Flexed fluid path-type accessories for filled fluid containers

Abstract

To provide accessories for autoinjectors.SOLUTION: An accessory for an autoinjector includes: at least one adapter 302 having a flex fluid path; and at least one fastening member. The at least one adapter 302 is sized and shaped to sterilely couple a flexed fluid path to at least a distal end of a fluid container 350. The at least one fastening member is sized and shaped to couple a main body of the fluid container 350 to an autoinjector. The at least one fastening member has an adjustable inner diameter. The at least one adapter 302 and the at least one fastening member are configured to couple at least one of a plurality of containers having different sizes and different types of tips to the autoinjector.SELECTED DRAWING: Figure 3B

Description

[Technical field]

[0001] The present invention in some embodiments relates to a self injector, particularly but not exclusively to a patch type self injector. [Background technology]

[0002] Subcutaneous (SC) injection is a method of administering drugs under the skin, typically into the fatty tissue between the skin and muscle. For example, the current trend is to inject biologics subcutaneously using autoinjectors, such as reusable pens, disposable pens, autoinjectors, and patch-type injectors that are attached to the surface of the skin, allowing users the freedom to self-inject at home.

[0003] Modified drugs are often highly concentrated and sometimes viscous, with desired injection volumes exceeding 1 mL. Highly viscous products can be painful even for injections of 10 seconds or less, which can lead to non-compliance with the prescribed treatment regimen. Also, it can be difficult for users to hold a pen or other upright injector stationary at the correct injection angle for injection periods of more than 10 seconds or even minutes. Thus, patch auto-injectors or patch auto-injectors for self-administered SC injections are becoming more common.

[0004] Additional background art includes U.S. Patent No. 6,843,782 and U.S. Patent No. 5,858,001. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent No. 6,843,782 [Patent Document 2] U.S. Patent No. 5,858,001 (Summary of the Invention)

[0006] One aspect of some embodiments of the present invention provides an add-on for an autoinjector, the add-on comprising an adapter having at least one coupling member and a tortuous fluid path having a first end configured to penetrate tissue and a second end coupled to the adapter, the at least one coupling member being sized and shaped to couple the adapter to a fluid container, the add-on coupled to the fluid container forming an integrated autoinjector cartridge unit configured to be sterilized and filled with an injection substance.

[0007] In some embodiments of the invention, the attachment comprises a needle protection cap. In some embodiments, the fluid path is bent at a 90 degree angle. In some embodiments, the attachment further comprises at least one fastener sized to couple the body of the container to the autoinjector.

[0008] An aspect of some embodiments of the present invention provides an accessory for an autoinjector, the accessory comprising an adapter having at least one coupling member and a bent fluid path having a first end configured to penetrate tissue and a second end coupled to the adapter, the at least one coupling member being sized and shaped to couple the adapter to a fluid container, such that when the accessory is coupled to the fluid container, a sterile fluid connection is established between the container and the first end of the bent fluid path. In some embodiments of the present invention, the bent fluid path has a coupling member at a second end, the coupling member of the bent fluid path being sized and shaped to couple the bent fluid path to the adapter and to establish a sterile fluid connection therebetween. In some embodiments of the present invention, the accessory further comprises at least one fastener sized to couple a body of the container to the autoinjector. In some embodiments of the present invention, the bent fluid path includes a hollow needle. In some embodiments of the present invention, the fluid path is bent at a 90 degree angle.

[0009] In some embodiments of the invention, the container is a pre-filled cartridge. In some embodiments of the invention, the container is a syringe. In some embodiments of the invention, the container is a vial. In some embodiments of the invention, the container is at least partially formed of glass. In some embodiments of the invention, the container is at least partially formed of a plastic material. In some embodiments of the invention, the attachment is entirely sterilizable. In some embodiments of the invention, the adapter coupling member is a Luer lock type coupling member. In some embodiments of the invention, the adapter coupling member is a vial adapter. In some embodiments of the invention, the adapter coupling member is a slide-on type fluid container coupling member. In some embodiments of the invention, the adapter further includes a coupling member sized and shaped to couple the attachment to an autoinjector.

[0010] One aspect of some embodiments of the present invention provides an accessory for an autoinjector, the accessory comprising at least one adapter having at least one flex fluid path and sized to couple the sterile flex fluid path to at least a tip of a fluid container, and at least one fastener sized for a body of the fluid container and the autoinjector, the adapter and fastener configured to couple at least one of a plurality of containers having different sizes and different tip types to the autoinjector.

[0011] In some embodiments of the invention, the spacing between the adapter and the fastener is adjustable. In some embodiments of the invention, the inner diameter of the fastener is adjustable. In some embodiments of the invention, the appendage further comprises an attachment member sized and shaped to fit over the inner diameter of the fastener. In some embodiments of the invention, the attachment member reduces the inner diameter of the fastener. In some embodiments of the invention, at least a portion of the fastener is formed from a plastic material. In some embodiments of the invention, at least a portion of the fluid container is formed from glass. In some embodiments of the invention, at least a portion of the fluid container is formed from a plastic material. In some embodiments of the invention, the bent fluid path includes a hollow needle. In some embodiments of the invention, the fluid path is bent at a 90 degree angle.

[0012] In some embodiments of the invention, the container is a pre-filled cartridge. In some embodiments of the invention, the container is a fluid container. In some embodiments of the invention, the container is a vial. In some embodiments of the invention, the attachment is entirely sterilizable. In some embodiments of the invention, the adapter coupling member is a Luer lock type coupling member. In some embodiments of the invention, the adapter coupling member is a vial adapter. In some embodiments of the invention, the adapter coupling member is a slide type fluid container coupling member. In some embodiments of the invention, the adapter further comprises a coupling member sized and shaped to couple the attachment to an autoinjector.

