 326 by a circumferential space 330. The syringe 310 differs from the syringe 210 shown in FIGS. 2A and 2B in the shape of its needle portion. In the embodiment described with reference to FIGS. 2A and 2B, the parenteral interface includes a single needle 214 attached to the support 226. However, in the embodiment shown in FIGS. 3A and 3B, the needle portion forms a microneedle array 394. The array includes a plurality of microneedles configured to deliver a drug to an injection site. Thus, the flexible conduit 320 is configured to deliver medication to an array of microneedles 394, rather than being connected to only a single hollow syringe needle as shown in Figures 2A and 2B.

[0067] Similar to the embodiment shown in Figures 2A and 2B, as the housing 316 is displaced relative to the injection site, the flexible foam layer deforms, allowing the housing 316 to move relative to the injection site while keeping the microneedle array 394 in place.

[0068] It will be appreciated that the support portion of the above embodiments is movable relative to the housing by being attached to a resiliently deformable platform, such as a flexible foam layer, thereby isolating the parenteral-contact portion from impacts to the housing. While the above embodiments are depicted as including a flexible foam layer, other deformable materials could be used. For example, a layer of gel or rubber could be used. Furthermore, it is contemplated that the deformable platform may include the material as a single layer or as multiple discrete portions. For example, multiple deformable portions may form the deformable platform, be adjacent to each other (and even touching each other, if desired), or be spaced apart. In some embodiments where ease of assembly is a primary consideration, a flexible foam layer may be particularly suitable. For example, the support portion may be glued in place to a layer of flexible material, which itself may be glued to a component within the housing.

[0069] It will be appreciated that the deformable platform need not be statically attached to the housing. For example, the components may be incorporated into a syringe that includes a movable needle hub configured to advance the needle from a retracted position before injection (where the needle does not extend from the housing) to an advanced position during injection (where the needle extends from the housing and penetrates the injection site). In such an embodiment, the resiliently deformable platform may be located between the support and the needle hub.

[0070] A third embodiment of the present invention will now be described with reference to Figures 4A and 4B. The embodiment shown in Figures 4A and 4B is largely similar to the embodiment described with reference to Figures 2A and 2B. Like Figure 2A, Figure 4A shows a syringe 410 at rest (undisplaced). Figure 4B shows the syringe 410 undergoing an impact that displaces the syringe 410 against the skin 212 at the injection site.

[0071] As shown in FIG. 4A , the syringe 410 includes a housing 416. The housing 416 is configured to be secured to the skin 212 at the injection site with an adhesive portion 422. The housing 416 includes a cavity 424. The cavity is configured to house a parenteral interface portion. The parenteral interface portion includes a support portion 426 and a needle portion. In this embodiment, the needle portion forms a needle 414 for hypodermic injection. The needle 414 is configured to communicate with a medication container (not shown) through a flexible conduit 420. The cavity 424 includes a sidewall 424 a, and a circumferential gap 430 extends between the outer surface of the support portion 426 and the inner wall 424 a of the cavity. The circumferential gap 430 allows the support portion 426 to move laterally within the cavity 424, thereby allowing the needle 414 to be displaced relative to the housing 416 of the syringe 410.

[0072] While the support portion 226 of the syringe 210 is attached to a flexible foam layer, in the embodiment shown in FIG. 4, the support portion 426 is attached to a plurality of springs 432. These springs are configured to deform and move the support portion 426 relative to the housing 416, as shown in FIG. 4B. The springs 432 are arranged non-coaxially relative to one another. The springs 432 are also preferably symmetrically positioned relative to the needle 414 to ensure that force is applied in the z-axis direction of the needle 414 toward the injection site. This non-coaxial arrangement allows the support portion 426 to be stably attached to the plurality of smaller diameter springs, allowing for lateral movement relative to the housing 416.

[0073] In some embodiments, support 426 may be attached to two springs arranged symmetrically, such as in a face-to-face arrangement, relative to needle 414. In other embodiments, one, three, four or more springs may be arranged non-coaxially relative to one another to movably support support 426 relative to the housing.

[0074] Figures 5A and 5B show a fourth embodiment of a syringe in accordance with the present invention. The syringe 510 shown in Figures 5A and 5B is similar to the syringe 410 shown in Figures 4A and 4B. Like Figure 4A, Figure 5A shows the syringe 510 at rest (undisplaced). Figure 5B shows the syringe 510 undergoing an impact that displaces the syringe 510 against the skin 212 at the injection site.

[0075] The syringe 510 includes a housing 516. The housing 516 is configured to be secured in place on the skin using an adhesive layer 522, i.e., an adhesive patch. The housing 516 includes a cavity 524 that houses a parenteral interface portion. The parenteral interface portion includes a support portion 526 attached to a plurality of springs 534. The cavity 524 has a sidewall 524a and is optionally separated from the support portion 526 by a circumferential space 530. The syringe 510 differs from the syringe 410 shown in FIGS. 4A and 4B in the shape of the needle portion. In the embodiment described with reference to FIGS. 4A and 4B, the parenteral interface portion includes a needle 414 attached to the support portion 426. However, in the embodiment shown in FIGS. 5A and 5B, the needle portion forms a microneedle array 594. The array includes a plurality of microneedles configured to deliver a drug to an injection site. Thus, the flexible conduit 520 delivers the agent to an array of microneedles 594, rather than being connected to just one hollow syringe needle as shown in Figures 4A and 4B.

[0076] Similar to the embodiment shown in Figures 4A and 4B, as the housing 516 is displaced relative to the injection site, the spring 534 deforms, causing the housing 516 to move relative to the injection site while keeping the microneedle array 594 in place.

