Injector device with subsequent assembly

Abstract

A method for attaching a medication fluid injection device to a patient is provided. [Solution] The method includes the steps of preparing a medicinal fluid injection device having a skin-facing surface, wherein a skin adhesive and a substantially adjacent folded first film segment covering at least a portion of the skin adhesive are held by the skin-facing surface, the first film segment including a first fold line dividing the first film segment into a first adhesive contact portion releasably adhered to the skin adhesive and a first free portion, applying tension to the first free portion of the first film segment to gradually pull the first skin adhesive contact portion away from the skin adhesive to expose the skin adhesive, and attaching the exposed skin adhesive to the patient's skin.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 571,579, filed Oct. 12, 2017, the disclosure of which is hereby incorporated by reference in its entirety.

[0002] The present disclosure generally relates to a body - worn medicament fluid injection device assembly and a combination of a body - worn medicament fluid injection device and a fluid transfer device that may be associated therewith. More specifically, the present application relates to a body - worn injection device having a skin adhesive configuration that exposes a skin adhesive when the injection device is removed from a support structure such as a package or transfer device. The present disclosure also relates to an assembly of an injection device and a transfer device used to transfer medicament fluid to the injection device, which automatically exposes an adhesive layer of the injection device (to secure the device to the patient during injection) when the injection device is removed from the fluid transfer device. The present disclosure further relates to a body - worn injection device skin adhesive structure that adheres to a patient's body in an enhanced form to various body shapes.

Background Art

[0003] Injectors that are temporarily or permanently worn by a patient are well known in the medical field and are sometimes referred to as wearable injectors. The subject matter of the present application relates to an assembly for securing a body-worn pharmaceutical fluid injector and / or an associated fluid transfer device to a patient. The subject matter is applicable to a variety of pharmaceutical fluid injectors and / or associated fluid transfer devices, but the description specifically and non-exclusively refers to the body-worn pharmaceutical fluid injector described in U.S. Patent Application Publication No. 2016 / 0144105, filed on June 17, 2014. The present application also refers to the use of an injector in combination with a pharmaceutical fluid transfer device, as described in U.S. Provisional Patent Application No. 62 / 571,419, entitled "Fluid Transfer Devices and Systems," filed on the same date as U.S. Provisional Patent Application No. 62 / 520,335, filed on June 15, 2017. All of the above applications are hereby incorporated by reference as if fully recited herein. SUMMARY OF THE INVENTION

[0004] In a first aspect, the present disclosure provides a pharmaceutical fluid injection device comprising a housing of a wearable injector configured to receive a supply of pharmaceutical fluid, and an adhesive assembly including an injection needle held by the housing and movable between a retracted position within the housing and an injection position extending from the housing, the housing further including a skin-facing surface that faces the patient's skin when the wearable injector is on the patient's body. The wearable pharmaceutical fluid injection device with the adhesive assembly also includes a skin adhesive held by at least a portion of the skin-facing surface to secure the housing to the patient's skin during injection, and a plurality of substantially adjacent folded film segments covering the skin adhesive, each film segment including a fold line that divides the film segment into an adhesive contact portion peelably adhered to the skin adhesive and a free portion operable to gradually pull the adhesive contact portion away from the skin adhesive when tension is applied.

[0005] In a second aspect, the present disclosure provides a wearable pharmaceutical fluid injection device comprising a housing configured to receive a supply of pharmaceutical fluid, and an adhesive assembly including an injection needle held by the housing and movable between a retracted position within the housing and an injection position extending from the housing, the housing further including a skin-facing surface that faces the patient's skin when the wearable injection device is on the patient's body. The wearable pharmaceutical fluid injection device with the adhesive assembly also includes a flexible skin contact substrate having one side attached to the skin-facing surface of the housing and an opposite side holding a skin adhesive for adhering to the patient's skin. A protective film is removably adhered to the skin adhesive to cover the skin adhesive until the wearable injection device is used, and the flexible skin contact substrate is not attached to the wearable injection device on one side and has a peripheral portion holding the skin adhesive on the opposite side, whereby the peripheral portion not attached to the wearable injection device allows the flexible substrate to conform better to the patient.

