Improved-type automatic injector assembly

Abstract

To provide an improved method and device for supplying one or more drug solutions and / or drugs to a body.SOLUTION: The device includes an improved-type automatic injector assembly, in general. The provided improved-type automatic injector assembly substantially improves injection of one or more drug solutions and / or drugs to a body.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] (Priority Claim) This application claims the benefit of U.S. Provisional Application No. 63 / 596,820, filed on November 7, 2023, which is hereby incorporated by reference in its entirety.

[0002] (Joint Application) U.S. Patent Application No. 13 / 961,422, filed on August 7, 2013, entitled "Methods and Apparatus for Simultaneously Recording and Treating Tension Pneumothorax and / or Hemothorax"; U.S. Patent Application No. 14 / 581,339, filed on December 23, 2014, entitled "Percutaneous Channel System and Method"; U.S. Patent Application No. 16 / 113,707, filed on August 27, 2018, entitled "Percutaneous Access Path System"; U.S. Patent Application No. 16 / 354,418, filed on March 15, 2019, entitled "Systems and Methods Related to Medical Use of Synthetic Polymer Formulations"; U.S. Patent Application No. 16 / 948,885, filed on October 5, 2020, entitled "Percutaneous Access Path System"; U.S. Patent Application No. 17 / 876,187, filed on July 28, 2022, entitled "Wound Treatment Apparatus"; U.S. Patent Application No. 18 / 448,455, filed on August 11, 2023, entitled "Percutaneous Access Path System"; U.S. Patent Application No. 18 / 485,800, filed on October 12, 2023, entitled "Systems and Methods Related to Medical Applications of Thermoreversible Polymer Formulations" are hereby incorporated by reference in their entirety.

[0003] This invention was made with government support under Contract No. HT9425-23-C-011, "RX-Shooter Wearable Wound Infection Treatment Device," awarded by the U.S. Army Medical Research Acquisition Activity (USAMRAA). The U.S. government has certain rights in this invention.

[0004] This disclosure generally relates to the field of medical devices, and more particularly, to devices and methods for delivering one or more chemical solutions and / or drugs to the body.

Background Art

[0005] Despite significant advances in military medicine, in recent wars including those in Iraq and Afghanistan, more than one-third of combat-wounded patients evacuated to hospitals in the United States were diagnosed with infections during their initial hospitalizations. Open combat wounds are particularly prone to infection during combat and can be a cause of morbidity and death following combat injuries. To prevent the onset of infectious diseases, current Tactical Combat Casualty Care (TOCC) guidelines recommend treatment of open wounds sustained in the battlefield with antibiotics. If indicated, antibiotics should be administered immediately after trauma, and even a delay of 1-2 hours significantly increases the infection rate. However, there is a gap between recommendation and reality, and currently available far-forward treatments for infection prevention are rarely utilized.

[0006] Currently, troops are issued Combat Wound Medicine Packs (CWMPs), which are included in Individual First Aid Kits (IFAKs). CWMPs contain two tablets of acetaminophen (650 mg), one tablet of moxifloxacin (400 mg), and one tablet of meloxicam (15 mg). The point recommended by TCCC for open wounds is the administration of the antibiotic moxifloxacin (400 mg, once daily orally) from CWMP. However, recent surveys have shown that less than 1% of the wounded who met the criteria for CWMP administration received the intervention. Compliance is low for many reasons, including lack of tolerance to oral administration. When the wounded are unable to take it due to shock or loss of consciousness, the TCCC recommendation refers the medic for intravenous (IV) administration. This is a problem in the far-forward environment as rapid intravenous administration can be hindered by personnel, materials, and time requirements. This also applies to civilian patients treated by traditional Emergency Medical Services (EMS). Furthermore, multi-domain operations can further impede the management of such wounds on future battlefields. Such initial responses for infection prevention after such wounds, future deployable treatment methods, would be a major advance for military combat medicine in long-term treatment and treatment during movement in a harsh combat environment, and at the same time would be beneficial in civilian trauma scenarios.

[0007] An autoinjector is a medical device designed to administer a specific drug into a patient's body (e.g., inject oneself or another person). Typically, an autoinjector simplifies and / or facilitates at least one step in the process of injecting a drug as compared to a manual drug injection by a healthcare provider. This facilitates self - administration or administration by untrained or minimally trained staff. Classically, autoinjectors are pre - loaded with a single dose of a drug and are usually administered via a spring - loaded syringe similar to a pen. However, the literature describes a wide range of technologies related to autoinjectors and related in - body syringes.

[0008] Autoinjectors and related technologies have the potential to overcome the problems associated with CWMP and more traditional intravenous administration means, provide an administration method that does not require oral administration and is simple enough to be used by oneself or with the assistance of a peer. The current state of autoinjector technology is limited to appropriate combat and many civilian uses.

[0009] Despite the availability and ease of use of autoinjectors, current autoinjector technology has many drawbacks. First, with the exception of the Antidote Treatment Nerve Agent Autoinjector (ATNAA), most autoinjectors are for a single drug and each is the size of a large pen marker. This also includes self - injectors for naloxone (e.g., for opioid overdose) and epinephrine (e.g., for anaphylaxis). Carrying such devices, especially when repeated dosing is likely, adds size and weight to an already overloaded fighter aircraft. In addition, there are a number of other drugs that could be useful and are not currently available in autoinjectors. An example of drugs in an autoinjector is shown in Figure 1. As far as we know, there are currently no antibiotics available as self - injectors approved for use by the FDA.

