Drug delivery device, manufacturing method, and method of use

Abstract

To provide a prefilled delivery device which can be filled with a suitable drug solution prior to use.SOLUTION: A wearable drug delivery device 9610 includes a container filled at least partially with a drug including at least one of a PCSK9 (proprotein convertase subtilisin / kexin type 9) specific antibody, a granulocyte colony-stimulating factor (G-CSF), a sclerostin antibody, and a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device 9610 includes a needle and an insertion mechanism 96200 configured to insert the needle into a patient. A fluid pathway connector defines a sterile fluid flowpath between the container and the insertion mechanism 96200. In addition, a cannula initially disposed about the needle is included. The cannula may be retained in the patient at an injection site created by the needle after the needle is withdrawn from the patient.SELECTED DRAWING: Figure 115A

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of priority of each of U.S. Provisional Patent Application No. 62 / 320,438, filed on April 8, 2016, and International Patent Application No. PCT / US2017 / 017627, filed on February 13, 2017. The entire contents of each of the foregoing applications are hereby expressly incorporated by reference herein for all purposes.

[0002] The present disclosure generally relates to drug delivery devices, and more particularly to drug delivery devices that can be worn by a patient while the drug delivery device delivers a drug to the patient.

Background Art

[0003] The parenteral delivery of various drugs, that is, delivery by means other than passing through the digestive tract, has become a desired method of drug delivery for several reasons. This form of drug delivery by injection can increase the effect of the substance being delivered and ensure that an unchanged pharmaceutical reaches its intended site at a high concentration. Similarly, unwanted side effects associated with other delivery routes, such as systemic toxicity, can potentially be avoided by parenteral delivery. By bypassing the digestive system of mammalian patients, the degradation of the active ingredient caused by catalytic enzymes in the digestive tract and the liver can be avoided, and the required amount of the drug can be ensured to reach the target site at the desired concentration.

[0004] Traditionally, manually operated syringes and injection pens have been used to deliver parenteral drugs to patients. More recently, parenteral delivery of liquid drugs into the body has been achieved by sequentially administering bolus injections using needles and reservoirs via gravity-driven dispensers, or through transdermal patch technology. Bolus injections often do not fully match the clinical needs of patients and usually require individual doses higher than the desired dose at the specific time they are given. Sequential delivery of drugs by gravity-fed systems interferes with patients' mobility and lifestyle and limits treatment to an overly simplified flow rate and profile. Transdermal patches, another form of drug delivery, have similar limitations. Transdermal patches often require specific molecular drug structures for efficacy, and the control of drug administration through transdermal patches is significantly limited.

[0005] Portable infusion pumps have been developed for delivering liquid medications to patients. These infusion devices have the ability to provide a precise fluid delivery profile, achieving bolus requirements, continuous infusion, and delivery at variable flow rates. The performance of these infusions typically results in better efficacy and less toxicity of drugs and therapies to the patient's system. Currently available portable infusion devices are expensive, difficult to program and prepare for infusion, bulky, heavy, and tend to be very fragile. Filling these devices can be difficult and requires the patient to carry both the medication of the intent and the filling accessories. Devices often require special care, maintenance, and cleaning to ensure proper functionality and safety for their intended long-term use, making them cost-ineffective for patients or healthcare workers.

[0006] Compared to syringes and injection pens, pump-type delivery devices can be far more convenient for patients because the drug dose can be calculated and automatically delivered to the patient at any time, day or night. Furthermore, when used in conjunction with metabolic sensors or monitors, the pump can be automatically controlled to provide the appropriate dose of the fluid medium at the appropriate time, based on the sensed or monitored metabolic level. As a result, pump-type delivery devices have become an important aspect of modern medical treatment for various types of medical conditions, such as diabetes.

[0007] While pump-type delivery systems have been used to address some patient needs, manually operated syringes and injection pens often remain the preferred option for drug delivery because they now offer integrated safety features and are easily readable to identify the status of drug delivery and the completion of dose dispensing. However, manually operated syringes and injection pens are not universally applicable and are not preferable for the delivery of all drugs. There is still a need for a precise, reliable, and adjustable (and / or programmable) infusion system that can offer clinicians and patients a small, low-cost, lightweight, and simple-to-use alternative for parenteral delivery of liquid medications.

[0008] There is a strong market demand for drug delivery devices that are easy to use, cost-effective, and include integrated safety features. However, the manufacture of such devices can be cost-intensive, resulting in higher costs for patients. A significant portion of the manufacturing cost can be attributed to the need to maintain a sterile fluid passage from the drug container to the needle before the drug is delivered to the patient. Some commercially available products attempt to maintain the sterility of the device by manufacturing the components in a non-sterile environment and then sterilizing the entire device. A recognized drawback of this process is that, since most pharmaceutical compounds cannot withstand the device sterilization process, the drug container must be filled separately after device sterilization but before drug injection. Alternatively, drug delivery devices may be manufactured as pre-filled devices, which are aseptically filled with the drug during assembly. Such a manufacturing process can be costly because the entire process must be maintained in a sterile environment, and the filling and assembly lines must be specially adapted for the device. This, therefore, adds substantial operating costs to pharmaceutical companies and contract drug fillers.

[0009] Drug delivery devices are generally manufactured by molding or shaping various components and then assembling those components. Devices produced through the assembly process and other processing operations typically then must be cleaned to remove any fine particles adhering to the surface in order to meet the hygiene standards for drug delivery devices. After cleaning, conventional drug delivery devices are packaged and sterilized. Such delivery devices have been classified into several general types. The first type is assembled and placed in sterile packaging, which may be shipped together with vials or ampoules of the drug or other injectable solution. The delivery device is filled with the drug or other solution at the time of use and injected into the patient. These devices have the disadvantages of adding time and the difficulty of filling the device at the time of use, increasing the risk of contamination of the delivery device and / or drug solution, and also increasing the possibility of accidental drug spillage. There is an additional risk that glass particles from the ampoule may contaminate the drug solution when the ampoule is opened. Furthermore, healthcare personnel and / or patients may require training to ensure that the device is properly filled.

[0010] Some of these drawbacks can be overcome by providing pre-filled delivery devices that can be filled with a suitable drug solution before use. A pre-filled delivery device is a device that is filled by a drug manufacturer and shipped to healthcare workers or self-administering patients in a ready-to-use state, as the term is known in the art. Vials or ampoules are generally made of glass or other transparent material that does not interfere with the stability of the drug during long-term storage. Pre-filled delivery devices have the advantage of being convenient and easy to apply, as well as having a reduced risk of drug contamination. Pre-filled drug delivery devices are generally assembled and packaged in a clean room to maintain an appropriate level of hygiene. The clean room is equipped with a large-scale filter assembly and air conditioning system to remove particulate matter and pyrothermic particles from the air in the room and to prevent particulate matter and pyrothermic particles from entering the room. Operators and other personnel in the clean room are required to wear appropriate protective clothing to reduce contamination of the air and the drug delivery devices being manufactured or assembled. The risk of contamination by and introduction of exogenous particulate matter and pyrothermic particles increases when people and equipment enter and exit a clean room. Various operations can be performed to form clean and sterile drug delivery devices. However, subsequent handling, filling, and printing of drug delivery devices can contaminate them. Therefore, it is necessary to clean and sterilize such conventional drug delivery devices before use. Consequently, there is a continuous need in the industry for improved systems for manufacturing, assembling, and filling clean and sterile medical devices. [Overview of the project]

[0011] One aspect of the present disclosure provides a wearable drug delivery device comprising a main housing, a container, a drug, a window, a trocar or guide needle, a cannula, a drive mechanism, an insertion mechanism, a fluid passage connector, a button, and a trigger assembly. The container may be located within the main housing. The container may include a barrel, a plunger seal movable through the barrel, and a first perforated seal controlling access to the inside of the barrel. The drug may be located within the barrel. The drug may include at least one of the following: a proprotein convertase subtilisin / kexin type 9 (PCSK9) specific antibody, granulocyte colony-stimulating factor (G-CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The trocar or guide needle may have a proximal and distal end. The cannula may be initially positioned surrounding the distal end of the trocar or guide needle. The drive mechanism may be located within the main housing. The drive mechanism may include a drive housing, a piston movable relative to the drive housing and configured to impart movement to the plunger seal, a gear assembly, an electric actuator, a gear interface, a piston biasing member, and a tether. The gear interface may be rotatable by the electric actuator. Rotation of the gear interface may allow the gear interface to selectively engage with the gear assembly to prevent or allow rotation of the gear assembly. A piston biasing member may be positioned between the drive housing and the piston. The piston biasing member may be initially held in a biased state. The piston biasing member may be configured to move the piston as the piston biasing member is released. A tether may be connected to the gear assembly and the piston at opposite ends. The tether may initially hold the piston biasing member in a biased state. Rotation of the gear assembly may cause slack in the tether, allowing the piston biasing member to be released. A fluid passage connector can define the flow path of sterile fluid between the container and the insertion mechanism. The fluid passage connector may include a tubular conduit, a container access needle, and a connecting hub. The tubular conduit may have a first end and a second end. The second end of the tubular conduit may be in fluid communication with the hollow interior of the cannula during drug delivery.The container access needle may be configured to penetrate a first perforable seal to establish fluid communication between the barrel and the tubular conduit during drug delivery. A connecting hub may be connected to the container access needle and the first end of the tubular conduit. The connecting hub may provide fluid communication between the container access needle and the tubular conduit during drug delivery. The insertion mechanism may be located within the main housing. The insertion biasing mechanism may include a base, an insertion mechanism housing rotatable relative to the base, a rotational biasing member connected to the insertion mechanism housing, a first retainer, a hub, a retraction biasing member, and a second retainer. The rotational biasing member may be initially held in a biased state. The rotational biasing member may be configured to rotate the insertion mechanism housing as the rotational biasing member is released. The first retainer may be movable between (i) a holding position of the first retainer in which the first retainer holds the rotational biasing member in a biased state and (ii) a release position of the first retainer in which the first retainer allows the rotational biasing member to be released. The hub may be connected to the proximal end of the trocar or guide needle and may be configured to move parallel to the insertion mechanism housing. A retraction biasing member may be positioned between the hub and the base. The retraction biasing member may have a biased state. The retraction biasing member may be configured to move the hub proximal as the retraction biasing member is released. The second retainer may be movable between (i) a retaining position in which the second retainer holds the retraction bias member in a biased state and (ii) a release position in which the second retainer allows the bias of the retraction bias member to be released. The button may protrude from the main housing and be manually displaced by the user. The trigger assembly may be configured to move the first retainer from the retaining position to the release position in response to the displacement of the button by the user.

[0012] Another aspect of the present disclosure provides a wearable drug delivery device comprising a container, a drug placed within the container, a trocar or guide needle, a patient-operated actuator, an insertion mechanism, a fluid passage connector, a locking assembly, and a selector. The drug may comprise at least one of the following: a proprotein convertase subtilisin / kexin type 9 (PCSK9) specific antibody, granulocyte colony-stimulating factor (G-CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The insertion mechanism may be configured to move the trocar or guide needle between a retracted position and an insertion position, and the insertion mechanism may comprise a rotatable housing and a rotatable bias member initially held in a biased state. A fluid passage connector may define a flow path for sterile fluid between the container and the insertion mechanism. The locking assembly may have (i) a locking configuration in which the locking assembly engages with the rotatable housing to prevent rotation of the rotatable housing, and (ii) a release configuration in which the locking assembly engages with the rotatable housing to allow rotation of the rotatable housing. The selector may have a first configuration in which (i) the selector operationally separates the actuator and the locking assembly, and a second configuration in which the selector operationally connects the actuator and the locking assembly, allowing the actuator to change the locking assembly from a locked configuration to an unlocked configuration.

[0013] This disclosure will be better understood in conjunction with the accompanying drawings. Some of the drawings may be simplified by omitting selected elements for the purpose of more clearly illustrating other elements. Such omissions of elements in some drawings do not necessarily indicate the presence or absence of a particular element in any of the exemplary embodiments, unless explicitly shown in the corresponding description. Furthermore, none of the drawings are necessarily to scale. [Brief explanation of the drawing]

