Integrated adhesive liner and needle shield remover for drug delivery systems

Abstract

This invention relates to an injection device and method for delivering fluids into a patient's body by injection. [Solution] The drug delivery system includes a housing, a needle having a retracted position within the housing and an extended position outside the housing, an adhesive pad element coupled to the bottom portion of the housing, the adhesive pad element including a primary adhesive layer and a removable liner, and a needle shield portion. The system also includes a needle shield remover having an elongated member configured to extend along the bottom portion of the housing in a first position and to extend away from the bottom portion of the housing in a second position, the bottom portion of the elongated member coupled to a removable liner adjacent to the edge position of the adhesive pad element, so that the removable liner is peeled away from the primary adhesive layer when the elongated member of the needle shield remover is moved from the first position to the second position.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims priority to U.S. Provisional Application No. 63 / 169,589, filed on April 1, 2021, entitled "Integrated Adhesive Liner and Needle Shield Remover for Drug Delivery System", the entire disclosure of which is incorporated herein by reference.

[0002] The present disclosure generally relates to injection devices and methods for delivering fluids into a patient's body by injection.

Background Art

[0003] Various types of automatic injection devices have been developed to enable the administration of drug solutions and other liquid therapeutic formulations by non - skilled individuals or for self - injection. Generally, these devices include a reservoir pre - filled with a liquid therapeutic formulation and some kind of automatic needle injection mechanism that can be triggered by a user. When the amount of fluid or drug to be administered is generally below a specific amount, such as 1 mL, an auto - injector is usually used, which typically has an injection time of about 10 - 15 seconds. When the amount of fluid or drug to be administered exceeds 1 mL, generally the injection time becomes longer and it becomes difficult for the patient to maintain contact between the device and the target area of the patient's skin. Further, as the amount of drug to be administered increases, it becomes desirable to lengthen the injection time. The conventional method of slowly injecting a drug into a patient is to initiate an IV (intravenous injection) and slowly inject the drug into the patient's body. Such procedures are usually performed in a hospital or clinic.

[0004] Certain devices enable self-injection in a home setting and allow for the gradual injection of liquid therapeutic formulations into the patient's skin. In some cases, these devices are small enough (both in height and overall size) to allow the liquid therapeutic formulation to be injected into the patient while the patient remains "wearing" the device. These devices typically include a pump or other type of discharge mechanism to drain the liquid therapeutic formulation from the reservoir and into the injection needle. Such devices also typically include a valve or flow control mechanism to initiate the flow of the liquid therapeutic formulation at the appropriate time, and a trigger mechanism to start the injection.

[0005] In certain wearable injectors, the device is attached to the patient's skin via an adhesive pad, and the side of the adhesive pad not facing the patient is also partially adhered to the bottom surface of the injector. Before use, the patient-facing side of the adhesive pad is covered with a liner, which must be removed to expose the adhesive surface of the pad and position it on the patient's skin. In addition, a needle shield remover may be provided in a substantially central position above both the adhesive pad and the liner, with a portion of the needle shield remover passing through the liner, the adhesive pad, and an opening in the bottom surface of the injector to reach a needle shield formed at its end. The needle shield is configured to protect the injection needle inside the injector before use and to prevent the injection process from being started unintentionally.

[0006] In the above-described wearable injection device, the needle shield remover may include a gripping portion (e.g., a ring) which may be rotatable from a non-use position to a use position, for example, via a molded hinge. Furthermore, a portion of the needle shield remover may be fixed to the liner, for example, via a mechanical connection, adhesive, etc. Thus, when the injection device is ready to be placed on the patient's skin, the gripping portion is rotatable to the use position and pulled in a direction substantially perpendicular to the bottom surface of the injection device. Such a tensile force on the gripping portion not only removes the needle shield but also removes the liner from the adhesive pad via the connection between the needle shield remover and the liner, thereby preparing the injection device for placement on the patient's skin in a single step.