[0010] Second, autoinjectors are not adapted for use in a far - future environment. Pen - type autoinjectors are not shock - resistant and are limited to a 1 - meter drop impact. In addition, some devices for drugs with higher viscosities have problems related to pre - activation or glass breakage due to over - driving the spring - driven system. That is, although autoinjectors have the potential to provide rapid and easy life - saving treatment on the battlefield, existing devices are not well - made enough to withstand their unique challenges.

[0011] Third, all such autoinjectors must be administered to very specific parts of the body via traditional intramuscular injection in order to avoid important underlying structures (e.g., larger veins, arteries, and nerves). This often requires additional training requirements to ensure proper use and minimize complications.

[0012] Insulin pumps for diabetics are currently the major devices approved by the FDA for human use in injecting a drug solution into the body. There are two micro - needle patch insulin pumps (the Omnipod Insulin Management System from Insulet and the V - Go from Valeritas) approved for sale in the United States, as well as an additional system (the Accu - Check Solo from Roche) approved in Europe [7][8]. They have a drug reservoir that holds up to 2 - 4 mL, about the size of a deck of cards, and these are worn directly on the body via an adhesive patch (i.e., without a traditional pump tube). Both the Omnipod and the Accu - Check can be worn straight for several days. The Omnipod is also waterproof for up to 60 minutes down to a depth of 7.62 mm. However, these pumps and related technologies cannot be directly transferred to a combat environment because 1) they are cartridge - based systems that require a planetary gear device with limited power output due to battery power and motor size, 2) they are single - use with no way to supply without battery power, and / or 3) they are expensive due to the use of technology focused on providing time - titration, in contrast to the much less expensive bolus dosing that is the standard for most drug deliveries.

[0013] Microneedle technology has recently been integrated into "peel & stick" formats such as patches developed by Micron Biomedical. Micron's microneedle patches are applied by pressing them against the skin, enabling easy self - administration. When the patch is applied to the skin, the polymeric microneedles penetrate the upper layer of the skin and then rapidly dissolve, releasing their drugs. After a few minutes, the patch is removed from the skin. This technology has advantages in terms of portability and ease of use, but the system has fundamental limitations. First, the drugs that can be delivered via this system are limited to those specially formulated to be compatible with the dissolving microneedle technology, significantly restricting its benefits to combatants. Second, there is no way to achieve long - term automated repeated dosing with this system. Instead, the user must manually administer the treatment as needed. For this reason, in the hectic combat environment, this technology is functionally limited to single - dose use and is not practical for long - term care (e.g., up to 72 hours of PFC). Finally, since there is a limit to the amount that can be administered intradermally, the types of antibiotics and other pharmaceuticals that can be administered by this means are severely restricted.

[0014] Fourthly, many autoinjectors store the drug as a fluid, which limits the drug's stability and the library of drugs that can be delivered using the device. Products (i.e., medicaments) dried by lyophilization or other methods can often be stored for longer periods and can then be mixed with a fluid (i.e., a diluent). Reconstitution means mixing the powder (e.g., a lyophilized medicament) with a diluent (e.g., a liquid). The diluent often does not have a pharmacological effect but is necessary to reconstitute the drug. Commonly used solvents for the diluent solution include, but are not limited to, sterile water, bacteriostatic water, water for injection, bacteriostatic 0.9% sodium chloride, and 0.9% sodium chloride. Prior art, e.g., U.S. Patent No. 10,226,583 to Edwards et al., includes an autoinjector where the diluent can be stored separately from the medicament and, upon actuation, the combination of the diluent and the medicament is mixed to reconstitute the medicament for delivery. Such autoinjectors are often referred to as "wet / dry" autoinjectors since one medicament can be a liquid (e.g., water or another diluent) and the other medicament can be substantially solid or dry (e.g., a drug powder). In use, the first medicament and the second medicament must be mixed prior to injection.

[0015] Fifthly, most current autoinjectors have the end user select the administration site. Currently, there are no autoinjectors where a separate provider can identify an on-board location for a multi-dose supply of injections that the user can use later.

[0016] Sixthly, there are wearable autoinjectors, but the prior art for these wearable autoinjectors does not integrate an individual and changeable drug capsule containing the drug of interest with the protection of the automated medical device before and after supply.

[0017] In the civilian market, parenteral antibiotics may be required because they have beneficial properties over oral antibiotics. In such cases, in current medicine, patients often have to be hospitalized, start receiving parenteral antibiotics (usually by intravenous injection), have a PICC line inserted, and then nurses need to transfer to home care where intravenous injections are given through the PICC line.

[0018] The literature discloses various additional known methods and devices related to autoinjectors. However, all are limited in some aspects.

[0019] Each of the above-mentioned patents and published patent applications is incorporated herein by reference.

Summary of the Invention

[0020] The present disclosure overcomes and substantially alleviates the disadvantages of the prior art by providing an assembled device and method related to supplying one or more chemical solutions and / or drugs to the body. In various aspects, the improved autoinjector assembly is formed via different methods and devices and includes the aforementioned technologies described as the background art of the present disclosure and incorporated by reference. The provided improved autoinjector assembly substantially improves the injection of one or more chemical solutions and / or drugs into the body.

[0021] In an embodiment, the improved autoinjector assembly technology provides a mechanized injection supply system that can rapidly and accurately administer one or more drugs. One aspect of the present disclosure provides an improved autoinjector assembly that includes one or more drug capsules and one or more drug supply holders. The purpose of this system is to enable easy interoperability between the drug capsules and the supply holders, such that individual drug capsules (e.g., having the same type of drug and / or having different types of drugs) can all function using different drug supply holders (e.g., the same type of drug supply holder and / or different types of drug supply holders).