[0006] In a third aspect, the present disclosure provides a wearable drug fluid injection device having an adhesive assembly that includes a drug fluid injection device and a fluid transfer device configured to hold the drug fluid in a cooperating relationship therewith. The drug solution injection device includes a housing configured to receive a supply of the drug fluid, and an injection needle held by the housing and movable between a retracted position within the housing and an injection position extending from the housing. The housing further includes a skin-facing surface that faces the patient's skin when the drug fluid injection device is on the patient's skin. The drug fluid injection device also includes a skin adhesive held by at least a portion of the skin-facing surface of the housing to fix the housing to the patient's skin during injection, and a plurality of substantially adjacent folded film segments that cover the skin adhesive. Each folded film segment includes a fold line that divides the film segment into an adhesive contact portion releasably adhered to the skin adhesive and a free portion operable to gradually pull the adhesive contact portion away from the skin adhesive when tension is applied. The fluid transfer device includes a base having a support surface and is configured to releasably hold the drug fluid injection device on the support surface of the base. The transfer device is further configured to engage each free portion of each film segment, whereby, in the release of the drug fluid injection device from the base and the separation of the drug fluid injection device from the support surface of the base, the transfer device applies tension to the free portion of each folded film segment to remove the film from the skin adhesive.

[0007] As described above and as further described herein, an exemplary injection device with an adhesive assembly and an exemplary method of using the same of the present disclosure have several advantageous features. It should also be understood that both the foregoing general description and the following detailed description are exemplary and provided for the purpose of illustration only and are not limiting of the claimed subject matter. Further features and objects of the present disclosure will become more fully apparent from the following description of the preferred embodiments and the appended claims.

Brief Description of the Drawings

[0008] When describing the preferred embodiments, reference is made to the accompanying drawings in which like parts have like reference numerals.

[0009] Figure 1a is a side view of an exemplary wearable injection device comprising an adhesive assembly having a skin adhesive configuration.

[0010] Figure 1b is an exploded perspective view of the skin adhesive structure held under the injection device assembly of Figure 1a, with the relative thickness exaggerated for illustration purposes.

[0011] Figure 2 is a top view of the wearable injection device comprising the adhesive assembly of Figure 1a.

[0012] Figure 3 is a perspective view of the underside of the injection device assembly of Figure 1a.

[0013] Figures 4a - 4c schematically show a wearable injection device assembly being gradually pulled away from a support surface, such as the support surface of a transfer device (or other packaging), while simultaneously the skin adhesive release liner is being pulled away from the skin adhesive under the injection device.

[0014] Figures 5a - 5e show a wearable injection device assembly being gradually pulled away from a support surface while simultaneously the skin adhesive release liner is being pulled away from the skin adhesive under the injection device.

[0015] Figures 6a - 6d show the advantages of the skin adhesive structure incorporated into the injection device assembly of Figure 1a, using a balloon, to conform to various body shapes.

[0016] Figure 7 illustrates the removal of the injection device assembly of Figure 1a from the patient's skin after injection is complete.

[0017] Figure 8a is a perspective view of a combination of a wearable drug fluid injection device comprising the adhesive assembly of Figure 1a, viewed from one angle of view, and a drug fluid transfer device to which a standard medical drug vial and syringe are attached.

[0018] FIG. 8b is a perspective view of the combination of FIG. 8a as seen from different viewing angles.

[0019] FIG. 9 is an exploded perspective view of the combination of FIG. 8a.

[0020] It should be understood that the drawings are not to scale. Some details of the exemplary injection device with an adhesive assembly, including potential alternative configurations, are not included, but such details are considered to be within the scope of understanding of those skilled in the art in light of the present disclosure. It should also be understood that the present invention is not limited to the exemplary embodiments shown.

DETAILED DESCRIPTION OF THE INVENTION

[0021] Referring to FIG. 1a, an example of an injection device with an adhesive assembly is shown as a wearable drug fluid injection device 102 including a wearable injection device 104 and a skin adhesive structure 106 (see also FIG. 1b). The injection device 104 has an upper or top surface 108 and a bottom or lower surface 110 that faces the patient's skin during injection. The skin adhesive structure 106 is held on the bottom surface 110 and functions as described below.

[0022] Details of the illustrated injection device can be found in U.S. Patent Application Publication No. 2016 / 0144105, filed on Jun. 17, 2014, which is incorporated herein by reference. This device is used for illustrative purposes only and not by way of limitation. The features of the adhesive structure of the present application can also find application to wearable injection devices of different shapes, structures, or operating principles.