[0007] However, the existing correlation between needle shield removal and liner removal on the adhesive pad has certain drawbacks. Specifically, the needle shield remover is centrally positioned relative to the liner and adhesive pad. Therefore, when the needle shield is removed by pulling the gripping portion of the needle shield remover, the removal of the liner begins near this central position on the adhesive pad. Such "inverted" removal of the liner requires making cuts or perforations along specific parts of the liner, known as "kiss cuts," so that the liner can be removed via the needle shield remover in a spring-like or spiral manner. However, providing these cuts or perforations only in the liner (and not in the adhesive pad underneath) is complex and difficult to reliably achieve during manufacturing. Furthermore, the joints of such cuts or perforations in the liner need to be reinforced to prevent tearing due to impact loads when the gripping portion is pulled and / or when the needle shield remover and needle shield are removed from the injection device. Furthermore, peeling the liner in this manner is far less common than starting to peel / remove it from the edges of the pad, which can be cumbersome or confusing for the user. [Overview of the project] [Means for solving the problem]

[0008] In one aspect of the present disclosure, a drug delivery system includes a housing having an upper and a bottom portion, and a needle having a retracted position within the housing and an extended position outside the housing. The drug delivery system also includes an adhesive pad element coupled to the bottom portion of the housing, the adhesive pad element including a primary adhesive layer and a removable liner. The drug delivery system further includes a needle shield portion configured to at least partially cover the needle in the retracted position, and a needle shield remover coupled to the needle shield portion. The needle shield remover includes an elongated member configured to extend along the bottom portion of the housing in a first position and to extend away from the bottom portion of the housing in a second position, the bottom portion of the elongated member coupled to a removable liner adjacent to the edge position of the adhesive pad element, so that the removable liner is peeled away from the primary adhesive layer when the elongated member of the needle shield remover is moved from the first position to the second position.

[0009] In a further configuration of the drug delivery system, the needle shield remover further includes a gripping portion at the distal end of an elongated member. Optionally, the gripping portion includes a pull tab. The pull tab may be angled upward with respect to the bottom portion of the housing when the elongated member is in a first position. In a further configuration, the gripping portion includes a pull ring.

[0010] In another configuration, the needle shield remover further includes a hinge portion. In one embodiment, the elongated member moves from a first position to a second position by pivoting around the hinge portion. If necessary, the bottom portion of the elongated member is attached to a removable liner by adhesive. The adhesive pad element further includes an extension portion that extends below the bottom portion of the elongated member. In a particular configuration, the shield portion of the needle shield remover allows the needle to penetrate in the extended position by passing through the liner of the adhesive pad element, the primary adhesive layer of the adhesive pad element, and an opening formed in the housing.

[0011] In additional configurations, the adhesive pad element further includes a syringe removal tab. If necessary, the peripheral portion of the adhesive pad element extends beyond the mounting area of ​​the housing. Note that the adhesive pad element may be formed from one or more flexible materials. Furthermore, the elongated portion of the needle shield remover may be formed from a flexible material. The elongated portion of the needle shield remover may be substantially flat along the bottom portion of the housing when in the first position.

[0012] According to another embodiment of the present invention, a method for preparing a wearable drug delivery system for use includes providing a drug delivery system comprising a housing having an upper and a bottom portion, a needle having a retracted position within the housing and an extended position outside the housing, and an adhesive pad element coupled to the bottom portion of the housing. The adhesive pad element may include a primary adhesive layer and a removable liner. The drug delivery system further includes a needle shield portion configured to at least partially cover the needle in the retracted position, and a needle shield remover coupled to the needle shield portion. The needle shield remover may include an elongated member having a gripping portion at its distal end, the elongated member being configured to extend along the bottom portion of the housing in a first position and in a direction away from the bottom portion of the housing in a second position. The bottom portion of the elongated member may be coupled to a removable liner adjacent to the edge position of the adhesive pad element. The method further includes rotating the elongated member from the first position to the second position so that the removable liner is peeled away from the primary adhesive layer at the edge position of the adhesive pad element. In addition, the method further includes both pulling the gripping portion of the needle shield remover to remove the needle shield portion from the housing and removing the removable liner from the primary adhesive layer.

[0013] In certain configurations, rotating the elongated member from a first position to a second position includes rotating the elongated member around the hinge portion of the needle shield remover. Optionally, the gripping portion of the needle shield remover includes a pull tab. The gripping portion of the needle shield remover may also include a pull ring. In certain configurations, the edge position of the adhesive pad element is the leading edge portion bonded to the bottom portion of the housing via adhesive. The bottom portion of the elongated member may be bonded to a removable liner of the adhesive pad element at a position close to the leading edge portion.