[0077] It will be appreciated that the support portion of the above embodiments is movable relative to the housing by being attached to multiple springs, thereby isolating the parenteral contact portion from impact with the housing. While the above embodiments are depicted as including multiple coil springs, other springs could be used. For example, multiple leaf springs, conical springs, or other springs could also be used. In some embodiments where it is desirable for the support portion to urge the needle portion toward the skin, utilizing a spring as a resiliently deformable platform sandwiched between the support portion and the housing may be particularly suitable. For example, in some embodiments, the spring may be configured to compress slightly when the parenteral contact portion is in contact with the injection site, thereby urging the support portion into a position where the skin-contacting surface of the support portion extends beyond the bottom surface of the housing. The syringe may be configured so that the spring is slightly compressed in the position of the syringe shown in FIG. 5A, and then expand when the housing 516 is pulled away from the injection site. This may maintain needle penetration depth, or at least cushion movement of the needle away from the injection site.

[0078] It will be appreciated that the deformable spring mount need not be statically attached to the housing. For example, the elements may be incorporated into a syringe having a movable needle hub configured to advance the needle from a retracted position (needle not extending from the housing) prior to injection to an advanced position (needle extending from the housing and penetrating the injection site) during injection. In such an embodiment, the spring mount may be located between the support and the needle hub.

[0079] Figures 6A and 6B show yet another embodiment of a syringe according to the present invention. The embodiment shown in Figures 6A and 6B shows a syringe 610 that utilizes an active displacement countermeasure system to maintain the parenteral contact portion in contact with the skin. As with the previous figures, Figure 6A shows the syringe 610 undisplaced relative to the injection site, and Figure 6B shows the syringe 610 when the housing has been displaced by an external device.

[0080] 6A, syringe 610 is similar to syringes 210, 310, 410, 510 described above and includes a housing 616 and an adhesive layer or one or more adhesive patches 622. Adhesive patches 622 are configured to secure syringe 610 to skin 212 at the injection site.

[0081] Syringe 610 further includes a cavity 624 that houses a parenteral interface portion. Parenteral interface portion includes a needle portion (in this embodiment, a hypodermic needle 614) and a support portion 626 (which supports needle portion 614). Needle 614 communicates with a flexible conduit 620, which is configured to deliver medication from a medication container to needle 614.

[0082] Instead of a passive system for positioning the parenteral interface portion (such as the elastically deformable layer or spring described above), the syringe 610 includes an active system for positioning the parenteral interface portion. The system includes one or more actuators 636 coupled to motors configured to actively control the position of the support portion 626 within the cavity 624. For example, the system may include one or more servomotors configured to drive one or more extendable actuators 636. The actuators 636 are configured to advance the support portion 626 in the z-axis direction relative to the housing 616. The servomotors may be in communication with one or more sensors 638 configured to detect detachment of the housing 616 and / or the parenteral interface portion from the skin 212. A controller (not shown) is configured to activate the servomotors and control the extension of the extendable actuators in response to detecting detachment of the syringe 610 from the skin 212.

[0083] Sensor 638 may be located on the bottom of housing 616 and may be configured to sense removal of housing 616 from skin 212. The corrective action taken by actuator 636 upon sensing removal of housing 616 from skin 212 is shown schematically in FIG. 6B.

[0084] In the embodiment shown in Figures 6A and 6B, two actuators 636 are shown, each configured to be driven by an associated motor. Two sensors 638 are also shown, one associated with each actuator 636. In this embodiment, the right sensor detects disengagement (see Figure 6B, arrow D indicates disengagement), which activates the actuator 636 to prevent disengagement of the support portion 626 from the injection site. The parenteral interface may be configured such that activation of one actuator 636 in response to sensing disengagement of one side of the housing 616 tilts the parenteral interface, particularly the support portion 626, relative to the housing, counteracting asymmetric disengagement of the housing 616 from the skin surface. If desired, the support portion 626 may be appropriately mechanically secured to the actuator 636 to allow it to pivot relative to the extendable actuator.

[0085] In the embodiment shown in FIGS. 6A and 6B, the sensors 638 may be configured as microneedle electrode sensors. Each sensor 638 may be configured as an array of microneedles fixed to the housing 616 of the syringe 610. The array may be configured to characterize the force of contact of the electrodes with the skin. One way to measure the force between the microneedle electrode sensor 638 and the skin (e.g., skin 212 at the injection site) may be by analyzing the signal-to-noise ratio (which depends on the contact force between the skin and the microneedle array) of an ECG (electrocardiogram) signal sensed using an array of microneedles configured as "dry electrodes." An example of a contact force analysis technique is described in Non-Patent Document 1, the contents of which are incorporated herein by reference in their entirety.

[0086] Those skilled in the art will appreciate that other sensors may be used to determine the correct position of the needle relative to the injection site. For example, a capacitance sensor or "touch sensor" may be used to detect contact between the support and the injection site in addition to (or instead of) a microneedle electrode sensor configured as an ECG electrode. Displacement sensors may also be used to detect when the support has moved out of its correct position in contact with the injection site. Microneedle electrode sensors configured to detect contact with interstitial fluid in the skin may also be used. It will be apparent to those skilled in the art in light of the disclosure herein that other suitable sensors may be suitable for connection with products of the present invention.

[0087] While the embodiment shown in Figures 6A and 6B includes two sensors, two motors, and two actuators, it will be understood that other combinations are possible. For example, there may be one sensor, one motor, and one actuator. Alternatively, there may be one, two, or more than two sensors, motors, and actuators. Those skilled in the art will also understand that the ratio of sensors, motors, and actuators does not have to be 1:1:1. Instead, multiple sensors may provide feedback to a controller that operates one or more actuators, or multiple actuators may be (selectively) driven by a single motor.

[0088] Additionally, although the embodiment shown in Figures 6A and 6B includes a circumferential space 630 between the outer peripheral edge of support 626 and inner wall 624a of cavity 624, this arrangement is not required in all embodiments, as noted above.

[0089] Alternatively (or in addition) to a sensor located on the housing, a sensor 638 may be located on the support portion 626 (optionally as an array of microneedles for medication delivery) configured to detect detachment of the support portion 626 from the skin 212 and advance the support portion 626 to prevent detachment from the skin 212, thereby maintaining needle penetration depth at the injection site.