[0013] One aspect of some embodiments of the present invention is to provide an accessory to an autoinjector coupling system, comprising: an autoinjector including a support plate having a plurality of attachment points; at least one adapter having at least one bent fluid path and sized to couple the sterile bent fluid path to at least a tip portion of a fluid container; and at least one fastener sized to couple to the body and at least one of the attachment points of the fluid container.

[0014] In some embodiments of the invention, the adapter is sized to couple to at least one of the attachment points. In some embodiments of the invention, the attachment points are distributed on the support plate at different distances from the adapter. In some embodiments of the invention, the different distances correspond to different lengths of the fluid container. In some embodiments of the invention, the inner diameter of the fastener is adjustable. In some embodiments of the invention, the system further comprises a mounting member sized and shaped to mount along the inner diameter of the fastener. In some embodiments of the invention, the mounting member reduces the inner diameter of the fastener.

[0015] One aspect of some embodiments of the present invention is to provide an autoinjector kit that includes at least one autoinjector including a support plate having a plurality of attachment points, a plurality of adapters having at least one bent fluid path and sized to couple the sterile bent fluid path to at least a tip of at least one type of fluid container, and a plurality of fasteners sized to couple to at least one diameter of the body of the fluid container and at least one of the attachment points.

[0016] In some embodiments of the invention, the adapter further comprises at least one attachment member sized and shaped to fit over an inner diameter of at least one of the plurality of fasteners. In some embodiments of the invention, the attachment member reduces the inner diameter of the fastener. In some embodiments of the invention, the fluid container is at least one of a pre-filled cartridge, a syringe, and a vial. In some embodiments of the invention, the fluid container is at least partially formed from glass. In some embodiments of the invention, the fastener is at least partially formed from a plastic material. In some embodiments of the invention, at least one of the adapters is sterile.

[0017] One aspect of some embodiments of the present invention provides a method of assembling an accessory for an autoinjector, comprising the steps of selecting an empty fluid container, coupling at least a tip of the fluid container to an adapter having at least one tortuous fluid path and sized to fluidly couple a flexible fluid path to at least the tip of the fluid container to form a cartridge unit of the autoinjector, and forming a fluid connection between the fluid container and the tortuous fluid path.

[0018] In some embodiments of the invention, the method further includes sterilizing the cartridge, filling the fluid container with a sterile injectable substance, inserting a plunger into a non-bent end of the fluid path of the fluid container, and sterilely sealing the end of the fluid container. In some embodiments of the invention, the method further includes selecting at least one fastener and coupling the fastener to the body of the fluid container and coupling the fastener to a corresponding attachment point of at least one of the syringes.

[0019] An aspect of some embodiments of the present invention provides a method of coupling an autoinjector accessory to a fluid container, comprising the steps of selecting a fluid container, coupling at least a distal end of the fluid container to an adapter having at least one flex fluid path and sized to fluidly couple the flex fluid path to at least the distal end of the fluid container, and forming a sterile connection between the fluid container and the flex fluid path.

[0020] In some embodiments of the invention, the method further includes selecting at least one fastener and coupling the fastener to the body of the fluid container and coupling the fastener to a corresponding attachment point of at least one of the syringes.

[0021] It should be noted that, unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which the present invention belongs. In addition, the embodiments of the present invention can be carried out and tested using methods or materials similar or equivalent to those described herein, and the following are exemplary methods and / or materials. In the event of any conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are for reference only and are not necessarily intended to be limiting. [Brief description of the drawings]

[0022] Some embodiments of the present invention will now be described, by way of example, with reference to the accompanying drawings, in which: While specific and detailed reference will now be made to the drawings, it is emphasized that the matter shown is by way of example and is intended to illustratively illustrate embodiments of the invention. In this regard, those skilled in the art will be able to see from the description how embodiments of the invention may be practiced, by way of consideration of the drawings. In the accompanying drawings: FIG. 1 is a simplified side view of a patch-type autoinjector. 2A and 2B are simplified side views of a modular patch autoinjector according to an optional exemplary embodiment. 3A-3P are simplified cross-sectional and perspective views of a syringe and fluid container coupling member according to an exemplary embodiment. 4A-4H are simplified top and perspective views of a modular fluid container-syringe coupling system according to an exemplary embodiment. 5A, 5B, 5C, 5D, 5E, 5F and 5G are simplified partial cross-sectional side views illustrating the location of fasteners that couple a fluid container to an autoinjector. FIG. 6 is a simplified top view of a home kit for self-injection. BEST MODE FOR CARRYING OUT THEINVENTION

[0023] The present invention in some embodiments relates to a self injector, particularly but not exclusively to a patch-type self injector.

[0024] An aspect of some embodiments of the present invention relates to an autoinjector sized to allow fluid containers of various different sizes and tip types to be coupled to the syringe. In some embodiments, the autoinjector comprises at least a needle holder and at least one fastener. The at least one fastener is attachable to the syringe and at least the barrel of the fluid container. In some embodiments, the needle holder comprises a needle protection cap. In some embodiments, the autoinjector and the fluid container are sterilized. For example, the container, needle holder and needle protection cap may be assembled together and sterilized together. In some embodiments, the autoinjector and the fluid container may not be sterilized. In some embodiments, the autoinjector and the fluid container are sterilized before being filled with an injectable substance. In some embodiments, after sterilization, the sterilized fluid container is filled with an injectable substance and the sterilized fluid container is sealed and covered with a protective cap while maintaining sterility. In some embodiments, the spacing between the needle holder and the fastener is adjustable. In some embodiments, the inner radius of the fastener is adjustable. In some embodiments, the syringe comprises a patch-type autoinjector. In some embodiments, the syringe comprises a bent needle. In some embodiments, the needle is bent at a 90 degree angle. In some embodiments, at least a portion of the syringe has at least a bore sized to accommodate the tip of the fluid container. In some embodiments, at least a portion of the needle extends through the bore. In some embodiments, the needle holder is fixed in place. In some embodiments, the fluid container comprises a syringe. In some embodiments, the fluid container comprises a vial. In some embodiments, the fluid container comprises a pre-filled cartridge.