[0014] [Figure 1A] An isometric view of a drug delivery pump with an integrated safety insertion mechanism according to one embodiment of the present invention is shown. [Figure 1B] Figure 1A shows an isometric view of the internal components of the drug delivery pump. [Figure 1C] Figure 1A shows an isometric view of the bottom of the drug delivery pump. [Figure 2A] This shows an isometric view of the internal components of a second embodiment of a drug delivery device. [Figure 2B] A second diagram of the internal components of the drug delivery device shown in Figure 2A is provided. [Figure 3A] This is an isometric view of an embodiment of a fluid passage connection assembly and a drug container in an uninstalled configuration. [Figure 3B] This is an isometric view of the embodiment shown in Figure 3A, which is installed but not activated. [Figure 4A] An exploded view of a fluid passage connection assembly according to at least one embodiment of the present invention is shown. [Figure 4B] Figure 4A shows a cross-sectional view of the disassembled fluid passage connection assembly. [Figure 5A] This is a cross-sectional side view of an embodiment of a fluid passage connection assembly and a drug container in an installed but not activated configuration. [Figure 5B] Figure 5A is an enlarged partial cross-sectional side view of the embodiment shown. [Figure 6A] Figure 4A is a cross-sectional side view of an embodiment of the fluid passage connection assembly and drug container in the activated configuration. [Figure 6B] This is an enlarged partial cross-sectional side view of the embodiment shown in Figure 6A. [Figure 7A] These are cross-sectional side views of embodiments of the fluid passage connection assembly and drug container shown in Figures 4A and 6A, which are part of the delivery configuration. [Figure 7B] This is an enlarged partial cross-sectional side view of the embodiment shown in Figure 7A. [Figure 8] An isometric view of a connection hub according to at least one embodiment of the present invention is shown. [Figure 9] An isometric view of a plate according to at least one embodiment of the present invention is shown. [Figure 10]An isometric view of an embodiment of a piercing member retainer according to at least one embodiment of the present invention is shown. [Figure 11] An isometric view of an embodiment of an induction member retainer according to at least one embodiment of the present invention is shown. [Figure 12A] An isometric view of a second embodiment of a fluid passage connection assembly and a drug container in an uninstalled configuration. [Figure 12B] An isometric view of the embodiment shown in FIG. 12A in a installed but unactivated configuration. [Figure 13A] A cross-sectional side view of an embodiment of a fluid passage connection assembly and a drug container of FIGS. 11A-1IB in a installed but unactivated configuration. [Figure 13B] An enlarged partial cross-sectional side view of the embodiment shown in FIG. 13A. [Figure 14A] A cross-sectional side view of an embodiment of a fluid passage connection assembly and a drug container of FIG. 12A in an activated configuration. [Figure 14B] An enlarged partial cross-sectional side view of the embodiment shown in FIG. 14A. [Figure 15A] A cross-sectional side view of an embodiment of a fluid passage connection assembly and a drug container of FIGS. 12A and 13A in a delivery configuration. [Figure 15B] An enlarged partial cross-sectional side view of the embodiment shown in FIG. 15A. [Figure 16A] A further isometric view of a fluid passage connection assembly and a container of FIGS. 12A-12B in a installed but unactivated configuration. [Figure 16B] An enlarged partial isometric view of the fluid passage connection assembly of FIG. 16A. [Figure 17A] A further isometric view of a fluid passage connection assembly and a container of FIGS. 12A-12B in an activated configuration. [Figure 17B] An enlarged partial isometric view of the fluid passage connection assembly of FIG. 17A. [Figure 18A] A further isometric view of a fluid passage connection assembly and a container of FIGS. 12A-12B in a delivery configuration. [Figure 18B] Figure 18A is an isometric view of an enlarged portion of the fluid passage connection assembly. [Figure 19A] Figure 18A is a side view of the fluid passage connection assembly and the bottom of the container. [Figure 19B] Figure 19A is an isometric view of an enlarged portion of the fluid passage connection assembly and drug container. [Figure 20] An isometric view of a connection hub according to at least one embodiment of the present invention is shown. [Figure 21] This shows an isometric view of an embodiment of a guide member holder according to at least one embodiment of the present invention. [Figure 22] This shows an isometric view of an embodiment of a penetrating member holder according to at least one embodiment of the present invention. [Figure 23] An isometric exploded view of a fluid passage connection assembly according to at least one embodiment of the present invention is shown. [Figure 24A] Figure 23 shows an isometric view of the fluid passage connection assembly and drug container in an uninstalled configuration. [Figure 24B] Figure 24A is an isometric view of the fluid passage connection assembly and drug container in an installed but not activated configuration. [Figure 24C] Figure 24B is an isometric view of the fluid passage connection assembly and drug container in the activated configuration. [Figure 24D] Figures 24B-24C are isometric views of the fluid passage connection assembly and drug container in the delivery configuration. [Figure 25A] Figure 24B is a cross-sectional side view of the fluid passage connection assembly and drug container in an installed but not activated configuration. [Figure 25B] Figure 25A is an enlarged partial cross-sectional side view of the embodiment shown. [Figure 26A] Figure 24B is a cross-sectional side view of an embodiment of the fluid passage connection assembly and drug container in the activated configuration. [Figure 26B] Figure 26A is an enlarged partial cross-sectional side view of the embodiment shown. [Figure 27A]Figures 25A and 26A are cross-sectional side views of embodiments of the fluid passage connection assembly and drug container in the delivery configuration. [Figure 27B] This is an enlarged partial cross-sectional side view of the embodiment shown in Figure 27A. [Figure 28] An isometric view of a connection hub according to at least one embodiment of the present invention is shown. [Figure 29] A side elevation view of an embodiment of a guide member holder according to at least one embodiment of the present invention is shown. [Figure 30] This shows an isometric view of an embodiment of a penetrating member holder according to at least one embodiment of the present invention. [Figure 31] Figures 23-27B show partial isometric views of the internal components of a drug delivery pump incorporating the fluid passage connection assembly. [Figure 32A] This is an isometric view of a fluid passage connection assembly and a portion of a drug container according to at least one embodiment of the present invention, during fluid connection. [Figure 32B] Figure 32A is a partial isometric view of the fluid passage connection assembly and drug container when separated. [Figure 33A] An isometric view of the internal components of a drug delivery device having a multifunctional drive mechanism according to one embodiment of the present disclosure is shown (without adhesive patches). [Figure 33B] Figure 33A shows an isometric view of the internal components of the drug delivery device from a different perspective (shown without adhesive patches). [Figure 33C] Furthermore, an isometric view of the internal components of the drug delivery device shown in Figure 33A is presented from a different perspective (shown without adhesive patches). [Figure 34A] This is an isometric view of an embodiment of a flow path connection assembly and a drug container in an uninstalled configuration. [Figure 34B] This is an isometric view of the embodiment shown in Figure 34A, in its installed configuration. [Figure 34C] This is a cross-sectional isometric view of the embodiment shown in Figure 34A, in its installed configuration. [Figure 35A]This is an isometric view of an embodiment of a flow path connection assembly and a drug container in an uninstalled configuration. [Figure 35B] This is an isometric view of the embodiment shown in Figure 35A, in its installed configuration. [Figure 35C] This is a cross-sectional isometric view of the embodiment shown in Figure 35A, in its installed configuration. [Figure 35D] This is an isometric cross-sectional view of the embodiment shown in Figure 35A after the flow path has been connected. [Figure 36A] This is a cross-sectional side view of an embodiment of a flow path connection assembly and drug container in an installed configuration. [Figure 36B] This is a cross-sectional side view of the embodiment shown in Figure 36A, after the first and second films have been punctured. [Figure 36C] This is a cross-sectional side view of the embodiment shown in Figure 36A, after the external piercing member has retracted. [Figure 36D] This is a cross-sectional side view of the embodiment shown in Figure 36A after the flow path has been connected. [Figure 37A] This is a cross-sectional side view of an embodiment of a flow path connection mechanism and a drug container in an uninstalled configuration. [Figure 37B] This is a cross-sectional side view of the embodiment shown in Figure 37A, after the first and second films have been punctured by the external puncturing member. [Figure 37C] This is a cross-sectional side view of the embodiment shown in Figure 37A after the flow path has been connected. [Figure 38A] This is a cross-sectional side view of an embodiment of a flow path connection mechanism and a drug container in an uninstalled configuration. [Figure 38B] This is a cross-sectional side view of the embodiment shown in Figure 38A, in its installed configuration. [Figure 38C] This is a cross-sectional side view of the embodiment shown in Figure 38A, after the first and second films have been punctured by the external puncturing member. [Figure 38D] This is a cross-sectional side view of the embodiment shown in Figure 38A after the flow path has been connected. [Figure 39A]This is a cross-sectional side view of an embodiment of a flow path connection mechanism and drug container in an installed configuration. [Figure 39B] This is a cross-sectional side view of the embodiment shown in Figure 39A after the flow path has been connected. [Figure 40A] This is a cross-sectional side view of an embodiment of a flow path connection mechanism and a drug container in an uninstalled configuration. [Figure 40B] This is a cross-sectional side view of the embodiment shown in Figure 40A, in its installed configuration. [Figure 40C] This is a cross-sectional side view of the embodiment shown in Figure 40A after the flow path has been connected. [Figure 41A] This is a cross-sectional side view of an embodiment of a flow path connection mechanism and a drug container in an uninstalled configuration. [Figure 41B] This is a cross-sectional side view of the embodiment shown in Figure 41A, in its installed configuration. [Figure 41C] This is a cross-sectional side view of the embodiment shown in Figure 41A during UV sterilization. [Figure 41D] This is a cross-sectional side view of the embodiment shown in Figure 41A after the flow path has been connected. [Figure 42] This shows a flow path connection according to at least one embodiment of the present disclosure. [Figure 43] An isometric view of a drug container according to at least one embodiment of the present disclosure is shown. [Figure 44] An isometric view of a drug container and a fluid passage connection according to at least one embodiment of the present disclosure is shown. [Figure 45A] Figure 44 shows an isometric view of the drug container and fluid passage connection in a configuration that is not yet installed. [Figure 45B] Figure 44 shows a cross-sectional isometric view of the drug container and fluid passage connection in the initial installation configuration. [Figure 45C] Figure 44 shows an isometric cross-sectional view of the drug container and fluid passage connection section in the intermediate installation configuration. [Figure 45D] Figure 44 shows an isometric cross-sectional view of the drug container and fluid passage connection in the installed configuration. [Figure 46A]This shows an isometric view of an embodiment of a drug container and fluid passage connection in a configuration that is not yet installed. [Figure 46B] Figure 46A shows an isometric cross-sectional view of the drug container and fluid passage connection in the installed configuration. [Figure 47] A detailed cross-sectional view of a fluid passage connection according to at least one embodiment of the present disclosure is shown. [Figure 48] This shows a cross-sectional isometric view of an embodiment of a drug container and fluid passage connection in a configuration that is not yet installed. [Figure 49] This shows an isometric view of an embodiment of a drug container and fluid passage connection in a configuration that is not yet installed. [Figure 50] This shows a cross-sectional view of an embodiment of a drug container and fluid passage connection in a configuration that is not yet installed. [Figure 51] This shows a cross-sectional isometric view of an embodiment of a drug container and fluid passage connection in a configuration that is not yet installed. [Figure 52A] This shows an isometric view of an embodiment of a drug container and fluid passage connection in a configuration that is not yet installed. [Figure 52B] This shows an end view of a drug container. [Figure 52C] This shows a cross-sectional view of the drug container and fluid passage connection in an uninstalled configuration. [Figure 52D] This shows a cross-sectional view of the drug container and fluid passage connection in a connected configuration. [Figure 53A] This is an isometric view of an integrated sterilization fluid passage connection and drug container according to one embodiment. [Figure 53B] Figure 53A shows an isometric cross-sectional view of the integrated sterilization fluid passage connection and drug container. [Figure 54A] This is an exploded side view of the components of an embodiment of an integrated sterilization fluid passage connection and drug container. [Figure 54B] Figure 54A is a cross-sectional exploded view of the embodiment. [Figure 55A] Figure 53A is a cross-sectional view of the integrated sterile fluid passage connection and drug container, as shown, before operation by the user. [Figure 55B] This is a cross-sectional view of an embodiment in which fluid passages are connected. [Figure 55C] This is a cross-sectional view of an embodiment showing the end of drug delivery. [Figure 56A] This is an isometric perspective view of an integrated sterilization fluid passage connection according to one embodiment of the present invention. [Figure 56B] Figure 56A is an exploded perspective view of the components of the integrated sterilization fluid passage connection shown. [Figure 57A] This is a cross-sectional view of an embodiment of an integrated sterile fluid passage connection unit having a piercing member guide and a drug container, before operation by the user. [Figure 57B] Figure 57A shows an isometric perspective view of the perforating member guide and the perforating member according to the embodiment shown. [Figure 57C] Figure 57A is an isometric view of the piercing member guide, piercing member, and connector hub of the embodiment. [Figure 58] This is a cross-sectional view of an integrated sterile fluid passage connector and drug container according to one embodiment, before operation by the user, in which the drug container has one or more drug chambers, each drug chamber being separated from the next by a perforable membrane. [Figure 59A] This is a cross-sectional view of an embodiment of a sterile fluid connector in which a perforable seal is configured to maintain different positions within the connector in response to air pressure and / or hydraulic pressure. [Figure 59B] This is a cross-sectional view of an embodiment of a sterile fluid connector in which a perforable seal is configured to maintain different positions within the connector in response to air pressure and / or hydraulic pressure. [Figure 59C] This is a cross-sectional view of an embodiment of a sterile fluid connector in which a perforable seal is configured to maintain different positions within the connector in response to air pressure and / or hydraulic pressure. [Figure 59D] This is a cross-sectional view of an embodiment of a sterile fluid connector in which a perforable seal is configured to maintain different positions within the connector in response to air pressure and / or hydraulic pressure. [Figure 59E]This is a cross-sectional view of an embodiment of a sterile fluid connector in which a perforable seal is configured to maintain different positions within the connector in response to air pressure and / or hydraulic pressure. [Figure 60A] This is a cross-sectional view of an embodiment of a sterile fluid connector in which a perforable seal engages with or disengages from a sensor mechanism capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector in response to air pressure and / or hydraulic pressure. [Figure 60B] This is a cross-sectional view of an embodiment of a sterile fluid connector in which a perforable seal engages with or disengages from a sensor mechanism capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector in response to air pressure and / or hydraulic pressure. [Figure 60C] This is a cross-sectional view of an embodiment of a sterile fluid connector in which a perforable seal engages with or disengages from a sensor mechanism capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector in response to air pressure and / or hydraulic pressure. [Figure 60D] This is a cross-sectional view of an embodiment of a sterile fluid connector in which a perforable seal engages with or disengages from a sensor mechanism capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector in response to air pressure and / or hydraulic pressure. [Figure 60E] This is a cross-sectional view of an embodiment of a sterile fluid connector in which a perforable seal engages with or disengages from a sensor mechanism capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector in response to air pressure and / or hydraulic pressure. [Figure 60F] This is a cross-sectional view of an embodiment of a sterile fluid connector in which a perforable seal engages with or disengages from a sensor mechanism capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector in response to air pressure and / or hydraulic pressure. [Figure 60G] This is a cross-sectional view of an embodiment of a sterile fluid connector in which a perforable seal engages with or disengages from a sensor mechanism capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector in response to air pressure and / or hydraulic pressure. [Figure 60H]This is a cross-sectional view of an embodiment of a sterile fluid connector in which a perforable seal engages with or disengages from a sensor mechanism capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector in response to air pressure and / or hydraulic pressure. [Figure 61A] Perspective and cross-sectional views of another embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector. [Figure 61B] Perspective and cross-sectional views of another embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector. [Figure 61C] Perspective and cross-sectional views of another embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector. [Figure 61D] Perspective and cross-sectional views of another embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector. [Figure 61E] Perspective and cross-sectional views of another embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector. [Figure 61F] Perspective and cross-sectional views of another embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector. [Figure 61G] Perspective and cross-sectional views of another embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector. [Figure 62A] These are cross-sectional and isometric views of another embodiment of a sterile fluid connector, which is capable of transmitting signals indicating the status of fluid transfer from a sterile fluid container to the connector, showing a more specific configuration of the sensors in the open and closed positions. [Figure 62B] These are cross-sectional and isometric views of another embodiment of a sterile fluid connector, which is capable of transmitting signals indicating the status of fluid transfer from a sterile fluid container to the connector, showing a more specific configuration of the sensors in the open and closed positions. [Figure 62C]These are cross-sectional and isometric views of another embodiment of a sterile fluid connector, which is capable of transmitting signals indicating the status of fluid transfer from a sterile fluid container to the connector, showing a more specific configuration of the sensors in the open and closed positions. [Figure 62D] These are cross-sectional and isometric views of another embodiment of a sterile fluid connector, which is capable of transmitting signals indicating the status of fluid transfer from a sterile fluid container to the connector, showing a more specific configuration of the sensors in the open and closed positions. [Figure 63A] These are cross-sectional and isometric views of an embodiment of a sterile fluid connector capable of transmitting signals indicating the status of fluid transfer from a sterile fluid container to the connector, illustrating the unpressurized (Figure 63B), pressurized (Figure 63C), and delivery completion (Figure 63D) positions of the components of the sterile fluid connector. [Figure 63B] These are cross-sectional and isometric views of an embodiment of a sterile fluid connector capable of transmitting signals indicating the status of fluid transfer from a sterile fluid container to the connector, illustrating the unpressurized (Figure 63B), pressurized (Figure 63C), and delivery completion (Figure 63D) positions of the components of the sterile fluid connector. [Figure 63C] These are cross-sectional and isometric views of an embodiment of a sterile fluid connector capable of transmitting signals indicating the status of fluid transfer from a sterile fluid container to the connector, illustrating the unpressurized (Figure 63B), pressurized (Figure 63C), and delivery completion (Figure 63D) positions of the components of the sterile fluid connector. [Figure 63D] These are cross-sectional and isometric views of an embodiment of a sterile fluid connector capable of transmitting signals indicating the status of fluid transfer from a sterile fluid container to the connector, illustrating the unpressurized (Figure 63B), pressurized (Figure 63C), and delivery completion (Figure 63D) positions of the components of the sterile fluid connector. [Figure 64A] Perspective and cross-sectional views of another embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector. [Figure 64B]Perspective and cross-sectional views of another embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector. [Figure 64C] Perspective and cross-sectional views of another embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector. [Figure 65A] This is a cross-sectional view of another embodiment of a sterile fluid connector, which is capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector. [Figure 65B] This is an isometric cross-sectional view of another embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector. [Figure 66A] This is an isometric cross-sectional view of another embodiment of a sterile fluid connector, in which a perforable seal comprising a conductive material or coating is capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector. [Figure 66B] This is an isometric cross-sectional view of another embodiment of a sterile fluid connector, in which a perforable seal comprising a conductive material or coating is capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector. [Figure 67] This is a cross-sectional isometric view of another embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector, the signal being mediated using a conductive elastomer film. [Figure 68] This is a cross-sectional isometric view of another embodiment of a sterile fluid connector, which is capable of transmitting a signal indicating the status of fluid transfer from a sterile fluid container to the connector, with the signal being mediated using a dome switch. [Figure 69A] An isometric view of the internal components of a drug delivery pump with a multi-functional drive mechanism according to one embodiment of the present invention is shown (shown without adhesive patches). [Figure 69B] Figure 69A shows an isometric view of the internal components of the drug delivery pump from a different perspective (shown without adhesive patches). [Figure 69C]Furthermore, an isometric view of the internal components of the drug delivery pump shown in Figure 69A is presented from a different perspective (shown without adhesive patches). [Figure 69D] Figure 69A shows a top view of the internal components of the drug delivery pump along axis "A". [Figure 70A] An isometric view of a multifunctional drive mechanism according to at least one embodiment of the present invention before operation is shown. [Figure 70B] This shows an isometric view of a multifunctional drive mechanism according to at least one embodiment of the present invention in operation. [Figure 70C] This shows an isometric view of a multifunctional drive mechanism according to at least one embodiment of the present invention at a later stage of operation. [Figure 70D] This shows an isometric view of a multifunctional drive mechanism according to at least one embodiment of the present invention, near or at the completion of drug delivery. [Figure 71A] Figure 71A shows top views corresponding to the operation steps shown in Figures 70A-70D, respectively. [Figure 71B] Figure 71B shows top views corresponding to the operating steps shown in Figures 70A-70D, respectively. [Figure 71C] Figure 71C shows top views corresponding to the operating steps shown in Figures 70A-70D, respectively. [Figure 71D] Figure 71D shows top views corresponding to the operating steps shown in Figures 70A-70D, respectively. [Figure 72] This shows a multifunctional drive mechanism according to at least one embodiment of the present invention, separated from the drug delivery device. [Figure 73A] Figure 72 shows the top and bottom views of the multi-functional drive mechanism, respectively. [Figure 73B] Figure 72 shows the top and bottom views of the multi-functional drive mechanism, respectively. [Figure 73C] Figure 72 shows the front and rear perspective views of the multi-functional drive mechanism, respectively. [Figure 73D] Figure 72 shows the front and rear perspective views of the multi-functional drive mechanism, respectively. [Figure 74A]A cross-sectional view of the drug container and safety mechanism in the initial, unrestricted configuration is shown. [Figure 74B] Figure 74A shows a cross-sectional view of the drug container and safety mechanism in the activated configuration. [Figure 75A] This shows an isometric view of a drug delivery pump in which the insertion mechanism includes a rotating deflection member. [Figure 75B] Figure 75A shows an enlarged view of the drive mechanism. [Figure 76A] This is an exemplary block diagram illustrating one embodiment of a power and control system for a drug delivery pump. [Figure 76B] This is an exemplary block diagram illustrating one embodiment of a drive control system for a drug delivery pump. [Figure 76C] This is an exemplary block diagram of one embodiment illustrating various control mechanisms of a drug delivery pump. [Figure 76D] This is an exemplary block diagram of another embodiment illustrating communication between an exemplary drug delivery pump device, an exemplary mobile device, an exemplary cloud server, and one or more exemplary sensors. [Figure 77A] This is a flowchart illustrating an embodiment illustrating a method of drug delivery using this drug delivery device based on one or more mechanisms. [Figure 77B] This is a flowchart illustrating an embodiment illustrating a method of drug delivery using this drug delivery device based on one or more mechanisms. [Figure 77C] This is a flowchart illustrating an embodiment illustrating a method of drug delivery using this drug delivery device based on one or more mechanisms. [Figure 78A] This is an exemplary block diagram illustrating one embodiment of a power and control system for a drug delivery pump. [Figure 78B] This is an exemplary block diagram illustrating one embodiment of a drive control system for a drug delivery pump. [Figure 78C] This is an exemplary block diagram of one embodiment illustrating various control mechanisms of a drug delivery pump. [Figure 79A]This is a flowchart illustrating an embodiment illustrating a method of drug delivery using this drug delivery device based on one or more mechanisms. [Figure 79B] This is a flowchart illustrating an embodiment illustrating a method of drug delivery using this drug delivery device based on one or more mechanisms. [Figure 80A] An isometric view of a drug delivery pump having a controlled delivery drive mechanism according to one embodiment of the present invention is shown. [Figure 80B] Figure 80A shows an isometric view of the internal components of the drug delivery pump (shown without adhesive patch). [Figure 80C] Figure 80A shows an isometric view of the bottom of the drug delivery pump (shown without adhesive patch). [Figure 81A] This shows an exploded view of the drive mechanism and drug container along axis "A" of one embodiment of the present invention. [Figure 81B] An exploded view of axis "B" of one embodiment of the present invention is shown (for clarity, the deflection member, covering sleeve, plunger seal, barrel, and cap are not shown). [Figure 82A] This shows an isometric view of a controlled delivery drive mechanism according to at least one embodiment of the present invention. [Figure 82B] An isometric view of a controlled delivery drive mechanism according to at least one embodiment of the present invention is shown (the piston is shown disassembled to illustrate the mounting of the tether). [Figure 83A] This shows an enlarged view of the escapement adjustment mechanism of a drive mechanism according to at least one embodiment of the present invention. [Figure 83B] This shows an enlarged view of the escapement adjustment mechanism of a drive mechanism according to at least one embodiment of the present invention. [Figure 83C] This shows an enlarged view of the escapement adjustment mechanism of a drive mechanism according to at least one embodiment of the present invention. [Figure 83D] Figures 83A-83C show the progress of the escapement adjustment mechanism according to the embodiment shown in operation. [Figure 83E] Figures 83A-83C show the progress of the escapement adjustment mechanism according to the embodiment shown in operation. [Figure 83F] Figures 83A-83C show the progress of the escapement adjustment mechanism according to the embodiment shown in operation. [Figure 83G] Figures 83A-83C show the progress of the escapement adjustment mechanism according to the embodiment shown in operation. [Figure 83H] Figures 83A-83C show the progress of the escapement adjustment mechanism according to the embodiment shown in operation. [Figure 84A] Figure 81 shows an isometric view of the drive mechanism and drug container in their initial deactivated state. [Figure 84B] Figure 81 shows an isometric view of the drive mechanism, which completes drug delivery. [Figure 85A] Figure 81 shows a cross-sectional view of the drive mechanism in its initial deactivated state. [Figure 85B] Figure 81 shows a cross-sectional view of the drive mechanism in an activated state that controls the rate or profile of drug delivery. [Figure 85C] Figure 81 shows a cross-sectional view of the drive mechanism, which allows the organization to complete drug delivery and optionally provide a final push through compliance to ensure the completion of drug delivery. [Figure 86A] An isometric view of a drug delivery pump having a controlled delivery drive mechanism according to one embodiment of the present invention is shown. [Figure 86B] Figure 86A shows an isometric view of the internal components of the drug delivery pump (shown without adhesive patch). [Figure 86C] Figure 86A shows an isometric view of the bottom of the drug delivery pump (shown without adhesive patch). [Figure 87] This shows an isometric view of a controlled delivery drive mechanism according to at least one embodiment of the present invention. [Figure 88] Figure 87 shows an exploded view of the drive mechanism along axis "A" (but excluding the plunger seal, barrel, and cap for clarity). [Figure 89A] Figure 87 shows an isometric view of the drive mechanism in its initial deactivated state. [Figure 89B] Figure 87 shows an isometric view of the drive mechanism in an activated state that controls the rate or profile of drug delivery. [Figure 89C] Figure 87 shows an isometric view of the drive mechanism, which completes drug delivery. [Figure 90A] Figure 89A shows a cross-sectional view of the drive mechanism in its initial deactivated state. [Figure 90B] Figure 89B shows a cross-sectional view of the drive mechanism in an activated state that controls the rate or profile of drug delivery. [Figure 90C] Figure 89C shows a cross-sectional view of the drive mechanism, which allows the organization to complete drug delivery and optionally provide a final push through compliance to ensure completion of drug delivery. [Figure 91] A perspective view of a drive mechanism incorporating an incremental status indicator according to a further embodiment of the present invention is shown. [Figure 92A] An isometric view of a drug delivery pump having a variable-speed controlled delivery drive mechanism according to one embodiment of the present invention is shown. [Figure 92B] Figure 92A shows an isometric view of the internal components of the drug delivery pump (shown without adhesive patch). [Figure 92C] Figure 92A shows an isometric view of the bottom of the drug delivery pump (shown without adhesive patch). [Figure 93] This shows an isometric view of a controlled delivery drive mechanism according to at least one embodiment of the present invention. [Figure 94A] Figure 93 shows a partially exploded view of the drive mechanism along axis "A". [Figure 94B] Figure 93 shows a complete exploded view of a specific component of the drive mechanism shown, along axis "A" and along the vertical axis "B". [Figure 95A] This shows an enlarged view of the escapement adjustment mechanism of a drive mechanism according to at least one embodiment of the present invention. [Figure 95B]This shows an enlarged view of the escapement adjustment mechanism of a drive mechanism according to at least one embodiment of the present invention. [Figure 95C] This shows an enlarged view of the escapement adjustment mechanism of a drive mechanism according to at least one embodiment of the present invention. [Figure 95D] Figures 95A-95C show the progress of the escapement adjustment mechanism according to the embodiment shown during operation. [Figure 95E] Figures 95A-95C show the progress of the escapement adjustment mechanism according to the embodiment shown during operation. [Figure 95F] Figures 95A-95C show the progress of the escapement adjustment mechanism according to the embodiment shown during operation. [Figure 95G] Figures 95A-95C show the progress of the escapement adjustment mechanism according to the embodiment shown during operation. [Figure 95H] Figures 95A-95C show the progress of the escapement adjustment mechanism according to the embodiment shown during operation. [Figure 96A] Figure 93 shows an isometric view of the drive mechanism in its initial deactivated state. [Figure 96B] Figure 93 shows an isometric view of the drive mechanism in an activated state that controls the rate or profile of drug delivery. [Figure 96C] Figure 93 shows an isometric view of the drive mechanism, which completes drug delivery. [Figure 97A] Figure 96A shows a cross-sectional view of the drive mechanism in its initial deactivated state. [Figure 97B] Figure 96B shows a cross-sectional view of the drive mechanism in an activated state that controls the rate or profile of drug delivery. [Figure 97C] Figure 96C shows a cross-sectional view of the drive mechanism, which allows the organization to complete drug delivery and optionally provide a final push through compliance to ensure the completion of drug delivery. [Figure 98] This shows an isometric view of a control delivery drive mechanism incorporating a status indicator, according to at least one embodiment of the present invention. [Figure 99] An isometric view of a controlled delivery drive mechanism according to another embodiment of the present invention is shown. [Figure 100A] An isometric view of a drug delivery pump having a variable-speed controlled delivery drive mechanism according to one embodiment of the present invention is shown. [Figure 100B] Figure 100A shows an isometric view of the internal components of the drug delivery pump (shown without adhesive patches). [Figure 100C] Figure 100A shows an isometric view of the bottom of the drug delivery pump (shown without adhesive patch). [Figure 101] This shows an isometric view of a variable-speed controlled delivery drive mechanism according to at least one embodiment of the present invention. [Figure 102] Figure 101 shows an exploded view of the drive mechanism along axis "A". [Figure 103A] Figure 101 shows an isometric cross-sectional view of the drive mechanism in its initial deactivated state. [Figure 103B] Figure 101 shows an isometric cross-sectional view of the drive mechanism in an activated state that controls the rate or profile of drug delivery. [Figure 103C] Figure 101 shows an isometric cross-sectional view of the drive mechanism, which completes drug delivery. [Figure 104A] Figure 103A shows a cross-sectional view of the drive mechanism in its initial deactivated state. [Figure 104B] Figure 103B shows a cross-sectional view of the drive mechanism in an activated state that controls the rate or profile of drug delivery. [Figure 104C] Figure 103C shows a cross-sectional view of the drive mechanism, which allows the organization to complete drug delivery and optionally provide a final push through compliance to ensure completion of drug delivery. [Figure 105] An isometric view of a variable-speed controlled delivery drive mechanism according to another embodiment of the present invention is shown. [Figure 106] Figure 105 shows an exploded view of the drive mechanism along axis "A". [Figure 107A]Figure 105 shows an isometric cross-sectional view of the drive mechanism in its initial deactivated state. [Figure 107B] Figure 105 shows an isometric cross-sectional view of the drive mechanism in an activated state that controls the rate or profile of drug delivery. [Figure 107C] Figure 105 shows an isometric cross-sectional view of the drive mechanism, which completes drug delivery. [Figure 108A] Figure 107A shows a cross-sectional view of the drive mechanism in its initial deactivated state. [Figure 108B] Figure 107B shows a cross-sectional view of the drive mechanism in an activated state that controls the rate or profile of drug delivery. [Figure 108C] Figure 107C shows a cross-sectional view of the drive mechanism, which allows the agency to complete drug delivery and optionally provide a final push through compliance to ensure completion of drug delivery. [Figure 109A] An isometric view of a variable-speed controlled delivery drive mechanism incorporating a mechanical status indicator, according to a further embodiment of the present invention, is shown. [Figure 109B] An isometric view of a variable-speed controlled delivery drive mechanism incorporating an optical status indicator, according to yet another embodiment of the present invention, is shown. [Figure 110A] An isometric view of a drug delivery pump with a drive mechanism according to one embodiment of the present invention is shown (shown without adhesive patch). [Figure 110B] This is an isometric view. Figure 110A shows the internal components of the drug delivery pump (shown without adhesive patch); [Figure 110C] Furthermore, an isometric view of the drug delivery pump shown in Figure 110A is presented from a different perspective (shown without the adhesive patch). [Figure 111A] A top view of an exemplary drug delivery pump's internal components along axis "A" is shown. [Figure 111B] An isometric view of the drive mechanism according to at least one embodiment of the present invention before operation is shown. [Figure 111C]An isometric view of a drive mechanism according to at least one embodiment of the present invention in operation is shown. [Figure 111D] This shows an isometric view of the drive mechanism according to at least one embodiment of the present invention at a later stage during operation. [Figure 111E] This shows an isometric view of the drive mechanism according to at least one embodiment of the present invention, near or at the completion of drug delivery. [Figure 112A] Figures 111A and 111E show the operation steps and corresponding top views. [Figure 112B] Figures 111A and 111E show the operation steps and corresponding top views. [Figure 112C] Figures 111A and 111E show the operation steps and corresponding top views. [Figure 112D] Figures 111A and 111E show the operation steps and corresponding top views. [Figure 113] This shows an isometric view of a drive mechanism according to at least one embodiment of the present invention, separated from the drug delivery device. [Figure 114A] Figure 113 shows the top view and bottom view of the drive mechanism, respectively. [Figure 114B] Figure 113 shows the top view and bottom view of the drive mechanism, respectively. [Figure 114C] Figure 113 shows the front perspective view and rear perspective view of the multi-functional drive mechanism. [Figure 114D] Figure 113 shows the front perspective view and rear perspective view of the multi-functional drive mechanism. [Figure 115A] This is an isometric view of a drug delivery pump in which the insertion mechanism includes a rotating deflection member. [Figure 115B] Figure 115A is an enlarged view of the drive mechanism shown. [Figure 116A] This is an isometric view of the insertion mechanism in the initial configuration. [Figure 116B] Figure 116A is an isometric view of an enlarged portion of the insertion mechanism. [Figure 117A] This is a side elevation view of the insertion mechanism shown in Figure 116A, which is part of the initial configuration. [Figure 117B] Figure 117A is an enlarged side elevation view of the insertion mechanism. [Figure 118A] This is an isometric view of the insertion mechanism shown in Figure 116A, which is part of the intermediate configuration. [Figure 118B] Figure 118A is an isometric view of an enlarged portion of the insertion mechanism. [Figure 119A] This is a side elevation view of the insertion mechanism shown in Figure 118A, which is part of the intermediate configuration. [Figure 119B] Figure 119A is an enlarged side elevation view of the insertion mechanism. [Figure 120A] This is an isometric view of the insertion mechanism in its open configuration, as shown in Figure 116A. [Figure 120B] Figure 120A is an isometric view of an enlarged portion of the insertion mechanism. [Figure 121A] This is a side elevation view of the insertion mechanism shown in Figure 120A, in its open configuration. [Figure 121B] Figure 121A is an enlarged side elevation view of the insertion mechanism. [Figure 122A] This is a side elevation view of an activation mechanism according to at least one embodiment of the present invention. [Figure 122B] Figure 122A is an enlarged side elevation view of the activation mechanism. [Figure 123] This is an isometric view of an adjustment mechanism according to at least one embodiment of the present invention. [Figure 124A] This is an isometric view of a positioning pin according to at least one embodiment of the present invention. [Figure 124B] This is an isometric view of a positioning pin according to at least one embodiment of the present invention. [Figure 124C] This is an isometric view of a positioning pin according to another embodiment of the present invention. [Figure 125] This is a plan view of a main gear according to at least one embodiment of the present invention. [Figure 126A] This is an isometric view of the drive mechanism according to one embodiment of the first configuration. [Figure 126B] This is an isometric view of an enlarged portion of the drive mechanism shown in Figure 126A, which is part of the first configuration. [Figure 127A]This is an isometric view of the drive mechanism shown in Figure 126A, which is part of the second configuration. [Figure 127B] This is an isometric view of an enlarged portion of the drive mechanism shown in Figure 127A, which is part of the second configuration. [Figure 128A] This is an isometric view of the drive mechanism shown in Figure 126A, which is part of the third configuration. [Figure 128B] This is an isometric view of an enlarged portion of the drive mechanism shown in Figure 128A, which is part of the third configuration. [Figure 129A] This is an isometric view of the drive mechanism shown in Figure 126A, which is part of the fourth configuration. [Figure 129B] This is an isometric view of an enlarged portion of the drive mechanism shown in Figure 129A, which is part of the fourth configuration. [Figure 130A] This is an isometric view of one embodiment of the winch drum and winch gear in the first configuration. [Figure 130B] Figure 130A is an isometric view of the winch drum and winch gear, which are part of the second configuration. [Figure 131] Figures 130A and 131B are isometric views of the winch gear according to the embodiment. [Figure 132] Figures 131A and 131B show isometric views of the winch drum coupler according to the embodiment. [Figure 133] Figures 130A and 130B show isometric views of the capstan of the winch drum according to the embodiment. [Figure 134A] This is a cross-sectional view of a safety mechanism according to one embodiment of the present invention, as shown in the initial configuration. [Figure 134B] This is an enlarged partial cross-sectional view of the safety mechanism shown in Figure 134A, which is part of the initial configuration. [Figure 135A] This is a cross-sectional view of the safety mechanism shown in Figure 134A in the activated configuration. [Figure 135B] This is an enlarged partial cross-sectional view of the safety mechanism shown in Figure 135A in its activated configuration. [Figure 136A] This is a cross-sectional view of the safety mechanism shown in Figure 134A, which is in a recessed configuration. [Figure 136B] This is an enlarged partial cross-sectional view of the safety mechanism shown in Figure 136A, which is in a recessed configuration. [Figure 137A]This is a cross-sectional view of a safety mechanism according to another embodiment of the present invention. [Figure 137B] This is a cross-sectional view of a safety mechanism according to another embodiment of the present invention. [Figure 138] Figures 137A and 137B are isometric views of one embodiment of the spring retainer for the safety mechanism. [Figure 139] Figures 137A and 137B are isometric views of another embodiment of the spring retainer for the safety mechanism. [Figure 140] Figures 137A and 137B are isometric views of the sleeve for the safety mechanism. [Figure 141A] This is a partial cross-sectional view of a drug container and safety mechanism in the initial, unrestricted configuration. [Figure 141B] Figure 141A is a partial cross-sectional view of the drug container and safety mechanism in their activated configuration. [Figure 142A] An exploded view of the insertion mechanism, disassembled along axis "A", according to at least one embodiment of the present disclosure is shown. [Figure 142B] This shows a cross-sectional exploded view of the insertion mechanism disassembled along axis "A" according to at least one embodiment of the present disclosure. [Figure 143A] An isometric view of an insertion mechanism housing according to at least one embodiment of the present disclosure is shown. [Figure 143B] Figure 143A shows a cross-sectional view of the insertion mechanism housing. [Figure 144] An isometric view of a hub according to at least one embodiment of the present disclosure is shown. [Figure 145] An isometric view of a sleeve according to at least one embodiment of the present disclosure is shown. [Figure 146] An embodiment of the base of an insertion mechanism according to at least one embodiment of the present disclosure is shown. [Figure 147A] An isometric view of the insertion mechanism according to at least one embodiment of the present disclosure, as shown in the initial configuration, is shown. [Figure 147B] A cross-sectional view of the insertion mechanism according to at least one embodiment of the present disclosure, as shown in the initial configuration, is provided. [Figure 148A]An isometric view of an insertion mechanism according to at least one embodiment of the present disclosure, in which a needle is inserted. [Figure 148B] A cross-sectional view of an insertion mechanism according to at least one embodiment of the present disclosure, in which a needle is inserted, is shown. [Figure 149A] An isometric view of an insertion mechanism according to at least one embodiment of the present disclosure, in which the needle is in a retracted configuration, is shown. [Figure 149B] A cross-sectional view of an insertion mechanism according to at least one embodiment of the present disclosure, in which the needle is in a retracted configuration, is shown. [Figure 150] An isometric view of an insertion mechanism according to at least one embodiment of the present disclosure is shown. [Figure 151] Figure 150 shows a cross-sectional side view of the embodiment. [Figure 152] Figure 150 shows a cross-sectional front view of the embodiment. [Figure 153A] The initial configuration shows a cross-sectional view of the insertion mechanism according to at least one embodiment of the present invention. [Figure 153B] Figure 153A shows a cross-sectional view of the insertion mechanism in the inserted configuration. [Figure 153C] Figure 153A shows a cross-sectional view of the insertion mechanism in the delivery configuration. [Figure 154A] A cross-sectional side elevation view of an insertion mechanism housing according to at least one embodiment of the present invention is shown. [Figure 154B] Figure 154A shows a cross-sectional isometric view of the insertion mechanism housing. [Figure 155A] Figures 153A-153C show enlarged partial cross-sectional views of the insertion mechanism during delivery configuration. [Figure 155B] Figures 153A-153C show enlarged partial cross-sectional views of the insertion mechanism while it is in the retracted position. [Figure 156A] The initial configuration shows a cross-sectional view of the insertion mechanism according to at least one embodiment of the present invention. [Figure 156B] Figure 156A shows a cross-sectional view of the insertion mechanism in the inserted configuration. [Figure 156C] Figure 156A shows a cross-sectional view of the insertion mechanism, in which the needle hub is partially retracted. [Figure 156D] Figure 156A shows a cross-sectional view of the insertion mechanism in a configuration where the needle hub is fully retracted. [Figure 157A] This shows a cross-sectional view of the insertion mechanism in the initial configuration of Figure 156A, rotated 45° relative to the original figure in Figure 156A. [Figure 157B] Figure 157A shows a cross-sectional view of the insertion mechanism in the inserted configuration. [Figure 157C] Figure 157A shows a cross-sectional view of the insertion mechanism, in which the needle hub is retracted. [Figure 158A] Figure 157A shows a cross-sectional view of the insertion mechanism in the initial configuration, as seen in Figures 156A and 157A, rotated 270° relative to the original diagram. [Figure 158B] Figure 158A shows a cross-sectional view of the insertion mechanism in the inserted configuration. [Figure 158C] Figure 158A shows a cross-sectional view of the insertion mechanism, in which the needle hub is retracted. [Figure 159] Figures 156A and 158C illustrate an isometric view of a clip. [Figure 160] Figures 156A and 158C are isometric views of the cannula holder illustrated in the diagram. [Figure 161] Figures 156A and 158C illustrate an isometric view of the needle hub. [Figure 162] Figures 156A and 158C illustrate an isometric cross-sectional view of the housing. [Figure 163A] This is an isometric view of the NIM operating mechanism according to at least one embodiment of the present invention, as shown in the initial configuration. [Figure 163B] Figure 163A is an isometric view of the NIM operating mechanism in its activated configuration. [Figure 164A] This is a top view of a NIM retraction mechanism according to at least one embodiment of the present invention, which is in a delivery configuration. [Figure 164B] Figure 164A is a top view of the NIM retraction mechanism in a retracted configuration. [Figure 165]This is an isometric view of a drug delivery device incorporating an embodiment of a fill-finish cartridge according to an aspect of the present disclosure. [Figure 166A] This is a schematic diagram of an exemplary filled-to-final formulation cartridge of the present disclosure. [Figure 166B] This is an exemplary combination of components of a chart of a filled-to-final-formulated cartridge according to an aspect of the present disclosure. [Figure 167] This is an exploded isometric view of a filled-to-final-formulated cartridge according to one embodiment of the present disclosure. [Figure 168] Figure 167 is an enlarged isometric cross-sectional view of the fluid passage connector of the filled-to-final formulation cartridge, with the mesh shading removed for clarity. [Figure 169] Figure 169 is an isometric view of the filled-to-final formulation cartridge of Figure 167 before the insertion of the plunger seal, with elements shown partially transparent. [Figure 170] Figure 30 is an isometric view of the filled-to-final formulation cartridge in Figure 167 after the insertion of the plunger seal, with elements shown partially transparent. [Figure 171] Figure 170 is an exploded isometric view of a tray that may be used to hold multiple filled-to-final formulation cartridges for use in the filled-to-final formulation process, with some elements shown as partially transparent. [Figure 172] Figure 171 is an isometric view of the tray, which is in an assembled form and holds multiple filled-to-final formulation cartridges for use in the filled-to-final formulation process. [Figure 173] This is a side elevation view of another embodiment of a filled-to-final formulation cartridge, in which the cartridge includes a completely disposable carrier. [Figure 174] Figure 173 is an exploded view of the filled-to-final formulation cartridge. [Figure 175] Figures 173 and 174 show cross-sectional views of the filled-to-final formulation cartridge, with the mesh shading removed for clarity. [Figure 176]Figures 173-175 are side elevation views of the filled-to-final formulation cartridge after the carrier has been removed. [Figure 177] This is an isometric view of a drug delivery device incorporating another embodiment of the filled-to-final formulation cartridge according to the present disclosure, with a portion of the drug delivery device housing removed. [Figure 178] Figure 177 is a side elevation view of the filled-to-final formulation cartridge, including a partially disposable carrier before placement within the housing. [Figure 179] Figure 177 is a cross-sectional view of the filled-to-final formulation cartridge, with the mesh shading removed for clarity. [Figure 180] This is a side elevation view of another embodiment of a filled-to-final formulation cartridge in an assembled configuration. [Figure 181] Figure 180 is a cross-sectional view of the filled-to-final formulation cartridge, with the mesh shading removed for clarity. [Figure 182] Figures 180 and 181 are partial exploded views of the filled-to-final formulation cartridge, showing the fluid conduit in its final configuration. [Figure 183] Figures 180-182 are exploded views of the fluid passage connectors in the filled-to-final formulation cartridge. [Figure 184] Figure 180 is a cross-sectional view of the filled-to-final formulation cartridge, similar to Figure 181, but before the fluid passage connector is connected to the needle insertion mechanism, with the mesh shading removed for clarity. [Figure 185] This is a side elevation view of another embodiment of a filled-to-final formulation cartridge in an assembled configuration. [Figure 186] Figure 181 is a cross-sectional view of the filled-to-final formulation cartridge, with the mesh shading removed for clarity. [Figure 187] This is a cross-sectional view of the filled-to-final formulation cartridge shown in Figure 181, similar to the diagram in Figure 182, but before the fluid passage connector is connected to the needle insertion mechanism, with the mesh shading removed for clarity. [Figure 188]This is a schematic illustration of a drug delivery device including a temperature control system according to one embodiment of the present disclosure. [Figure 189A] Embodiments of adhesive patches for drug delivery devices constructed in accordance with the principles of this disclosure are illustrated. [Figure 189B] Embodiments of adhesive patches for drug delivery devices constructed in accordance with the principles of this disclosure are illustrated. [Figure 190] An embodiment of a non-adhesive patch liner combined with a drug delivery device constructed in accordance with the principles of this disclosure is illustrated. [Figure 191A] An exploded view illustrating an embodiment of an adhesive patch for a drug delivery device constructed in accordance with the principles of this disclosure is provided. [Figure 191B] Figure 191A illustrates the adhesive patch in its assembled form. [Figure 192] An isometric view illustrating an isometric view of a drug delivery device including an adhesive patch with a rigidizing member according to one embodiment of the present disclosure. [Figure 193] A bottom view illustrating an embodiment with a non-adhesive patch liner is provided. [Figure 194A] Figure 192 illustrates the process of attaching the drug delivery device to the patient's skin. [Figure 194B] Figure 192 illustrates the process of attaching the drug delivery device to the patient's skin. [Figure 194C] Figure 192 illustrates the process of attaching the drug delivery device to the patient's skin. [Figure 195] This is a schematic diagram of a drug delivery device communicating with a data processing network according to one embodiment of the present disclosure. [Figure 196A] This is a schematic diagram illustrating the operation of an energy management system according to one embodiment of the present disclosure. [Figure 196B] This is a schematic diagram illustrating the operation of an energy management system according to one embodiment of the present disclosure. [Figure 196C] This is a schematic diagram illustrating the operation of an energy management system according to one embodiment of the present disclosure. [Figure 197A]This is a schematic diagram illustrating the operation of an energy management system according to another embodiment of the present disclosure. [Figure 197B] This is a schematic diagram illustrating the operation of an energy management system according to another embodiment of the present disclosure. [Figure 197C] This is a schematic diagram illustrating the operation of an energy management system according to another embodiment of the present disclosure. [Figure 198A] This is a schematic diagram illustrating the operation of an energy management system according to another embodiment of the present disclosure. [Figure 198B] This is a schematic diagram illustrating the operation of an energy management system according to another embodiment of the present disclosure. [Figure 198C] This is a schematic diagram illustrating the operation of an energy management system according to another embodiment of the present disclosure. [Figure 199] This is an isometric view of an energy management system according to another embodiment of the present disclosure. [Figure 200] This is an isometric view of an energy management system according to another embodiment of the present disclosure. [Figure 201A] This diagram shows an exploded view of a medical device comprising an integrated stimulation source according to at least one embodiment of the present invention. [Figure 201B] Figure 201A shows a medical device in an embodiment applied to a patient's skin with the stimulant activated. [Figure 201C] Figure 201A shows the medical device of the embodiment after removal from the patient's skin. [Figure 202A] This diagram shows an exploded view of a medical device equipped with an external stimulus source according to at least one embodiment of the present invention. [Figure 202B] Figure 202A shows a medical device of the embodiment applied to a patient's skin. [Figure 202C] Figure 202A shows the medical device of the embodiment with the stimulation source activated after the main body of the medical device has been removed. [Figure 202D] This illustrates the removal of adhesive from the patient's skin. [Figure 203A]Cross-sectional view of an embodiment with a fluid passage connector and a drug container before drug delivery. [Figure 203B] Cross-sectional view of an embodiment of the fluid passage connector and the drug container of FIG. 203A during drug delivery. [Figure 203C] Cross-sectional view of an embodiment of the fluid passage connector and the drug container of FIG. 203A after completion of drug delivery. **DETAILED DESCRIPTION**