[0014] Further details and advantages of the present invention will become apparent by reading the following detailed description in conjunction with the accompanying drawings, where similar parts are given the same reference numerals throughout.

[0015] The above-mentioned and other features and benefits of this disclosure, as well as the methods for achieving them, will become more apparent and the disclosure itself will be better understood by referring to the following descriptions of embodiments of this disclosure in conjunction with the accompanying drawings. [Brief explanation of the drawing]

[0016] [Figure 1] This is a perspective view of a drug delivery system according to one aspect of the present invention. [Figure 2] This is a perspective cross-sectional view of a drug delivery system according to one aspect of the present invention shown in Figure 1. [Figure 3] This is a front cross-sectional view of a drug delivery system according to one aspect of the present invention, as shown in Figure 1. [Figure 4] Figure 1 is a top view of a drug delivery system according to one aspect of the present invention, showing the drug delivery system in its pre-use position with the upper part of the housing removed. [Figure 5] Figure 1 is a top cross-sectional view of a drug delivery system according to one aspect of the present invention, showing the drug delivery system in its pre-use position. [Figure 6] Figure 1 is a front cross-sectional view of a drug delivery system according to one aspect of the present invention, showing the drug delivery system in its pre-use position. [Figure 7]Top view of the drug delivery system of FIG. 1 according to one aspect of the present invention, showing the drug delivery system with the upper part of the housing removed and in the initial operating position. [Figure 8] Cross-sectional top view of the drug delivery system of FIG. 1 according to one aspect of the present invention, showing the drug delivery system in the initial operating position. [Figure 9] Cross-sectional front view of the drug delivery system of FIG. 1 according to one aspect of the present invention, showing the drug delivery system in the initial operating position. [Figure 10] Top view of the drug delivery system of FIG. 1 according to one aspect of the present invention, showing the drug delivery system with the upper part of the housing removed and in the use position. [Figure 11] Cross-sectional top view of the drug delivery system of FIG. 1 according to one aspect of the present invention, showing the drug delivery system in the use position. [Figure 12] Cross-sectional front view of the drug delivery system of FIG. 1 according to one aspect of the present invention, showing the drug delivery system in the use position. [Figure 13] Top view of the drug delivery system of FIG. 1 according to one aspect of the present invention, showing the drug delivery system with the upper part of the housing removed and in the post-use position. [Figure 14] Cross-sectional top view of the drug delivery system of FIG. 1 according to one aspect of the present invention, showing the drug delivery system in the post-use position. [Figure 15] Cross-sectional front view of the drug delivery system of FIG. 1 according to one aspect of the present invention, showing the drug delivery system in the post-use position. [Figure 15A] Cross-sectional front view of the drug delivery system of FIG. 1 according to one aspect of the present invention, showing a pad with the drug delivery system in the pre-use position. [Figure 15B] Perspective cross-sectional view of the drug delivery system of FIG. 1 according to one aspect of the present invention, showing a pad with the drug delivery system in the pre-use position. [Figure 15C]A perspective cross-sectional view of the drug delivery system of FIG. 1, according to one aspect of the present invention, showing a pad comprising the drug delivery system in its pre-use position. [Figure 16] A partial cross-sectional view of the drug delivery system of FIG. 1, according to one aspect of the present invention, showing a valve assembly. [Figure 17] A top perspective view of an integrated adhesive liner and needle shield remover, according to one aspect of the present disclosure. [Figure 18] A bottom perspective view of the integrated adhesive liner and needle shield remover of FIG. 17 in a first position. [Figure 19] A partial bottom perspective view of an integrated adhesive liner and needle shield remover, according to another aspect of the present disclosure. [Figure 20] A bottom perspective view of an integrated adhesive liner and needle shield remover, according to another aspect of the present disclosure. [Figure 21] A bottom perspective view of the integrated adhesive liner and needle shield remover of FIG. 18 in a second position.