[0022] In an embodiment, each drug capsule is for single use, supplies a fixed dose, and is color-coded for each drug for easy identification. A clear and visible label is attached so that the desired drug can be quickly selected by choosing the appropriate drug capsule. In an embodiment, the drug capsule not only contains its individual drug, but also at least partially includes means for delivering that drug to the body. For example, each drug may have different properties when mixed with a diluent, such as viscosity, and therefore it may be necessary to adjust the components of an autoinjector to suit the delivery of that drug. In an embodiment, all of these drug-specific improvements are incorporated within the drug capsule itself, thus enabling it to not require improvements to the drug delivery holder based on the drug capsule used in conjunction therewith. In an embodiment, each drug capsule includes at least one drug for injection, at least a part of an injection mechanism, and a needle.

[0023] Under an embodiment, the drug capsule has safety features such that it can be safely carried and handled by a user without concern for sterility or medical device risk. In an embodiment, this includes a drug capsule cap that functions in conjunction with the remainder of the drug capsule prior to use to prevent damage from the external environment, prevent early release during storage, and / or maintain the sterility of at least some regions of the drug capsule. Under an embodiment, when the drug capsule cap is removed, the drug capsule has additional safety features to prevent premature discharge until it is connected and / or placed within a drug delivery holder. This improved system enables even minimally trained users to easily load the drug capsule into the drug delivery holder and thus facilitates its use. In an embodiment, the drug capsule further includes a display window or other related means for visualizing the drug prior to use of the drug capsule (e.g., to confirm that the drug is fully dissolved, to confirm that the drug is unchanged, to confirm that the drug has been fully delivered, etc.). In an embodiment, the drug capsule includes specific information regarding the drug contained therein (e.g., dosage, drug type, indication, contraindication, side effect, instructions for use).

[0024] In an embodiment, when placed within and disposed with such a drug supply holder, the drug capsule can be triggered to supply the drug to the body. In an embodiment, an individual who is not the primary user can place the holder in front of the user who uses the rest of the system (e.g., a healthcare provider can place the holder in its correct anatomical position so that the patient user does not need to determine the appropriate injection site). In an embodiment, the instrument does not require and does not include a drug supply holder. In an embodiment, the drug supply holder can hold two or more drug capsules. Examples include serial insertion of drug capsules into a predetermined capsule receiving region, parallel insertion of drug capsules into a plurality of different capsule receiving regions, and / or a combination of the two. In an embodiment, the drug supply holder is at least partially reusable, while each drug capsule is disposable and is disposable after use. In an embodiment, the single-use sterile needle of the drug capsule exits the drug capsule through a sterile barrier specific to the drug capsule and is then inserted into the patient. In an embodiment, the improved auto-injector assembly then injects the liquid drug from its drug storage chamber through one or more hollow needles.

[0025] In an embodiment, drug injection is actuated by the release of pressurized gas and sequentially performs needle insertion and drug supply. In other embodiments, at least a portion of this process is actuated by using one or more springs or other elastic biasing mechanisms.

[0026] In embodiments, the improved auto-injector assembly delivers the drug through different routes. For example, in some embodiments, the needle is of an appropriate structure to deliver the drug intradermally (ID), subcutaneously (SQ), intramuscularly (IM), and / or intravenously (IV). In various aspects, the needle has an injection depth in the range of 0 - 0.5 cm, 0.5 - 1 cm, 1 - 1.5 cm, 1.5 - 2 cm, 2 - 2.5 cm, 2.5 - 3 cm, 3 - 3.5 cm, 3.5 - 4 cm, 4 - 4.5 cm, 4.5 - 5 cm, and / or 5 - 10 cm. In some embodiments, SQ injection is used to minimize the risk to underlying structures (e.g., larger arteries, veins, nerves, and other important tissues) while still allowing multiple locations for placing the device on the body. In embodiments, the drug capsule can enable injections of different volumes (e.g., about 0.5 mL, about 1 mL, about 1.5 mL, about 2 mL, about 2.5 mL, about 3 mL, about 3.5 mL, about 4 mL, about 4.5 mL, about 5 mL, >5 mL).

[0027] In embodiments, upon drug delivery, the improved auto-injector assembly retracts one or more needles into the drug capsule. In embodiments, after drug delivery, the needles are retracted back into the drug capsule by the reaction force from the internal spring. In embodiments, this mechanism minimizes the time the needles are in the body and thus reduces pain from needle penetration and the risk of complications. Under embodiments, this functions to prevent and / or reduce the chance of needlestick injury by using the drug capsule as a sharp protective container. Once the dangerous needles are retracted into the drug capsule, the drug capsule can be removed from the drug delivery holder for safe disposal. In embodiments, a visual indicator is displayed to indicate by operation that the drug capsule has been used to avoid confusion with unused drug capsules. Under embodiments, the used drug capsule is permanently changed to indicate previous use and / or physically changed to prevent reuse. This provides advantages regarding subsequent concerns of needlestick injury and / or biohazard contamination.

[0028] In embodiments, the drug delivery holder has different sizes and shapes. In embodiments, the drug delivery holder is an off-body system that functions to enable a patient to use drug capsules (e.g., the combination of a drug capsule and a drug delivery holder forms an assembly such as a pen or a gun for drug delivery). In embodiments, the drug delivery holder is an on-body system that can stay on the patient with a strap while one or more drug capsules are being used. Examples include different versions of securely attaching the device to the body, including Velcro®-compatible straps, other straps, skin-safe adhesive pads, and / or integration into the uniform itself. In embodiments, the drug delivery holder accepts one, two, three, four, five, six, or more drug capsules at a time. In embodiments, the drug delivery holder accepts only a single drug capsule and is used continuously to deliver one drug at a time. In embodiments, a larger drug delivery holder accepts multiple drug capsules simultaneously. For example, multiple drug capsules of the same or different drug types can be inserted into the drug delivery holder and the device can be used to deliver them over a set period of time (e.g., every 12 hours over 3 days). In embodiments, the activation of the drug capsule is manual, automated, or a combination of both.