[0015] The present disclosure provides a drug delivery device having advantageous insertion mechanisms, drive mechanisms, sterile fluid passage assemblies, status indicators, safety features, and other advantageous components. Such drug delivery devices are safe, easy to use, and aesthetically and ergonomically appealing for self-administering patients. The drug delivery devices described herein incorporate features that simplify the operation, manipulation, and lockout of the drug delivery device even for untrained patients. The drug delivery devices of the present disclosure provide these desirable features without the various problems associated with known prior art devices. Further, the sterile fluid passage assemblies of the present disclosure can be filled with pharmaceutical therapeutic agents using standard filling equipment and systems. This advantage is enabled by the filling-final formulation cartridges of the present disclosure, which function to maintain the sterility of the fluid passage assemblies as they are nested, installed, or removably inserted into trays for standard filling-final formulation processes.

[0016] As will be discussed in more detail below, the drug delivery devices of the present disclosure may contain a drug, which may also be referred to as a medicine or a pharmaceutical. The drug can be various biological agents (e.g., peptides, peptibodies, or antibodies), bioconjugates, macromolecular drugs (e.g., drugs having a molecular weight of approximately 900 Daltons or more), small molecule drugs (e.g., drugs having a molecular weight of approximately 900 Daltons or less), high viscosity drugs, low viscosity drugs, drugs exhibiting non-Newtonian fluid properties such as shear thinning, and / or drugs exhibiting Newtonian fluid properties, but is not limited thereto. The drug can be in a fluid or liquid form, but the present disclosure is not limited to a specific state (e.g., no distinction is intended between, for example, a solution, a gel, or a lyophilized product as examples).

[0017] One recognized disadvantage of certain known drug delivery devices is their lack of ability to deliver highly viscous drugs, such as certain biological agents, in a timely manner and / or with little discomfort to the patient. Highly viscous drugs typically require more time to inject than low viscosity drugs. The patient may find it difficult and / or undesirable to hold an autoinjector or syringe against their skin for the amount of time required to inject a highly viscous drug. The injection time can be reduced by increasing the force of the drive mechanism, but a more powerful drive mechanism increases the risk of breakage of the drug container and other internal components of the device. Also, a more powerful drive mechanism increases the likelihood that the patient will receive an impact or mechanical shock wave, which may confuse or startle the patient. As a result, the patient may attempt to pull the drug delivery device away from the skin, thereby interfering with complete dosing.

[0018] Longer injection times are more likely to be tolerated by patients when the drug is administered via a wearable drug delivery device. Unlike syringes or self-injection devices, wearable drug delivery devices do not require the patient to hold them in place during drug delivery. Therefore, patients can resume physical activity after the wearable drug delivery device has been implanted in the skin and activated, or without being burdened by holding the drug delivery device in place.

[0019] However, certain embodiments of attachable drug delivery devices have hindered their adoption in the field of high-viscosity drugs. To achieve a low-profile, compact design that does not protrude significantly from the patient's body, attachable drug delivery devices often include a drug container that is offset and orthogonal to the insertion mechanism. This configuration typically requires a tubular conduit with one of more turns to fluidly connect the drug container and the insertion mechanism. Therefore, compared to syringes and self-injection devices, the internal fluid channels of attachable drug delivery devices tend to be relatively long and meandering.

[0020] For drugs exhibiting Newtonian fluid behavior (i.e., fluids where shear rate is directly proportional to flow velocity), longer flow paths can result in lower flow velocities. Therefore, attachable drug delivery devices, due to their long internal flow paths, potentially exacerbate injection problems associated with high-viscosity drugs. While the force of the drive mechanism can be increased to compensate for the reduced flow velocity, a stronger drive mechanism is typically considered undesirable because it increases the risk of drug container rupture. For these reasons alone, attachable drug delivery devices have been considered by some to be particularly unsuitable for the delivery of high-viscosity drugs.

[0021] The inventors of this disclosure have found that various high-viscosity drugs (e.g., PCSK9-specific antibodies, G-CSF, sclerostin antibodies, and CGRP antibodies) exhibit non-Newtonian fluid properties when injected via a wearable drug delivery device. One such property is shear thinning, which is the ability of a non-Newtonian fluid to exhibit reduced viscosity when subjected to shear strain. Shear thinning reduces the viscosity of a fluid as it is forced through a conduit. Therefore, the force required to force the fluid through the conduit is less than the force required if the fluid were Newtonian. In the context of wearable drug delivery devices, shear shinning reduces clogging of the device's long internal channels. Thus, an unexpected benefit of the wearable drug delivery devices found by the inventors of this disclosure is that they are well suited for delivering high-viscosity drugs with non-Newtonian properties such as shear thinning. The inventors of this disclosure have found that shear reduction often occurs in drugs such as biologics that have relatively large protein molecules with a molecular weight of approximately (e.g., ±10%) 900 Daltons or more. Any of the attachable drug delivery devices described herein may have a drug container filled with a high-viscosity drug having shear reduction properties, and thus can realize the unexpected benefits of shear reduction for the operation and use of the device.

[0022] Certain non-limiting embodiments of the drug delivery device and its respective components are described below with reference to the accompanying figures.

[0023] When used herein to describe any of the drive mechanisms, insertion mechanisms, fluid passage connectors, drug delivery devices, or the relative positions of components of the present disclosure, the terms “axial” or “axially” generally refer to a longitudinal axis “A” around which a component is preferably positioned, not necessarily symmetrically, but around it. The term “radial” generally refers to a direction perpendicular to axis A. The terms “proximal,” “rear,” “posterior,” “reverse,” or “reverse direction” generally refer to an axial direction in direction “P.” The terms “distal,” “front,” “forward,” “downward,” or “forward direction” generally refer to an axial direction in direction “D.” When used herein, the term “glass” should be understood to include, but not limited to, certain non-reactive polymers such as cyclic olefin copolymers (COCs) and cyclic olefin polymers (COPs), as well as other similarly non-reactive materials suitable for use in pharmaceutical-grade applications that typically require glass. The term “plastic” may include both thermoplastic and thermosetting polymers. Thermoplastic polymers can be softened again to their original state by heat, but thermosetting polymers cannot. As used herein, the term “plastics” primarily refers to moldable thermoplastic polymers such as polyethylene and polypropylene, or acrylic resins, which typically also contain other components such as healers, fillers, reinforcing agents, colorants, and / or plasticizers, and which can be formed or molded under heat and pressure. As used herein, the term “plastics” is not intended to include glass, non-reactive polymers, or elastomers that are authorized for use in applications where they are in direct contact with therapeutic fluids that may interact with the plastics, or decompose by substituents that may otherwise enter the liquid from the plastics. The terms “elastomer,” “of elastomers,” or “elastomer materials” primarily refer to cross-linked thermosetting rubber-like polymers that are more easily deformable than plastics, are authorized for use with pharmaceutical-grade fluids, and are less susceptible to leaching or gas transfer under ambient temperature and pressure.As used herein, “fluid” primarily refers to a liquid, but may also include a suspension of solids dispersed in a liquid, and gases dissolved in or present together in the liquid within the fluid-containing portion of a drug delivery device. According to the various aspects and embodiments described herein, “biasing member” is referred to, for example, in relation to one or more biasing members for the insertion or withdrawal of a needle, trocar, and / or cannula. It will be understood that the biasing member may be any member capable of storing and releasing energy. Non-limiting examples include, for example, springs such as coil springs, compression or tension springs, torsion springs, and leaf springs, elastically compressible or expandable bands, or any other member having a similar function. In at least one embodiment of this disclosure, the biasing member is a spring, preferably a compression spring. Also, as used herein, the term “drug delivery device” is intended to include any number of devices capable of dispensing a fluid to a patient when in operation. Such drug delivery devices include, for example, attachable drug delivery devices, on-body infusion devices, off-body infusion devices, self-infusion devices, infusion pumps, bolus infusion devices, and the like. Furthermore, as used herein, the term “attachable drug delivery device” is intended to include any number of devices that are capable of dispensing fluid to a patient when in operation and can be attached to the patient’s skin or clothing. Such attachable drug delivery devices include, for example, on-body infusion devices and off-body infusion devices.