Best Mode for Carrying Out the Invention

[0017] Corresponding reference characters indicate corresponding parts throughout the several views. The examples described herein illustrate exemplary aspects of the present disclosure and such examples should not be construed as limiting the scope of the present disclosure in any way.

[0018] The following description is provided to enable one skilled in the art to make and use the described aspects contemplated for carrying out the present invention. However, various changes, equivalents, modifications, and alternatives will be readily apparent to one skilled in the art. Any and all such changes, modifications, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.

[0019] For the purposes of the following description, the terms “up,” “down,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “side,” “vertical,” and their derivatives are used in relation to the present invention as oriented in the drawings. However, it should be understood that the present invention may be subject to various alternative modifications unless explicitly identified as contrary to them. Furthermore, it should be understood that the specific devices shown in the accompanying drawings and described in the following specification are merely illustrative embodiments of the present invention. Accordingly, specific dimensions and other physical features relating to the embodiments disclosed herein should not be considered limiting.

[0020] Referring to Figures 1 to 16, a drug delivery system 10 according to one aspect of the present invention includes a drive assembly 12, a container 14, a valve assembly 16, and a needle actuator assembly 18. The drive assembly 12, container 14, valve assembly 16, and needle actuator assembly 18 are at least partially housed within a housing 20. The housing 20 includes an upper portion 22 and a bottom portion 24, although other suitable arrangements may be used with respect to the housing 20. In one aspect, the drug delivery system 10 is an injection device, which is fitted or secured to a user and configured to deliver a predetermined dose of drug provided in the container 14 to the user via injection. The system 10 may be used to deliver a "bolus injection," in which the drug is delivered within a set time. The drug may be delivered over a maximum period of 45 minutes, but other suitable injection doses and durations may be available. Bolus administration or delivery may be carried out by speed control, or may not have special speed control. System 10 can deliver the drug to the user at a fixed pressure and a variable speed. The general operation of System 10 is described below with reference to Figures 1 to 16.

[0021] Referring again to Figures 1 to 16, the system 10 is configured to operate via the engagement of an actuation button 26 by the user, which results in the needle 28 of the needle assembly 18 puncturing the user's skin, activating the drive assembly 12 to place the needle 28 in fluid communication with the container 14, discharging fluid or drug from the container 14, and removing the needle 28 after the drug injection is complete. The general operation of the drug delivery system is shown and described in International Publications 2013 / 155153 and 2014 / 179774, which are incorporated herein by reference in their entirety. The housing 20 of the system 10 includes an indicator window 30 for observing an indicator device 32 configured to provide the user with an indication of the status of the system 10, and a container window 31 for observing the container 14. The indicator window 30 may be a magnifying lens for clear observation of the indicator device 32. The indicator device 32 moves with the needle actuator assembly 18 during the use of the system 10 to indicate the pre-use state, the use state, and the post-use state of the system 10. The indicator device 32 provides a visual indicator of the state, but other suitable indicators, such as auditory or tactile ones, may be provided as alternative or additional indicators.

[0022] Referring to Figures 4-6, during the pre-use position of the system 10, the container 14 is separated from the drive assembly 12 and the valve assembly 16, and the needle 28 is in the retracted position. During the initial operation of the system 10, as shown in Figures 7-9, the drive assembly 12 engages with the container 14, moving the container 14 toward the valve assembly 16, which is configured to puncture the seal 36 of the container 14 and place the drug in the container 14 into fluid communication with the needle 28 via a tube (not shown) or other suitable arrangement. The drive assembly 12 is configured to engage with the stopper 34 of the container 14, which first moves the entire container 14 to engage with the valve assembly 16 due to the incompressibility of the fluid or drug in the container 14. As will be described in more detail below, the initial operation of the system 10 is triggered by the user engaging the actuation button 26, thereby releasing the needle actuator assembly 18 and the drive assembly 12. During the initial operation, the needle 28 remains in the retracted position and is about to move to the extended position in order to inject into the user of system 10.