[0029] In embodiments, an improved autoinjector assembly facilitates the administration of one or more therapeutic agents by a patient and / or a less-skilled user rather than a trained provider. For example, the drug delivery holder can be initially positioned by a healthcare provider to ensure that the injection is made in the correct location. The patient can then go home, and the patient and / or family can use the device to administer the injection over a period of time without being supervised by a healthcare provider. This is an improvement over current autoinjector technology where the patient needs to identify the appropriate anatomical site for each injection.

[0030] In embodiments, the improved auto-injector assembly further includes a connection to a built-in sensor and / or an external sensor and / or a communication infrastructure. For example, in some embodiments, the system pairs electronically with a biometric sensor and, when triggered, automatically delivers one or more selected drugs as needed. Embodiments enable the possibility of manual, semi-automatic, and / or automatic triggering via various routes such as self-administration, buddy care, use of local providers, and / or telemedicine in remote locations. In embodiments, this includes a connection to artificial intelligence and / or machine learning algorithms.

[0031] In embodiments, the improved self-injector is adapted for use in out-of-hospital environments (e.g., combat in a far-forward line, emergency medical services, at home, home healthcare, caregiving), while others are adapted for in-hospital environments. In embodiments, the assembly is rugged, reliable, compact, lightweight, cost-effective, and / or affordable, suitable for use over a wide range of temperature and operating environmental conditions, easy to operate for self, buddy, and provider assistance, and / or has a rapid start of operation. In embodiments, the improved auto-injector assembly is designed to be worn comfortably by a combatant under, over, or as part of a uniform and / or protective clothing.

[0032] In embodiments, the improved auto-injector assembly uses modular drug capsule technology to provide the ability to supply an interoperable library of drugs in different drug capsule forms. In embodiments, the improved auto-injector assembly can repeatedly administer a drug over a long period of time. In embodiments, the improved auto-injector assembly can be used for only the time it takes to operate the system to deliver the drug, hours, days, weeks, and / or months. These advantages are in comparison to conventional auto-injectors that can only make one injection at a time to a specific anatomical area. In some embodiments, the drug delivery holder is retained on the body for 7 - 10 days, although additional drug capsules may be inserted into the body as needed.

[0033] In an embodiment, the improved auto-injector assembly meets one or more of the following operating requirements. The drug capsule must not be activated outside the drug supply holder, the improved auto-injector assembly must be activated only directly after manual input, the auto-injector assembly must be operable after exposure in the temperature range of 5°C to 40°C, the auto-injector assembly must be operable after experiencing a one-meter drop, it must be easy to insert the drug capsule into the drug supply holder, it must be possible to easily remove the drug capsule from the drug supply holder, the drug capsule must not fall out of the drug supply holder by itself, the drug capsule must be visible within itself before insertion into the drug supply holder, the therapeutic agent must be protected from light within the drug capsule during storage, the drug capsule must be sealed within the container before the drug supply holder is ready, and / or the patient must not suffer an adverse reaction from receiving multiple injections at the same location.

[0034] In an embodiment, the improved auto-injector assembly meets one or more of the following physical requirements. The drug capsule diameter is less than 55 mm, the total height profile of the drug capsule is less than 68 mm, the total mass of the drug capsules when required up to the maximum volume is less than 50 g, the drug capsule supplies a drug product solution of 0.3 mL to 2.0 mL excluding the holding volume (HUV), and / or the markings on the drug capsule, drug supply holder, and / or auto-injector assembly are legible within an illumination condition of 100 lx at a distance of 30 cm to 70 cm.

[0035] In an embodiment, the improved auto-injector assembly meets one or more of the following performance requirements. The improved auto-injector assembly enables placement of a strap drug supply holder on either the arm and / or thigh, the drug supply holder can stay in a fixed position for 7 to 10 days, after placement, the drug supply holder must be firmly held in its starting position, the supply of the therapeutic drug must be automatic after manual activation, the improved auto-injector assembly must indicate that it is ready for supply, the non-deployed state of the improved auto-injector assembly must be clearly different from its deployed state, the improved auto-injector assembly and / or its components must withstand a 1-meter drop, and / or the drug capsule needle must be protected after administration.

[0036] In an embodiment, the improved auto-injector assembly and / or its components meet one or more of the following additional requirements. The improved auto-injector assembly and / or its components are provided sterile, the improved auto-injector assembly and / or its components should not be resterilized, the auto-injector assembly within its end package is designed to withstand exposure to any environmental damage that may reasonably be expected during air or ground transportation within the United States and international locations, the improved auto-injector assembly remains stable when stored at a temperature of 15 to 30 °C, the expiration date of the device is 12 months or more from the date of manufacture, the auto-injector assembly system is for single-patient use and should be discarded in accordance with federal, state, and local regulations for medical device and infectious material waste, the application of the improved auto-injector assembly should be simple, quickly deployed, and with a minimum number of steps, and / or the application of the device is possible with the patient standing, sitting, or lying down.