[0024] I. Drug delivery devices Figures 1A–1C show an exemplary drug delivery device 10 according to at least one embodiment of the present disclosure. The drug delivery device 10 may be used to deliver a therapeutic drug into a patient's body. As shown in Figures 1A–1C, the drug delivery device 10 includes a housing 12. The housing 12 may include one or more housing sub-components that are fixedly engageable for easier manufacturing, assembly, and operation of the drug delivery device 10. For example, the drug delivery device 10 includes a housing 12 comprising an upper housing 12A and a lower housing 12B. The drug delivery device 10 may further include an operating mechanism 14, a status indicator 16, and a window 18. The window 18 may be any translucent or transparent surface through which the operation of the drug delivery device 10 can be seen. In at least one embodiment, the window 18 may be configured to connect and hold together the upper housing 12A and the lower housing 12B. As shown in Figure 1B, the drug delivery device 10 further includes an assembly platform 20, a drive mechanism 100 having a sterile fluid conduit 30 and a drug container 50, an insertion mechanism 200, a fluid passage connector 300 configured to establish a flow path for sterile fluid between the drug container 50 and the needle or cannula of the insertion mechanism 200, and a power and control system 400. One or more of the components of the drug delivery device 10 may be modular in that they may be pre-assembled as separate components during manufacturing, for example, and configured to fit into a predetermined position on the assembly platform 20 of the drug delivery device 10. In some embodiments, the assembly platform 20 may be a part of the housing 12, for example, a part of the lower housing 12, or alternatively, a separate component.

[0025] The housing 12 may accommodate some or all of the device components. In some embodiments, the housing 12 may provide means for detachably attaching the drug delivery device 10 to the patient's skin or clothing, thereby rendering the drug delivery device 10 into a wearable drug delivery device. In some embodiments, a layer of adhesive may be applied to the outer surface of the housing 12, for example, a surface through which the cannula penetrates and protrudes during operation, in order to detachably attach the drug delivery device 10 to the patient's skin.

[0026] The housing 12 also provides protection for the internal components of the drug delivery device 10 from environmental influences. In some embodiments, the housing may be configured to at least partially prevent contaminants and other harmful substances from entering the drug delivery device 10. For example, the housing 12 may be configured to restrict the passage of fluid into the drug delivery device 10. This may allow the drug delivery device 10 to be worn while showering, swimming, and / or other water-related activities. The housing 12 is ergonomically and aesthetically designed in terms of size, shape, and related features to facilitate easy packaging, storage, handling, and use by patients who may be untrained and / or physically disabled. Furthermore, the outer surface of the housing 12 may be used to provide product labels, safety instructions, etc. Additionally, as described above, the housing 12 may include certain components such as status indicators 16 and windows 18 that can provide operational feedback to the patient.

[0027] Container 50, or any other container described herein, may be configured to hold a variety of different drug dose volumes, including drug dose volumes in the range of approximately (e.g., ±10%) 0.5 to 20 mL, or 1 to 10 mL, or 2 to 10 mL, or 2 to 8 mL, or 2 to 6 mL, or 2 to 4 mL, or 0.5 to 2 mL, or 0.5 to 1 mL, or 3.5 mL, or approximately (e.g., ±10%) 3.0 mL or less, or approximately (e.g., ±10%) 2.5 mL or less, or approximately (e.g., ±10%) 2.0 mL or less, or approximately (e.g., ±10%) 1.5 mL or less, or approximately (e.g., ±10%) 1.0 mL or less. Container 50 may be fully or partially filled with the drug. The drug may be one or more of the drugs listed below, such as granulocyte colony-stimulating factor (G-CSF), PCSK9 (proprotein convertase subtilisin / kexin type 9) specific antibodies, sclerostin antibodies, or calcitonin gene-related peptide (CGRP) antibodies.

[0028] In at least one embodiment, the drug delivery device 10 provides an actuation mechanism that the patient displaces to trigger an initiation command to the power and control system 400. In a preferred embodiment, the actuation mechanism is an initiation button 14 located through the housing 12, such as through an opening between the upper housing 12A and the lower housing 12B, and in contact with a control arm 40 of the power and control system 400. In at least one embodiment, the initiation button 14 may be a push button, and in other embodiments, it may be an on / off switch, a toggle, or any similar actuation feature known in the art. The housing 12 also provides a status indicator 16 and a window 18. In other embodiments, one or more of the actuation mechanism 14, the status indicator 16, and the window 18, and combinations thereof, may be provided on the upper housing 12A or the lower housing 12B, such as the side visible to the patient when the drug delivery device 10 is immobilized on the patient's body. The housing 12 will be described further hereafter with reference to other components and embodiments of the present disclosure.

[0029] The drug delivery device 10 may be configured such that when activated by a patient by pressing down on the actuation mechanism, the drug delivery device 10 is activated to insert the fluid passage into the patient, enable, connect, or open the necessary connections between the drug container, the fluid passage, and the sterile fluid conduit, and push the drug fluid contained in the drug container through the fluid passage and fluid conduit for delivery into the patient. One or more optional safety mechanisms may be used to prevent, for example, premature activation of the drug delivery device 10. For example, an optional on-body sensor 24 (shown in Figure 1C) may be provided in one embodiment as a safety feature that ensures that the power and control system 400 or the actuation mechanism cannot be engaged unless the drug delivery device 10 is in contact with the patient's body. In such an embodiment, the on-body sensor 24 is located at the bottom of the lower housing 12B, which may come into contact with the patient's body. Displacement of the on-body sensor 24 allows the actuation mechanism to be pressed down. Therefore, in at least one embodiment, the on-body sensor 24 is a mechanical safety mechanism, such as a mechanical lockout, that prevents the drug delivery device 10 from being triggered by the actuation mechanism 14. In another embodiment, the on-body sensor may be an electromechanical sensor, such as a mechanical lockout, that transmits a signal to the power and control system 400 to allow operation. Still in other embodiments, the on-body sensor may be electrical-based, such as a conductive-based, capacitive-based, or impedance-based sensor, which must detect tissue before allowing operation of the power and control system 400. In at least one embodiment, such an electrical-based on-body sensor may incorporate a resistor having an impedance of approximately (e.g., ±10%) 1 MΩ. These concepts are not mutually exclusive, and one or more combinations may be used within the scope of this disclosure to prevent, for example, premature operation of the drug delivery device 10. In a preferred embodiment, the drug delivery device 10 utilizes one or more mechanical on-body sensors. Additional integrated safety mechanisms are described herein with reference to other components of the drug delivery device 10.

[0030] The fluid passage connector 300 includes a sterile fluid conduit 30, a piercing member, a connecting hub, and a sterile sleeve. The fluid passage connector 300 may further include one or more flow limiting sections. When the drug delivery device 10 is properly activated, the fluid passage connector 300 is activated to connect the sterile fluid conduit 30 to the drug container 50. Such connection is facilitated by a piercing member, such as a needle, which penetrates the pierceable seal of the drug container 50. The sterility of this connection can be maintained by making the connection within a flexible sterile sleeve. When the insertion mechanism is substantially simultaneously activated, the fluid passage between the drug container and the insertion mechanism is completed, allowing drug delivery into the target tissue.

[0031] In at least one embodiment of this disclosure, the penetrating member of the fluid passage connector is designed to penetrate a perforable seal on the drug container of the drive mechanism by direct action of the user, for example, by the user pushing down the actuation mechanism. For example, the actuation mechanism itself may apply pressure to the fluid passage connector such that the displacement of the actuation mechanism from its original position also causes a displacement of the fluid passage connector. In a preferred embodiment, the connection is activated by the user pushing down the actuation mechanism, thereby driving the penetrating member through the perforable seal, for the reason of preventing fluid from flowing out of the drug container until the user desires. In such an embodiment, a compressible sterile sleeve may be fixedly mounted between the cap of the drug container and the connection hub of the fluid passage connector. The penetrating member may remain within the sterile sleeve until the connection between the fluid passage connector and the drug container is desired. The sterile sleeve may be sterilized to ensure the sterility of the penetrating member and the fluid passage before operation.

[0032] Alternatively, or additionally, the sterility of the flow path may be preserved by one or more membranes or foils defining one or more sterilization chambers of the fluid passage connector. The membranes or foils may be punctured by a puncturing member, or alternatively, by a guide member, at the time of use of the drug pump. In such embodiments, the puncturing member is at least partially positioned within the lumen of the guide member to prevent the puncturing member from coming into contact with foreign matter.

[0033] The drug pump is capable of delivering various drugs having different viscosities and volumes. The drug pump is capable of delivering drugs at a controlled flow rate (velocity) and / or a specified volume. In one embodiment, the drug delivery process is controlled by one or more flow limiters in the fluid passage connector and / or sterile fluid conduit. In other embodiments, other flow rates may be provided by changing the geometry of the fluid passage or delivery conduit, by changing the speed at which components of the drive mechanism advance into the drug container and dispense the drug therein, or by a combination thereof. Further details of the fluid passage connector 300 and the sterile fluid conduit 30 are provided hereafter in later sections with reference to several embodiments.

[0034] Another embodiment of the drug delivery device 6010 is shown in Figures 2A-2B. The drug delivery device 6010 includes many of the same elements as the drug delivery device 10. Elements of the drug delivery device 6010 that are similar to or identical to those of the drug delivery device 10 are denoted by the same reference numerals, incremented by 6010. Descriptions of many of these elements are abbreviated or even omitted for the sake of brevity. The drug delivery device 6010 may include a container 6050 filled with a certain volume of fluid(s) for delivery to a patient. The fluid(s) may include one or more drugs, such as granulocyte colony-stimulating factor (G-CSF), PCSK9 (proprotein convertase subtilisin / kexin type 9) specific antibodies, sclerostin antibodies, or calcitonin gene-related peptide (CGRP) antibodies. In the drug delivery device 6010, one or more of the insertion mechanism 6200, the fluid passage connector 6300, and the drive mechanism 6100 are controlled by the motion of a motor 6207, a solenoid or other electric actuator, and the rotation of one or more gears 6209. Additionally or alternatively, an escapement mechanism may be used to control the rotational speed of one or more gears 6209. One of the gears 6209 may engage with a tooth 6208 of the insertion mechanism housing 6202. In this way, the rotation of one or more gears 209 of the gear train can control the rotation of the insertion mechanism housing 6202, and thereby the insertion of a needle or trocar into the patient's skin. The operation of various embodiments of the insertion mechanism 6200 is described in more detail below.

[0035] II. Power and Control Systems The power and control system 400 includes a power supply, one or more feedback mechanisms, a microcontroller, a circuit board, one or more conductive pads, and one or more interconnects, which provide energy to various electrical components within the drug delivery device 10. Other components commonly used in such electrical systems will be understood by those skilled in the art, but may also be included. One or more feedback mechanisms may include, for example, an audible alarm such as a piezo alarm and / or a light indicator such as a light-emitting diode (LED). The microcontroller may be, for example, a microprocessor. The power and control system 400 controls several interactions of the device with the patient and interfaces with the drive mechanism 100. In one embodiment, the power and control system 400 interfaces directly or indirectly with an on-body sensor 24 to determine when the drug delivery device 10 is activated, by determining when the device is in contact with the patient and / or the actuation mechanism 14. The power and control system 400 may also interface with a status indicator 16 of the housing 12, which may be made of a translucent or semi-transparent material that allows light transport to provide visual feedback to the patient. The power and control system 400 interfaces with the drive mechanism 100 through one or more interconnections to relay status indicators such as operation, drug delivery, and completion of medication to the patient. Such status indicators may be presented to the patient via auditory tones, for example by an audible alarm, and / or via visual indicators, for example by an LED. In a preferred embodiment, the control interface between the power and control system and other components of the drug delivery device 10 is not engaged or connected until activated by the patient. This is a desirable safety feature that prevents accidental operation of the drug delivery device 10 and further allows for the maintenance of energy contained within the power supply during storage, transport, etc.

[0036] The power and control system 400 may be configured to provide several different status indicators to the patient. For example, the power and control system 400 may be configured to provide a start-ready status signal via the status indicator 16 if no errors are reported by the device activation check after the on-body sensor and / or trigger mechanism has been pressed. After providing the start-ready status signal, in embodiments having an optional on-body sensor, if the on-body sensor remains in contact with the patient's body, the power and control system 400 supplies power to the drive mechanism 100 to initiate the delivery of drug therapy to the needle or cannula of the insertion mechanism 200 through the fluid passage connector 300 and the sterile fluid conduit 30. In a preferred embodiment of the present disclosure, the insertion mechanism 200 and the fluid passage connector 300 may be directly actuated by patient operation of the actuation mechanism 14. During the drug delivery process, the power and control system 400 is configured to provide a dispensing status signal via the status indicator 16. After the drug has been administered into the patient's body and after any additional dwell time has elapsed to ensure that substantially the entire dose has been delivered to the patient, the power and control system 400 may provide a removable status signal via the status indicator 16. This can be independently verified by the patient by viewing the drive mechanism 100 and drug dose delivery through the window 18 of the housing 12. Additionally, the power and control system 400 may be configured to provide one or more alarm signals via the status indicator 16, such as alarms indicating a malfunction or operational failure.

[0037] Additionally, the power and control system 400 can be configured to identify removal of the drug delivery device from its packaging. The power and control system 400 can be mechanically, electrically, or electromechanically connected to the packaging such that removal of the drug delivery device from the packaging can activate the power and control system for use or turn on its power supply, or simply enable the power and control system to be powered on by the patient. In such an embodiment, without removal of the drug delivery device from the packaging, the drug delivery device cannot be activated. This provides an additional safety mechanism for the drug delivery device 10 and for the patient. In at least one embodiment, the drug delivery device 10 or the power and control system can be electrically or electromechanically connected to the packaging by, for example, one or more interaction sensors from the following various sensors, namely, Hall effect sensors; giant magnetoresistance (GMR) or magnetic field sensors; optical sensors; capacitive or capacitance change sensors; ultrasonic sensors; and linear travel, LVDT, linear resistance, or radioactive measurement linear resistance sensors; and combinations thereof, which sensors can be coordinated to transmit signals between components to identify their positions relative to each other. Additionally or alternatively, the drug delivery device or the power and control system can be mechanically connected to the packaging, for example, by a pin and slot relationship that activates the system when the pin is removed (i.e., when the drug delivery device is removed from the packaging).

[0038] In a preferred embodiment of the present disclosure, when the power and control system 400 is activated, a multifunction drive mechanism (e.g., drive mechanism 100) is started to activate the insertion mechanism 200 and the fluid passage connector 300, while simultaneously allowing the drug fluid to be pushed out of the drug container 50. During the drug delivery process, the power and control system 400 is configured to provide a dispensing status signal via a status indicator (e.g., status indicator 16). After the drug has been administered into the patient's body and after any additional residence time to ensure that substantially the entire dose has been delivered to the patient, the power and control system 400 may provide a removable status signal via the status indicator. This can be independently verified by the patient by viewing the drive mechanism and drug dose delivery through a window 18 formed in the housing 12. Additionally, the power and control system 400 may be configured to provide one or more alarm signals via the status indicator, such as alarms indicating a malfunction or operational failure.

[0039] The power and control system 400 may also be configured to accept various inputs from the patient for dynamically controlling the drive mechanism 100 to meet a desired drug delivery rate or profile. For example, the power and control system 400 may receive inputs, such as partial or complete operation, depressing, and / or release of the actuation mechanism, for setting, starting, stopping, or adjusting the control of the drive mechanism 100 via the power and control system 400 to meet a desired drug delivery rate or profile. Similarly, the power and control system 400 may be configured to receive inputs such as adjusting the drug dose volume, priming the drive mechanism, fluid passage connectors, and fluid conduits, and / or starting, stopping, or pausing the operation of the drive mechanism 100. Such inputs may be received, for example, by the patient directly interacting with the drug delivery device 10 using the actuation mechanism 14 or a different control interface, or the power and control system 400 may be configured to receive such inputs from a remote control device. In addition or alternatively, such inputs may be pre-programmed.

[0040] Other power and control system configurations may be used in conjunction with the drug delivery device of this disclosure. For example, certain operating delays may be used during drug delivery. As described above, one such delay optionally included in the system configuration is a dwell time that ensures substantially the entire drug dose has been delivered before signaling completion to the patient. Similarly, the operation of the drug delivery device 10 may require a delayed depression (i.e., pressing) of the operating mechanism 14 of the drug delivery device 10. Additionally, the system may include features that allow the patient to respond to a drug delivery completion signal and to deactivate or turn off the drug delivery device 10. Such features may similarly require a delayed depression of the operating mechanism to prevent accidental activation of the deactivation device. Such features provide desirable safety integration mechanisms and user-friendly parameters for the drug delivery device 10. Additional safety features may be integrated into the operating mechanism to prevent partial depression of the drug delivery device and, therefore, partial activation. For example, the operating mechanism and / or power control system may be configured so that the device is either completely off or completely on to prevent partial operation. Such features will be further detailed later with respect to other embodiments of the drug delivery device 10.

[0041] The above description of the power and control system 400 applies to the power and control system 6400 of the drug delivery device 6010, where appropriate.

[0042] III. Fluid passage connectors At least some of the drug delivery devices described in this application, including those described in relation to Figures 1A to 2B, may be configured to incorporate embodiments of fluid passage connectors described below in relation to Figures 3A to 32B. Where appropriate, embodiments of fluid passage connectors described below in relation to Figures 3A to 32B may be used to replace, in whole or in part, the fluid passage connectors 300 or 6300 described above, or any other fluid passage connectors described herein.

[0043] This disclosure provides a container connector that maintains the sterility and / or sterile state of a fluid passage, and a drug delivery pump incorporating such a sterile fluid passage connector assembly to a drug container. Such a device is safe, easy to use, and aesthetically and ergonomically appealing to self-administering patients. The fluid passage connector can be started directly by the user or actuated by another mechanism of the device (described herein) after some initial action by the user. The devices described herein incorporate features that simplify the operation, handling, and lockout of the device, even for untrained users. The novel devices of this disclosure provide these desirable features without the problems associated with known prior art devices. Certain non-limiting embodiments of the novel drug delivery pump, fluid passage connector assembly, and their respective components are further described herein with reference to the accompanying drawings.

[0044] Conventional drug delivery devices often require filling at the time of use because the device cannot be fully sterilized while the drug is inside the drug container. Various drug substances cannot withstand the temperature, pressure, and other conditions required for sterilization of the device after assembly. In other words, drugs cannot be “prefilled” into the device before sterilization because existing manufacturing processes require sterilization of the entire device. This adds a complex process after the final assembly of the device, which often requires costly additional equipment, handling of separate drug containers, and / or patient training for the patient to perform the filling process themselves before injection. Instead, embodiments of the present disclosure enable the manufacture, assembly, and use of prefilled drug delivery devices that maintain the sterility and / or sterile state of the fluid passage assembly throughout various manufacturing processes.

[0045] Additionally, since the drug delivery devices according to this disclosure do not require final sterilization, the components of the devices can be constructed from other, often less expensive, materials that would not normally withstand a sterile environment. For example, since the devices do not need to be sterilized after assembly, less expensive plastics can be used for certain device components. Furthermore, embodiments of this disclosure allow for the integration of device architectures and / or components in a manner unsuitable for devices requiring final sterilization. For example, when the entire device needs to be sterilized, the device architecture often requires sufficient spacing between components to allow sterilization gases or materials to effectively reach the target surface. Eliminating the need for final sterilization allows for a reduction or elimination of these spacings, resulting in device architectures that offer smaller overall dimensions, human-factor advantages, and / or industrial design options that are not available for devices requiring final sterilization.

[0046] In other words, embodiments of the present disclosure may enable manufacturers to sterilize only the components that are in contact with the drug fluid and / or necessary to maintain sterile and / or sterile fluid passages. These embodiments may also enable pharmaceutical excipients to maintain the sterility and / or sterile state of these components during the filling and finishing processes associated with the assembly of the drug delivery device. Similarly, drug delivery devices incorporating the fluid passage connector assemblies of the present disclosure may have smaller or more efficient geometry because the device does not need to be configured for post-assembly sterilization.

[0047] Additionally, embodiments of the present disclosure enable the filling of drug containers using a standard fill-to-final formulation process. This significantly simplifies the manufacturing process used to construct drug delivery devices. A standard fill-to-final formulation process utilizes a tray holding multiple drug containers, such as syringes. Embodiments of the present disclosure enable drug delivery device manufacturers, pharmaceutical companies, or contract drug fillers to fill drug containers or injection pumps for infusions using this same standard fill-to-final formulation process. These drug containers can be filled aseptically in a cost-effective manner, in accordance with common industry practice. After the installation of the fluid passage connector assembly, the combined assembly can then be mated to a drug delivery device without requiring the remaining device components to be sterilized. Thus, embodiments of the present disclosure may provide a novel component that enables a fluid passage assembly to be sterilized, assembled, filled, and incorporated into a drug delivery device in a cost-effective and efficient process.

[0048] In the filling process of drug containers and other drug delivery devices, it is sometimes necessary to connect two or more sterile components or subassemblies. For example, a mountable injector or drug delivery device may include a drug container that can be filled with a fluid drug using a standard pharmaceutical filling-final formulation process. After filling the drug container, it may be necessary to connect the drug container to one or more additional components or subassemblies to establish fluid communication between the drug container and these components. Maintaining the flow path in a sterile state is essential to prevent the introduction of harmful microorganisms or particles into the drug and / or fluid passages. The connection of two or more sterile components or subassemblies is typically performed in a sterile environment, such as a clean room, thereby ensuring that no harmful microorganisms or particles are introduced into the assembly. This, however, can lead to increased costs for the manufactured drug delivery device.

[0049] This disclosure provides a fluid passage connector assembly having an integrated safety feature and a drug delivery pump incorporating such a fluid passage connector assembly. Such a device is safe, easy to use, and aesthetically and ergonomically appealing to self-administering patients. The device described herein incorporates features that simplify the operation, handling, and lockout of the device, even for untrained users. The novel devices of this disclosure provide these desirable features without any of the problems associated with known prior art devices. Certain non-limiting embodiments of novel drug delivery devices, fluid passage connector assemblies, and their respective components are further described herein with reference to accompanying figures. The devices described herein may be configured for controlled substance delivery and may further include features to prevent so-called "runaway" drug delivery. When delivering controlled substances, this can be an important safety feature to protect the patient. For example, some drugs can be dangerous, and even potentially lethal, if administered in too large an amount and / or at too fast a rate. Patient safety can be ensured by providing such an automatic safety stop mechanism.