[0025] In some embodiments, the autoinjector is sized to accommodate a refillable fluid container. In some embodiments, the autoinjector is sized to accommodate a pre-filled fluid container. In some embodiments, the tip of the pre-filled fluid container is sealed to maintain sterility. In some embodiments, the syringe includes one or more adapters for coupling a needle to one or more types of tips of the fluid container. In some embodiments, the adapter is sized to couple a needle to a slip-on or push-on tip of the fluid container. In some embodiments, the adapter is sized to couple a needle to a luer lock tip of the fluid container. In some embodiments, the adapter is sized to couple a needle to a catheter tip of the fluid container. In some embodiments, the adapter is sized to couple a needle to a fluid container having a tip in a central location. In some embodiments, the adapter is sized to couple a needle to a fluid container having a tip in an eccentric location.

[0026] An aspect of some embodiments of the present invention relates to an autoinjector including a modular fluid container-syringe coupling system. In some embodiments, the modular system includes a support plate sized to accommodate a variety of different types and sizes of fluid containers. In some embodiments, the syringe includes a bent needle. In some embodiments, the needle is bent at a 90 degree angle. In some embodiments, the support plate includes one or more notches configured to accommodate a fastening member that secures the fluid container to the syringe. In some embodiments, at least a portion of the one or more fastening members are fixedly coupled to the support plate of the autoinjector. In some embodiments, at least a portion of the one or more fastening members are removably coupled to the support plate of the autoinjector. In some embodiments, the one or more fastening members include at least an opening sized to accommodate a tip of the fluid container. In some embodiments, the one or more fastening members include a bent needle. In some embodiments, at least one fastening member includes at least a hole sized to accommodate a tip of the fluid container. In some embodiments, at least a portion of the needle extends through the opening or hole.

[0027] In some embodiments, the at least one fastening member comprises a latch and a hinge. In some embodiments, the at least one fastening member comprises one or more latches. In some embodiments, the at least one fastening member is sized to fasten a barrel of the fluid container. In some embodiments, the at least one fastening member is sized to fasten a finger flange of the fluid container. In some embodiments, the at least one fastening member comprises at least one fitting sized for a particular diameter of the barrel of the fluid container. In some embodiments, the at least one fastening member comprises an at least partially resilient pad. In some embodiments, at least a portion of the fluid container is biased against the resilient pad when the fluid container is locked into place within the syringe. In some embodiments, the resilient pad prevents leakage from the interface between the tip of the fluid container and the needle. In some embodiments, the resilient pad comprises an opening for the tip of the needle.

[0028] An aspect of some embodiments of the present invention relates to an autoinjector having a curved needle and a luer lock coupling. The luer lock coupling is sized to receive a fluid container having a male luer lock tip. In some embodiments, the luer lock coupling comprises a cylinder coupled at one end to the syringe. The cylinder comprises a tabbed rim configured to threadably engage the male luer lock tip of the fluid container. In some embodiments, at least a portion of the curved needle is disposed within a lumen of the cylinder. In some embodiments, at least a portion of the needle is attached to an inner wall of the cylinder. In some embodiments, at least a portion of the lumen of the cylinder between a portion of the needle and the inner wall comprises a seal. In some embodiments, at least one end of the curved needle extends beyond the tabbed edge of the cylinder. In some embodiments, the end of the curved needle that extends beyond the tabbed edge of the cylinder comprises a protective sheath. In some embodiments, the protective sheath maintains the sterility of the end of the curved needle. In some embodiments, the protective sheath maintains the sterility of a portion of the curved needle from within the lumen of the cylinder to the end of the curved needle that extends beyond the barbed edge. In some embodiments, the edge of the male luer lock biases the protective sheath against the tip of the needle upon coupling. In some embodiments, the tip of the needle breaks the protective sheath biased against the tip of the needle by the edge of the male luer lock.

[0029] An aspect of some embodiments of the invention relates to an autoinjector sized to accommodate a variety of different types and sizes of fluid containers while providing a sterile environment. In some embodiments, the autoinjector includes a coupling member that maintains the sterility of the injection pathway during or after coupling to the fluid container containing the injection. In some embodiments, the coupling member of the syringe includes a needle end that is at least partially isolated by at least one protective sheath. In some embodiments, the tip of the coupled fluid container is biased against the at least one sheath against the needle end upon coupling, causing the protective sheath to break. In some embodiments, the tip of the coupled fluid container includes a sealing membrane over an opening in the tip. In some embodiments, the needle of the syringe is biased against the sealing membrane upon coupling, penetrating the tip of the fluid container.

[0030] An aspect of some embodiments of the invention relates to an autoinjector kit comprising a support plate and a plurality of fasteners and a plurality of attachment members sized to be attached to the support plate. In some embodiments, the plurality of fasteners and the plurality of attachment members are sized to accommodate a variety of different types and sizes of fluid containers in a sterile condition. In some embodiments, the plurality of fasteners comprises quick attachment type coupling members. In some embodiments, the plurality of fasteners comprises at least one one-click type coupling member. In some embodiments, the various fasteners can be attached to various desired locations on the support portion. In some embodiments, the at least one fastener comprises a bent needle. In some embodiments, the one or more fasteners are configured to receive the at least one attachment member. In some embodiments, the one or more fasteners and / or the one or more attachment members comprise one or more openings having different inner diameters for attaching at least one barrel portion and / or finger flange of the at least one fluid container.