[0037] The improved auto-injector assembly can supply one or more medicaments and / or drugs to the body (i.e., drugs, therapeutics, medicines). In embodiments, these include all existing types of standard pharmaceutical formulations, as well as the adjustment of such formulations for longer storage and / or use in the improved auto-injector assembly. In embodiments, the auto-injector assembly includes one or more therapeutics. In embodiments, the assembly includes a library of different injectable drug products. By way of example, and not limited to these categories and drugs, examples include antibiotics (e.g., cefazolin, ceftriaxone, ertapenem, levofloxacin, teicoplanin), analgesics (e.g., fentanyl, hydromorphone, ketamine, ketorolac, morphine), anticonvulsants (e.g., diazepam, lorazepam, midazolam), antiemetics (e.g., metoclopramide, promethazine), heart / ACLS drugs (e.g., epinephrine), chemobiodefense drugs (e.g., 2-PAM, atropine), opioid antagonists (e.g., naloxone), and / or numerous others (e.g., diphenhydramine, insulin, tranexamic acid).

[0038] In some embodiments, the drug to be supplied is in a liquid solution prior to supply. In some embodiments, the drug to be supplied is stored in a dry form (e.g., lyophilized) prior to initiating the supply process. This has the added advantage of increasing storage time and environmental stability. In some embodiments where the drug is in a dry form, there is an additional reconstitution step (e.g., automatic or manual) of first mixing the dry drug with a fluid prior to injection. For example, in embodiments, the drug capsule cap and / or another portion of the drug capsule contains a diluent within a diluent chamber. The diluent actuator mixes the diluent with the dry drug. The user can then view the combined product through a viewing window in the drug capsule and can shake the drug capsule to dissolve the drug into solution. Once combined, the user can then insert the drug capsule into a drug supply holder and supply the drug as described elsewhere.

[0039] In an embodiment, one or more of the regions and / or elements of the device are provided to the user aseptically. In an embodiment, one or more layers of the packaging maintain the asepticity of the device (e.g., prevent contamination from the external environment). In an embodiment, one or more of the following methods are used for the sterilization of one or more regions and / or components of the device. Namely, steam sterilization, ethylene oxide, peracetic acid, dry heat, radiation (e.g., gamma rays, electron beam, X-rays), and / or hydrogen peroxide (e.g., vaporized gas plasma). In an embodiment, sterilization is performed finally and / or during the process.

[0040] Methods and devices related to autoinjectors are exemplified and described herein. While specific embodiments of the present disclosure have been described, the present disclosure is as broad as permitted in the art and is not intended to be limited thereto as the present specification is intended to be read in the same way.

[0041] From the above, it can be seen that the present invention provides improved means for autoinjection in animals, particularly humans. In various aspects, the device is used for autoinjection into different body regions. These include intradermal, subcutaneous, intramuscular, intravenous, and certain structures (e.g., intra-articular, intracavitary, central nervous system). Exemplary subcutaneous injections are sometimes used to illustrate the present disclosure but should not be limited in scope as they can be used similarly to access anatomical locations.

[0042] Furthermore, the device can be made in various lengths, sizes, and capacities, and it is also clear that the exact configuration of the device can be appropriately changed to treat adults, children, and infants. Although the device has been described with a certain degree of particularity, it is clear that many changes can be made to the details of the configuration and the arrangement of the components without departing from the spirit and scope of the present disclosure. The present disclosure is not limited to the embodiments described herein for illustrative purposes, and it is understood that the elements of a particular embodiment can be combined with the elements of other embodiments. Further objects, advantages, and novel features of the present disclosure will be described in the following description and will become apparent to those skilled in the art by examining the following detailed description and the drawings. It should be understood that not all of the described features need to be incorporated into a given system or method.

Brief Description of the Drawings

[0043]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Modes for Carrying Out the Invention

[0044] Referring to the drawings, FIGS. 1-2 illustrate one embodiment of a portion of the present disclosure. For ease of reference, the distal end refers to the end of the device that is furthest from the user, and the proximal end refers to the end of the device that is closest to the user. In this embodiment, an improved auto-injector assembly including a drug capsule 20 is shown. In the embodiment, the drug capsule 20 includes a drug capsule cap 30 and a drug capsule container 39. In the embodiment, the drug capsule cap 30 further includes a drug capsule actuator 40 and a drug capsule body 50. In the embodiment, the drug capsule 20 further includes one or more drug information regions 22 that provide capsule-specific drug information that enables a user to easily identify the drug and / or other applicable details (e.g., dosage, supply frequency, drug type) contained within the capsule. In the embodiment, a cap connector 38 prevents removal of the drug capsule cap 30 from the drug capsule container 39 until desired by the user and / or permitted by the device. Prior to removal, the drug capsule cap 30 and / or the cap connector 38 can serve to protect the sterile distal region of the drug capsule 20 (e.g., during transportation and / or handling) and / or maintain its sterile state. In the embodiment, removal of the drug capsule cap 30 from the remainder of the drug capsule 20 is prevented by the cap connector 38. In the embodiment, removal of the cap connector 38 is manually performed by the user. In the embodiment, the cap connector 38 is an internal mechanism of the device that can only be disengaged manually, semi-automatically, and / or automatically after a diluent has been successfully transferred from the capsule cap 30 to the drug capsule container 39. In the embodiment, the drug capsule cap 30 facilitates filling the system with a diluent 32, for example, by first moving a separately stored fluid diluent 32 into an injection chamber 74 and mixing it with a dry (e.g., lyophilized) drug 71, thus resulting in a mixture that is injectable (e.g., reconstituted). In the embodiment, the user first removes or otherwise disengages a diluent actuator lock 35, and then enables movement of a diluent actuator 36.In an embodiment, the diluent actuator 36 is similar to a standard syringe plunger system and is connected to a rubber stopper 37 disposed within the diluent chamber 34. In the illustrated embodiment, the user then pushes the diluent actuator 36 in the distal direction, thereby causing the patient needle 76 to pierce the needle septum 96 and create a space continuous with the diluent chamber 34, thus enabling the diluent 32 to move into the drug capsule container 39 and the injection chamber 74. In an embodiment, there is a locking mechanism (not shown) that prevents the diluent actuator 36 from subsequently retracting proximally once the diluent has been sufficiently transferred to the drug capsule container 39. In an embodiment, there is a separation mechanism (not shown) that releases and / or enables the release of the engagement of the cap connector 38 once the diluent has been sufficiently transferred to the drug capsule container 39 only once.