[0050] This disclosure provides a device and method for establishing a sterile connection between two or more components or subassemblies. The device may be used in medical devices such as drug delivery pumps. In some embodiments, a connection is formed between a drug container and a fluid passage connector assembly. The fluid passage connector assembly may include a connecting hub, a piercing member, and a piercing member holder. The mechanism may further include a first film or seal that covers the opening and thereby maintains the sterility of a cavity adjacent to the opening. The drug container may include a piercing seal that holds a fluid drug. A second film may cover one or more components of the drug container and the opening of the seal and thereby maintain the sterility of the piercing seal. The piercing member may be configured to pierce the first and second films and the piercing seal to open a fluid passage for delivery of the fluid drug to a patient.

[0051] In a first embodiment, the disclosure provides a fluid passage connector. The fluid passage connector assembly includes a connecting hub, a perforating member, a perforating member holder, and a drug container having a cap, a perforable seal, and a barrel, the perforating member being at least partially positioned within a sterile cavity defined by the connecting hub. The drug container may contain a drug fluid for delivery to a target through the fluid passage connector assembly. The perforable seal includes a seal barrier that can be punctured by the perforating member. The fluid passage connector assembly may further include a first film fixedly attached to cover the opening of the connecting hub to prevent foreign matter such as microorganisms from entering the sterile cavity formed by the connecting hub. The drug container may further include a second film fixedly attached to cover the cavity formed by the perforable seal, the second film preventing foreign matter such as microorganisms from entering the cavity. The first and second films may be punctured by the perforating member. The fluid passage connector can be activated directly by the user or by another mechanism of the device (as described herein) after some initial action by the user.

[0052] In another embodiment, the Disclosure provides a drug delivery pump with integrated sterility maintenance features, having a housing and assembly platform, on which a drive mechanism having an operating mechanism, a fluid passage connector assembly, a power and control system, and a drug container may be mounted, the fluid passage connector assembly comprising a drug container having a connection hub, a piercing member, a piercing member holder, and a cap, a piercing seal, and a barrel, the piercing member being at least partially located within a sterile cavity defined by the connection hub. The drug container may contain a drug fluid for delivery to a target through the fluid passage connector assembly. The piercing seal includes a seal barrier that can be pierced by the piercing member. The fluid passage connector assembly may further include a first film fixedly attached to cover the opening of the connection hub to prevent foreign matter such as microorganisms from entering the sterile cavity formed by the connection hub. The fluid passage connector assembly may further include a second film fixedly attached to cover the cavity formed by the piercing seal to prevent foreign matter such as microorganisms from entering the cavity. The first and second films may be punctured by the puncturing member.

[0053] The devices described herein may further include features that prevent the delivery of excessive volume or excessively rapid delivery of a drug, for example, preventing runaway conditions of uncontrolled or unwanted drug delivery. By providing such automatic safety mechanisms, patient safety can be ensured. Some drugs, such as insulin for diabetes or other therapeutic drugs, can be dangerous, and even potentially lethal, if they are not delivered according to specified parameters. The safety features described below can ensure that drug delivery is terminated if delivery deviates from specified parameters.

[0054] In further embodiments of the present disclosure, the fluid passage connector assembly may include one or more biasing members. In such an embodiment, a biasing member may be included that biases the fluid passage connector assembly to connect the drug container and the fluid conduit, i.e., to open the fluid passage between the drug container and the fluid conduit, thereby enabling the drug to flow to the needle insertion mechanism and into the target. In such a configuration, the fluid passage connector assembly is biased to facilitate connection, for example, when a pin or blocking mechanism moves. In at least one embodiment, the biasing member(s) may be located inside and / or outside the fluid passage connector assembly to facilitate connection when triggered. In addition or alternatively, one or more biasing members may be included for disrupting the fluid passage connector assembly. This may provide a desirable safety feature, which is to disrupt the fluid passage automatically by the drug delivery pump or when the user takes action in the event of an error condition signal transmission. When the fluid passage connector assembly is disconnected, the flow of drug fluid between the drug container and the fluid conduit is restricted or blocked, limiting or preventing the flow of fluid to the needle insertion mechanism and into the target.

[0055] According to one aspect of the present disclosure, a fluid passage connector assembly is provided for use with a drug container in a drug delivery pump. The drug container includes a barrel, a cap, and a punctureable seal. The fluid passage connector assembly includes an unactivated configuration, an activated configuration, and a delivery configuration. The fluid passage connector assembly includes a connection hub including an opening, a first film, a guide member, a puncture member, and a puncture member retainer. The first film is sealed along the opening. The connection hub includes a sterile cavity sealed by the first film. The guide member is at least partially positioned within the sterile cavity in the unactivated configuration. The puncture member is configured to be fitted out of the guide member. The puncture member includes a puncture tip, at least partially positioned within the guide member in the unactivated configuration. The puncture member retainer is connected to the puncture member. The guide member is configured to move relative to the connection hub from the unactivated configuration to the activated configuration in which the guide member punctures the first film. The piercing member is configured to be inserted from a non-activated configuration into a delivery configuration in which the piercing tip is not positioned within the piercing member. The piercing member is adapted to pierce a pierceable seal in the delivery configuration, and the piercing member provides a fluid passage through the piercing member connection hub in the delivery configuration. In at least one embodiment, a combination of a fluid passage connector assembly and a drug container is provided. In at least one embodiment, a drug delivery pump is provided, comprising a housing, an operating mechanism, a fluid passage connector assembly, and a drug container.

[0056] In at least one embodiment, the fluid passage connector assembly is configured to move the penetrating member from a delivery configuration to a retracted configuration in which the penetrating member engages and disengages from a penetrating seal in response to a termination mechanism.

[0057] Embodiments of fluid passage connector assemblies that allow a connection to be formed between two or more components or subassemblies of a drug delivery device disclosed herein in a dirty environment while maintaining this configuration of the fluid passage are described below. As can be seen, the fluid passage connector assemblies may be arranged in any orientation. For example, as illustrated in Figures 3A-311, the piercing members may be aligned axially with the drug container. In other embodiments, as shown in Figures 23-30, the fluid passage connector assemblies may be arranged such that the piercing members of the fluid passage connector assemblies are oriented obliquely with respect to the drug container. In alternative embodiments, the piercing members may be arranged in a bow configuration. Exemplary embodiments of such arrangement configurations are shown in Figures 12A-22. The orientation of the fluid passage connector assemblies may be selected based on the desired overall size and shape of the drug delivery device 10, as well as the available space within the drug delivery device 10.

[0058] Figures 3A–311 show one embodiment of such a fluid passage connector. As can be seen in Figures 3A–3B, the fluid passage connector 300 can be connected to a drug container 50. Figure 3A shows these components before connection, and Figure 3B shows the components after connection. As described herein, the fluid passage connector 300 can be installed on the drug container 50 without compromising the sterility of the fluid passage. The fluid passage connector 300 includes a guide member 320, a piercing member 316, a guide member holder 330, a piercing member holder 314, a connecting hub 312, a plate 334, a biasing member 336, a sterile boot 340, and a first film 318. Figures 4A–4B show exploded views of the fluid passage connector 300. As used herein, “piercing member” may refer to any container access needle having at least one tip and a hollow interior configured to establish fluid communication with the drug container 50.

[0059] According to one aspect of the present disclosure (see Figures 5A and 5B), the connecting hub 312 includes a cavity 312A. A sterile boot 340 may further define the cavity 312A in a sterile manner. In one embodiment, the sterile boot 340 is fixedly connected at a first end to the connecting hub 312 and at a second end to the guide member holder 330. The sterile boot 340 may be constructed from a flexible material such as an elastomer, thereby allowing the sterile boot to deform to maintain engagement with both the connecting hub 312 and the guide member holder 330 during operation. A first film 318 is positioned to cover the opening 312B of the connecting hub 312 to prevent microorganisms and other contaminants from entering the cavity 312A through the opening 312B. In this way, the areas enclosed or bordered by the sterile boot 340, the connection hub 312, and the first film 318 define the cavity 312A and maintain the sterile state of the cavity 312A.

[0060] In uninstalled configurations such as the one illustrated in Figure 3B, and in the initial unactivated configurations shown in Figures 5A-5B, at least a portion of the guide member 320 is located within the sterile cavity 312A. At least the piercing tip of the piercing member 316 is partially held within the lumen 320A of the guide member 320, and the piercing member 316 is positioned to fit into the guide member 320. The piercing member 316 is also at least partially located within the piercing member holder 314. In this way, the guide member 320 and the piercing member 316 are similarly maintained in a sterile state within the cavity 312A.

[0061] The piercing member 316 engages with the piercing member holder 314, thereby transmitting the translational movement of the piercing member holder 314 to the piercing member 316, so that they maintain a substantially fixed spatial relationship throughout the operation. The piercing member 316 can be engaged with the piercing member holder 314 by any method known to those skilled in the art, such as fixing, press-fitting, or crimping. The piercing member 316 may be, for example, a hollow needle.

[0062] The guide member 320 is at least partially held by the guide member holder 330 and engages with the guide member holder 330 so that the translational movement of the guide member holder 330 is transmitted to the guide member 320, thereby causing them to maintain a substantially fixed spatial relationship throughout the operation. The guide member 320 may be engaged with the guide member holder 330 by any method known to those skilled in the art, such as fixing, press-fitting, crimping, or any other suitable method.

[0063] The piercing member holder 314 and the guide member holder 330 are engaged with the connecting hub 312 and may be configured to move parallel to the connecting hub in a direction parallel to the long axis of the piercing member 316 (axis "A" shown in Figure 5B). The connecting hub 312, the piercing member holder 314, and the guide member holder 330 may include one or more features that maintain orientation and position relative to each other, as will be described in more detail below.

[0064] The fluid passage connector 300 may further be provided with an insertion drive device arranged to advance one or both of the piercing member 316 and the guide member 320 toward the drug container 50. In this embodiment, at least one biasing member 336 is provided for advancing one or both of the piercing member 316 and the guide member 320 toward the drug container 50. The biasing member 336 is initially in a compressed or biased state and is limited to being released from compression or bias. A first end of the biasing member 336 is in contact with an axially fixed plate 334, and a second end of the biasing member 336 is in contact with the piercing member holder 314. In one embodiment, the biasing member 336 is in contact with the shoulder portion 314D of the piercing member holder 314. During assembly, the movement of plate 334 (see Figure 9) is restricted by the engagement of the connecting hub 312 with the snap 312C of the plate 334 (see Figure 9), which is inserted through the passage 334A of plate 334. In the initial configuration, the shaft 314A of the piercing member holder 314 (see Figure 10) passes through the central hole 334B of plate 334 and is engaged by the fitting 338 (see Figures 3A, 3B, 5A, 5B). The fitting 338 is located distal to plate 334 and engages with one or more protrusions 314B on the shaft 314A to prevent parallel movement of the piercing member holder 314 relative to plate 334. In this way, the decompression or de-biasing of the biasing member 336 is restricted. As further described herein, the fitting portion 338 is modified to a configuration that does not restrict the parallel movement of the penetrating member holder 314, thereby enabling the decompression of the biasing member 336 and connection of the fluid passage to the drug container 50.

[0065] The drug container 50 may include a crimped cap 324 that maintains the connection between the pierceable seal 326 and the barrel 58. The pierceable seal keeps the fluid drug within the barrel and prevents microorganisms and other substances from entering the drug chamber. A recess 328 (best seen in Figure 5B) is formed by the geometry of the pierceable seal 326. A second film 322 is attached to the drug container to enclose the recess 328, thereby maintaining the recess 328 in a sterile state.

[0066] The first and second films may be constructed from any material capable of providing the barrier properties necessary to maintain the sterility of the associated surface. In a preferred embodiment, the film is constructed from a foil material. Alternatively, the film may be any kind of sterilizable membrane, film, or foil. Additionally, the film may be removable and / or permeable, as well as breathable and / or permeable.

[0067] A surface treatment agent may be applied to the outer surfaces of both the first film 318 and the second film 322 before the fluid passage connector and the drug container are joined together. The surface treatment agent may contain antimicrobial, antimicrobial, or antiviral compounds that limit or reduce the number of such substances on the surface of the seal.

[0068] The connecting hub 312 may include a barrel engagement configuration 312D. The barrel engagement configuration 312D may include one or more bent arms 312E configured to engage with the crimp cap 324 and / or neck 58A of the barrel 58. During connection, the bent arms 312E may engage with the crimp cap 324 or another part of the drug container, thereby limiting the axial translation of the fluid passage connector relative to the drug container. In this position, the first film 318 and the second film 322 are in contact with each other or very close to each other. In one embodiment, the first film 318 and the second film 322 contain an adhesive so that the films are joined together during assembly.

[0069] Figures 5A-5B show cross-sectional side views of the connecting hub 312 and drug container 50 in their installed, non-activated configuration, i.e., after they have been joined. In this configuration, the guide member 320 is positioned at least partially within the cavity 312A, and the engagement of the fitting portion 338 with the perforating member holder 314 holds the biasing member 336 in a compressed or biased state. The first film 318 and the second film 322 are intact, thereby maintaining the sterility of the cavity 312A and the perforated seal 326, respectively.

[0070] The activated configuration is illustrated in Figures 6A-6B. In one embodiment, the actuation may displace or alter the fitting portion 338 so that it no longer restricts the translation of the piercing member holder 314. During actuation, the piercing member holder 314 and the guide member holder 330 may be translated axially relative to the connecting hub and the drug container 50. The translation may be caused by the decompression or de-biasing of the biasing member 336. In one embodiment, the biasing member 336 is a compression spring. Since the piercing member holder 314 is in contact with the guide member holder 330, when the piercing member holder 314 is translated, the guide member holder 330 is translated along with the piercing member holder 314. For example, the proximal surface 314C of the piercing member holder 314 (see Figure 10) may be in contact with the projection 330A of the guide member holder 330 (see Figure 11). The proximal surface 314C may include a chamfer or rounded portion that contacts the projection 330A. The contact surfaces of the piercing member holder 314 and the guide member holder 330 may be configured such that the piercing member holder 314 applies radially inward forces to the projection 330A and, by extension, the extension 330D, in addition to axial forces. However, firstly, the fingers 330C of the extension 330D are prevented from inward displacement by contact with the ribs 312G of the connecting hub 312 (see Figures 4A, 4B, and 6B). Therefore, the guide member holder 330 moves parallel to the piercing member holder 314. The parallel movement of the piercing member holder 314 causes the piercing member 316 to move parallel, and the parallel movement of the guide member holder 330 causes the guide member 320 to move parallel. This translation causes the guide member 320 to penetrate the first film 318 and the second film 322, as shown in Figures 6A and 6B. Since the penetrating member 316 is positioned within the guide member 320, it does not come into contact with the first 318 and second 322 films, and therefore, it will be understood that no contaminants present on the surface of the films come into contact with the penetrating member 316.

[0071] After the guide member 320 has penetrated the first film 318 and the second film 322, the translation of the guide member holder 330 is restricted so that the tip of the guide member is positioned within the recess 328 (i.e., the guide member does not pass through the perforable seal 326). The translation of the guide member holder 330 can be restricted, for example, by contact of a portion of the proximal surface 330B with the flange 312F of the connecting hub 312. It is not necessary for the entire proximal surface 330B of the guide member holder 330 to be in contact with the flange 312F. For example, the finger 330C may be in contact with the flange 312F. In this position, the finger 330C is no longer in contact with the rib 312G of the connecting hub 312. This allows the extension 330D to bend radially inward. As a result, by continuing to release the compression of the biasing member 336 and translating the piercing member holder 314, the extension portion 330D moves inward, and the piercing member holder 314 can pass through the guiding member holder 330.

[0072] Next, Figures 7A-7B illustrate the delivery configuration of the fluid passage connector 300. By continuing to decompress the bias member 336, the piercing member holder 314 may be further displaced, leading to the piercing seal 326 being pierced by the piercing member 316. Thus, by continuing to decompress the bias member 336, with further parallel movement of the guide member holder 330 prevented by contact with the connecting hub 312, the piercing member holder 314 will move proximal to the guide member holder 330. After piercing the piercing seal, a flow path is established from the drug container and through the piercing member 316. Those skilled in the art will understand that the piercing member 316 may also be in fluid communication with a conduit 30 (as shown in Figure 31), which is configured to transport the fluid contents to a delivery mechanism such as an insertion mechanism for delivery to a patient.

[0073] In an alternative embodiment, penetration of the first and second films occurs during assembly. In such an embodiment, penetration of the perforated seal during or near use can be initiated by interaction with the operating mechanism.

[0074] In at least one embodiment, the first and second films are punctured by the guide member at a first time point, e.g., during assembly, and the puncturing member punctures the puncturable seal at a later time point, e.g., during operation. In such an embodiment, the end of the puncturing member may remain positioned within the recess 328 until use. The puncturable seal may be configured such that the puncturable seal 326 deforms or displaces in response to the hydraulic and / or pneumatic pressure in the drug chamber to come into contact with the puncturing member. This deformation of the puncturable seal 326 leads to puncture of the seal by the puncturing member 316. In such an embodiment, the guide member 320 may retract after puncturing the first and second films.

[0075] The embodiments shown in Figures 3A-311 are configured such that the piercing member 316 is substantially aligned axially with the drug container 50, but those skilled in the art will recognize that this orientation can be any orientation. For example, the axis of the piercing member 316 may be oriented perpendicular to the central axis of the drug container 50. Alternatively, this axis may be oriented at any angle between parallel and perpendicular. The choice of this angle or orientation may be selected based on the spatial requirements of the drug delivery device 10.

[0076] In another embodiment shown in Figures 12A to 22, the guide member and the piercing member are arranged in an arc shape. The arc shape of the fluid passage connector allows for a reduction in the installation area of ​​the fluid passage connector, resulting in a smaller overall size for the drug delivery device 10. The fluid passage connector 1300 includes a guide member 1320, a piercing member 1316, a guide member holder 1330, a piercing member holder 1314, a connecting hub 1312, a shaft 1342, and a first film 1318. As described above, the connecting hub 1312 may be configured to engage with the drug container 1050, for example, by engaging with the crimp cap 1324 and / or neck 1058A of the drug container 1050.

[0077] The guide member 1320 can be connected to the guide member holder 1330 directly or indirectly. For example, in the shown embodiment, the guide member 1320 is fixedly connected to the first sleeve 1344. Next, the first sleeve 1344 is engaged with the second sleeve 1346. Finally, the second sleeve 1346 is engaged with the guide member holder 1330, for example, by the positioned engagement shown. The first sleeve 1344 and the second sleeve 1346 can further hold a partition wall 1348, through which the penetrating member 1316 can pass.

[0078] Similarly, the piercing member 1316 can be directly or indirectly connected to the piercing member holder 1314. In the shown embodiment, the piercing member 1316 engages with the keeper 1350. The keeper 1350 engages with the piercing member holder 1314, for example, by the positioned arrangement configuration shown.

[0079] In the initial, unactivated configuration shown in Figures 13A-13B, the guide member 1320 is initially positioned at least partially within the cavity 1312A. The piercing member 1316 is positioned at least partially within the lumen 1320A of the guide member 1320. The cavity 1312A is kept sterile by the first film 1318. The sterility of the cavity 1312A is further maintained by the cap 1354 and the ring seal 1352. The ring seal 1352 is held in a sealed engagement with the connecting hub 1312 and / or the guide member 1320 by the cap 1354. The ring seal 1352 is shown here in a circular cross-section, but the ring seal may exhibit any shape known to those skilled in the art. Alternatively, for example, sterility may be maintained by a septum.

[0080] During operation, the guide member holder 1330 and the piercing member holder 1314 are rotated about the shaft 1342. It will be understood that the shaft 1342 may be integrally formed with the connecting hub 1312 as shown in Figure 20, may be a feature of the housing 12, or may be a pin or other component engaged with the connecting hub 1312 or the housing 12. The latter two of these embodiments are not specifically illustrated, but will be readily understood by those skilled in the art. An insertion drive mechanism may be provided to advance one or both of the piercing member 1316 and the guide member 1320 toward the drug container 1050. For example, rotation about the shaft may be caused by the release of biasing member such as a torsion spring. Alternatively, rotation may be caused by a drive member of the drug delivery device 10. For example, the needle insertion mechanism 200 may include a drive member that, when in operation, contacts a certain aspect of the piercing member holder 1314, causing rotation of the piercing member holder 1314 and the guide member holder 1330. In another embodiment, a biasing member of the needle insertion mechanism applies pressure to the piercing member holder 1314, causing its rotation.

[0081] The piercing member holder 1314 and the guide member holder 1330 can initially rotate as a single unit. Referring to Figures 16B and 22, the guide member holder 1330 can initially be positioned between the projection 1314E and the teeth 1314F, both of which are features of the piercing member holder 1314. Together, these holders move into the activated configuration shown in Figures 14A-14B. In this position, the guide member 1320 has pierced the first film 1318 and the second film 1322, but not the pierceable seal 1326. In or near this position, the bent arm 1314G of the piercing member holder 1314 comes into contact with the connecting hub 1312 and / or cap 1354. Therefore, as the piercing member holder 1314 continues to rotate, the bent arm 1314G is displaced downward. As a result, contact between the projection 1314E and the guide member holder 1330 will no longer cause rotation of the guide member holder 1330. Therefore, further rotation of the piercing member holder 1314 will not cause additional rotation of the guide member holder 1330.

[0082] As illustrated in the delivery configuration illustrated in Figures 15A-15B, the continuous rotation of the piercing member holder 1314 causes the piercing member 1316 to pierce the pierceable seal 1326, thus opening a flow path from the drug container 1050 through the piercing member 1316. The piercing member 1316 may be in fluid communication with the insertion mechanism 200, for example, by a fluid conduit, to enable delivery of the fluid drug to the patient. As shown in Figures 19A-19B, in this configuration, the teeth 1314F can engage with the cap 1354 and / or the connecting hub 1312 to prevent the piercing member 1316 from retracting.

[0083] Figure 23 shows an exploded view of another embodiment of the fluid passage connector 2300. The fluid passage connector 2300 includes a connecting hub 2312, a guide member 2320, a guide member retainer 2330, a piercing member 2316, a piercing member retainer 2314, and optionally, a blocking element 2356. Additionally, a first film 2318 may be provided so as to maintain the sterility of at least a portion of the fluid passage connector. The fluid passage connector may also include a ring seal 2352 and a partition wall 2348 configured to maintain the sterility of at least a portion of the fluid passage connector as described above. The blocking element 2356 may be configured with a fitting 2338 that engages with the connecting hub 2312 in the connecting element 2312H. Additionally or alternatively, the blocking element 2356 may be configured to engage with a certain aspect of the housing 12. The blocking element 2356 may be configured to rotate about these engagement points.

[0084] Figure 24A shows the drug container 50 and fluid passage connector 2300 in an unactivated configuration before assembly. As can be understood from the above considerations, this assembly process may occur in an uncontrolled or less controlled environment than required by the prior art design. To mount the fluid passage connector 2300 onto the crimp cap 2324 connecting the perforated seal 2326 to the barrel 2058, the barrel engagement configuration may include one or more bent arms 2312E of the connecting hub 2312 that engage with the perforated seal 2326 or the crimp cap 2324. Figures 23B–23D show isometric views of the operational stages of the fluid passage connector 2300 after it has been mounted on the drug container 2050.