[0031] An aspect of some embodiments of the invention relates to a method for mounting fluid containers of various different types and sizes to an autoinjector. In some embodiments, the method includes one or more fasteners appropriately sized for a barrel portion and finger flanges of a selected fluid container. In some embodiments, the method includes, for example, selecting at least one mounting member appropriately sized for a barrel portion and finger flanges of a selected fluid container. In some embodiments, the method includes, for example, further sliding or coupling the one or more mounting members to a barrel portion or finger flanges of the fluid container. In some embodiments, the method includes, for example, further sliding or coupling the one or more fasteners to a barrel portion or finger flanges of the fluid container. In some embodiments, the method includes, for example, inserting a tip of the fluid container into an opening in a needle portion of the syringe. In some embodiments, the method includes, for example, inserting a tip of the fluid container into an opening in a fastener of a needle holder. In some embodiments, the method includes, for example, coupling the fastener to a support plate. In some embodiments, the method further includes connecting the fluid reservoir to a plunger drive system of the fluid reservoir of the syringe.

[0032] [Introduction] FIG. 1 is a simplified side view of a patch-type autoinjector, which is described in U.S. Provisional Patent Application No. 62 / 284,806, the disclosure of which is incorporated herein in its entirety. The autoinjector 100 includes a bent needle 102 coupled to a cartridge 104. The bent needle 102 is bent, for example, at a 90 degree angle. The cartridge 104 may be pre-filled with an injection substance. The cartridge 104 may be mounted on a support plate 106 and may include a plunger 108 that is driven by a drive gear 110 of an electric motor. The cartridge 104 may be discarded after an injection procedure and replaced with a new filled cartridge.

[0033] The syringe power train and plunger drive system are described in detail in the above-mentioned U.S. Provisional Patent Application No. 62 / 284,806, and therefore will not be repeated here.

[0034] [Optional components of the modular autoinjector-fluid container coupling system] 2A, 2B, and 2C (collectively, FIG. 2) are simplified side views of a modular patch-type autoinjector according to any of the exemplary embodiments. As shown in FIG. 2, the autoinjector 200 may be sized to accommodate a variety of different types and sizes of fluid containers. As in the example shown in FIG. 1, the autoinjector 200 includes a bent needle 202 in some embodiments. The bent needle 202 is bent, for example, at a 90 degree angle. As described in more detail elsewhere in this disclosure, the autoinjector 200 includes at least a needle holder 206 of the bent needle 202 in some embodiments, along with a support plate 204. The needle holder 206 includes at least a hole 208 in some embodiments, sized to accommodate the tip 252 of the fluid container 250 or the fluid container 255. The hole 208 includes an opening 210 that, in some embodiments, leads to a bent portion 212 of the needle 202. At least a portion of the needle 202, in some embodiments, extends through the opening 210 into the hole 208 while maintaining a seal. The needle holder 206, in some embodiments, is fixed on the support plate 204.

[0035] As shown in Figure 2A, hole 208 is located in an eccentric position within needle holder 206 in some embodiments to accommodate an eccentric tip of a fluid container. As shown in Figure 2B, hole 208 is located in a central position within needle holder 206 in some embodiments to accommodate a standard (centered) tip of a fluid container.

[0036] [Optional examples of connecting members between syringe and fluid container] Commonly used tips for fluid containers include slip-on or push-on tips and Luer lock tips. Plastic fluid containers have both types of plastic tips, while glass fluid containers generally have tips made of metal. Some glass fluid containers have glass slip-on tips. Commonly used fluid container-needle coupling techniques provide a sterilized passageway for the injection material, which can be difficult in some cases. A typical technique involves storing the fluid container and needle in a sterile pouch, limiting the time the fluid container and needle are exposed to the environment between removal from the pouch and injection. This technique is not practical for autoinjectors, especially patch-type autoinjectors.

[0037] [Inlay / push-in type] 3A-3P (collectively, FIG. 3) are simplified cross-sectional and perspective views of a syringe-fluid container coupling member according to an exemplary embodiment. The exemplary embodiment shown in FIGS. 3A-3L shows one or more adapters for coupling the curved needle 202 to one or more different types of tips of a fluid container. For example, FIG. 3A shows a needle holder 206 with an adapter 302. The adapter 302 is sized to couple the curved needle 202 to a snap-on or push-in tip 352 of a fluid container. A central hole 308 opens on one side at an opening 306 and terminates on the opposite side at an opening 310. The opening 306 faces the fluid container to receive the tip of the fluid container. The opening 310 is sized to accommodate at least a portion of the curved needle 202 while maintaining a seal. The hole 308, for example, in some embodiments, has a conical shape. Alternatively, the hole 308, for example, in some embodiments, has a cylindrical shape. 3C, for example, needle holder 206 may further include a resilient mounting member 312 in some embodiments. Mounting member 312 may be attached over opening 306 by adhesive or other suitable means. Mounting member 312 may include an opening 314 in some embodiments. Opening 314 may be sized to accommodate a slide-on tip of a correspondingly sized fluid reservoir. Resilient mounting member 312 may, in some embodiments, be locked into place in syringe 200 to reduce the likelihood of leakage from the tip-needle interface when at least a portion of fluid reservoir 350 is biased against resilient mounting member 312.

[0038] For example, in some embodiments, the attachment member 312 may be constructed of a suitable elastic-type material, such as silicone, such that the attachment member 312 acts as a seal to seal the opening 306 when the barrel portion 352 of the fluid container is biased against the needle holder 206, as shown in FIG.