[0090] Figures 7A and 7B show another embodiment of a syringe in accordance with the present invention. The syringe 710 shown in Figures 7A and 7B is similar to the syringe 610 shown in Figures 6A and 6B. Like Figure 6A, Figure 7A shows the syringe 710 at rest (undisplaced). Figure 7B shows the syringe 710 undergoing an impact that displaces the syringe 710 against the skin 212 at the injection site.

[0091] The syringe 710 includes a housing 716. The housing 716 is configured to be secured in place on the skin using an adhesive layer 722, i.e., an adhesive patch. The housing 716 includes a cavity 724. A parenteral interface portion is housed therein. The parenteral interface portion includes a support portion 726 attached to at least one actuator 736. The actuator 736 is driven by a motor in response to a sensor 738 detecting the removal of the housing 716 from the skin 212.

[0092] The cavity has a sidewall 724a and is optionally separated from the support 326 by a circumferential space 730. The syringe 710 differs from the syringe 610 shown in Figures 6A and 6B in the shape of its needle portion. In the embodiment described with reference to Figures 6A and 6B, a single needle 614 is attached to the support 626 that includes the parenteral interface. However, in the embodiment shown in Figures 7A and 7B, the needle portion forms a microneedle array 794. The array includes multiple microneedles configured to deliver a medication to an injection site. Thus, the flexible conduit 720 is configured to supply a medication to the microneedle array 794, rather than being connected to only a single hollow injection needle as shown in Figures 6A and 6B.

[0093] Similar to the embodiment shown in Figures 6A and 6B, the actuator 736 is configured such that as the housing 716 is displaced relative to the injection site, the actuator 736 actively realigns the position of the support portion 726 relative to the housing 316 in response to the sensor 738 detecting the removal of the housing 716 from the skin 212.

[0094] 6A-7B, a sensor is located on the bottom surface of the housing and is configured to sense disengagement of the housing from the skin. The actuator is then configured to advance (or retract) the parenteral contact portion relative to the skin to counteract the housing disengagement and maintain a desired contact pressure and / or penetration depth between the needle portion and the skin at the injection site. Alternatively or additionally, a sensor may be located on the support portion of the parenteral contact portion to directly sense the contact pressure of the parenteral contact portion against the skin, and the actuator may be used to actively counteract the detected disengagement.

[0095] The support portion of the above embodiments is attached to one or more actuators that drive one or more motors configured to realign the parenteral contact portion relative to the housing in response to withdrawal of the syringe from the injection site. This allows the support portion to be movably attached to the housing, isolating the parenteral contact portion from impacts on the housing. While the above embodiments describe extendable actuators driven by connected servomotors, other configurations are also possible. Some embodiments may be particularly suited to the use of a system that can actively align the parenteral contact portion relative to the housing, for example, where it is desirable to maintain a constant contact pressure between the parenteral contact portion and the injection site. This may be particularly advantageous for wearable syringes whose needle portion includes an array of microneedles, as this allows the microneedle penetration depth to be controlled near an ideal value throughout the injection, preventing medication leakage. By configuring the syringe to actively maintain contact force between the parenteral contact portion and the injection site even when the housing is withdrawn from the injection site, the needle penetration depth can be maintained.

[0096] It will be appreciated that the above-described system for actively aligning the parenteral contact portion need not be statically attached to the housing. For example, the above-described components may be incorporated into a syringe having a movable needle hub. The needle hub is configured to advance the needle from a retracted position (where the needle does not extend from the housing) prior to injection to an advanced position (where the needle extends from the housing and penetrates the injection site) during injection. In such an embodiment, an actuator 636 may be disposed between the support and the needle hub. Alternatively, the actuator 636 may be configured to control needle insertion prior to injection.

[0097] Hereinafter, still another embodiment will be described with reference to Figures 8 and 9. In this embodiment, the parenteral contact portion is movable relative to the housing.

[0098] Figure 8 shows a syringe 810 similar to syringes 210, 310, 410, 510, 610, and 710 described above. However, instead of utilizing a spring, deformable material, or actuator to maintain the position of the parenteral contact portion relative to the injection site, the embodiment of Figure 8 may include a support to which the needle portion is rotatably mounted.

[0099] As shown in FIG. 8 , the syringe 810 includes a housing 816. The housing 816 is configured to be secured to the skin 212 using an adhesive 822 or adhesive patch. The housing 816 includes a cavity 824. The cavity is configured to house a parenteral interface. The parenteral interface includes a support 826 that is mounted for rotation relative to the housing 816. A gimbal 840 or ball-and-socket joint may be provided as the rotation platform. Other configurations of rotary joints are also possible, and may have fewer degrees of rotational freedom than a ball-and-socket or gimbal joint. For example, a simple torsional joint may be provided, allowing the support 826 to rotate relative to the housing 816 about only one axis.

[0100] The support 826 is configured to rotate about at least one axis, for example, the z-axis. By mounting the support 826 to rotate about the z-axis relative to the housing 816, rotation of the housing 816 in the x-y plane relative to the skin does not cause the needle 814 to twist within the injection site. In at least some embodiments, the support 826 is configured to rotate about all three axes (x, y, z) and pivots within the cavity 824, allowing the parenteral contact portion to remain in contact with the skin even if the housing 816 is twisted at or lifted from the injection site.

[0101] 8, cavity 824 has sidewalls 824a and is optionally separated from support portion 826 by a circumferential space 830. This circumferential space allows the parenteral interface portion to tilt and pivot within cavity 824 and maintain contact with skin 212 at the injection site.

[0102] Figure 9 shows a syringe 910, which is similar to syringe 810 described above. Syringe 910 differs from syringe 810 of Figure 8 in the shape of its needle. In the embodiment described with reference to Figure 8, the parenteral interface includes a needle 814 attached to a support 826. However, in the embodiment shown in Figure 9, the needle defines a microneedle array 994. The array includes multiple microneedles configured to deliver a medication to an injection site. Thus, flexible conduit 920 is configured to supply medication to the microneedle array 994, rather than being connected to just a single hollow injection needle as shown in Figure 8.