[0023] During the use of the system 10, as shown in Figures 10 to 12, the needle 28 is in an extended position at least partially outside the housing 20, with the drive assembly 12 having moved the stopper 34 into the container 14, delivering the drug from the container 14 to the user through the needle 28. In the use position, the valve assembly 16 has already punctured the seal 36 of the container 14, placing the container 14 in fluid communication with the needle 28, and also allows the drive assembly 12 to move the stopper 34 relative to the container 14, distributing the fluid from the container 14. In the post-use position of the system 10, as shown in Figures 13 to 15, the needle 28 is in a retracted position, engaged with the pad 38, sealing the needle 28 and preventing any remaining flow of fluid or drug from the container 14. The container 14 and valve assembly 16 may be the container 14 and valve assembly 16 shown and described in International Publication No. 2015 / 081337, which is incorporated herein by reference in its entirety.

[0024] Referring to Figures 15A to 15C, the pad 38 is biased into the pad as the needle actuator body 96 moves from the operating position to the post-operation position. In particular, the pad 38 is received by a pad arm 122 having a cam surface 124, which cooperates with a cam track 126 on the bottom portion 24 of the housing 20. The pad arm 122 is connected to the needle actuator body 96 via a twist bar 128. The cam surface 124 is configured to engage with the cam track 126 and deflect the pad arm 122 downward, thereby allowing the pad 38 to pass under the needle 28 and then biased upward into the needle 28. The twist bar 128 allows the pad arm 122 to twist about the pivot of the needle actuator body 96. The pad 38 can be press-fitted into the opening of the pad arm 122, but other suitable arrangements for securing the pad 38 may be utilized.

[0025] Referring to Figures 1 to 16, a needle actuator assembly 18 according to one aspect of the present invention is shown. The needle actuator assembly 18 includes a needle actuator body 96 having a guide surface 98, a needle shuttle 102 having a cam surface 104, and a needle 28, which is received by the needle shuttle 102 and configured to be in fluid communication with the container 14 as discussed above. The needle actuator body 96 is substantially rectangular and has a guide surface 98 projecting radially inward. The needle shuttle 102 is received within the needle actuator body 96. As described above, the needle actuator body 96 is movable within the housing 20 from a pre-use position (shown in Figures 4 to 6), an initial operating position (Figures 7 to 9), a use position (Figures 10 to 12), and a post-use position (Figures 13 to 15). The needle actuator body 96 is biased from the pre-use position to the post-use position via an extension spring 106, although other suitable biasing devices may be used. The needle actuator body 96 is released upon engagement of the actuation button 26 and moves freely from the pre-use position to the use position, which will be discussed in more detail below. Before the needle actuator body 96 moves from the use position to the post-use position, the limiting member 86 is rotated.

[0026] Next, referring to Figures 17 and 18, another embodiment of the System 10 of the present disclosure is shown. In particular, the System 10 shown in Figures 17 and 18 includes an adhesive pad element 200 that is at least partially fixed to the bottom portion 24 of the housing 20. The adhesive pad element 200 may be fixed to the bottom portion 24 by any suitable means, such as mechanical bonding or adhesive bonding. The adhesive pad element 200 may be formed of any suitable flexible material, such as foam, rubber, plastic, or cloth. The patient-facing side of the adhesive pad element 200 (i.e., the side facing away from the bottom portion 24) is configured to include an adhesive surface, thereby allowing the System 10 to be selectively adhered to the patient's skin before the injection procedure. In some embodiments, the peripheral portion of the adhesive pad element 200 may extend beyond the installation area of ​​the housing 20, thereby increasing the surface area and improving the adhesion contact between the adhesive pad element 200 and the patient's skin. Furthermore, due to the flexible nature of the adhesive pad element 200, the adhesive pad element 200 can substantially conform to the contour of the patient's skin surface to which the system 10 is attached.

[0027] Figure 18 shows a bottom perspective view of the system 10 including the adhesive pad element 200. In its pre-use configuration, the adhesive pad element 200 includes at least two layers: a primary adhesive layer 202 and a removable liner 204. The patient-facing surface of the primary adhesive layer 202 is the adhesive surface, and the liner 204 is configured to cover the primary adhesive layer 202 before use. The liner 204 is configured to be completely removable (i.e., peelable) from the primary adhesive layer 202, exposing the adhesive surface of the primary adhesive layer 202 only immediately before attaching the system 10 to the patient's skin surface. As part of the adhesive pad element 200, both the primary adhesive layer 202 and the liner 204 may be formed from any suitable flexible material, such as foam, rubber, plastic, or cloth, and may be formed from the same material or from different materials.