[0039] As shown in FIGS. 3A and 3B, the end of the needle 316 may extend at least partially into the bore 308 and into the lumen of the tip 354 of the fluid container when the fluid container 350 is coupled to the autoinjector, in some embodiments. As shown in FIGS. 3D and 3E, the tip of the fluid container 350 may be sealed to maintain sterility. For example, the opening of the tip 356 of the fluid container (FIG. 3D) may be sealed by a membrane 358. Alternatively, the tip 360 of the fluid container (FIG. 3E) may be covered by a protective sheath 362. The end 316 of the needle 202 extending into the bore 308 may be configured in some embodiments to break most types of seals on the tip of the fluid container when coupled to the fluid container 350. The seal protects the sterility of the injection material inside the fluid container 350. 3F, the opening 314 of the mounting member 312 may, in some embodiments, be sealed by a membranous seal 320. The tip 356 or tip 360 of the fluid container 350 may breach the membranous seal 320 when the autoinjector 200 is coupled to the fluid container 350.

[0040] [Luer lock type] The self-injection device 200 shown in Figures 3G-3I includes a curved needle 202 and a luer lock coupling member 316. The luer lock coupling member 316 is sized to receive a fluid container 350 having a luer lock male tip 362. In some embodiments, the luer lock coupling member 316 includes a cylinder. One end of the cylinder is sealingly coupled to the curved needle 202 and the self-injection device 200. The opposite end of the cylinder includes a tabbed rim 322. The opposite end of the cylinder opens toward the hole 308 of the opening 306. In some embodiments, the tabbed rim 322 is configured to thread into a sleeve 364 provided on the luer lock male tip 362 of the fluid container. Figure 3I shows a configuration in which the luer lock coupling member 316 and the luer lock tip 362 of the fluid container 350 are completely integrated.

[0041] The exemplary embodiment shown in Figures 3J-3L shows a luer lock coupling system similar to those described elsewhere in this disclosure. As shown in Figure 3J, the end 324 of the curved needle 202 in some embodiments extends beyond the barbed edge 322 of the luer lock coupling member 316 and may include, for example, a protective sheath 318. The protective sheath 318 is configured to maintain the sterility of the curved needle end 324. The protective sheath 318 in some embodiments is comprised of a flexible membranous material. The flexible membranous material may be, for example, rubber, polyurethane, or other suitable material. The edge 366 of the luer lock male tip 362 of the fluid container 350 in some embodiments biases the protective sheath 318 against the curved needle end 324 when they are joined together as shown in Figure 3K. As shown in Figure 3K, the curved needle end 324, in some embodiments, breaches the protective sheath 318 by entering the lumen 368 of the luer lock tip 362 of the fluid container. Figure 3L shows a fully integrated arrangement of the luer lock coupling member 316 and the luer lock tip 362 of the fluid container 350. The luer lock male tip 316 of the fluid container also includes a seal similar to seal 358 of the fluid container tip 356, for example, in some embodiments.

[0042] As shown in Figures 3M and 3N, the autoinjector may include a bent needle adapter 370 in some embodiments. The bent needle adapter 370 includes a fluid container coupling member similar to the examples described elsewhere in this disclosure, and a second coupling member 375 located at a second end of the adapter 370. In the example shown in Figures 3M and 3N, the second coupling member 375 includes a luer lock tip. A cover 377 protects the second coupling member 375 from the environment, thereby maintaining the sterility of the needle adapter 370. The adapter 370 may include a standard needle 379 in some embodiments that may be coupled to the autoinjector 200. In the exemplary embodiment shown in Figure 3N, the protective cap 377 has been removed, and a luer lock tip needle 379 is coupled to the bent needle adapter 370 and the fluid container 350.

[0043] As shown in Figures 3O and 3P, the bent needle adapter 376 of the exemplary embodiment includes a vial adapter 357, such as the vial adapter from MediMop Medical Projects Limited described in U.S. Patent No. 7,326,194. The bent needle adapter 376 includes a sterile cover 359 in some embodiments. The bent needle adapter 376 includes a needle cap 377 in some embodiments. Alternatively, as shown in Figure 3P, the bent needle adapter 376 may be attached to, for example, an empty vial 378, thereby forming a single, non-sterile autoinjector cartridge unit 365. In some embodiments, the cartridge 365 may be subsequently sterilized and filled with an injection.

[0044] [Optional examples of fastening and mounting materials] An aspect of some embodiments of the present invention relates to an autoinjector with a modular fluid container-syringe coupling system. Autoinjectors, particularly patch autoinjectors, are designed to minimize pain associated with injections by preventing needle migration within tissue during the injection process. This is accomplished by various coupling methods that fixedly attach the needle and / or fluid container cartridge to the autoinjector housing.

[0045] 4A-4H (collectively, FIG. 4) are simplified top and perspective views of a modular fluid container-syringe coupling system according to an exemplary embodiment. The autoinjector 200, in the example shown in FIG. 4, includes one or more fasteners 402. The fasteners 402 are sized to accommodate at least a barrel portion 452 or finger flanges 454 of a fluid container 450. As shown in FIGS. 4A and 4B, the syringe 200, in some embodiments, includes one or more fasteners configured to couple a variety of different types and sizes of fluid containers to the autoinjector 200. As shown in FIG. 4A, the fasteners 404, in some embodiments, include a ring shape. The ring shape of the fasteners 404 is sized to slide over a barrel portion of a fluid container having a corresponding diameter. The fasteners 404, in some embodiments, further include at least one protrusion 406 extending from a periphery of the fasteners 404. The protrusions 406 extend tangentially from the ring portion of the fastener 404 in the exemplary embodiment shown in FIG. 4A. However, the protrusions 406 may extend radially or have any other suitable geometric configuration. The protrusions 406 are oriented parallel to at least a surface 408 of the support plate 410 in some embodiments. At least one protrusion 406 is fixedly coupled to the support plate 410 by at least one retaining member in the exemplary embodiment shown in FIG. 4A. The attachment member includes a retaining cantilever 412 in the example shown in FIG. 4A. The retaining lever 412 is resilient in some embodiments and / or includes at least a resilient coupling member for the support plate 410. However, the attachment member may include any type of suitable attachment mechanism. The retaining cantilever 412 is configured to releasably couple the protrusions 406 of the fastener 404 to the support plate in some embodiments. 4B and 4C show an exemplary embodiment in which the fastening member 414 has an inverted U-shape.The support plate 410, in some embodiments, includes a number of notches 416 configured to receive legs 418 of the fasteners 414. The notches 416 in the support plate 410, in some embodiments, include a retention cantilever 420 configured to attach to one or more corresponding recesses 422 in the legs 418 to removably couple the fasteners 414 to the support plate. The recesses 422 optionally facilitate adjusting an inner radius of the fasteners 414 by adjusting the depth to which the one or more legs 418 of the fasteners 414 are inserted into the support plate 410. The recesses 422 allow the fasteners 414 to be configurable to have a size equivalent to various sizes of fluid containers.