[0085] Initially, in the unactivated configuration illustrated in Figure 24B, the blocking mechanism 2356 is initially engaged with the piercing member holder 2314 so as to prevent the piercing member holder 2314 from moving toward the drug container 2050. Additionally, or alternatively, one or more arms 2330E (see Figure 29) of the guide member holder 2330 are initially positioned within one or more primary windows 2312J (see Figure 28) of the connecting hub 2312. This engagement can further prevent accidental operation of the fluid passage connector. For example, in at least one embodiment, the arms 2330E are configured to resist disengaging from the primary windows 2312J and provide sufficient flexural stiffness to prevent accidental operation. The application of sufficient force to actuate causes the arms 2330E to disengage from the primary windows 2312J, allowing for the piercing member holder 2330 to move toward the drug container 2330.

[0086] During operation, the blocking mechanism 2356 is displaced, for example, by rotation around axis C. After the displacement of the blocking mechanism 2356, the piercing member holder 2314 is movable toward the drug container 2050 in accordance with the application of driving force from an insertion drive device such as the rotary biasing member 2210 shown in Figure 31. Figure 31 is a detail diagram showing one method of activating the fluid passage connector 2300. As shown, the rotary biasing member 2210 is initially held in a compressed or biased state. The first end of the rotary biasing member 2210 engages with a part of the fluid passage connector 2300, which is here the piercing member holder 2314. Furthermore, the blocking mechanism 2356, such as a rotatable latch, prevents the biasing of the rotary biasing member 2210 from being released and, therefore, the operation of the fluid passage connector 2300. To activate the fluid passage connector 2300, the blocking portion 2356 can be displaced such that it no longer restricts the de-biasing of the rotational biasing member 2210. In this way, when the locking portion 2356 is displaced, the rotational biasing member 2210 is at least partially de-biased, allowing the fluid passage connector 2300 to open a passage to the drug container 2050, thereby fluidly connecting the drug container 2050 to the needle insertion mechanism 200 via the fluid passage connector 2300, as well as the puncture member 2316 and the sterile fluid conduit 30 connected to the needle insertion mechanism 200. The displacement of the blocking portion 2356 may occur in response to a user pressing down on the actuation mechanism 14, or alternatively, may be controlled by interaction with a separate mechanism.

[0087] Returning to Figures 24B-27B, initially, as will be further described later, the piercing member holder 2314 and the guide member holder 2330 move together toward the drug container 2050. Figure 24C shows the fluid passage connector in the activated configuration, i.e., after the guide member 2320 has pierced the first film 2318 and the second film 2322. After piercing the first film 2318 and the second film 2322, the guide member 2320 is restricted from further movement. In one embodiment, the arm 2330E of the guide member holder 2330 is positioned within one or more secondary windows 2312K in this configuration. This engagement can lock the guide member holder in place, preventing accidental parallel movement toward or away from the drug container. As the piercing member holder 2314 continues to move in parallel, the piercing member 2316 penetrates the pierceable seal 2326, thereby opening the fluid passage from the drug container 2050. This delivery configuration is shown in Figure 24D.

[0088] Figures 25A and 25B show cross-sectional views of the fluid passage connector in its initial, unactivated configuration. As can be seen in these figures, the blocking element 2356 engages with the piercing member holder 2314 to prevent the piercing member holder 2314 from moving toward the drug container. The piercing member 2316 is at least partially located within the guide member 2320. As shown, in this or any embodiment, the guide member 2320 is an integral part of the guide member holder 2330. Both the guide member 2320 and the piercing member 2316 are at least partially located within the sterile cavity 2312A, defined by the connecting hub 2312, the first film 2318, the ring seal 2352, and the partition wall 2348. The shoulder portion 2314H of the piercing member holder 2314 is in contact with the extension portion 2330D of the guide member holder 2330. The extension 2330D is configured to be a relatively flexible form of the guide member holder 2330. However, in the initial configuration, the extension 2330D is prevented from bending by contact with the connecting hub 2312. Therefore, initially, the parallel movement of the piercing member holder 2314 toward the drug container 2050 causes a balanced parallel movement of the piercing member holder 2314.

[0089] Figures 26A and 26B show the fluid passage connector 2300 in an intermediate activated configuration. In this configuration, the blocking portion 2356 is displaced so as not to restrict the parallel movement of the perforating member holder 2314. The guide member 2320 perforates the first film 2318 and the second film 2322, and the perforating member 2316 is positioned adjacent to the perforable seal 2326. Also in this configuration, the extension portion 2330D is positioned adjacent to the recess 2312L of the connecting hub 2312. Therefore, the extension portion 2330D is no longer restricted to bending outward (i.e., in the direction of the shaded arrow in Figure 26B). Because the extension 2330D is bendable outward into the recess 2312L, any additional translation of the piercing member holder 2314 causes the shoulder portion 2314H to disengage from the extension 2330D. This allows the piercing member holder 2314 to move toward the drug container 2050 without causing translation of the guide member holder 2330. As shown in the delivery configuration in Figures 27A-26B, this allows the piercing member 2316 to pierce the pierceable seal 2326 and open a fluid passage from the drug container 2050.

[0090] In some embodiments, an additional film or seal may be present at the tip of the guide members 320, 1320, 2320 to seal the lumen of the guide member and thereby further isolate the lumen of the guide member and thus the guide member, in order to maintain the sterility of the piercing member. This film may remain intact when the guide member pierces the first films 318, 1318, 2318 and the second films 322, 1322, 2322. This may further prevent any microorganisms or other contaminants present on the surface of the seal from coming into contact with the guide member.

[0091] In at least one other embodiment, the first and second films are removed from the fluid passage connector and the drug container immediately before the fluid passage connector 300 is installed on the drug container 50. Before the removal of the films, their placement maintains the sterility of the drug container and the perforable seal of the cavity 312A. The connection hub 312 and the drug container 50 may be configured such that the connection of the connection hub to the barrel provides a sealing engagement that maintains the sterility of the perforable seal and the perforating member. In such embodiments, the connection hub 312 and / or the drug container 50 may include an elastomer configuration configured to provide a sealing engagement.

[0092] In another embodiment, after the connection hub 312 is installed on the drug container 50, the cavity 312A and the perforated seal 326 may be sterilized using UV sterilization. The connection hub 312 may be able to seal and engage with the drug container such that, after sterilization, microorganisms and other contaminants cannot come into contact with the sterile surface. In such an embodiment, at least a portion of the connection hub may be constructed from a substantially translucent material such as glass.

[0093] In each of the embodiments described herein, the connecting hub, the piercing member retainer, and / or the guide member retainer may include one or more features that prevent accidental operation of the fluid passage connector during assembly, storage, transport, and handling. These features may prevent operation unless a force exceeding a threshold is applied. These features may include, for example, a flexible or fragile configuration that is displaced or broken when a force exceeding a threshold is applied.

[0094] In addition to the advantages described herein, the insertion mechanisms described herein may also be capable of terminating the flow of a drug to target tissue by interrupting the flow path. This may be an important safety feature for protecting the patient. For example, some drugs, such as insulin, can be dangerous, and even potentially lethal, if administered in too large an amount and / or at too fast a rate. By providing such an automatic safety termination mechanism, so-called "runaway" delivery of drugs can be prevented, thereby ensuring patient safety. While methods and related structures for terminating the flow may be considered in relation to one or more specific insertion mechanisms disclosed herein, it will be understood that these methods and related structures may be used or adapted to any of the fluid passage connector assemblies disclosed herein or within the spirit and scope of this disclosure.

[0095] Interruption of drug delivery by the fluid passage connector may be triggered, for example, by an error in drug delivery or input from the user. For example, a user may realize that they have already taken their drug dose and wish to pause or terminate drug delivery from the device. Upon such user input to the device, drug delivery may be stopped and / or the fluid passage through the perforating member may be terminated by the retraction of the perforating member to its retracted position, as described below.

[0096] In addition, or alternatively, the device may pause or terminate drug delivery if it receives an error alarm during operation. For example, if the drive mechanism is not functioning correctly, the fluid passage connector may be triggered to retract the penetrating member from the penetrating seal, thereby terminating drug delivery through the fluid passage connector, in order to prevent drug overdose. This capability of the fluid passage connector provides a valuable safety feature with respect to drug delivery to the target.

[0097] In some embodiments, retraction is activated when the drug delivery device is removed from the target tissue. In other embodiments, retraction is activated when it is determined that an error has occurred in the delivery of the substance to the target tissue. For example, an obstruction in the drug delivery pathway that blocks the flow of the drug may be detected by the sensing function of the drug delivery pump. Upon detection of the obstruction, the retraction of the needle may be initiated using an electrical or mechanical input.

[0098] In addition or alternatively, one or more biasing members may be included to interrupt the fluid passage connector. This may provide a desirable safety feature that interrupts the fluid passage either automatically by the drug delivery pump or when the user takes action upon signaling an error condition. For example, a locking mechanism may initially limit the extension of a secondary biasing member from its original biased state. When the locking mechanism is activated, the secondary biasing member is de-biased from its original position, thereby acting against the piercing member holder to axially translate it and interrupt the piercing member from the piercing seal. When the fluid passage connector is interrupted, the flow of drug fluid between the drug container and the fluid conduit is restricted or interrupted, limiting or preventing the flow of fluid to the needle insertion mechanism and into the target. As described herein, interruption may be triggered by several operations, automatically by the system and / or directly or indirectly by the user, as an additional safety precaution to prevent over-delivery of drug fluid to the target.

[0099] One such embodiment is shown in Figures 32A and 32B. As shown in Figure 32A, the secondary deflection member 362 is initially restricted between the connecting hub 312 and one or more release arms 360A of the locking mechanism 360. The locking mechanism 360 is positioned relative to the proximal surface of the connecting hub 312, with one or more release arms extending distally. In the event of a malfunction in the operation of the drug delivery device or during activation by the user, the locking mechanism 360 is rotated around its axis from the position shown in Figure 32A to the position shown in Figure 32B. The rotation may be caused, for example, by contact between the throw arm and the actuation arm 360B. When the locking mechanism 360 is rotated, each of the one or more release arms 360A contacts the inclined surface 312M of the connecting hub 312. Contact with the inclined surface 312M causes radial displacement outward of one or more release arms 360A, or alternatively, fracture of one or more release arms 360A. As a result, the secondary biasing member 362 is decompressed or de-biased. The secondary biasing member 362 comes into contact with the piercing member holder 314, causing distal translation of the piercing member holder 314. This translation causes the piercing member to withdraw from the piercing seal. Therefore, no additional medication is delivered through the piercing member, thereby terminating delivery to the patient. As shown in Figure 32B, after rotation, each of the one or more release arms 360A may bend radially outward to allow de-biasing of the secondary biasing member 362, and then return radially inward to be positioned within the notch 312N of the connecting hub. The locking mechanism 360 can thereby prevent any further rotation.

[0100] Any of the illustrated embodiments may be equipped with such safety features. Alternatively, a component of the drug delivery device may directly engage with a portion of the fluid passage connector to remove the puncturing member from the punctureable seal. For example, a slide or throw arm may contact the puncturing member retainer 2314, and displacement of the slide or throw arm may cause displacement of the puncturing member retainer 2314 to remove the puncturing member from the punctureable seal.

[0101] The removal of the piercing member from the piercing seal may be activated, for example, in the event of tether failure or loss of tension, drive mechanism failure, removal of the drug delivery device from the target tissue, or activation by the user. The safety mechanism may be purely mechanical, or alternatively, may include a power and control system. For example, an electrical signal from the power and control system may initiate the removal of the piercing member from the piercing seal.

[0102] From the above description, it will be understood that the fluid passage connector assemblies and drug delivery devices disclosed herein provide a system that is efficient and easy to operate for automated drug delivery from drug containers. The novel devices of this disclosure provide a container connector that maintains the sterility of the fluid passage, and a drug delivery pump that incorporates such a fluid passage connector assembly to a drug container. Such devices are safe, easy to use, and aesthetically and ergonomically appealing to self-administering patients. The devices described herein incorporate features that simplify the operation, handling, and lockout of the device, even for untrained users. The fluid passage connector, drug container, drug fluid, and the entire device are kept sterile because the flow path is interrupted until the user desires drug delivery. These embodiments provide users with highly desirable storage, transport, and safety advantages. Furthermore, the novel configurations of the fluid passage connector assemblies and drug delivery devices of this disclosure maintain the sterility of the flow path throughout the operation of the device. Because the passage through which the drug fluid travels within the device is kept completely sterile, these components only need to be sterilized during the manufacturing process. Such components include a drug container for the drive mechanism, a fluid passage connector, a sterile fluid conduit, and an insertion mechanism. In at least one embodiment, the power and control system, assembly platform, operating mechanism, housing, and other components of the drug delivery device do not need to be sterilized. This significantly improves the manufacturability of the device and reduces associated assembly costs. Thus, the devices of this disclosure do not require final sterilization upon completion of assembly. A further benefit is that the components described herein are designed to be modular, such as the pump drug housing and other components being easily configured to accept and operate connection hubs 312, 1312, 2312, or some other variations of the components described herein.

[0103] The assembly and / or manufacture of any of the fluid passage connectors 300, 1300, 2300, the drug delivery pump 10, or any of the individual components may utilize several materials and techniques known in the art. For example, components and / or devices may be cleaned using several known cleaning fluids, such as isopropyl alcohol and hexane. Several known adhesives or glues may also be used in the manufacturing process. In addition, known silicone treatments and / or lubricating fluids and treatments may be used during the manufacture of the new components and devices. Furthermore, known sterilization processes may be used in one or more of the manufacturing or assembly stages to ensure the sterility of the final product.

[0104] The fluid passage connector and drug container can be assembled in several ways. In one assembly method, the drug container 50 can be assembled and filled with a fluid for delivery to a target. The drug container 50 includes a cap 324, a punctureable seal 326, a barrel 58, and a plunger seal 60. The plunger seal 60 may be inserted into the barrel 58. The barrel 58 may be filled with the drug fluid through its distal opening before insertion of the punctureable seal at the distal opening of the barrel 58. The punctureable seal 326 can then be fixedly engaged between the cap 324 and the barrel 58 at the distal end of the barrel 58. In this way, the drug container can be filled and sealed using standard filling-final formulation processes and equipment. For example, the drug container 50 can be filled and sealed using processes and equipment commonly used in standard vial filling and sealing. Additionally, the cap 324 may be a crimped cap similar to those commonly used in such processes. The second seal or film 322 may be applied to the distal surface of the drug container 50 before or after the cap 324 is applied.

[0105] The piercing member 316 can be fixedly engaged with the piercing member holder 314. The shaft 314A of the piercing member holder 314 can be inserted through the central hole 334B of the plate 334, and the fitting portion 338 can engage with the piercing member holder 314 so as to prevent the biasing member 336 from being decompressed. The guide member 320 can be fixedly connected to the guide member holder 330. Additionally, a sterile boot 340 can be fixedly connected to the guide member holder 330. The guide member holder 330 can be positioned within the piercing member holder 314 such that the piercing member 316 is at least partially positioned within the lumen 320A of the guide member 320. The connecting hub 312 can then be connected to the plate 334 by insertion of a snap 312C through the passage 334A. In this position, a portion of the guide member 320 is positioned within the cavity 312A, and the sterile boot 340 is engaged with the connecting hub 312. The second film 322 may be positioned to cover the opening 312B of the connecting hub 312 so as to define the cavity 312A. Additionally, during assembly, the fluid conduit may be fluidly connected to the puncture member 316. The insertion mechanism 200 may be assembled and attached to the other end of the fluid conduit. The fluid passage connector may then be assembled to the drug container 50. The connection of the fluid passage connector to the drug container may or may not occur in a clean room or sterile environment. The flow path is not exposed to contaminants so that the first film 318 and the second film 322 maintain the sterility of the punctureable seal 326 and cavity 312A, respectively.

[0106] The assembly process may also optionally include arranging the locking mechanism with respect to the proximal face of the connecting hub. The assembly process may also include arranging the secondary biasing member concentrically around a portion of the connecting hub such that the secondary biasing member is held in a compressed or biased state by the locking mechanism.

[0107] In the embodiments shown in Figures 12A to 122, the assembly may include the steps outlined above, or it may include additional or different steps. Additional or different steps may include connecting the cap 1354 to the connecting hub 1312 so that the ring seal 1352 is positioned between the connecting hub 1312 and the cap 1354. Additional or different steps may also include positioning the piercing member holder 1314 and the guide member holder 1330 on the shaft 1342 so that they are rotatable about the shaft 1342. Additionally, this step may include fixedly engaging the guide member 1320 with the first sleeve 1344, engaging the first sleeve 1344 with the second sleeve 1346, and engaging the partition wall 1348 so that it is positioned between these sleeves. This step may also include fixedly engaging the piercing member 1316 with the keeper 1350.

[0108] The embodiments shown in Figures 23-30 may also be assembled using any of the steps outlined above, and may also include additional or different steps. Additional or different steps may include, for example, connecting the disconnection mode to the connection hub in the connection mode of the connection hub.

[0109] The drive mechanism 100 can be attached to the proximal end of the drug container 50. Certain components of this subassembly can be mounted on the assembly platform 20 or directly inside the housing 12, while other components are mounted on the guide 390 for operation by the user.

[0110] The manufacture of a drug delivery device includes the step of mounting both the fluid passage connector and the drug container, either separately or as combined components, to the assembly platform or housing of the drug delivery device. The manufacturing method further includes mounting the drive mechanism, drug container, and insertion mechanism to the assembly platform or housing. Additional components of the drug delivery device, including the power and control system, actuation mechanism, and control arm, may be mounted to the assembly platform or housing, pre-formed, or pre-assembled. Adhesive patches and patch liners may be attached to the housing surface of the drug delivery device, which will come into contact with the target during the operation of the device.

[0111] A method for operating a drug delivery device includes the steps of the user activating an actuation mechanism, displacing a control arm to activate an insertion mechanism, activating a fluid passage connector, and activating a power and control system to actuate a drive control mechanism to drive a fluid drug flow through the drug delivery device, wherein the activation of the fluid passage connector involves a penetrating member piercing a pierceable seal, thereby opening a flow path from the drug container to the fluid passage connector. The method may further include the step of engaging an optional on-body sensor before activating the actuation mechanism. Furthermore, the operating method may include translating a plunger seal within the drive control mechanism and drug container to push the fluid drug flow through the drug container, fluid passage connector, sterile fluid conduit, and insertion mechanism for delivery of the fluid drug to its target.

[0112] IV. Additional Embodiments of Fluid Passage Connectors At least some of the drug delivery devices described in this application, including those described in relation to Figures 1A to 2B, may be configured to incorporate embodiments of fluid passage connectors described below in relation to Figures 33A to 33C. Where appropriate, embodiments of fluid passage connectors described below in relation to Figures 33A to 33C may replace, in whole or in part, the fluid passage connectors 300 or 6300 described above, or any other fluid passage connectors described herein.

[0113] Several fluid passage connectors may be used within embodiments of the present disclosure. Generally, a preferred fluid passage connector includes a sterile fluid conduit, a piercing member, and a sterile sleeve attached to the drug container or a sliding, piercing seal integrated within the drug container. The fluid passage connector may further include one or more flow limiting members. When the delivery device 8000 is properly activated, the fluid passage connector 8300 is activated to connect the sterile fluid conduit 8030 to the drug container of the drive mechanism 8100. Such connection is facilitated by a piercing member, such as a needle, that penetrates the piercing seal of the drug container of the drive mechanism 8100. The sterility of this connection may be maintained by making the connection within a flexible sterile sleeve. When the insertion mechanism is substantially simultaneously activated, the fluid passage between the drug container and the insertion mechanism is completed, allowing drug delivery into the patient's body. In such an embodiment, the fluid passage connector may be substantially similar to that described in International Patent Application PCT / US2012 / 054861, which is incorporated herein by reference in its entirety for all purposes. In such an embodiment, a compressible sterile sleeve may be fixedly mounted between the cap of the drug container and the connection hub of the fluid passage connector. The piercing member may remain within the sterile sleeve until connection between the fluid connection passage and the drug container is desired. The sterile sleeve may be sterilized to ensure the sterility of the piercing member and the fluid passage before operation.

[0114] Alternatively, the fluid passage connector may be integrated into the drug container, for example, as described in International Patent Application No. PCT / US2013 / 030478 or PCT / US2014 / 052329, the entirety of which is incorporated herein by reference for its entirety. According to such embodiments, the drug container may have a drug chamber in a barrel between a puncturable seal and a plunger seal. The drug fluid is contained in the drug chamber. When the patient activates the activation device, the drive mechanism exerts force on the plunger seal contained in the drug container. As the plunger seal exerts force on the gap or bubbles between the drug fluid and any air / gas, a combination of pneumatic and hydraulic pressure accumulates due to the compression of the air / gas and drug fluid, and this force is transferred to a sliding puncturable seal. The puncturable seal is slid toward the cap and punctured by a puncturing member held within an integrated sterile fluid passage connector. Therefore, the integrated sterile fluid passage connector is connected (i.e., the fluid passage is opened) by the combined pneumatic / hydraulic force of air / gas and drug fluid within the drug chamber, generated by the operation of the drive mechanism. Once the integrated sterile fluid passage connector is connected or opened, the drug fluid is allowed to flow from the drug container through the integrated sterile fluid passage connector, sterile fluid conduit, and insertion mechanism, and into the patient's body for drug delivery. In at least one embodiment, the fluid flows only through the cannula and / or needle of the manifold and insertion mechanism, thereby maintaining the sterility of the fluid passage before and during drug delivery.

[0115] In a preferred embodiment, the sterile fluid passage connector is started by the movement of the needle insertion mechanism, which in turn is started by a multifunction drive mechanism. In addition or alternatively, the sterile fluid passage connector is started directly by the movement of the multifunction drive mechanism. For example, the multifunction drive mechanism may include rotating gears such as the star gear described above, which act simultaneously or sequentially to control the rate of drug delivery, start the needle insertion mechanism, and / or start the sterile fluid passage connector. In one particular embodiment shown in Figures 33A-33C, the multifunction drive mechanism performs all of these steps substantially simultaneously. The multifunction drive mechanism rotates gears that act on several other components. These gears act on a gear assembly to control the rate of drug delivery, while also contacting the needle insertion mechanism that guides the fluid passage into the patient. When the needle insertion mechanism is activated, the connection of the sterile fluid allows the flow of drug fluid from the drug container through the fluid conduit into the needle insertion mechanism for delivery into the patient, while the gears and gear assembly of the multi-function drive mechanism control the rate of drug delivery.

[0116] Regardless of the fluid passage connector used by the drug delivery device, the drug delivery device is capable of delivering a variety of drugs having different viscosities and volumes. The drug delivery device is capable of delivering a drug at a controlled flow rate (velocity) and / or a specified volume. In one embodiment, the drug delivery process is controlled by one or more flow limiters within the fluid passage connector and / or sterile fluid conduit. In other embodiments, other flow rates may be provided by changing the geometry of the fluid passage or delivery conduit, by changing the speed at which components of the drive mechanism advance into the drug container and dispense the drug therefrom, or by a combination thereof. Further details of the fluid passage connector 8300 and the sterile fluid conduit 8030 are provided hereafter in later sections with reference to other embodiments.

[0117] V. Other Embodiments of Fluid Passage Connectors At least some of the drug delivery devices described in this application, including those described in relation to Figures 1A-2B and 33A-33C, may be configured to incorporate embodiments of fluid passage connectors described below in relation to Figures 34A-42. Where appropriate, embodiments of fluid passage connectors described below in relation to Figures 34A-42 may be used to replace, in whole or in part, the fluid passage connectors 300, 6300, or 8300 described above, or any other fluid passage connectors described herein.