[0103] Similar to the embodiment shown in FIG. 8, the support portion 926 is configured such that as the housing 916 is displaced relative to the injection site, the support portion 926 tilts and / or rotates relative to the housing, maintaining contact between the support portion 926 and the skin 212.

[0104] As noted above, it will be appreciated that the support portion of the embodiment is mounted on a gimbal or ball-and-socket joint, for example to rotate about a pivot point, thereby movably mounting the support portion relative to the housing and isolating the parenteral contact portion from impacts to the housing.

[0105] It will be appreciated that the gimbal (or other rotating mount for supporting the needle support) need not be statically mounted relative to the housing. For example, the above elements may be incorporated into a syringe having a movable needle hub configured to advance the needle from a retracted position before injection (needle not extending from the housing) to an advanced position during injection (needle extending from the housing and inserted into the injection site). In such an embodiment, a rotating mount may be located between the support and the needle hub.

[0106] Referring now to Figures 10A and 10B, yet another embodiment will be described. This embodiment includes an insertion mechanism. Figures 10A and 10B show a syringe 1010 similar to syringes 210, 310, 410, 510, 610, 710, 810, and 910 described above. Syringe 1010 differs from the syringes described above in that it includes an insertion mechanism. The insertion mechanism is configured to advance the needles (in this embodiment, an array of microneedles 1094) from a retracted position (shown in Figure 10A) (where the needles do not extend from the housing 1016 of the syringe 1010) to an advanced position (shown in Figure 10B) (where the needles extend from the housing 1016 and contact the skin at the injection site).

[0107] The insertion mechanism includes a support base 1052 and an actuator 1050. The support base 1052 is movably mounted relative to the housing 1016 and is configured to move between a first position (shown in FIG. 10A) and a second position (shown in FIG. 10B). The actuator 1050 is configured to move the support base 1052 between the first and second positions. The actuator 1050 may be any suitable mechanism for advancing the needle to the injection site. The mechanism may be configured to include a power source, such as a mechanical spring or a motor, that drives the actuator to move the support base 1052 to the second position.

[0108] The support base 1052 is connected to the parenteral interface 1026 by a plurality of springs 1032 arranged as shown in Figures 10A and 10B. However, those skilled in the art will appreciate that the insertion mechanism described with reference to Figures 10A and 10B may be configured to include any of the parenteral interface support structures described with reference to Figures 1-9.

[0109] The insertion mechanism may be configured to advance the support portion 1026 to a position where the parenteral-contacting portion projects beyond the underside of the housing when the spring 1032 is uncompressed (as shown in FIG. 10B). This configuration is preferred because it ensures that the spring 1032 is only slightly compressed when the syringe is secured to the skin at the injection site. This allows the spring 1032 to urge the parenteral-contacting portion toward the skin, maintaining contact with the injection site, even if the syringe is momentarily or persistently about to become dislodged from the injection site.

[0110] 10A and 10B also show an optional additional element, a releasable locking mechanism 1054, configured to maintain the insertion mechanism in the operating position (shown in FIG. 10A). In this embodiment, the locking mechanism 1054 is shown as a latch arm that is configured to engage with the support base 1052 and prevent the support base 1052 from advancing to the second position.

[0111] As shown in Figure 10B, the latch arm, which in this embodiment forms a releasable locking mechanism 1054, is flexible to a non-operating position (see Figure 10B) in which the latch arm allows the support base 1052 to advance relative to the housing 1016, thereby extending the parenteral interface and needle portion to the injection position. While Figures 10A and 10B show flexible latch arms, those skilled in the art will appreciate that other releasable locking mechanisms are possible.

[0112] Another embodiment of the present invention will now be described with reference to Figures 11A and 11B. Figures 11A and 11B show a syringe 1110 similar to syringes 210, 310, 410, 510, 610, 710, 810, and 910 described above. Syringe 1110 differs from the syringes described above in that it includes a deployment mechanism 1160. This mechanism is configured to deploy a needle (in this embodiment, an array of microneedles 1194) at an injection location. As shown in Figures 11A and 11B, the deployment mechanism is configured to move the needle from a retracted position (where the needle does not extend from the housing 1116 of syringe 1110 (see Figure 11A)) to an extended position (where the needle extends from the housing 1116 and contacts the skin at the injection site (see Figure 11B)).

[0113] In this embodiment, the deployment mechanism 1160 forms a manual deployment actuator that allows a user to advance the parenteral interface, which includes a needle portion (in this embodiment, a microneedle array 1194), into an injection site. The deployment mechanism 1160 is in the form of a key that fits into the parenteral interface support 1126 at a first end 1162. The key extends through a hole in the housing 1116 to a second end. The second end is provided with an actuation member 1164, or handle. The deployment mechanism 1160 is slidable within the housing between a first position (see FIG. 11A) and a second position (see FIG. 11B). Because the first end 1162 of the key fits into the support 1126, moving the actuation member 1164 to the position shown in FIG. 11B brings the needle portion (in this embodiment, a microneedle array 1194) into contact with the injection site.

[0114] 11A and 11B, the support 1126 is attached to a support base 1152 within the housing by a plurality of springs 1132. However, those skilled in the art will appreciate that the positioning mechanism 1160 described with reference to FIGS. 11A and 11B may be incorporated into any of the above embodiments.

[0115] Additionally, the positioning mechanism 1160 may be configured to maintain the support portion 1126 in the retracted position shown in Figure 11A with the spring 1132 compressed between the support portion 1126 and the support base 1152. In the position shown in Figure 11B, the spring 1132 is still compressed, but to a lesser extent than in the position shown in Figure 11A, thereby maintaining the parenteral contact portion in contact with the skin at the injection site.