[0023] The illustrated wearable injection device 104 has an overall rigid plastic outer housing 112 configured to receive a supply of medicament fluid and holds an injection needle movable between a retracted position within the housing 112 and an injection position extending from the housing 112. The housing 112 also includes a skin-facing surface or bottom surface 110 that faces the patient's skin when on the patient's body. As seen in FIG. 1a, the skin-facing surface or bottom surface 110 is generally flat and planar, curving convexly upward at its periphery. The bottom surface 110 has a central opening not shown in FIG. 1a through which the injection needle extends movably (to penetrate the patient's skin) during injection.

[0024] As pointed out above, the skin adhesive 116 is held by at least a portion of the skin-facing surface 110 to fix the housing 112 to the patient's skin during injection. The skin adhesion structure 106 is held on the bottom surface 110 of the injection device 104. The illustrated skin adhesive structure 106 includes a skin-adhering layer 114 seen in FIGS. 1a and 1b, which may be constructed of any suitable material and is preferably flexible. In this example, the skin-adhering layer 114 is shown as a flexible non-woven polymer material, or a PET material, which may be referred to as a non-woven carrier substrate or a flexible skin-contact substrate. This skin-adhering layer 114 is sized to extend outwardly to the outermost periphery of the housing 112 of the wearable injection device 104.

[0025] The flexible skin-contact substrate or skin-adhering layer 114 may also include a radially extending portion forming a removal tab 122, as seen in FIGS. 1a, 2, and 3. The removal tab 122 improves ease of removal from the patient. The removal tab 122 is part of the skin-adhering layer 114 but does not include adhesive to facilitate handling by the patient. When the patient wishes to remove the injection device 104 from the injection site on the patient's skin, the patient can grip the injection device 104 with the removal tab 122 held against the edge of the injection device 104, and the injection device 104 is lifted and twisted, for example, as seen in FIG. 7, thereby pulling the skin-adhering layer 114 at an angle from the patient's skin.

[0026] One of the flexible skin contact substrates or skin attachment layers 114 on one side is preferably permanently bonded to the bottom surface 110 of the injection device housing 112 by the device-side adhesive 116. The device-side adhesive 116 can be any adhesive with appropriate strength, for example, a medical-grade acrylic adhesive. In FIG. 1a, it can be seen that the device-side adhesive 116 does not extend to the entire peripheral edge of the injection device 104. Instead, a margin or peripheral portion 118 of the flexible skin contact substrate or skin attachment layer 114 without adhesive remains. As will be described in more detail later, this provides relaxation of tension and enhanced conformity to the curve of the surface of the patient's body. Alternatively, the skin attachment layer 114 can be permanently bonded to the underside of the injection device by using appropriate mechanical means such as heat staking or ultrasonic welding.

[0027] To adhere the injection device 104 to the patient's skin during injection, the skin adhesive 120 is preferably provided along the entire surface facing the skin on the side opposite to the skin attachment layer 114 (excluding the removal tab 122). The skin adhesive 120 can be made of any appropriate adhesive with sufficient strength for the desired wear time and biocompatibility, for example, a medical-grade acrylic adhesive. Regarding strength, of course, the skin adhesive 120 is weaker than the device-side adhesive 116 so that after the injection is completed, the injection device 104 and the skin attachment layer 114 can be removed from the patient's skin.

[0028] The skin adhesive 120 on the side opposite to the flexible skin contact substrate or skin attachment layer 114 is covered with a release layer or liner 124 that needs to be removed during transportation and storage to expose the skin adhesive 120 and enable attachment of the injection device 104 to the patient's skin. According to the present disclosure, the release layer 124 includes a film made of a material such as PET that does not strongly adhere to the skin adhesive 120 and can be easily manually peeled off from the skin adhesive 120 with a relatively small force.

[0029] More specifically, the release layer or liner 124 is formed from a plurality of substantially adjacent folded film segments that cover the skin adhesive 120 and protect the skin adhesive 120 from inadvertent contact. As shown for purposes of illustration, each folded segment includes a fold line that is folded along itself or back onto itself, the fold line extending along a fold line that substantially bisects the skin-facing surface 110 of the housing 112 and dividing the segment into a skin-adhesive contact portion that is releasably adhered to the skin adhesive 120 and a free portion that is connected to and underlies the skin-adhesive contact portion and that operates to pull along a release line that provides a lower resistance to removal compared to the simultaneous removal of the release layer 124 across the entire surface area of the skin adhesive 120 so as to gradually move the skin-adhesive contact portion away from the skin adhesive 120 in response to tension.