[0046] As shown in FIG. 4D, the support plate 410 in some embodiments includes multiple attachment points 412 or 416 to accommodate fluid containers of various different lengths. The multiple attachment points 412 or 416 are distributed such that the fasteners 402, 414, or 424 are coupled to the support plate 410 at various different distances from the needle holder 206. The attachment points 412 or 416 include, for example, in some embodiments, a cantilever 420 of the type shown in FIG. 4A. The attachment points 412 or 416 include, for example, in some embodiments, a notch 416 and a retaining cantilever 420 configured to removably couple a fastener of the type shown in FIGS. 4B and 4C. The attachment points 412 or 416 include, for example, in some embodiments, a sliding hinge and retaining lever having the configuration shown in FIGS. 4E and 4F. Additionally, attachment point 412 or attachment point 416 may comprise any suitable attachment mechanism similar to, for example, the exemplary embodiments described herein.

[0047] 4E and 4F show an exemplary embodiment in which the fastener 424 has a hinged inverted U-shape. In the example shown in FIGS. 4E and 4F, one leg 426 includes a sliding hinge 428 that is configured to provide a large gap when opened to remove or receive a fluid container barrel portion 452. The unhinged leg 426 of the fastener 424 is locked in place by a retaining cantilever 420 in the closed configuration shown in FIG. 4E.

[0048] At least one of the fasteners 402, 414, and 424, in some embodiments, have the same size so that they are mounted on the same support plate 410. As shown in FIGS. 4G and 4H, the fasteners 402, 414, and 424 are attached with one or more ring-shaped attachment members 430 (FIG. 4H) having various diameters in some embodiments. The attachment members 430 are sized to correspond to the corresponding diameter of a particular barrel portion of the fluid container. The attachment members 430, in some embodiments, are configured to slide over the barrel portion 452 of the fluid container 450 to generate sufficient friction when the fasteners (e.g., the fasteners 414 or 424) are in a closed state. This prevents axial sliding and movement of the barrel portion 452 of the fluid container relative to the support plate 410.

[0049] It should be noted that although Figures 4G and 4H show fasteners of the type shown in Figures 4B and 4C, attachment member 430 may be attached to any of the fasteners described herein or other similar types of fasteners.

[0050] [Examples of locations of connecting members and fastening members between the adapter and the fluid container] In order to ensure a secure coupling between the fluid container and the autoinjector, in addition to securing the fluid container to a surface such as support plate 410, fasteners such as fasteners 420, 414 and 424 must be adjusted to the length of the barrel of the fluid container. This is often accomplished by sliding the fasteners along the barrel of the fluid container and / or by coupling the fasteners to finger flanges of the fluid container, as described elsewhere in this disclosure. The modular support plate 410 structure described elsewhere in this disclosure allows the fasteners to be positioned in almost any desired location, for example, for attachment to the barrel or finger flanges of the fluid container. FIGS. 5A-5G are simplified partial cross-sectional side views showing the location of fasteners coupling the fluid container to the autoinjector.

[0051] In the exemplary embodiment shown in FIG. 5A, the fluid reservoir 590 is empty and is coupled to the needle holder 534. The fluid reservoir 590 and the needle holder 534 are coupled to form a single, integrated autoinjector cartridge unit 535. The cartridge unit 535 is sterile in some embodiments and non-sterile in some embodiments. In some embodiments, the cartridge unit 535 is sterile and is provided to be filled with an injectable while maintaining a sterile condition, thereby rendering the cartridge unit 535 sterile, sealed, and ready for use. In the exemplary embodiment shown in FIG. 5B, the cartridge unit 535 is sterile and pre-filled and is coupled to the support plate 410 by one or more fasteners 402 (FIG. 4A). The cartridge unit 535 includes a plunger 570 in some embodiments and is sealed with a seal 595 after filling to maintain a sterile condition. The cartridge unit 535 is delivered non-sterile in some embodiments to be sterilized and packaged in an envelope, such as a plastic blister 539. As shown in FIG. 5C, the fluid container 550, e.g., a 20 cc fluid container, includes a slip-on tip and is mounted on the autoinjector 500. The tip 502 is shown inserted into the needle holder 506 in the exemplary embodiment shown in FIG. 5C in a manner described elsewhere in this disclosure, and a description thereof will be omitted to avoid redundancy. In the exemplary embodiment shown in FIG. 5C, the needle holder 506 includes a coupling member similar to that of the fastener 504 and is reversibly coupled to the support plate 410. In some embodiments, one or more fasteners 504 are disposed along the barrel portion 452, at least one of which abuts against the finger flange 454 and couples the barrel portion 452 of the fluid container 450 to the support plate 410. The shape and function of the fastener 504 are described elsewhere in this disclosure, and a description thereof will be omitted to avoid redundancy.Fastener 504, in some embodiments, when closed, provides sufficient friction against barrel portion 452 to prevent axial slippage and movement of barrel portion 452 relative to support plate 410. Alternatively, for example, in some embodiments, an attachment member of the type described elsewhere in this disclosure may be attached to the interior of fastener 504 to provide sufficient friction against barrel portion 452 to prevent axial slippage and movement of barrel portion 452 relative to support plate 410.