[0116] To prevent the parenteral contact portion from unintentionally retracting from the injection site after the needle portion is deployed at the injection location, the deployment mechanism 1160 may be configured to be removable from the syringe 1110. For example, after deploying the parenteral contact portion, the user can slide the first end 1162 of the key off the support portion 1126 and withdraw the key from the housing 1116.

[0117] While the positioning mechanism described with reference to FIGS. 11A and 11B forms a manual key configured to move the support 1126 from the first position to the second position, those skilled in the art will appreciate that other configurations are possible. For example, instead of a manual positioning mechanism, an automatic positioning mechanism may include a power source (mechanical or electrical) to move the support to the position shown in FIG. 11B. In the above embodiments, each of the syringes 210, 310, 410, 510, 610, 710, 810, 910, 1010, and 1110 includes a configuration that moves the parenteral interface relative to the housing in response to movement of the syringe relative to the injection site. However, it will be appreciated that the movable parenteral interface mounts described above in some embodiments may be combined. For example, a passively counteracting parenteral interface mount (e.g., a support mount including a deformable material, multiple springs, or a pivoting mount) may be combined with the above-described active counteracting mechanism. For example, a support mounted for rotation (at least about the z-axis) may be combined with the motor-driven support of the parenteral contactor described above. Because an extendable actuator cannot counteract rotation of the housing about the z-axis (e.g., resulting from twisting of the syringe as shown in FIG. 1C), an active displacement counteracting mechanism, such as those shown in FIGS. 6A-7B, may be combined with a support mounted for rotation of the kind shown in FIG. 8 or 9.

[0118] In each of the above embodiments, an adhesive layer or adhesive patch has been described as being attached to the bottom of the housing to secure the syringe to the skin. However, it will be understood that the wearable syringe may be secured to the skin in other ways. For example, an adhesive separate from the syringe may be used to secure the syringe in place. An adhesive may also be attached to the parenteral contact portion to maintain the parenteral contact portion in place relative to the injection site. This may also secure the elements attached to the housing of the wearable syringe.

[0119] In any of the above embodiments including a sensor configured to detect syringe displacement, the controller may be further configured to collect data regarding the location and position control of the microneedle or the pattern of medication delivery by the syringe.

[0120] For ease of explanation, the above embodiments have been described in terms of a wearable medication delivery device, which is configured as a self-contained unit including a medication reservoir and a drive system for transporting the medication from the reservoir through a conduit to the needle. However, it will be appreciated that the benefits of the above embodiments also apply to wearable injectors configured to utilize an external medication reservoir, as well as portable auto-injectors, particularly those worn on the skin and designed to deliver a single dose of medication over an extended injection time, e.g., 10-120 seconds.

[0121] In addition to the syringes described above, the present invention also provides a number of example methods. In particular, this specification provides example methods for manufacturing a syringe according to any of the above embodiments, as well as methods for supporting the needle of a syringe. Methods for supporting the needle of a syringe include methods for supporting the needle in an injection position in preparation for an injection, and methods for supporting the needle of a syringe in an injection position between doses of a medication. The latter is particularly applicable to wearable syringes configured to deliver boluses of medication at scalable time intervals.

[0122] In one embodiment, a method for supporting a needle portion of a syringe in preparation for injection of a medication comprises the steps of: attaching the syringe to an injection site; the syringe comprising a housing having a hollow cavity and a parenteral interface portion disposed within the cavity; the parenteral interface portion including a support portion and a needle portion attached to the support portion; the needle portion configured to deliver a dose of medication to the injection site; the support portion attached to a plurality of springs, the springs extending from the same spring base within the housing and having different longitudinal axes; the method further comprises securing the syringe to the injection site using an adhesive provided on the housing; and compressing the springs between the support portion and the spring base.

[0123] The method may further comprise the step of compressing and expanding at least one of the springs to move the parenteral contact portion relative to the housing and maintain contact between the parenteral contact portion and the skin.

[0124] In another embodiment, a method for supporting a needle portion of a syringe in preparation for injection of a medication comprises the steps of: attaching the syringe to an injection site; the syringe comprising a housing having a cavity and a parenteral interface portion disposed within the cavity; the parenteral interface portion including a support portion and a needle portion attached to the support portion; the needle portion configured to deliver a dose of medication to the injection site; the support portion attached within the cavity to an elastically deformable mount coupled to the housing; the support portion having an outer wall, the cavity having an inner wall, the outer wall of the support portion separated from the inner wall of the cavity by a circumferential space extending around the outer wall; the method further comprises securing the syringe to the injection site using an adhesive provided on the housing; and compressing the elastically deformable mount between the support portion and the housing.

[0125] The method may further comprise the step of compressing and expanding the elastically deformable platform to move the parenteral contact portion relative to the housing and maintain contact between the parenteral contact portion and the skin.

[0126] In yet another embodiment, a method for supporting a needle portion of a syringe in preparation for injection of a medication comprises the steps of: attaching the syringe to an injection site; the syringe comprising a housing having a hollow cavity and a parenteral interface portion disposed within the hollow cavity; the parenteral interface portion including a support portion, a needle portion attached to the support portion, and a flexible conduit; the needle portion configured to deliver a dose of medication to the injection site; the conduit configured to deliver medication from a medication container to the needle portion; the support portion attached to a plurality of motors and movable within the hollow cavity; the motors configured to maintain contact between the parenteral interface portion and the injection site; the method further comprises securing the syringe to the injection site using an adhesive on the housing and maintaining contact between the parenteral interface portion and the injection site by actuating at least one motor.

[0127] The method may further comprise the steps of sensing a contact force between the housing and the skin and / or between the parenteral contact portion and the skin, and activating the actuator in response to sensing that the parenteral contact portion has left a position where the needle penetration depth is a predetermined value.