[0030] In the illustrated embodiment, as seen in FIGS. 1a - 4c, there are two folded film segments 126a, 126b, each of which is generally circular and is folded along itself or back onto itself along a fold line along its diameter such that each segment forms a semi-circular or half-circle shape when folded.

[0031] As described above generally, each film segment 126a, 126b has its respective fold line 128a, 128b, and each segment is divided into a skin adhesive contact portion 130a, 130b releasably adhered to the skin adhesive 120 and a free portion 132a, 132b folded back along itself under the skin adhesive contact portion 130a, 130b. Thus, each of the folded film segments 126a, 126b covers substantially half of the collective skin adhesive contact portions 130a, 130b. Optionally, more than two segments can be used, such as by using a plurality of segments having, for example, a pie shape or other configurations. The free portions 132a, 132b can be tensioned downwardly to pull each skin adhesive contact portion 130a, 130b away from the skin adhesive 120 along a release line that gradually moves or progresses from the fold lines 128a, 128b to the periphery of the skin. As the downward tension continues to be applied to the free portions 132a, 132b, the skin adhesive contact portions 130a, 130b are gradually and stepwise pulled away from the skin adhesive 120.

[0032] The removal of the release layer 124 is schematically shown in FIGS. 4a - 4c and is shown in comparison to the wearable injection device 104 of FIGS. 5a - 5e. As shown in successive steps and as described above, the injection device 104 with the adhesive structure 106 is gradually separated from a support surface which can be any suitable fluid transfer device or packaging, or a support surface of another suitable structure. When the injection device 104 is separated from the support surface, the free portions 132a, 132b of the film segments 126a, 126b (secured to the support surface by radially extending attachment tabs 134a, 134b disposed 180 degrees apart) begin to pull away or peel away the skin adhesive contact portions 130a, 130b from the skin adhesive 120 located under the flexible skin contact substrate or skin attachment layer 114.

[0033] The pulling or peeling of the release liner film segments 126a, 126b begins at the fold lines 128a, 128b, and the release lines 136a, 136b between the release layer 124 and the skin adhesive 120 gradually progress outward along each segment 126a, 126b as the distance between the injection device 104 and the support surface increases until the film segments 126a, 126b are completely removed from under the skin adhesion layer 114. This allows the user to immediately place the injection device 104 on the patient's skin without delay and without the hassle of individually removing the release layer 124. The two-fold segments 126a, 126b allow for a very smooth and easy removal of the release layer 124. Also, the fold lines 128a, 128b where the segments 126a, 126b are folded back onto themselves provide the start of a release point or line between the release layer 124 and the skin adhesive 120 for separating the film of the release layer 124 from the skin adhesive 120.

[0034] As described above, there is no device-side adhesive 116 along the peripheral edge 118 of the flexible skin contact substrate or skin adhesion layer 114 (see FIGS. 1b, 4a, and 4b). This allows the skin adhesion layer 114 to better conform to the shape of the patient's body, or the curvature or undulations of the patient's skin, at the attachment location to the patient. FIGS. 6a - 6d illustrate this by modeling a curved skin surface using a balloon. The peripheral margin portion 118 of the skin adhesion layer 114 can bend with the skin and provides a stress relaxation that helps prevent accidental or premature separation of the injection device from the patient.

[0035] Referring to FIGS. 8a and 8b, these figures illustrate, for purposes of illustration and not limitation, an assembled transfer system comprising an injection device assembly 102 mounted on a support surface of a drug fluid transfer device 150 having a vial 152 and a syringe 154 attached to a transfer device 150. This particular transfer device (also shown in U.S. Provisional Patent Application No. 62 / 571,419, filed on the same day and incorporated by reference above) is shown for purposes of illustration only and not limitation. Other transfer devices of other configurations can be used without departing from the claimed subject matter.