[0052] Alternatively, as shown in FIG. 5D, the fastener 506 may, for example, in some embodiments, include a radial slot 508 along an inner wall 510. The slot 508 may be sized to accommodate a correspondingly sized finger flange 454 of the fluid container. Alternatively, as shown in FIG. 5E, the type of fastener 504 may, for example, in some embodiments, include a mounting member 512 attached to the inside of the fastener 504. The fastener 504 may, for example, include a radial slot 514 along an inner wall of the mounting member 512. The slot 514 may be sized to accommodate a correspondingly sized finger flange 454 of the fluid container. The mounting member 512 may, for example, in some embodiments, provide sufficient friction against the finger flange 454 to prevent axial slippage and movement of the barrel portion 452 relative to the support plate 410. Note that in FIG. 5D, the plunger of the fluid container is replaced by a plunger 570. The plunger 570 is configured to be driven by a plunger drive system (not shown) of the autoinjector 500.

[0053] Alternatively, the modular fluid container-syringe coupling system shown in FIG. 5F may couple, for example, a small fluid container 555 to the autoinjector 500. The fluid container 555 may be, for example, a 5 cc fluid container. The slip-on tip of the fluid container 555 is shown inserted into the needle holder 506 by methods described elsewhere in this disclosure, and a description thereof will not be repeated here. In some embodiments, one or more fasteners 504 are disposed along the barrel portion 552, at least one of which abuts against the finger flange 554 and couples the barrel portion 552 of the fluid container 555 to the support plate 410. Note that the shape and function of the fasteners 504 are described elsewhere in this disclosure, and a description thereof will not be repeated here. In some embodiments, the fasteners 504 provide sufficient friction against the barrel portion 552 when closed to prevent axial slippage and movement of the barrel portion 552 relative to the support plate 410. Or, for example, in some embodiments, a mounting member 430 of the type described elsewhere in this disclosure may be attached to the interior of fastener 504 to provide sufficient friction against barrel portion 552 to prevent axial slippage and movement of barrel portion 552 relative to support plate 410.

[0054] In the exemplary embodiment shown in FIG. 5F, the mounting member 512 mounted within the fastener 504 is sized to accommodate a correspondingly sized finger flange 554 of the fluid reservoir. As shown in FIG. 5G, the needle holder 506 has a support plate coupling member 537 similar to that of the fastener 504 and is reversibly coupled to the support plate 410. Alternatively, the needle holder 506 has any type of fastener coupling member described elsewhere in this disclosure and is reversibly coupled to the support plate 410. As shown in FIG. 5G, the fluid reservoir 590 does not have a finger flange in some embodiments and is attached to the needle holder 506 in a sealed manner. In the exemplary embodiment shown in FIG. 5G, the fluid reservoir 590 is a pre-filled vial that is attached to the needle holder 506 and has a fastener 402 (FIG. 4C) attached thereto as described elsewhere in this disclosure for mounting to the support plate 410. The needle holder 506, in some embodiments, includes a needle protection cap 377 for the needle 202. The fluid container 590, in some embodiments, is sealed with a seal 595 to maintain sterility. The filled fluid container 590 attached to the needle holder 506 is shipped in an envelope, for example a plastic blister 539. FIG. 6 is a simplified top view of a home kit for self-injection. As shown in FIG. 6, the kit 600, in some embodiments, includes an autoinjector. The autoinjector is represented in FIG. 6 by a modular support plate 410, a number of fasteners 602, and various attachment members 604 with various inner diameters.

[0055] Kit 600 may also include indicia, for example, in some embodiments, that correspond to the fluid container selected to assist the user in selecting the correct fastener or attachment member. For example, in some embodiments shown in FIG. 6, if the selected fluid container is a 50 cc fluid container, the user may select only the fastener to adequately couple the fluid container to the autoinjector. For a smaller fluid container, such as a 10 cc fluid container, the user may select a fastener and an attachment member marked "10 cc" to be inserted into the fastener. Kit 600 may include indicia, for example, "5 cc", "10 cc", "20 cc", "50 cc", "tip" and "flange", in some embodiments, that clearly indicate the attachment size and type of fastener and attachment member.

[0056] A user may couple a fluid container to the autoinjector using the kit 600 by, in some embodiments, removing the autoinjector from the kit and opening the cover to expose the support plate 410. The method, in some embodiments, further includes coupling a needle holder 506 to the fluid container. The needle holder 506, in some embodiments, includes a needle protection cap 377. The method, in some embodiments, further includes selecting one or more fasteners 602 and sliding the one or more fasteners onto the barrel portion 452 or 552 of the fluid container. Alternatively, the method may include coupling the one or more fasteners 602 to the support plate 410. The method may include, for example, inserting one or more attachment members 604 into the one or more fasteners 602 prior to sliding them onto the barrel portion 452 or 552 of the fluid container. The method may also include, for example, selecting a fastener 606 of the finger flange and coupling the flange of the fluid enclosure to the support plate 410. The method may also include, for example, inserting one or more attachment members 608 of the finger flange into one or more fasteners 602 prior to coupling the flange of the fluid enclosure to the support plate 410. The method may also include, for example, selecting at least one attachment point 412 or 416 and attaching a fastener 604 or 606 to the selected attachment point 412 or 416.