[0045] In an embodiment, the drug capsule cap 30 cannot be removed from the drug capsule container 39 until the drug capsule container 39 is sufficiently filled with fluid (e.g., prevented by interaction with the cap connector 38). In an embodiment, the cap connector 38 is manually removed after the system is charged. In an embodiment, charging of the system is automatically performed when the drug capsule cap 30 is removed from the remainder of the drug capsule container 39. In an embodiment, the user is facilitated to shake and / or agitate the drug capsule cap 30 and / or the drug capsule container 39 to dissolve the drug 71 in the diluent 32 to form a mixed solution. In an embodiment, with one or more observation windows 54, the user can view at least a portion of the injection chamber 74 from outside the drug capsule container 39. This can enable determining whether sufficient drug has dissolved into the liquid solution before deployment and / or whether sufficient liquid and / or drug product has been injected into the patient after actuation. In an embodiment, the drug capsule cap 30 facilitates shaking and / or agitation of the drug capsule 20.

[0046] In embodiments, removal of the drug capsule cap 30 from the drug capsule container 39 actuates other mechanisms and / or has other benefits. In embodiments, removal of the drug capsule cap 30 automatically causes removal of a partition that prevents light from passing through one or more viewing windows 54, which can adversely affect the drug and / or drug solution contained within the drug capsule. In some embodiments, by removing the drug capsule cap 30, the user can view the drug, which is a requirement for many auto-injectors, internally (e.g., to confirm that the drug has not been tampered with and to confirm dissolution of the drug into solution). In embodiments, removal of an adhesive sticker (not shown) serves to prevent ingress of light during storage, and removal thereof, once removed, enables viewing through the window. In embodiments, such a sticker may be adhered to the drug capsule cap 30, the drug capsule body 50, and / or the cap connector 38, such that it must be removed before or during removal of the drug capsule cap from the drug capsule body (e.g., to indicate whether it has been tampered with). In embodiments, the outer packaging of the drug capsule 20 serves to prevent ingress of light during storage, and removal thereof, once removed, enables viewing through the window.

[0047] Turning now to FIG. 3, some embodiments of the present disclosure are shown. In this embodiment, an improved auto-injector assembly is shown that includes a drug capsule container 39 and a drug supply holder 100. In embodiments, the drug capsule container 39 is designed such that at least a portion of the drug capsule container 39 can be connected to (e.g., disposed within) the drug supply holder 100 when the drug capsule cap 30 is removed from the drug capsule container 39. In embodiments, the drug capsule container 39 can be connected only to (e.g., disposed within) the drug supply holder 100 when the drug capsule cap 30 is removed from the drug capsule container 39. In embodiments, the drug supply holder 100 further includes one or more holder connection mechanisms 124 that interact with the drug capsule container 39 to hold the two components together reversibly and / or irreversibly.

[0048] In an embodiment, when the drug capsule container 39 is inserted into the drug supply holder 100, the connection mechanism 52 on the drug capsule body 50 connects and / or interacts with the holder safety mechanism 120 on the drug supply holder 100 in other ways. In this embodiment, the drug capsule container 39 cannot be actuated (i.e., to deploy the patient needle 76, not shown in this figure) unless the body connection mechanism 52 and the holder safety mechanism 120 are engaged with each other. Thus, this actuator safety mechanism has the advantage of preventing premature actuation of the improved auto-injector assembly when it is not properly positioned on the patient (e.g., during device setup, during charging). This further prevents and / or reduces the possibility that the user may inadvertently inject themselves during handling of the drug capsule container 39 (e.g., before insertion into the drug supply holder 100). In an embodiment, the holder safety mechanism 120 and the holder connection mechanism 124 are functionally combined.

[0049] In an embodiment, the drug supply holder 100 further includes one or more capsule receiving regions 110 for receiving the drug capsule container 39 (e.g., after the drug capsule cap 30 has been removed). Only one capsule receiving region 110 is shown in this figure. However, various embodiments may have various numbers of capsule receiving regions (e.g., from 1 to 30 or more). In an embodiment, the capsule receiving region 110 further has one or more adjustment mechanisms 112 that interact with the drug capsule container 39 to ensure its proper orientation (e.g., allow only placement in a specific orientation) when placed within the capsule receiving region 110. In an embodiment, the drug supply holder 100 further includes a patient fixation mechanism 130. In an embodiment, the patient fixation mechanism 130 includes an adhesive biocompatible backing that can adhere the drug supply holder 100 to the patient's skin. In an embodiment, the patient fixation mechanism 130 includes a strap for facilitating connection to the patient (e.g., for placement around a limb). In an embodiment, the drug capsule cap 30 is completely or partially removed by placement into the capsule receiving region 110 and is not manually removed before placement.