[0128] In yet another embodiment, a method for supporting a needle portion of a syringe in preparation for injection of a medication comprises the steps of: attaching the syringe to an injection site; the syringe comprising a housing having a cavity and a parenteral interface portion disposed within the cavity; the parenteral interface portion including a support portion and a needle portion attached to the support portion; the needle portion configured to deliver a dose of medication to the injection site; a flexible conduit communicating the medication container with the needle portion; the support portion being rotatably mounted relative to the housing and rotatable within the cavity; the method further comprising securing the syringe to the injection site using an adhesive provided on the housing; and contacting the parenteral interface portion with the injection site.

[0129] The method may further comprise the step of moving the parenteral portion relative to the housing by rotating the support about a swivel to maintain contact between the parenteral portion and the skin.

[0130] The foregoing detailed description describes a system and method for supporting a parenteral interface at an injection location. However, those skilled in the art will appreciate that the present invention is not limited to use with the example syringe described herein. Rather, one or more of the advantages associated with the present invention may be obtained with other medication delivery systems, as will be apparent to those skilled in the art in light of the foregoing detailed description.

[0131] It will also be understood that the terms "proximal," "distal," "front," "rear," "side," "upper," and "lower," when used, are used for convenience in interpreting the drawings and should not be construed as limiting the invention. The word "comprising" should be construed as meaning "including, but not limited to," and does not exclude the presence of unlisted elements.

[0132] The above-described embodiments and those illustrated in the accompanying drawings are provided as examples of how the invention may be put into effect and are not intended to limit the scope of the invention. Changes may be made, elements may be replaced with functionally and structurally equivalent parts, and elements may be combined between different embodiments without departing from the scope of the disclosure.

[0133] In view of the above embodiments, the invention can also be characterized as follows. 1. A syringe having a housing, a parenteral interface, and a flexible conduit, the housing is configured to accommodate a medication container; The parenteral contact portion is a support disposed in a cavity within the housing; a needle attached to the support and configured to administer a dose of medication to an injection site; Including, the conduit is configured to deliver a medication from the medication container to the needle; the support is movably mounted within the cavity; A plurality of motors are configured to move the support portion relative to the housing to maintain the parenteral contact portion in contact with the injection site. A syringe characterized by: 2. The syringe according to claim 1, wherein the needle portion comprises a hollow injection needle. 3. The syringe according to 1. or 2., wherein the needle portion comprises an array of microneedles. 4. A syringe described in any one of 1. to 3., wherein each of the plurality of motors is a servo motor. 5. A syringe according to any one of claims 1 to 4, wherein the housing includes a skin-contacting surface. 6. Each of the plurality of motors at least one sensor configured to sense the parenteral contact portion leaving the injection site; communicate with, A syringe according to any one of 1. to 5. 7. The syringe according to 6., wherein the at least one sensor is a microneedle electrode sensor. 8. The syringe according to claim 6 or 7, wherein the at least one sensor is provided on the skin-contacting surface of the housing. 9. A syringe described in any one of 6. to 8., wherein the at least one sensor is provided on the skin contact surface of the support portion. 10. The support has an outer wall; the cavity has an inner wall; an outer wall of the support portion separated from an inner wall of the cavity by a circumferential space extending around the outer wall; A syringe according to any one of claims 1 to 9. 11. The plurality of motors are a motor base movably mounted within said housing Attached to A syringe according to any one of claims 1 to 10. 12. The syringe of claim 11, wherein the motor base is rotatably mounted within the housing. 13. The syringe of claim 11 or 12, wherein the motor base is pivotally mounted within the housing. 14. A syringe as described in any one of 1. to 13., wherein the motor base is movably mounted within the housing and moves distally to advance the needle portion toward the skin from a retracted position to an extended position. 15. The plurality of motors move the support portion. a position in which the needle portion extends beyond the skin-contacting surface of the housing; configured to maintain A syringe according to any one of claims 1 to 14. 16. The skin-contacting surface of the housing is an adhesive portion configured to attach the syringe to the skin of a user; Equipped with A syringe according to any one of claims 5 to 15. 17. Adhesive portion provided on the skin contact surface of the support portion 17. The syringe of any one of claims 1 to 16, further comprising:

[0134] 18. A method of supporting a syringe needle for injection of a medication, comprising: A device having a hollow housing and a parenteral contact portion, The parenteral contact portion a support disposed within the cavity and attached to a plurality of motors so as to be movable within the cavity; a needle attached to the support and configured to administer a dose of medication to an injection site; a flexible conduit configured to deliver a medication from a medication container to the needle; Including, The plurality of motors are configured to maintain contact between the parenteral interface and the injection site. attaching the device to an injection site; securing the syringe to the injection site using an adhesive on the housing; maintaining contact between the parenteral contact portion and the injection site by actuating at least one of the plurality of motors; A method of providing 19. Each of the plurality of motors at least one sensor configured to detect the parenteral contact portion leaving the injection site; and configured to operate in response to sensing withdrawal of the parenteral contact portion from the injection site. 18. A syringe as described in claim 18.

[0135] 20. A method of manufacturing a syringe, comprising: configured to receive a medication container; Cavity with an opening on the skin contact surface Including housing providing a a support disposed within the cavity of the housing; a needle attached to the support and configured to administer a dose of medication to an injection site; Parenteral contact area containing within the cavity of the housing; a flexible conduit configured to deliver a medication from the medication container to the needle; providing a mounting the support portion within the housing to a plurality of motors configured to maintain contact between the parenteral contact portion and the injection site; A method of providing