[0028] The adhesive pad element 200 may also include a syringe removal tab 206. The syringe removal tab 206 may be formed as part of the primary adhesive layer 202 of the adhesive pad element 200, or it may be bonded to the primary adhesive layer 202 of the adhesive pad element 200. In the embodiment shown in Figure 18, the syringe removal tab 206 extends from one corner of the adhesive pad element 200. However, it should be understood that the syringe removal tab 206 may extend from any corner or edge of the adhesive pad element 200, and two or more syringe removal tabs 206 may be utilized. The syringe removal tab 206 includes two non-adhesive surfaces and is sized to be grasped by a patient or user. After the injection procedure is completed and the needle of the system 10 has been automatically removed from the patient's skin, the patient or other user can grasp and pull the syringe removal tab 206 to peel the adhesive pad element 200 from the skin surface, thereby removing the system 10 from contact with the skin surface.

[0029] Referring further to Figure 18, the system 10 further includes a needle shield remover 208. The needle shield remover 208 is positioned approximately in the center of the adhesive pad element 200, and the shield portion 218 of the needle shield remover 208 passes through the liner 204 and primary adhesive layer 202 of the adhesive pad element 200, and also through an opening (not shown) in the bottom portion 24 of the housing 20. The shield portion 218 forms a needle shield portion at its end, which is configured to protect the needle 28 of the needle assembly 18 of the system 10 before use (i.e., in the configuration shown in Figure 6). Furthermore, the shield portion 218 may also be configured to prevent the injection process from being inadvertently started when removal of the needle shield remover 208 is necessary to start the injection process.

[0030] The needle shield remover 208 further includes a gripping portion 210, an elongated arm 212, a base portion 214, and a hinge portion 216. As shown in Figure 18, in a first (or non-used) position, the elongated arm 212 extends along the bottom portion 24 of the housing 20 in the direction opposite to the direction of the adhesive pad element 200 and lies substantially flat along the bottom portion 24. In addition, the gripping portion 210 may be located at the distal end of the elongated arm 212 and angled upward away from the bottom portion 24 of the housing 20 to provide a gripping surface to the user, for example in the form of a pull tab. However, it should be understood that the needle shield remover 208 is not limited to such a gripping portion and / or elongated arm, and any suitable removal means of the needle shield remover may be utilized.

[0031] The base portion 214 can be coupled to the liner 204 of the adhesive pad element 200 by any suitable method, such as an adhesive or a mechanical connection. A hinge portion 216, substantially on or adjacent to the base portion 214, allows the elongated arm 212 to pivot at least partially relative to the bottom portion 24. If the user wishes to remove the needle shield portion (not shown) protecting the needle 28, the user pivots the elongated arm 212 by the gripping portion 210 from a first position substantially flat along the bottom portion 24 to a second position angled away from the bottom portion 24 (for example, substantially perpendicular to the bottom portion 24). From the second position, the needle shield remover 208 can be pulled in a direction substantially perpendicular to the bottom portion 24 of the housing 20 to disengage the needle shield (and the needle shield remover 208) from the system 10.

[0032] In addition, according to one aspect of the present disclosure, the movement of the elongated arm 212 of the needle shield remover 208 from a first position to a second position also acts to initiate the removal of the liner 204 from the primary adhesive layer 202, thereby enabling the removal of the needle shield remover 208 and the liner 204 in a single user procedure. As shown in Figure 18, the lower portion 220 of the elongated arm 212 may be fixed to the upper surface of the liner 204, for example, via an adhesive or a mechanical connection. The lower portion 220 is located in close proximity to the leading edge portion 222 of the adhesive pad element 200. The leading edge portion 222 itself is bonded to the bottom portion 24 of the housing 20. Thus, at the leading edge portion 222, the primary adhesive layer 202 of the adhesive pad element 200 is always held in contact with the bottom portion 24, regardless of the tensile force on the liner 204.