[0118] In the filling process of drug containers and other drug delivery devices, it is sometimes necessary to connect two or more sterile components or subassemblies. For example, a mountable injector or drug pump may include a drug container that can be filled with a fluid drug using a standard pharmaceutical filling-final formulation process. After filling the drug container, it may be necessary to connect the drug container to one or more additional components or subassemblies to establish fluid communication between the drug container and these components. Maintaining the flow path in a sterile state is essential to prevent the introduction of harmful microorganisms into the drug and / or fluid passages. The connection of two or more sterile components or subassemblies is typically performed in a sterile environment, such as a clean room, thereby ensuring that no harmful microorganisms are introduced into the assembly. This, however, can lead to increased costs for the manufactured drug delivery device.

[0119] Embodiments of the present disclosure enable the formation of a sterile connection between two or any components or subassemblies in a sterile environment. As can be seen in Figures 34A–34C, the connection hub 310 of a fluid passage connector (e.g., fluid passage connectors 300, 6300, and / or 8300) may be connected to a drug container 350. Figure 34A shows these components before connection. A first film 318 is positioned on the connection hub 312. The first film 318 is positioned to cover the opening 312B of the connection hub 312, preventing microorganisms from entering the cavity 312A through the opening 312B, thereby maintaining the cavity 312B and the piercing member 316 in a sterile state. The piercing member 316 is partially positioned within the cavity 312A and at least partially within the retainer 314. The piercing member may be a hollow needle. The retainer 314 is engaged with the connecting hub 312 and may be configured to move parallel to the connecting hub in a direction parallel to the long axis of the penetrating member 316. The retainer may include one or more locking arms 314A that can engage with one or more first recesses 312C in the connecting hub 312. The locking arms may include projections at their lower ends, which are at least partially positioned within the upper recess in the locked position. The engagement of the bending arms maintains the spatial relationship between the retainer and the connecting hub.

[0120] The drug container 350 may include a crimp cap 324 that maintains a connection between a punctureable seal 326 and a barrel (not shown). The punctureable seal keeps the fluid drug within the barrel and prevents microorganisms and other substances from entering the drug chamber. A recess 328 is formed by the geometry of the punctureable seal. A second film 322 is attached to the drug container, thereby enclosing the recess 328 and maintaining its sterility. The first and second films may be constructed from any material capable of providing the barrier properties required to maintain the sterility of the associated surfaces. In a preferred embodiment, the film is constructed from a foil material. Alternatively, the film may be any kind of sterilizable membrane, film, or foil. Additionally, the film may be removable and / or punctureable, as well as breathable and / or permeable.

[0121] The adhesive may be applied to the outer surfaces of both the first film 318 and the second film 322 before joining the fluid passage connector and the drug container 350. The adhesive may contain antimicrobial, antimicrobial, and antiviral compounds that limit or reduce the number of such substances on the surface of the seal. During connection, the bending arm 312E may engage with the crimp cap 324 or another part of the drug container 350, thereby limiting the axial translation of the fluid passage connector relative to the drug container 350. At this position, the first film 318 and the second film 322 are in contact with each other or very close to each other. If the adhesive is present on one or more surfaces of the films, these films may be joined together.

[0122] After the fluid passage connector and the drug container 350 are joined, the retainer 314 may be moved axially parallel to the connecting hub. This parallel movement of the retainer causes the locking arm 314A to bend and engage with and disengage from the first recess 312C. The parallel movement of the retainer also causes the needle 316 to move parallel to the first film 318 and the second film 322. After the parallel movement of the retainer, the piercing member is at least partially positioned within the recess 328 of the pierceable seal 326. The retainer may be moved parallel to the retainer, leading to the pierceable seal 326 being pierced by the piercing member 316. After the pierceable seal is pierced, a flow path is established from the drug container and through the needle. The needle may also be in fluid communication with a conduit, which is configured to transport the fluid contents to a delivery mechanism such as an insertion mechanism for delivery to a patient. Penetration of the first and second films may occur during assembly. Alternatively, film penetration may occur during or near the time of use of the drug delivery device. Penetration of the perforable seal during or near the time of use may be initiated by patient interaction with the operating mechanism.

[0123] In some embodiments, the end of the piercing member may remain positioned within the cavity 328 until use. The piercing seal may be configured to deform in response to the hydraulic and / or pneumatic pressure within the drug chamber, so as to come into contact with the piercing member. This deformation of the piercing seal leads to piercing of the seal by the piercing member.

[0124] Figures 35A–35D show an embodiment in which the fluid passage connector connecting hub 1312 is connected to the drug container such that the long axis of the penetrating member 1316 is perpendicular to the long axis of the drug barrel 1330 of the drug container. As can be seen in Figure 35B, the bent arm 1312E engages with a portion of the cap 1324 to securely connect the fluid passage connector to the drug container. The fluid passage connector may further include an insertion portion 1332 located within the connecting hub 1312. The extension 1314D of the retainer 1314 may be seal-engaged with the insertion portion 1332 and may be configured to move axially parallel to the insertion portion. The projection 1314B of the retainer 1314 is initially located within the first recess 1312C of the connecting hub 1312. In this position, the penetrating end of the penetrating member 1316 is located within the insertion portion 1332. Figure 35C shows a cross-sectional view of the drug container and fluid passage connector after assembly and before the flow path is connected. As can be seen in the cross-section, the cap 1324 may include a side port 1324A that allows a piercing member to access a pierceable seal. A conduit port 1314C, which may be configured to allow a conduit to be connected to the retainer, is also shown in Figure 35C. This conduit may provide a flow path that connects the drug container to a delivery mechanism for the delivery of a fluid drug to the patient. Figure 35D is a cross-sectional view showing the assembly in an open flow path configuration. As shown, the retainer 1314 is displaced toward the central axis of the drug container. The projection 1314B of the bent arm 1314 engages with and disengages from the first recess 1312C and engages with the second recess 1312D. The piercing member 1316 pierced the first film 1318, the second film 1322, and the pierceable seal 1326. Each of these pierces may occur in response to initiation by the patient during use. Alternatively, the first and second films may be pierced during assembly. This creates a fluid pathway from the drug container through a piercing member, conduit, and insertion mechanism for delivery to the patient. Connecting the fluid pathway connector such that the long axis of the piercing member is perpendicular to the long axis of the drug container can enable smaller implementations in drug delivery devices.

[0125] In other embodiments shown in Figures 36A to 36D, the penetrating member includes an internal penetrating member 2316A and an external penetrating member 2316B. The internal penetrating member 2316A is located within the hollow external penetrating member 2316B. After the connection of the connecting hub 2312 to the drug container 2330, the external penetrating member 2316B penetrates a first film 2318 covering the end of the connecting hub 2312 and a second film 2318 covering the end of the drug container 2330, while maintaining the internal penetrating member 2316A within its hollow internal cavity. Penetration may be caused by articulation of the penetrating members 2316A and 2316B toward the drug container, or alternatively, by the drug container displacing the connecting hub, thereby exposing the external penetrating member 2316B. Since the internal piercing member 2316A does not come into contact with the first and second films 2318 and 2322, no contaminants present on the surfaces of films 2318 and 2322 come into contact with the piercing member 2316A. After piercing the films 2318 and 2322, the external piercing member retracts, thereby exposing the internal piercing member 2316A. In this position shown in Figure 36C, the end of the internal piercing member 2316A is located within the cavity 2328 created by the pierceable seal 2326. Depending on the fluid and / or air pressure in the drug container, the pierceable seal 2326 may deform as shown in Figure 36D. The deformation of the pierceable seal 2326 allows the internal piercing member 2316A to pierce the pierceable seal 2326, thereby creating a channel through the internal piercing member 2316A from the drug container 2330 for delivery to the patient.

[0126] As shown in the alternative embodiments in Figures 37-38, the fluid passage connector may include an elastomer component 3334. At least a portion of the external perforating member 2316B may be embedded in the elastomer component 3334. The external perforating member 2316B may be embedded in the elastomer component 334 while in a sterile environment. The sterile condition of the embedded portion of the external perforating member 2316B is maintained even when the flow path connection mechanism is transferred to a dirty environment, due to the sealing engagement of the external perforating member 2316B with the elastomer component 3334. Therefore, after the fluid passage connector is installed in the drug container, the fluid passage connector can be transformed into an open configuration by first piercing the first and second films 2318 and 2322 with the external piercing member 2316B, and then, while fixing and maintaining the external piercing member 2316B, moving the internal piercing member 2316A relative to the external piercing member 2316B, thereby piercing the perforated seal 3324 with the internal piercing member 2316A. In this way, the internal piercing member 2316A is not contaminated by contact with the non-sterile outer surfaces of the first and second foils 2318 and 2322. In an alternative embodiment, the external piercing member 2316B may be the sole piercing member and / or may pierce the perforated seal 3324 in addition to the first and second films 2318 and 2322. As can be seen in further alternative embodiments in Figures 38A-D, the first film 2318 and / or the second film 2322 may further include an adhesive containing the antimicrobial agent described above. Initially, the antimicrobial adhesive of the first film 2318 may be covered by a removable liner 2319, and the antimicrobial adhesive of the second film 2322 may be covered by a removable liner 2323. The removable liners 2319 and 2323 may be removed before the first film 2318 is engaged with the second film 2322 for assembly. The presence of this antimicrobial adhesive on the outer surfaces of the first and second films 2318 and 2322 prevents or inhibits contamination of their surfaces when this assembly process is carried out in a non-sterile environment.

[0127] In some embodiments shown in Figures 39A-B, an internal cavity in the external piercing member 4316B and an additional film or seal 4336 that further separates the internal piercing member 4316A may be present on the external piercing member 4316B. This seal 4336 may remain intact when the external piercing member pierces the first film 4318 and the second film 4322. This can prevent any microorganisms present on the surface of the seal from coming into contact with the internal piercing member. After piercing the first and second films 4318 and 4322, the parallel movement of the external piercing member 4318B may be limited before the external piercing member pierces the piercable seal 4326. The internal piercing member 4316A continues to move parallel toward the drug container 2330, piercing the first and second films 4318 and 4322 and the piercable seal 4326, thereby opening the flow path. Furthermore, in the embodiments shown in Figures 39A-B, the antimicrobial adhesive 4325 may first coat the outer surface(s) of the first film 4318 and / or the second film 4322.

[0128] In other embodiments shown in Figures 40A-C, the first and second films are removed from the fluid passage connector and drug container immediately before the fluid passage connector is installed. Before removal, their placement maintains the sterility of the perforated seal of the drug container and the surfaces of the elastomer components of the fluid passage connector. Except for the removal of the first and second films before connection of the fluid passage connector and drug container and the omission of the external perforating member 2316B, the embodiments shown in Figures 40A-C include the same or similar elements as those in the embodiments shown in Figures 37A-C. Therefore, in both sets of figures, the same reference numerals are used to indicate the same or similar elements. Note that the external perforating member 2316B in the embodiments shown in Figures 37A-C may be implemented in alternative forms of the embodiments shown in Figures 40A-C. It should also be noted that the elastomer component 3334 in the embodiments of Figures 40A-C differs from the elastomer component 3334 in the embodiments of Figures 37A-C in that it includes a recess or cavity 2327 configured to receive the distal end 2329 of the drug container 2330 and form an interference fit (e.g., an airtight interference fit or press fit) with it. This interference fit can prevent the entry of contaminants and thereby maintain the sterility of the interface between the drug container and the fluid passage connector. In some embodiments, the distal end 2329 of the drug container 2330 may be inserted into the recess 2327 and the elastomer component 3334 under non-sterile or aseptic conditions so that contaminants are not trapped between the distal end 2329 of the drug container 2330 and the elastomer component 3334 as a result of assembly.

[0129] As shown in the alternative embodiments in Figures 41A–D, the fluid passage connector may also be installed in the drug container 2330 using a glass tube 2335. After installation, the glass tube 2335 and the surfaces of the elastomer perforating member holder or component 3334 and perforable seal 3324 may be sterilized using UV sterilization (see Figure 41C). The glass tube may be sealed and engaged (e.g., airtight seal) with both the drug container 2330 and the elastomer component 3334 of the fluid passage connector so that after sterilization, microorganisms and other contaminants cannot come into contact with the sterile surface, thereby maintaining the sterility inside the glass tube 2335. Except for the omission of the first and second foils 2318 and 2322 and the inclusion of the glass tube 2335, the embodiments shown in Figures 41A–D may include the same or similar elements as the embodiments shown in Figures 40A–C. Thus, in both sets of figures, the same reference numerals are used to indicate the same or similar elements.

[0130] The embodiment shown in Figure 42 illustrates a connection formed perpendicular to the long axis of the drug container. In this embodiment, the first film 5318 initially sits in place, covering the cavity 5312A of the connection hub 5312 and maintaining its sterility. During connection, the first film 5318 is punctured by the insertion section 5340 of the drug container. After puncture, the punctured portion is held within the recessed section 5342 of the insertion section. By holding this punctured portion within the recessed section, the non-sterile surface of the first film is isolated, preventing any substance present on it from contaminating the drug fluid or flow path. The second film 5322 initially sits in place, covering the opening 5340A in the insertion section 5340 and maintaining the sterility of the opening. The second film 5322 may be a rigid or elastomer component that fits tightly to the insertion section so as to prevent microorganisms and other contaminants from entering the opening. When the connecting hub is installed in the drug container, the second film may be displaced from its initial position, thereby allowing a flow path to be established from the drug container through the fluid passage connector. When the connecting hub is installed in the drug container, the opening 5340A in the insertion portion 5340 is aligned with the opening 5312B in the connecting hub 5312. A perforated seal may be in place, covering one or more of the openings that can be perforated by a perforating member to establish a flow path. One or more snap arms may hold the insertion portion in place relative to the drug barrel. The snap arms may be connected to the drug barrel itself or to another component of the drug container.

[0131] VI. Additional Embodiments of Fluid Passage Connectors At least some of the drug delivery devices described in this application, including those described in relation to Figures 1A-2B and 33A-33C, may be configured to incorporate embodiments of fluid passage connectors described below in relation to Figures 43-52D. Where appropriate, embodiments of fluid passage connectors described below in relation to Figures 43-52D may be used to replace, in whole or in part, the fluid passage connectors 300, 6300, or 8300 described above, or any other fluid passage connectors described herein.

[0132] As shown in the embodiments in Figures 43-45, the drug container 1850 may consist of a barrel 1858, a cap 1852, and a punctureable seal 1856. The base 1856A of the punctureable seal 1856 may engage with the inside of the barrel 1858. The cap 1852 may be fixedly engaged with the outside of the barrel 1858 and may hold the punctureable seal 1856 in place, restricting the punctureable seal 1856 from moving relative to the barrel 1858. The cap 1852 may include one or more locking arms 1852A extending substantially parallel to and distal to axis AA from the ring 1852B of the cap 1852. The locking arms 1852A may include projections 1852C extending radially at or near their distal ends. The drug container may further include a donut-shaped seal 1857. In the initial configuration shown in Figure 43, the donut-shaped seal is held between the projection 1852B and the proximal circumferential rib 1856B of the perforated seal 1856. The perforated seal 1856 may further include a distal circumferential rib 1856C that further holds the donut-shaped seal 1857. By positioning the donut-shaped seal in this position when the drug container is in a sterile environment, even if the drug container is moved to a contaminated environment, the portion of the perforated seal 1856 that is in contact with the inner surface of the donut-shaped seal 1857 (i.e., the area between the proximal and distal circumferential ribs) will remain sterile.

[0133] The fluid passage connector 18300 includes a connecting hub 18310, a retainer 18320, a penetrating member 18330, and a plug seal 18330. As shown in Figure 45A, the plug seal 18330 is initially positioned in the hole 18310A of the connecting hub 18310. When the fluid passage connector is assembled, the plug seal maintains the sterility of at least a portion of the fluid passage connector by maintaining a sealing engagement with the hole 18310A. The retainer is positioned to slide parallel to the connecting hub 18310 in a direction parallel to axis BB (shown in Figure 45D). Initially, the parallel movement of the retainer 18320 may be limited. This limitation may be due to the engagement of the bending arm 18320B with a recess in the connecting hub 18310. The piercing member 18330 may be fixedly engaged with the retainer 18320 so that the parallel movement of the retainer 18320 is transmitted to the piercing member. The piercing member may be coupled, press-fitted, or engaged with the retainer by other suitable means. The piercing member may initially be at least partially positioned within the cavity 18310D and / or opening 18310C of the connecting hub 18310. The cavities 18310D and 18310C are kept sterile by the plug seal 18340. The retainer 18320 may further include a conduit connector 18320A to which a sterile fluid conduit 30 (see Figure 1B) may be attached. This provides a sterile flow path from the sterile fluid passage connector to the insertion mechanism. The piercing member 18330 may be a hollow needle so that fluid passes through the hollow interior of the piercing member and enters the sterile fluid conduit.

[0134] Figures 45A–D illustrate the process of connecting a fluid passage connector to a drug container. This connection may be performed in a non-sterile environment. In Figure 45A, the plug seal of the fluid passage connector is substantially aligned with axis AA (i.e., the plug seal 18340 is aligned with the distal end of the perforated seal 56). Figure 45B shows a cross-sectional view of the fluid passage connector 18300 in contact with the drug container. The recess 18310B of the connecting hub 18310 is aligned with the locking arm 1852A, and this alignment guides the installation of the fluid passage connector and prevents rotation of the fluid passage connector relative to the drug container. As shown in Figure 45C, when the connecting hub is translated proximal along axis AA, the plug seal 18340 is prevented from translating with the connecting hub due to contact with the perforated seal 1856. This causes the plug seal to be displaced from its position within its hole 18310A. Additionally, the contact of the shoulder portion 18310E of the connecting hub 18310 with the donut-shaped seal 1857 causes the donut-shaped seal to move proximal parallel along axis AA. When the connecting hub is moved parallel along axis AA, only the hole 18310A comes into contact with the portion of the perforated seal that was previously covered by the donut-shaped seal 1857. Furthermore, when the connecting hub comes into contact with the donut-shaped seal, these components engage in a sealing manner so that microorganisms and other foreign matter cannot come into contact with the sterile portions of the perforated seal and the fluid passage connector. In this way, the sterility of the perforated seal 1856, the opening 18310C, the cavity 18310D, and the perforating member 18330 is maintained during the installation of the fluid passage connector.

[0135] As can be seen in Figure 45D, further proximal translation of the connecting hub brings it into contact with a portion of the drug container 1850, and thus prevents further distal translation of the connecting hub. In the shown embodiment, the connecting hub contacts a portion of the cap 1852. When the connecting hub reaches this position, the plug seal can be removed from the assembly and discarded. A snap arm 1852A may engage with one or more aspects of the connecting hub, thereby preventing the connecting hub from being removed from the drug container.

[0136] After installation, the piercing member is aligned with the sterile portion of the piercing seal that originally engaged with the donut-shaped seal. The components are assembled into the drug delivery device 10 (see Figures 1A-1C) and remain in this configuration until the user activates the drug pump. During activation, the retainer 18320 is moved parallel to the connecting hub in a direction parallel to axis BB, causing the piercing member 18330 to move parallel to it. This movement causes the piercing member to come into contact with the piercing seal 1856 and then pierce it. This opens a fluid passage from the drug container through the piercing member. The fluid passage may further include a sterile fluid conduit 30 (see Figure 1B) engaged with the conduit connection 18320A of the retainer 18320. In this way, a sterile flow path from the drug container to the insertion mechanism is provided for delivery to the patient.

[0137] Figures 46A–46B show another embodiment of the present disclosure in which the connecting hub 181310 includes a snap arm 181310F that can engage with the cap 181052 of the drug container 181050. The donut-shaped seal 181057 is initially held between the proximal circumferential rib 181056B and the distal circumferential rib 181056C of the perforated seal 181056 and is translated in the proximal direction by contact with the connecting hub. After the installation of the fluid passage connector to the drug container, opening of the fluid passage is substantially the same as described above.

[0138] Figure 47 shows a detailed view of the plug seal positioned within the hole of the connection hub. This illustrates a possible method of holding the plug seal in place using tabs 181310G. These tabs control the position of the plug seal within the internal hole.

[0139] Figures 48–50 illustrate additional embodiments of the present disclosure illustrating alternative configurations of the cap and perforable seal.

[0140] In the embodiment shown in Figure 51, the hole 182310A is sealed on its distal surface by a distal film 182350 and on its proximal surface by a proximal film 182352. The proximal and distal films may be constructed from materials having sufficient barrier properties to prevent the passage of foreign matter. For example, the films may be constructed from foil material. The films may be bonded to or firmly adhered to a connecting hub. In this way, the hole 182310A is maintained in a sterile state.

[0141] When the fluid passage connector is brought into contact with the drug container, a portion of the drug container penetrates, tears, or removes a portion of the proximal film 182352 from the connection hub. For example, as shown in Figure 51, a portion of the cap 182052 comes into contact with the proximal film during installation, disengaging a portion of it from the connection hub. The disengaged portion of the proximal seal 182352 is held within the gap 182055 formed by the cap 182052 and the perforated seal 182056, thereby preventing the unclean portion of the proximal film 182352 from coming into contact with the sterile portion of the perforated seal 182056.

[0142] Also shown in Figure 51, seal 182057 may be configured to maintain sterility only over a portion of the circumference of the perforated seal 182056. This portion may be configured to align with the opening 182310C and the perforating member 182330 after the installation of the fluid passage connector 182300. During installation, seal 182057 is displaced by the connecting hub as described with reference to other embodiments. Seal 182057 can be held in place relative to the perforated seal by the seal engaging with the slot 182052D of cap 182052, the proximal circumferential rib 182056B, and the distal circumferential rib 182056C. During displacement, the seal moves parallel to the proximal direction within slot 182052D.

[0143] Figures 52A–52D show alternative embodiments of the fluid passage connector, in which the fluid passage connector includes a first rotating disc 183360 and the drug container 183050 includes a second rotating disc 183051. The first rotating disc 183360 may be configured to rotate relative to the connecting hub 183310 about a central axis and may further include a first opening 183360A. As shown in Figure 52A, the first rotating disc may also include a post 183360B and a receptacle 183360C. The second rotating disc 183051 may include complementary features that allow the first opening 183360A to align with the second opening 183051A. The second rotating disc 183051 may be configured to rotate relative to the drug container and may have a second opening 183051A. One or both of the openings may be covered by a film first, thereby preventing foreign matter from entering the openings.

[0144] As can be seen in Figure 52C, during installation, the first and second rotating discs are brought into contact so that the first and second openings are aligned. The rotating discs may be joined by the use of adhesive, or alternatively, they may be held in contact by features such as snap arms as described earlier in relation to other embodiments. Once connected, the discs may be rotated so that they align with the chimney 183053 and the third opening 183310F in the connecting hub 183310. The chimney 183053 may be biased to move axially distally by a spring or other biasing member capable of storing energy. As shown in Figure 52D, when aligned with the first and second openings, the chimney moves distally in parallel through both the first and second openings. The chimney may have a pass-through that allows the contents to flow out of the drug container. In this way, a sterile flow path is created between the drug container and the fluid passage connector. The fluid passage connector may further include a piercing member, which, when activated by a user, is configured to pass through a chimney and pierce a pierceable seal of a drug container. After the pierceable seal is pierced, the drug fluid can pass through the piercing member and be delivered to the patient. The piercing member may engage with a retainer 183320. The retainer may also be configured to connect to a sterile fluid conduit 30 (see Figure 1B) at a conduit connector 183320A. Parallel movement of the piercing member may be caused by parallel movement of the retainer.