[0050] Turning now to FIG. 4, some embodiments of the present disclosure are shown. In this embodiment, the drug capsule container 39 is properly disposed within the drug supply holder 100, and once properly disposed therein, the drug capsule actuator 40 enables the operation of the automatic syringe drug supply mechanism of the device when actuated by a user (e.g., rotated, pressed, inverted, squeezed, twisted, and / or electronically triggered). The actuator release mechanism 80 ensures that the drug capsule container 39 can be actuated only when the drug capsule container 39 is in the proper position within the drug supply holder 100. When not fully disposed within the drug supply holder 100 (e.g., as shown in FIG. 3), the release key 88 is in its distal position biased to that position by the release spring 86. Since the release lock 84 is also laterally biased by the release lock spring 82, the interaction between the actuating grip 42 and the release lock 84 ensures that the actuating grip 42 cannot be actuated (e.g., rotated), and thus the drug capsule cannot be actuated in this configuration.

[0051] When the drug capsule container 39 is properly disposed within the drug supply holder 100 (as shown in FIG. 4), the holder safety mechanism 120 moves the release key 88 in the proximal direction, overcoming the release spring 86. Thereby, the release lock 84 overcomes the release lock spring 82 and moves inwardly, thus removing the interaction between the actuating grip 42 and the release lock 84, whereby in this configuration, the actuating grip 42 can be actuated (e.g., rotated). Thus, when the drug capsule container 39 is properly disposed within the drug supply holder 100, the drug capsule can be actuated, but in this embodiment, it is not automatically actuated until the actuating grip 42 is actuated separately.

[0052] In some embodiments, the drug capsule actuator 40 is disposed partially or fully on the drug supply holder 100 rather than being shown fully on the drug capsule container 39.

[0053] The actuating device consists of a drug capsule actuator 40, an actuating gripping part 42, an actuating pin 44, and a piercing pin 48. To activate drug supply, in this embodiment, the user holds the actuating gripping part 42 and rotates it relative to the drug capsule body 50. Thereby, the actuating pin 44 pierces a pressure cylinder 66 which is held in place by a pressure cylinder holder 64 and a capsule upper part 60, and then releases pressurized gas into a bellows 68 which is held in place by a bellows holder 67 and an actuating housing bottom 62. When the gas expands, first, the main container 70 overcomes the reaction force from the retraction spring 92 and moves distally, the patient needle 76 completely pierces the needle septum 96, and subsequently pierces the patient. In the embodiment, the needle septum 96 is a reusable sterile barrier.

[0054] When the distal movement stops due to the interaction between the main container 70 and the capsule bottom 90, the pressure released into the bellows 68 moves the piston 72 distally (as shown in FIG. 4), thus increasing the pressure in the injection chamber 74, and thus injecting the drug solution into the patient through the patient needle 76 which communicates with the injection chamber 74. When sufficient drug solution has been injected into the patient, the piercing needle 69 is in a position to pierce the bellows 68. This releases the pressurized gas in the bellows and then moves the main container 70 proximally due to the non-opposing force of the retraction spring 92. Thereby, the patient needle 76 retreats again past the needle septum 96 and enters the capsule bottom 90.

[0055] Although not shown in the embodiment, there is a second mechanism to ensure automatic retraction even if the needle path is blocked and the drug solution is not completely injected into the patient. This is a time-based mechanism for automatic retraction and is caused by a steady leakage of gas from the bellows 68.

[0056] Turning now to FIG. 5, some embodiments of the present disclosure are shown. In this embodiment, when the drug capsule container 39 is pre-activated (see, e.g., FIG. 4), the patient needle 76 fully and permanently retracts back into the container 39. This provides the advantage of the drug capsule container 39 functioning as a sharp container for its own needle and also ensures that the needle cannot be used a second time (e.g., on a different patient). In an embodiment, this occurs because the pressure cylinder 66 is fully discharged, the bellows 68 is punctured, the injection chamber 74 is locked in the folded position, and / or another mechanism causes the same result. In an embodiment, the capsule container 39 further has a visual indicator that can be seen by the user indicating whether the capsule container has already been activated. In an embodiment, the visual indicator is the observation window 54 through which the user can visualize the contents of the main container 70. In some embodiments, the visual indicator is one or more separate entities indicating past activation (e.g., a flag within the window, a permanent change in the structure). One advantage of this system is that once used and retracted, the system ensures that the drug capsule cannot be reused (e.g., on a different patient) or cause a sharp injury (i.e., the needle is fully contained within the device).

[0057] In this specification, various embodiments of systems, devices, and methods have been described. These embodiments are given by way of example only and are not intended to limit the scope of the present disclosure. Furthermore, it should be understood that the various features of the described embodiments can be combined in various ways to generate a number of additional embodiments. Additionally, various materials, dimensions, shapes, configurations, and positions, etc. have been described for use with the disclosed embodiments, but other than those disclosed can be utilized without exceeding the scope of the present disclosure.

[0058] Those skilled in the art will recognize that the subject matter of this specification may include fewer features than shown in any of the individual embodiments described above. The embodiments described herein are not meant to be an exhaustive presentation of all the ways in which the various features of the subject matter of this specification can be combined. Thus, the embodiments are not mutually exclusive combinations of features; rather, the various aspects can include combinations of different individual features selected from different individual embodiments, as will be understood by those skilled in the art. Further, elements described with respect to one embodiment can, unless otherwise stated, be practiced in other embodiments even if not described in such embodiments.

[0059] Dependent claims can refer in a claim to a particular combination with one or more other claims, but other embodiments can also include combinations of a dependent claim with the subject matter of other dependent claims, or combinations of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a particular combination is not intended.