[0033] Referring to Figures 18 and 21, when the user rotates the elongated arm 212 around the hinge portion 216 to remove the needle shield from the system 10, the bonded lower portion 220 of the elongated arm 212 peels the liner 204 from the primary adhesive layer 202, and the peeling process begins at or near the leading edge portion 222 of the adhesive pad element 200. When the user continues to rotate the elongated arm 212 to finally remove the needle shield remover 208 from the system 10, the liner 204 is simultaneously peeled from the primary adhesive layer 202 until it is completely removed together with the needle shield remover 208. Since the peeling process of the liner 204 begins at the leading edge portion 222 of the adhesive pad element 200, the peeling of the liner 204 is far more intuitive for the user than in the prior art configuration, and it eliminates the need to make complex cuts or punctures only on the liner to accommodate "inverted" peeling of the liner, as was done in the prior art configuration. Furthermore, since the leading edge portion 222 is also bonded to the bottom portion 24 of the housing 20, there is a low possibility that the adhesive pad element 200 will tear or be damaged by the peeling action via the elongated arm 212.

[0034] Although the needle shield remover 208 is shown in Figures 18 and 21 to include a hinge portion 216, it should be understood that in some embodiments, the hinge portion 216 may be omitted. In such a configuration, only the flexibility of the constituent material of the elongated arm 212 would be required for both peeling the liner 204 from the primary adhesive layer 202 and initiating the removal of the needle shield remover 208 from the system 10.

[0035] Next, referring to Figure 19, according to another aspect of the present disclosure, the adhesive pad element 200 may further include an extension portion 224. The extension portion 224 may be configured to extend only below the elongated arm 212, with the upper surface of the extension portion 224 being bonded to the underside of the elongated arm 212, for example, by an adhesive or mechanical connection. Such a configuration may reduce the initial peeling force on the liner 204 when the elongated arm 212 is rotated, thereby simplifying the removal of the liner 204 from the primary adhesive layer 202 and reducing the likelihood of the adhesive pad element 200 tearing or being damaged.

[0036] Referring now to Figure 20, a needle shield remover 308 according to another aspect of the present disclosure is shown. The needle shield remover 208 described with respect to Figures 18 and 21 utilizes an elongated arm 212 and a gripping portion 210 in the form of, for example, a pull tab, whereas the needle shield remover 308 shown in Figure 20 includes a pull ring 310 coupled to an extension portion 312, the extension portion 312 being pivotable around a hinge 316. The needle shield remover 308 also includes a shield portion 318, which passes through the liner 204 and primary adhesive layer 202 of the adhesive pad element 200 and also through an opening (not shown) in the bottom portion 24 of the housing 20. The shield portion 318 forms a needle shield at its end, which is configured to protect the needles 28 of the needle assembly 18 of the system 10 before use (i.e., in the configuration shown in Figure 6). Furthermore, the shield portion 318 may also be configured to prevent the injection process from being inadvertently started when the removal of the needle shield remover 308 is necessary to initiate the injection process.

[0037] Although not shown in Figure 20, it should be understood that the lower side of the extension 312 that contacts the upper surface of the liner 204 is bonded to the liner 204 at this position, for example, by an adhesive or mechanical connection. Therefore, if a user wants to remove the needle shield remover 308 from the system 10, the user grasps the pull ring 310 and pivots the pull ring 310 from a first position to a second position, where the second position is substantially perpendicular to the bottom portion 24. Then, by pulling in a direction substantially perpendicular to the bottom portion 24, the liner 204 is peeled away from the primary adhesive layer 202 at the same time as the removal of the needle shield remover 308. The connection between the needle shield remover 308 and the liner 204 is initially provided on the underside of the extension portion 312, so that this tensile force peels the liner 204 away from the end of the adhesive pad element 200, thereby eliminating the need to make complex cuts or perforations only on the liner to accommodate the "inverted" peeling of the liner, as was done in the prior art configuration.

[0038] An element of one disclosed aspect can be combined with one or more elements of other disclosed aspects to form different combinations, all of which are considered to fall within the scope of the present invention.

[0039] While this disclosure has been described as having exemplary designs, it may be further modified within the spirit and scope of this disclosure. Therefore, this application is intended to encompass any variations, uses, or adaptations of this disclosure using its general principles. Furthermore, this application is intended to cover any deviations from this disclosure that would fall within known or customary practices in the relevant art and that would fall within the limitations of the appended claims.