[0136] 21. A syringe having a housing, a parenteral interface, and a flexible conduit, the housing is configured to accommodate a medication container; The parenteral contact portion is a support disposed in a cavity within the housing; a needle attached to the support and configured to administer a dose of medication to an injection site; Including, the conduit is configured to deliver a medication from the medication container to the needle; The support is rotatably mounted relative to the housing and is rotatable within the cavity. A syringe characterized by: 22. The syringe according to claim 21, wherein the needle portion comprises a hollow injection needle. 23. The syringe according to claim 21 or 22, wherein the needle portion comprises an array of microneedles. 24.It is wearable, Fixing means for fixing the syringe to the user's body 24. A syringe according to any one of claims 21 to 23, comprising: 25. The support portion is a swivel joint configured to rotate the support within the housing about an axis extending proximally from the housing toward the skin; 25. The syringe according to any one of claims 21 to 24, comprising: 26. A syringe as described in any one of claims 21 to 25, wherein the support portion is configured to pivot about a pivot point. 27. A syringe as described in any one of claims 21 to 26, wherein the support portion is attached to the housing by a ball joint. 28. The support has an outer wall; the cavity has an inner wall; an outer wall of the support portion separated from an inner wall of the cavity by a circumferential space extending around the outer wall; A syringe according to any one of claims 21 to 27. 29. A syringe as described in any one of claims 21 to 28, wherein the support portion is rotatably mounted on a support base, is movable within the housing, and moves proximally to advance the needle portion from a retracted position to an extended position. 30. The support portion is The support portion, a position in which the needle portion extends beyond the skin-contacting surface of the housing; a plurality of springs configured to direct the Including, A syringe according to any one of claims 21 to 29. 31. The housing includes a skin-contacting surface; The skin contact surface is an adhesive portion configured to attach the syringe to the skin of a user; Including, A syringe according to any one of claims 21 to 30. 32. The support portion is a base movably mounted within the housing to advance the needle from a retracted position relative to the housing to a position extending toward the skin; Supported by A syringe according to any one of claims 21 to 31. 33. The base is attached to the housing. a first position in which the needle does not extend from the housing; a second position in which the needle extends from the housing and penetrates an injection site; an insertion mechanism configured to move the 32. The syringe according to claim 32, further comprising: 34. In an operating state, the support and / or the base are maintained in a first position relative to the housing so that the needle does not extend from the housing; In an inactive state, the support and / or the base are moved to a second position, causing the needle to extend from the housing. A releasable locking mechanism configured to The syringe according to claim 32 or 33, further comprising: 35. Connected to the support, a first position in which the needle does not extend from the housing; a second position in which the needle extends from the housing; a positioning mechanism configured to move the support between The syringe according to any one of claims 21 to 34, further comprising: 36. The syringe of claim 35, wherein the deployment mechanism is removably coupled to the housing. 37. Adhesive portion provided on the skin contact surface of the support portion 37. The syringe of any one of claims 31 to 36, further comprising:

[0137] 38. A method of supporting a syringe needle for injection of a medication, comprising: a hollow housing; a parenteral access portion disposed within the cavity; An apparatus having The parenteral contact portion is a support rotatably mounted relative to the housing for rotation within the cavity; a needle attached to the support and configured to administer a dose of medication to an injection site; Including, A flexible conduit is provided in communication between the drug container and the needle. attaching a device to the injection site, the device comprising: securing the syringe to the injection site using an adhesive provided on the housing; A method of providing

[0138] 39. A method of manufacturing a syringe, comprising: a housing configured to receive the medication container and including a cavity with an opening at the skin-contacting surface; providing a a support disposed within the cavity of the housing; a needle attached to the support and configured to administer a dose of medication to an injection site; Parenteral contact area containing within the cavity of the housing; a flexible conduit configured to deliver a medication from the medication container to the needle; providing a mounting the support within the cavity such that the support can rotate relative to the housing about at least one axis; A method of providing

[0139] 40. A syringe having a housing, a parenteral interface, and a flexible conduit, the housing is configured to receive a medication container; The parenteral contact portion is a support disposed in a cavity within the housing; a needle attached to the support and configured to administer a dose of medication to an injection site; Including, the conduit is configured to deliver a medication from the medication container to the needle; the support is mounted within the cavity on an elastically deformable platform connected to the housing; The support has an outer wall; the cavity has an inner wall; an outer wall of the support portion separated from an inner wall of the cavity by a circumferential space extending around the outer wall; A syringe characterized by: 41. The syringe of claim 40, wherein the elastically deformable mount comprises a foam layer. 42. The syringe of claim 41, wherein the foam layer is separated from the inner wall of the cavity by a circumferential space. 43. A syringe as described in any one of claims 40 to 42, wherein the needle portion comprises a hollow injection needle. 44. A syringe as described in any one of claims 40 to 43, wherein the needle portion comprises an array of microneedles. 45. A syringe as described in any one of claims 41 to 44, wherein the foam layer is fixed within the housing. 46. ​​A syringe as described in any one of claims 41 to 45, wherein the foam layer is fixed to a movable part within the housing. 47. The syringe according to claim 46, wherein the movable part is rotatably mounted to the housing. 48. The syringe of claim 46 or 47, wherein the movable part is pivotally mounted to the housing. 49. The movable part is configured to move proximally to advance the needle from a retracted position to a position extending from the housing toward the skin. A syringe according to any one of claims 46 to 48. 50. The elastically deformable platform is supported on a base; the base is movably mounted within the housing and configured to move proximally to advance the needle from a retracted position to a position extending from the housing toward the skin. A syringe according to any one of claims 40 to 49. 51. The base is attached to the housing. a first position in which the needle does not extend from the housing; a second position in which the needle extends from the housing and penetrates an injection site; an insertion mechanism configured to move the 50. The syringe according to claim 50, further comprising: 52. In an operating state, the support and / or the base are maintained in a first position relative to the housing so that the needle does not extend from the housing; In an inactive state, the support and / or the base are moved to a second position, causing the needle to extend from the housing. A releasable locking mechanism configured to The syringe according to claim 50 or 51, further comprising: 53. Connected to the support, a first position in which the needle does not extend from the housing; a second position in which the needle extends from the housing; a positioning mechanism configured to move the support between The syringe of any one of claims 40 to 52, further comprising: 54. The syringe of claim 53, wherein the deployment mechanism is removably coupled to the housing. 55. The housing includes a skin-contacting surface; The skin contact surface is an adhesive portion configured to attach the syringe to the skin of a user; A syringe according to any one of claims 40 to 54, comprising: 56. Adhesive portion provided on the skin contact surface of the support portion The syringe of any one of claims 40 to 55, further comprising:

[0140] 57. A method of supporting a syringe needle for injection of a medication, comprising: a hollow housing; a parenteral access portion disposed within the cavity; An apparatus having The parenteral contact portion is a support mounted within the cavity on a resiliently deformable platform connected to the housing; a needle attached to the support and configured to administer a dose of medication to an injection site; Contains attaching a device to the injection site, the device comprising: securing the syringe to the injection site using an adhesive on the housing; compressing the resiliently deformable platform between the support and the housing; Equipped with The support has an outer wall; the cavity has an inner wall; an outer wall of the support portion separated from an inner wall of the cavity by a circumferential space extending around the outer wall; A method characterized by: 58. A method of manufacturing a syringe, comprising: a housing configured to receive the medication container and including a cavity with an opening at the skin-contacting surface; providing a a support disposed within the cavity of the housing; a needle attached to the support and configured to administer a dose of medication to an injection site; Parenteral contact area containing within the cavity of the housing; a flexible conduit configured to deliver a medication from the medication container to the needle; providing a mounting the support within the cavity on a resiliently deformable mount connected to the housing; Equipped with The support has an outer wall; the cavity has an inner wall; an outer wall of the support portion separated from an inner wall of the cavity by a circumferential space extending around the outer wall; A method characterized by: 59. The method of claim 57 or 58, wherein the elastically deformable platform comprises a foam layer. 60. The method of claim 59, wherein the foam layer is separated from the inner wall of the cavity by a circumferential space.

Claims

1. A syringe comprising a housing, a parenteral interface, and a flexible conduit, the housing is configured to accommodate a medication container; The parenteral contact portion is a support disposed in a cavity within the housing; a needle attached to the support and configured to administer a dose of medication to an injection site; Including, the conduit is configured to deliver a medication from the medication container to the needle; the support is attached to a plurality of springs; The plurality of springs are connected to a spring base provided in the housing, Each of the plurality of springs has a major axis, and the major axes of the plurality of springs are different from one another; A circumferential gap is defined between an outer surface of the support portion and a side wall of the cavity so that the support portion can move laterally within the cavity of the housing. A syringe characterized by:

2. The syringe of claim 1 , wherein the needle portion comprises a hollow needle.

3. 3. The syringe of claim 1 or claim 2, wherein the needle portion comprises an array of microneedles.

4. 4. The syringe of claim 1, wherein the plurality of springs includes at least one coil spring.

5. The support has an outer wall; The housing cavity has an inner wall; an outer wall of the support portion is spaced from an inner wall of the cavity to form the circumferential gap; A syringe according to any one of claims 1 to 4.

6. 6. A syringe according to any one of claims 1 to 5, wherein the spring base is fixed within the housing.

7. 6. A syringe according to any one of claims 1 to 5, wherein the spring base is movably mounted within the housing.

8. 8. The syringe of claim 7, wherein the spring base is rotatably mounted to the housing.

9. 8. The syringe of claim 7, wherein the spring base is pivotally mounted to the housing.

10. 10. The syringe of claim 7, claim 8, or claim 9, wherein the spring base is movably mounted within the housing and configured to move distally to advance the needle from a retracted position to a position extending from the housing toward the skin.

11. The plurality of springs support the support portion. a position in which the needle portion extends beyond the skin-contacting surface of the housing; It is configured to direct A syringe according to any one of claims 1 to 10.

12. The spring base is attached to the housing. a first position in which the needle does not extend from the housing; a second position in which the needle extends from the housing and penetrates an injection site; an insertion mechanism configured to move the 12. The syringe of claim 1, further comprising:

13. maintaining the support or the spring base in the first position relative to the housing in an operating state; In a non-operating state, the support or the spring base is moved to the second position. A releasable locking mechanism configured to 13. The syringe of claim 12, further comprising:

14. The releasable locking mechanism is maintaining the support in the first position relative to the spring base to compress the plurality of springs; The force of the plurality of springs moves the support portion to the second position relative to the spring base. The syringe of claim 13, wherein the syringe is configured to:

15. connected to the support, a first position in which the needle does not extend from the housing; a second position in which the needle extends from the housing; a positioning mechanism configured to move the support between 15. The syringe of claim 1, further comprising:

16. 16. The syringe of claim 15, wherein the deployment mechanism is removably coupled to the housing.

17. the housing includes a skin-contacting surface; The skin contact surface is an adhesive configured to attach the syringe to the skin of a user; Including, A syringe according to any one of claims 1 to 16.

18. an adhesive portion provided on the skin contact surface of the support portion 18. The syringe of any one of claims 1 to 17, further comprising:

19. 1. A method of supporting a syringe needle for injection of a medication, comprising: a hollow housing; a parenteral access portion disposed within the cavity; It is a device having The parenteral contact portion a support portion attached to a plurality of springs extending from a spring base within the housing, the springs having different longitudinal axes; a needle attached to the support and configured to administer a dose of medication to an injection site; Contains attaching a device to the injection site, the device comprising: securing the syringe to the injection site using an adhesive on the housing; compressing the plurality of springs between the support and the spring base; Equipped with A circumferential gap is defined between an outer surface of the support portion and a side wall of the cavity so that the support portion can move laterally within the cavity of the housing. A method characterized by:

20. 1. A method of manufacturing a syringe, comprising: configured to receive a medication container; Cavity with an opening on the skin contact surface Including housing providing a A support part; a needle attached to the support and configured to administer a dose of medication to an injection site; Parenteral contact area containing within the cavity of the housing; a flexible conduit configured to deliver a medication from the medication container to the needle; providing a attaching the support to a plurality of springs connected to a spring base disposed within the housing; Equipped with Each of the plurality of springs has a major axis, and the major axes of the plurality of springs are different from one another; A circumferential gap is defined between an outer surface of the support portion and a side wall of the cavity so that the support portion can move laterally within the cavity of the housing. A method characterized by:

Images