[0060] Any incorporation by reference of the above documents is limited so that no subject matter that is contrary to the explicit disclosure of this specification is incorporated. Any incorporation by reference of the above documents is further limited so that the claims contained in such documents are not incorporated by reference into this specification. Any incorporation by reference of the above documents is further limited so that any definitions provided in such documents are not incorporated by reference into this specification unless explicitly included herein.

[0061] It is expressly intended that, unless the specific terms "means for" or "step for" are recited in a claim, the provisions of 35 U.S.C. § 112(f) shall not apply in the interpretation of the claims.

Claims

1. 1. An improved auto-injector assembly comprising: a drug capsule containing at least one therapeutic agent stored in dry form, the drug capsule having a drug capsule cap containing a fluid diluent stored separately from the therapeutic agent in dry form; a drug supply holder configured to be placed on a patient's body, the drug supply holder having one or more capsule receiving areas configured to receive one or more drug capsules; The drug capsule is configured to selectively mix the fluid diluent with the therapeutic agent in dry form to form a mixture configured to be injected into the body of the patient.

2. 10. The improved automatic injector assembly of claim 1, wherein said medication capsule includes an injection chamber and said fluid diluent is mixed with said therapeutic agent in dry form.

3. 3. The improved automatic injector assembly of claim 2, wherein said medication capsule includes one or more observation windows that allow a user to view at least a portion of said injection chamber from outside said medication capsule.

4. 4. An improved automatic injector assembly according to claim 2 or 3, wherein said therapeutic agent in dry form is initially stored in said injection chamber.

5. 10. The drug capsule of claim 1, further comprising a drug capsule body containing the therapeutic agent in dry form, a piston, an injection chamber in which the fluid diluent is mixed with the therapeutic agent in dry form, and a patient needle in fluid communication with the injection chamber.

6. 6. The improved auto-injector assembly according to any one of claims 1 to 3 or 5, wherein said drug capsule delivers a single dose of said mixture as a bolus dose to an intradermal, subcutaneous, intramuscular and / or intravenous portion of the patient's body.

7. 6. An improved automatic injector assembly according to any one of claims 1 to 3 or 5, wherein the drug capsule further comprises an automatic injector drug delivery mechanism configured to inject the mixture into the body of a user, and a drug capsule actuator configured to be actuated by a user to cause the automatic injector drug delivery mechanism to inject the mixture into the body of the patient.

8. 8. The improved automatic injector assembly of claim 7, wherein the drug capsule further includes an actuator release mechanism that ensures that the drug capsule actuator can only be actuated when the drug capsule is received in the one or more capsule receiving areas of the drug supply holder.

9. 6. An improved automatic injector assembly according to any one of claims 1 to 3 or 5, wherein the drug capsule further comprises one or more drug information regions providing capsule-specific drug information.

10. 6. An improved automatic injector assembly according to any one of claims 1 to 3 or 5, wherein the drug supply holder further comprises one or more patient fixation mechanisms which assist in adhering the drug supply holder to the patient.

11. 1. An improved auto-injector assembly comprising: a drug capsule containing at least one therapeutic agent, the drug capsule including: an automatic injector drug delivery mechanism configured to inject the at least one therapeutic agent into a patient's body; and a drug capsule actuator configured to be actuated by a user, the drug capsule actuator causing the automatic injector drug delivery mechanism to inject the at least one therapeutic agent into a patient's body; a medication supply holder configured to be placed on a patient's body, the medication supply holder including one or more capsule receiving areas configured to receive one or more medication capsules; The improved automatic injector assembly, wherein the drug capsule further includes an actuator release mechanism that ensures that the drug capsule actuator is activated only when the drug capsule is received within one or more capsule receiving areas of the drug supply holder.

12. 12. The improved automatic injector assembly of claim 11, wherein said at least one therapeutic agent is initially stored within said medication capsule in a dry form.

13. 13. The improved automatic injector assembly of claim 12, wherein the drug capsule has a drug capsule cap containing a fluid diluent stored separately from the therapeutic agent in dry form, the drug capsule being configured to selectively mix the fluid diluent with the therapeutic agent in dry form to form a mixture such that the at least one therapeutic agent is injected into the patient's body along with the mixture.

14. 14. The improved automatic injector assembly of claim 13, wherein said medication capsule includes an injection chamber in which said fluid diluent is mixed with said therapeutic agent in dry form.

15. 15. The improved automatic injector assembly of claim 14, wherein the medication capsule includes one or more observation windows that allow the user to view at least a portion of the injection chamber from outside the medication capsule.

16. 15. The improved automatic injector assembly of claim 14, wherein said therapeutic agent in a dry form is initially stored in said injection chamber.

17. 14. The drug capsule of claim 12 or 13, further comprising a drug capsule body containing the therapeutic agent in a dry form, a piston, an injection chamber in which a fluid diluent is mixed with the therapeutic agent in a dry form, and a patient needle in fluid communication with the injection chamber.

18. 17. An improved automatic injector assembly according to any one of claims 11 to 16, wherein the drug capsule further comprises one or more drug information regions providing capsule-specific drug information.

19. 17. The improved automatic injector assembly of any one of claims 11 to 16, wherein the drug supply holder further comprises one or more patient fixation mechanisms that assist in adhering the drug supply holder to the patient.

20. 17. The improved auto-injector assembly of any one of claims 11 to 16, wherein the drug capsule delivers a single dose of therapeutic drug as a bolus injection into intradermal, subcutaneous, intramuscular and / or intravenous parts of the patient's body.

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