[0036] FIGS. 8a and 8b are viewed from different angles of view and enable the assembly to be viewed from the opposite side of the transfer device 150. As shown in the figures, the illustrated transfer device 104 includes a transfer device base 156 having a support surface 158 on one side thereof on which the injection device 104 is placed, as seen in FIG. 8a. A harness or retainer 160 holds the injection device 104 on the transfer device base 156 within a peripheral ring or ring structure 162 attached to the base 156. Any valve assembly or sub-assembly 164, such as a three-way stopcock valve assembly, is attached to the underside of the transfer device base 156 and provides selective fluid communication between the drug fluid vial 152, the syringe 154, and the fluid transfer port 170 of the upright injection device associated with the valve sub-assembly when fixed to the vial port 166, the syringe port 168, and the valve sub-assembly 164. The basic operating principle of fluid transfer in this embodiment is essentially the same as that described above in the above-identified application (U.S. Provisional Patent Application No. 62 / 571,419) incorporated herein by reference.

[0037] Referring to FIG. 9, one side of the transfer device base 156 in this embodiment (which may be referred to as the top side or the upper side for convenience) provides a flat support surface 158 on which the injection device 104 rests when fixed to the base 156 by the holder 160. The radially protruding attachment tabs 134a, 134b, best seen in FIGS. 2 and 3, are attached to the transfer device at, for example, a ring structure or other connection area, such that when the injection device 104 is lifted from the support surface 158 of the transfer device 150, the free portions 132a, 132b of the folded segments 126a, 126b of the release layer 124 pull on and separate the skin adhesive contact portions 130a, 130b of the folded segments 126a, 126b. The release layer is removed in a similar manner as shown in FIGS. 4a - 4c and FIGS. 5a - 5e. Thus, the free portions 132a, 132b of each folded film segment 126a, 126b include a release connection to the extended attachment tabs 134a, 134b of the release layer 124, and the transfer device 150 is configured to engage the release connection 124. In this example, the release connection is present in the extensions 134a, 134b of the folded film segments 126a, 126b, and the transfer device 150 includes an engagement surface configured to connect to the extensions of the folded film segments 126a, 126b.

[0038] The subject matter has been described herein with reference to specific structures, methods, and examples, which are for illustrative purposes only, and it is understood that the subject matter is applicable to a wide range of devices and systems with different specific configurations and appearances while using this subject matter. For the scope of the subject matter, refer to the following claims. This patent is limited only by the appended claims and their legal equivalents.

Claims

1. A method for adjusting a pharmaceutical fluid injection device before attaching the device to a patient, the method comprising: (a) preparing the pharmaceutical fluid injection device, the pharmaceutical fluid injection device including a skin-facing surface having a skin adhesive held thereby and a substantially adjacent folded first film segment covering at least a portion of the skin adhesive, the first film segment including a first fold line dividing the first film segment into a first adhesive contact portion releasably adhered to the skin adhesive and a first free portion; (b) transferring a pharmaceutical from a pharmaceutical source to the injection device using a transfer device, the first free portion including a first extended attachment tab attached to the transfer device; (c) applying tension to the first free portion of the first film segment to gradually pull the first adhesive contact portion away from the skin adhesive to expose the skin adhesive by removing the injection device from the transfer device to which the first free portion is attached.

2. The first film segment covers a first portion of the skin adhesive, the pharmaceutical fluid injection device includes a substantially adjacent folded second film segment covering a second portion of the skin adhesive, the second film segment including a second fold line dividing the second film segment into a second adhesive contact portion releasably adhered to the skin adhesive and a second free portion, the second free portion including a second extended attachment tab attached to the transfer device, and (c) is a step of applying tension to the second free portion of the second film segment to gradually pull the second adhesive contact portion away from the skin adhesive to expose the first portion of the skin adhesive and further expose the second portion of the skin adhesive by removing the injection device from the transfer device to which the second free portion is attached, the method according to claim 1.

3. The first portion and the second portion of the skin adhesive each include half of the skin adhesive, the method according to claim 2.

4. (c) includes gripping the injection device, the method according to claim 2.

5. The method according to claim 4, wherein (c) includes gripping the periphery of the injection device.

6. The method according to claim 5, wherein (c) includes gripping the transfer device.

7. The method according to claim 1, wherein (c) includes gripping the injection device.

8. The method according to claim 7, wherein (c) includes gripping the periphery of the injection device.

9. The method according to claim 8, wherein (c) includes gripping the transfer device.

10. The skin adhesive is held by a skin-adhering layer bonded to the skin-facing surface of the injection device, and the skin-adhering layer includes a removal tab, according to the method of claim 1.

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