Claims

1. A housing having an upper part and a bottom part, A needle having a retracted position within the housing and an extended position outside the housing, An adhesive pad element attached to the bottom portion of the housing, comprising an adhesive pad element including a primary adhesive layer and a removable liner, A needle shield portion configured to at least partially cover the needle in the retracted position, A needle shield remover coupled to the needle shield portion, comprising an elongated member configured to extend along the bottom portion of the housing in a first position and to extend away from the bottom portion of the housing in a second position, wherein the bottom portion of the elongated member is coupled to a removable liner adjacent to the edge position of the adhesive pad element, and as a result, the removable liner is peeled away from the primary adhesive layer when the elongated member of the needle shield remover is moved from the first position to the second position, A drug delivery system equipped with the following features.

2. The drug delivery system according to claim 1, wherein the needle shield remover further includes a gripping portion at the distal end of the elongated member.

3. The drug delivery system according to claim 2, wherein the gripping portion includes a pull tab.

4. The drug delivery system according to claim 3, wherein the pull tab is at an upward angle with respect to the bottom portion of the housing when the elongated member is in the first position.

5. The drug delivery system according to claim 2, wherein the gripping portion includes a pull ring.

6. The drug delivery system according to claim 1, wherein the needle shield remover further includes a hinge portion.

7. The drug delivery system according to claim 6, wherein the elongated member moves from the first position to the second position by pivoting around the hinge portion.

8. The drug delivery system according to claim 1, wherein the bottom portion of the elongated member is bonded to the removable liner by an adhesive.

9. The drug delivery system according to claim 1, wherein the adhesive pad element further includes an extension portion that extends below the bottom portion of the elongated member.

10. The drug delivery system according to claim 1, wherein the shield portion of the needle shield remover allows the needle to pass through the liner of the adhesive pad element, the primary adhesive layer of the adhesive pad element, and the opening formed in the housing, thereby enabling the needle to penetrate in the extended position.

11. The drug delivery system according to claim 1, wherein the adhesive pad element further comprises a syringe removal tab.

12. The drug delivery system according to claim 1, wherein the peripheral portion of the adhesive pad element extends beyond the installation area of ​​the housing.

13. The drug delivery system according to claim 1, wherein the adhesive pad element is formed of one or more flexible materials.

14. The drug delivery system according to claim 1, wherein the elongated member of the needle shield remover is formed of a flexible material.

15. The drug delivery system according to claim 1, wherein the elongated member of the needle shield remover is substantially flat along the bottom portion of the housing when in the first position.

16. A method for preparing a wearable drug delivery system for use, A drug delivery system, A housing having an upper part and a bottom part, A needle having a retracted position within the housing and an extended position outside the housing, An adhesive pad element attached to the bottom portion of the housing, comprising an adhesive pad element including a primary adhesive layer and a removable liner, A needle shield portion configured to at least partially cover the needle in the retracted position, A needle shield remover coupled to the needle shield portion, having an elongated member having a gripping portion at its distal end, wherein the elongated member is configured to extend along the bottom portion of the housing in a first position and to extend away from the bottom portion of the housing in a second position, and the bottom portion of the elongated member is coupled to the removable liner adjacent to the edge position of the adhesive pad element, To provide a drug delivery system equipped with, The elongated member is rotated from the first position to the second position, and the removable liner is peeled off from the primary adhesive layer at the edge position of the adhesive pad element. The process involves both pulling the gripping portion of the needle shield remover to remove the needle shield portion from the housing and removing the removable liner from the primary adhesive layer, Methods that include...

17. The method according to claim 16, wherein rotating the elongated member from the first position to the second position includes rotating the elongated member around the hinge portion of the needle shield remover.

18. The method according to claim 16, wherein the gripping portion of the needle shield remover includes a pull tab.

19. The method according to claim 16, wherein the gripping portion of the needle shield remover includes a pull ring.

20. The method according to claim 16, wherein the edge position of the adhesive pad element is a leading edge portion bonded to the bottom portion of the housing via an adhesive, and further, the bottom portion of the elongated member is bonded to the removable liner of the adhesive pad element at a position close to the leading edge portion.

Images