[0057] The terms "comprises," "comprising," "includes," "including," "has," and "having," as well as conjugations thereof, mean "including, but not limited to."

[0058] The term "consisting of" means "including and limited to."

[0059] The term "consisting essentially of" means that a composition, method, or structure may include additional components, steps, and / or moieties, provided that such additional components, steps, and / or moieties do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0060] As used herein, the singular references "a," "an," and "the" include the plural of the referenced item unless the context clearly dictates otherwise.

[0061] Throughout this application, embodiments of the invention may be presented with reference to a range format. However, the description in range format is merely for convenience and brevity, and should not be construed as limiting the scope of the invention in any flexible manner. Thus, the description of a range should be considered to clearly disclose all possible subranges and individual numerical values ​​within the range. For example, a description of a range such as "1 to 6" should be considered to clearly disclose subranges such as "1 to 3", "1 to 4", "1 to 5", "2 to 4", "2 to 6", and "3 to 6", as well as individual numerical values ​​within the range, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0062] Numerical ranges given herein (e.g., any pair of numbers joined by "10-15," "10 to 15," or other expressions other than these range expressions) are meant inclusive of the limits of the range and inclusive of any numbers (fractional or integer) within the range indicated by the limits of the range given, unless the context clearly indicates otherwise. The phrases "between" a first indicator number and a second indicator number, and "from" a first indicator number and "to, up to, until, through" a second indicator number (or terms other than these range terms) are used interchangeably herein and are meant to include the first indicator number and the second indicator number, and all fractional and integer numbers therebetween.

[0063] Unless otherwise noted, the numbers used herein and any numerical ranges based on those numbers are approximations within reasonable measurement precision and rounding error, as will be understood by one of ordinary skill in the art.

[0064] Although some features of the invention are described in the context as separate embodiments for clarity, those features may also be combined in a single embodiment. Conversely, various features of the invention that are described in the context as a single embodiment for clarity may also be provided separately, in any suitable subcombination, or otherwise suitable in any other embodiment of the invention other than the described embodiment of the invention. Some features that are described in the context as various embodiments may also be provided separately, in any suitable subcombination, or otherwise suitable in any other embodiment of the invention other than the described embodiment of the invention. Unless the embodiment is inoperable without those elements, they should not be considered essential features of those embodiments.

[0065] While the present invention has been described in conjunction with specific embodiments, it will be apparent to those skilled in the art that many alternatives, modifications and variations may be made thereto, and it is therefore intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope defined by the appended claims.

[0066] All publications, patents, and patent applications mentioned herein are hereby incorporated by reference in their entirety to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference herein. Furthermore, citation or identification of a document in this application shall not be construed as an admission that the document exists as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.

Claims

1. An accessory for an autoinjector, comprising: at least one adapter having a tortuous fluid path; At least one fastening member; Equipped with the at least one adapter is sized and shaped to sterilely couple the serpentine fluid path to at least a distal end of a fluid container; the at least one fastener is sized and shaped to couple the body of the fluid container to the autoinjector; the at least one fastening member has an adjustable inner diameter; The at least one adapter and the at least one fastener are configured to couple at least one of a plurality of containers having different sizes and different tip types to the autoinjector. Autoinjector accessories.

2. The distance between the adapter and the fastening member is adjustable.

2. An accessory for the autoinjector of claim 1.

3. and a mounting member sized and shaped to fit along an inner wall of the fastener member.

2. An accessory for the autoinjector of claim 1.

4. The inner diameter of the fastener is reduced by the attachment member.

4. An accessory for the autoinjector of claim 3.

5. At least a portion of the fastening member is made of a plastic material.

2. An accessory for the autoinjector of claim 1.

6. At least a portion of the fluid container is formed from glass or a plastic material.

2. An accessory for the autoinjector of claim 1.

7. The tortuous fluid path is formed by including a hollow needle.

2. An accessory for the autoinjector of claim 1.

8. The bent fluid path is bent at an angle of 90 degrees.

2. An accessory for the autoinjector of claim 1.

9. The fluid container is a pre-filled cartridge or a vial.

2. An accessory for the autoinjector of claim 1.

10. The accessories are entirely sterilizable 2. An accessory for the autoinjector of claim 1.

11. The adapter is a Luer lock type coupling member or a vial adapter.

2. An accessory for the autoinjector of claim 1.

12. The adapter is a slide-type fluid container coupling member.

2. An accessory for the autoinjector of claim 1.

13. The adapter further includes a coupling member sized and shaped to couple the accessory to the autoinjector.

2. An accessory for the autoinjector of claim 1.

14. an autoinjector including a support plate having a plurality of attachment points; at least one adapter having at least one flex fluid path and sized to couple the sterilized flex fluid path to at least a distal end of a fluid container; at least one fastener sized to be coupled to a body of the fluid enclosure and to at least one of the plurality of attachment points; a retaining cantilever configured to releasably couple the at least one fastening member to the support plate; 11. An accessory for an autoinjector coupling system comprising:

15. The adapter is sized and adapted to be coupled to at least one of the plurality of attachment points.

15. An accessory for an autoinjector docking system according to claim 14.

16. The attachment points are distributed on the support plate at various different distances from the adapter.

15. An accessory for an autoinjector docking system according to claim 14.

17. The different distances correspond to different lengths of the fluid container.

15. An accessory for the autoinjector docking system of claim 14.

18. The inner diameter of the fastening member is adjustable 15. An accessory for an autoinjector docking system according to claim 14.

19. and a mounting member sized and shaped to fit along an inner wall of the fastener member.

15. An accessory for an autoinjector docking system according to claim 14.

20. The inner diameter of the fastening member is reduced by the mounting member.

20. An accessory for an autoinjector docking system according to claim 19.

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