[0145] In at least one embodiment, the disclosure provides a user-activated fluid passage connector. The fluid passage connector comprises a connecting hub, a penetrating member, a penetrating member retainer, and a drug container having a cap, a penetrable seal, and a barrel, the penetrating member being at least partially located within a sterile chamber defined by the connecting hub. The fluid passage connector is configured to be connected to a drug container while maintaining the sterility of the fluid passage. The drug container may contain a drug fluid for delivery. The fluid passage connector may further be in fluid communication with a conduit providing a fluid passage for delivery of a fluid drug to a patient. When activated by the user, the fluid drug is delivered to the user's body through the fluid passage. The penetrable seal includes a seal barrier that can be punctured by the penetrating member when activated by the user.

[0146] In another embodiment, the disclosure provides a drug delivery pump with integrated sterility-preserving features, having a housing and assembly platform, on which a drive mechanism having an operating mechanism, a fluid passage connector, a power and control system, and a drug container may be mounted, the fluid passage connector comprising a drug container having a connecting hub, a piercing member, a piercing member holder, and a cap, a piercing seal, and a barrel, the piercing member being at least partially located within a sterility chamber defined by the connecting hub. The fluid passage connector is configured so that it can be connected to a drug container while maintaining the sterility of the fluid passage. The drug container may contain a drug fluid for delivery. The fluid passage connector may further be in fluid communication with a conduit providing a fluid passage for delivery of the fluid drug to a patient. When activated by a user, the fluid drug is delivered to the user's body through the fluid passage connector. The piercing seal includes a seal barrier that can be pierced by the piercing member when activated by a user.

[0147] VII. Additional Embodiments of Fluid Passage Connectors At least some of the drug delivery devices described in this application, including those described in relation to Figures 1A-2B and 33A-33C, may be configured to incorporate embodiments of fluid passage connectors described below in relation to Figures 53A-68. Where appropriate, embodiments of fluid passage connectors described below in relation to Figures 53A-68 may be used to replace, in whole or in part, the fluid passage connectors 300, 6300, or 8300 described above, or any other fluid passage connectors described herein.

[0148] In general, this embodiment provides a container connector that maintains the sterility of a fluid passage and is integrated with a fluid container; a drug delivery device incorporating such a sterile fluid passage connector to a fluid container; a method for operating such a device; and a method for assembling such a device. The fluid passage connector of this embodiment provides an integrated safety feature that ensures the sterility of the fluid passage before, during, and after fluid delivery. In one embodiment, the fluid passage remains disconnected from the fluid container until the device is activated by an operator. In another embodiment, the fluid passage maintains the sterility of the piercing member before connection to the fluid container in a sterile cavity before being activated by an operator. When activated by an operator, at least a portion of the piercing seal is moved parallel to a substantially fixed piercing member, for example by air pressure and / or hydraulic pressure or a force in the fluid, thereby piercing the piercing seal and connecting or opening the fluid passage, allowing fluid to flow through the fluid passage for fluid delivery from the device.

[0149] Drug delivery devices, such as infusion pumps or bolus infusion devices, may be required to deliver a specific amount of fluid within a given period. For example, when delivering a drug fluid subcutaneously, it is important to control the flow of fluid delivered to the patient and to maintain the sterility of the fluid container and fluid passage before activating or operating the fluid delivery device. It may be desirable for the fluid passage connector to remain disconnected for the integrity, sterility, and other purposes of the container until the user activates the device and starts the flow of fluid from the container. Some drug delivery devices may utilize one or more active fluid passage control mechanisms to prevent premature fluid passage connector or drug delivery. Other drug delivery devices are configured such that the fluid passage connector is formed at the time of manufacture and fluid delivery is blocked until desired by the user. Such designs do not offer any beneficial advantages related to maintaining the integrity and sterility of the container of the internal components of the drug delivery device. This embodiment provides an integrated fluid passage connector mechanism for sterile drug delivery devices. Both of these novel embodiments provide a connection mechanism that opens or connects a sterile fluid passage between the fluid container and the fluid conduit without adding any unnecessary steps for the user. This is enabled by the operation of the drive mechanism and the parallel movement of the plunger seal, which brings about pneumatic and / or hydraulic pressure in the fluid, and this pressure forces parallel movement of at least a portion of the perforating seal, causing it to impact a substantially fixed perforating member, and thus opening a sterile fluid passage between the fluid container and the fluid conduit.

[0150] Accordingly, embodiments of the present disclosure provide a sterile fluid passage connector integrated into a fluid vessel, which is opened, connected, operated, or activated by the operation of the device and drive mechanism. The operation of the drive mechanism and the force transmitted from the drive mechanism to the plunger seal are themselves used to open the sterile fluid passage between the fluid vessel and the fluid conduit. Thus, the vessel integrity and sterility of the fluid vessel can be maintained before and during the operation of the device. This novel configuration also automates the sterile fluid passage connector process, significantly reducing the complexity of the device and the operation processes that need to be performed by the device or user. The novel embodiments of the present disclosure also allow for flexibility in the configuration of the device components and reduce the layout or overall footprint of the device, as no separate sterile fluid passage connector mechanism is required on the cap side of the fluid vessel. These embodiments may also be used in standard manufacturing of sterile fluids, including drug filling-final formulation processes, which may be implemented as a whole or in applications requiring vacuuming. Additionally, this embodiment may also integrate several different status indicators into the device, including utilizing the piercing member or plunger seal as a component of an indicator mechanism related to the status of fluid transfer from the sterile fluid container to the connector. For example, if the fluid container is a drug container, such components and the device provide a dosing completion indicator linked to the actual movement of the plunger seal and the drug delivery status.

[0151] At least one embodiment enables a sterile fluid passage connector comprising a piercing member, a connector hub, and a piercing seal. More specifically, at least one embodiment enables a sterile fluid connector comprising a first portion configured to connect to a sterile fluid passage and a second portion comprising a housing configured to house a container of sterile fluid; a connector hub; a piercing seal at least partially positioned between the connector hub and the container of sterile fluid, forming a sterile fluid chamber between the connector hub and the piercing seal; and a piercing member positioned within the connector hub capable of providing sterile fluid communication between the sterile fluid chamber and the sterile fluid passage, wherein at least a portion of the piercing seal is configured to transform from a non-operating state in which the piercing seal is intact to an operating state in which the piercing seal is broken by the piercing member, creating sterile fluid communication between the sterile fluid container and the sterile fluid passage. The housing may further be configured to recess a portion of the connector into the container of sterile fluid. The connector hub may further include at least one port or vent. The sterilization fluid passage may also include at least one sensor configured to indicate the status of fluid transfer from the sterilization fluid container to the connector. Additionally, the sterilization fluid passage connector may include one or more flow limiters. In at least one embodiment, the connector hub may function at least partially as a fluid conduit or flow limiter. In at least one embodiment, the fluid passage connector further includes a filter. Several known filters may be utilized within embodiments of the present disclosure, which will be readily apparent to those skilled in the art. For example, the filter may include a permeable, semipermeable, or porous membrane that seals the sterilization cavity from the outside environment.

[0152] The piercing member is initially held in a substantially fixed position within the sterile cavity between the connector hub and the piercing seal. When activated by an operator (e.g., a patient), at least a portion of the piercing seal is moved to a second position through which the piercing seal is pierced by the piercing member. A force, such as pneumatic and / or fluid pressure, applied to the piercing seal on the side opposite the sterile cavity causes at least a portion of the piercing seal to move parallel to the piercing member. This parallel movement of the piercing seal opens a fluid passage through the piercing seal, causing it to impact the substantially fixed or fixed piercing member. Thus, at least a portion of the piercing seal is configured to move from the first position to the second position due to the force applied to the piercing seal by the fluid. The piercing of the piercing seal by the piercing member as the portion of the piercing seal moves from the first position to the second position opens a fluid passage through the piercing seal and the fluid conduit through the piercing member.

[0153] In at least one embodiment, the perforable seal includes a seal barrier that can be penetrated by a perforating member. The perforating member may initially be in contact with or adjacent to the seal barrier.

[0154] The fluid passage connector may further include a perforating member guide, which engages with or is posable on the connector hub. The perforating member guide may function to ensure that at least a portion thereof of a perforated seal or seal barrier makes proper contact with the perforating member and moves posable on it to perforate, thereby opening a fluid passage to a fluid conduit through the perforated seal and perforating member.

[0155] The perforating member may be configured to pass through the connector hub and connect to a fluid conduit. In another embodiment, the connector hub may connect the perforating member to a fluid conduit, and the fluid conduit may be at least partially part of the connector hub. In at least one embodiment, the fluid conduit passes through the connector hub at a port of the connector hub.

[0156] In at least one embodiment, the sterile fluid connector includes at least one sensor configured to indicate the status of fluid transfer from the sterile fluid container to the connector. For example, the sterile fluid passage connector may further include one or more interconnects and, optionally, one or more corresponding contacts for transmitting signals to a user. For example, the interconnect(s) may be located in or at least partially proximal to a plunger seal that is movable in the fluid container, such that a penetrating member penetrates the plunger seal and the interconnect(s) may act as contacts for transmitting signals to a user. In addition or alternatively, to transmit signals to a user when the plunger seal and the penetrating seal are substantially in contact, the interconnect(s) or contact(s) may be located in or at least partially proximal to a plunger seal that is movable in the drug container, and the other in or at least partially distal to a penetrating seal. In addition, or alternatively, the interconnector(s) or contact(s) are located within a sterile cavity between the connector hub and the perforable seal, so that the release of pneumatic and / or hydraulic pressure at the end of fluid transfer disconnects the interconnects and transmits a signal to or stops the transmission of a signal to the user. Several known interconnectors and contacts may be used within embodiments of the present disclosure, which will be readily apparent to those skilled in the art. For example, various sensors, namely Hall effect sensors; giant magnetoresistance (GMR) or magnetic field sensors; optical sensors; capacitive or capacitance change sensors; ultrasonic sensors; and linear travel, LVDT, linear resistance, or radiometric linear resistance sensors; and combinations thereof may be used for such purposes, and these sensors can be harmonized to transmit signals between components to determine their positions.

[0157] Another embodiment enables an integrated fluid passage connector and drug container having a perforating member, a connector hub, and a perforated seal, at least partially integrated within a drug container having a barrel and a plunger seal. The perforated seal is translatably movable on a substantially fixed perforating member, and is configured to move from a first position in which the perforating member is positioned in a sterile cavity between the connector hub and the perforated seal to a second position in which the perforated seal is pierced by the perforating member. The fluid container houses a fluid chamber between the perforated seal and the plunger seal to initially hold the fluid, and is configured to move from the first position to the second position by the force exerted on the perforated seal by the fluid. In at least one embodiment, the perforated seal has a seal barrier that can be pierced by the perforating member, and the perforating member is initially in contact with or adjacent to the seal barrier.

[0158] The integrated fluid passage connector may further include a perforating member guide piece attached to the connector hub or perforating member, the perforating member guide slidably engaging with the connector hub or perforating member to allow parallel movement of the perforated seal, or a portion thereof, toward the fluid outlet from the connector. Parallel movement of the perforated seal toward the fluid container can be prevented by holding a portion of the perforated seal in place during operation, such as by a housing, for example, a crimped cap mounted on the fluid container barrel, which holds the connector hub, perforating member, and perforated seal in place. Using such a configuration, the fluid chamber of the fluid container may be evacuated by vacuum or the like before being filled with fluid, without impairing the function of the sterile fluid passage connector.

[0159] In at least one embodiment, the connector hub has a header having a conduit port, a chamber, and a vacuum port having a channel leading to the chamber so that a sterile cavity can be evacuated through the channel. The conduit port may have a membrane or seal that allows fluid to flow out of the chamber and may be plugged. Similarly, the vacuum port may be plugged by a polymer plug or the like. Such a configuration allows the sterile cavity to be evacuated, for example, to maintain both sterility and pressure equilibrium between the sterile cavity and the opposite side of the perforated seal, or to assist in maintaining the relative positions of components before or during operation of the device by the user.

[0160] In at least one embodiment, a perforated seal, or at least a portion thereof, is translatably movable on a perforating member, and the perforated seal is further configured to move from a second position in which the perforated seal is pierced by the perforating member to a third position in which at least one sensor indicates the status of fluid transfer from a sterile fluid container to a connector. For example, in the third position, one or more interconnects and one or more corresponding contacts are permitted to transmit a signal to a user. In such one embodiment, to transmit a signal to a user when the plunger seal and the perforated seal are substantially in contact, the interconnect(s) or contact(s) are located on some aspect of the drive mechanism, while the other is located within or at least partially proximal to the plunger seal. Alternatively, to transmit a signal to a user when the plunger seal and the perforated seal are substantially in contact, the interconnect(s) or contact(s) are located within or at least partially distal to the perforated seal, while the other is located proximal to the connector hub. In addition, or alternatively, the interconnector(s) or contact(s) are located within a sterile cavity between the connector hub and the perforable seal, so that the release of air and / or fluid pressure at the end of drug administration disconnects the interconnects and transmits a signal to or stops the transmission of a signal to the user. Several known interconnectors and contacts may be used with this embodiment, which will be readily apparent to those skilled in the art. For example, various sensors, namely Hall effect sensors; giant magnetoresistance (GMR) or magnetic field sensors; optical sensors; capacitive or capacitance change sensors; ultrasonic sensors; and linear travel, LVDT, linear resistance, or radiometric linear resistance sensors; and combinations thereof may be used for such purposes, and these sensors can be harmonized to transmit signals between components to determine their positions.

[0161] Another embodiment provides a drug delivery device with an integrated sterility-maintaining feature, comprising a housing in which a fluid container having an operating mechanism, an insertion mechanism, and a plunger seal can be installed. The fluid container is connected to the operating mechanism at one end and to a fluid passage connector at the other end. The fluid passage connector includes a piercing member, a connector hub, and a piercing seal, the piercing member being held in a sterile cavity between the connector hub and the piercing seal, and the piercing seal being configured to move from a first position to a second position in which the piercing seal is pierced by the piercing member. The fluid container houses a fluid chamber between the piercing seal and the plunger seal to initially hold the fluid, and the piercing fluid seal is configured to move from the first position to the second position by the force exerted on the piercing seal by the fluid. In at least one embodiment, the piercing seal has a seal barrier that can be pierced by the piercing member, the piercing member initially in contact with or adjacent to the seal barrier.

[0162] The drug delivery device may further include a piercing member guide piece engaged with a connector hub or piercing member, the piercing member guide slidably engaged with the connector hub or piercing member to allow distal translation (i.e., toward the fluid conduit) of the piercing seal or a portion thereof. Proximal translation of the piercing seal can be prevented by holding the piercing seal or a portion thereof by a housing, such as a crimped cap mounted on a barrel, which holds the connector hub, piercing member, and piercing seal in place during operation. Using such a configuration, the drug chamber of the drug container may be allowed to be evacuated by vacuum or the like before being filled with fluid without impairing the function of the sterile fluid passage connector. In at least one embodiment, the connector hub has a header with a conduit port, a chamber, and a vacuum port having a channel leading to the chamber so that the sterile cavity can be evacuated through the channel. Conduit ports may have filters, membranes, or seals that allow or restrict fluid from flowing out of the chamber. Similarly, vacuum ports may be plugged with polymer plugs or the like. Such configurations may allow the sterile cavity to be evacuated, for example, to maintain sterility between the sterile cavity and the opposite side of the perforated seal, to maintain pressure equilibrium, or to assist in maintaining the relative positions of components before or during operation of the device by the user.

[0163] In at least one embodiment, the perforated seal is translatably movable on an aspect of a perforating member or connector hub and is further configured to move from a second position through which the perforated seal is pierced by the perforating member to a third position in which one or more interconnects and one or more corresponding contacts are permitted to transmit signals to the user. The interconnector(s) and corresponding contact(s) are configured, for example, as follows: (a) to transmit a signal to the user when the plunger seal and the perforated seal are substantially in contact, the interconnector(s) or contact(s) are positioned above a drive mechanism, with the other positioned within or at least partially proximal to the plunger seal; (b) to transmit a signal to the user when the plunger seal and the perforated seal are substantially in contact, the interconnector(s) or contact(s) are positioned within or at least partially distal to the perforated seal, with the other positioned proximal to the connector hub; (c) the interconnector(s) and contact(s) are positioned within a sterile cavity between the connector hub and the perforated seal, such that after the seal is perforated, the continuing pressure within the drug chamber causes interconnection, which transmits a signal to the user, and the signal terminates once the pressure inside the drug chamber drops and the interconnection is lost (i.e., at the end of drug administration). Several known interconnects and contacts may be utilized within embodiments of the present disclosure, which will be readily apparent to those skilled in the art. For example, various sensors, namely Hall effect sensors; giant magnetoresistance (GMR) or magnetic field sensors; optical sensors; capacitive or capacitance change sensors; ultrasonic sensors; and linear travel, LVDT, linear resistance, or radiometric linear resistance sensors; and combinations thereof, may be used for such purposes, and these sensors can be harmonized to transmit signals between components to determine their positions.

[0164] Additionally, the fluid passage connector may include one or more flow restrictors. In at least one embodiment, the connector hub may function at least partially as a fluid conduit or flow restrictor. In at least one embodiment, the fluid passage connector further includes a filter. Several known filters may be utilized within embodiments of the present disclosure, which will be readily apparent to those skilled in the art. For example, the filter may be a permeable, semipermeable, or porous membrane that seals the sterile cavity from the outside environment.

[0165] The novel devices of this embodiment provide a container fluid passage connector integrated into a fluid container, which maintains the sterility of the fluid passage, and a drug delivery device incorporating such an integrated sterile fluid passage connector into the fluid container. Since the flow path is interrupted until the operator desires fluid delivery, sterility is maintained within the fluid passage connector, fluid container, fluid, and the entire device. Furthermore, the novel configurations of the fluid passage connector and drug delivery device of this disclosure maintain the sterility of the flow path throughout the operation of the device. Because the passage through which the fluid moves within the device is maintained in a completely sterile state, these components only need to be sterilized during the manufacturing process. Such components include the fluid container of the drive mechanism, the fluid passage connector, the sterile fluid conduit, and the insertion mechanism. In at least one embodiment of this disclosure, the power and control system, assembly platform, control arm, actuation mechanism, housing, and other components of the drug delivery device do not need to be sterilized. This significantly improves the manufacturability of the device and reduces associated assembly costs. Therefore, the devices of this embodiment do not require final sterilization upon completion of assembly. A further advantage of this embodiment is that the components described herein are designed to be modular, for example, so that the fluid passage connectors and other components of the device can be integrated into the housing and easily interfaced to function as a drug delivery device.

[0166] Further embodiments provide a method for assembling an integrated sterile fluid passage connector and fluid container. The sterile fluid passage connector may first be assembled and then mounted, installed, connected, or integrated into the fluid container so that at least a portion of the perforable seal is housed within the drug container. The fluid container may then be filled with fluid for delivery to the user and sealed with a plunger seal at the end opposite the perforable seal. The barrel may be filled with fluid through its proximal opening before insertion of the plunger seal from the proximal end of the barrel. The drive mechanism may then be mounted on the proximal end of the fluid container so that the components of the drive mechanism are in contact with the plunger seal. The insertion mechanism may be assembled and mounted on the other end of the fluid conduit. The entire subassembly, including the drive mechanism, drug container, fluid passage connector, fluid conduit, and insertion mechanism, may be sterilized as described above before assembly into a drug delivery device. Certain components of this subassembly may be mounted on an assembly platform within the housing or directly inside the housing, while other components may be mounted as guides, channels, or other components or embodiments for user operation. A method for manufacturing a drug delivery device includes the step of mounting both the fluid passage connector and the fluid container, either separately or as combined components, to the assembly platform or housing of the drug delivery device. The manufacturing method further includes mounting the drive mechanism, fluid container, and insertion mechanism to the assembly platform or housing. Additional components of the drug delivery device described herein, including power and control systems, actuation mechanisms, and control arms, may be mounted on the assembly platform or housing, pre-formed, or pre-assembled. In cases where the fluid is a drug and the drug delivery device is a portable infusion device, adhesive patches and patch liners may be attached to the housing surface of the drug delivery device that comes into contact with the user during the operation of the device.

[0167] A method for operating a drug delivery device includes one or more steps of the following: the user activating an actuation mechanism; displacing a control arm to activate an insertion mechanism; and activating a drive control mechanism to press a plunger seal, connect it to a sterile fluid passage connector, and drive a fluid drug flow through the drug delivery device, wherein pressing the plunger seal causes the fluid to move in parallel, thus deforming the perforated seal toward the fluid conduit, allowing it to be perforated by a perforating member, thereby opening a flow path from the fluid container to the fluid conduit. The drive control mechanism may be activated by activating a power control system. The method may further include the step of engaging an optional on-body sensor before activating the actuation mechanism. Furthermore, the operating method may include moving the plunger seal in parallel within the drive control mechanism and the fluid container to deliver the fluid to a desired target, e.g., the patient's body, thereby pushing the fluid flow through the fluid container, fluid passage connector, fluid conduit, and insertion mechanism for delivery of the fluid drug to the target.

[0168] The novel device of this embodiment provides a drug delivery device that maintains the sterility of the fluid passage and incorporates a container connector integrated with the fluid container, as well as such an integrated sterile fluid passage connector to the fluid container. For example, such a device is safe, easy to use, aesthetically and ergonomically appealing to self-administering patients.

[0169] In at least one embodiment, the sterile fluid passage connector of the present disclosure comprises a penetrating member, a connector hub, and a penetrating seal, wherein at least a portion of the penetrating seal is configured to move from a first position in which the penetrating member is held within a sterile cavity between the penetrating seal and the connector hub to a second position in which the penetrating seal is pierced by the penetrating member. A filter may be used to seal the sterile cavity from the outside environment. Such a fluid passage connector may be integrated with a fluid vessel having a barrel and a plunger seal. Components of the fluid passage connector may further transmit signals to the user upon completion of fluid delivery, for example, upon contact between the plunger seal and the penetrating seal. A fluid delivery pump includes such an integrated fluid passage connector and fluid vessel.

[0170] Novel embodiments presented herein provide an integrated sterile fluid passage connector and fluid container, as well as a drug delivery device utilizing such a connector, configured to maintain the sterility of the fluid passage before, during, and after device operation, thereby enabling active safety control of the device. Integrating the fluid passage connector into a portion of the fluid container helps ensure the integrity of the container and the sterility of the fluid passage. Additionally, by integrating the sterile fluid passage connector into a portion of the fluid container, the connection for fluid transfer can be controlled by the user (i.e., user-operated) and activated by the function of a drive mechanism. Thus, user-operated processes and the internal operation of drug delivery devices can be greatly simplified by the novel integrated sterile fluid passage connector of this embodiment.

[0171] This novel embodiment provides a drug delivery device that incorporates a container connector integrated with a fluid container, maintaining the sterility of the fluid passage, and such an integrated sterile fluid passage connector into the fluid container. This embodiment also further integrates the sterile passage connector with the fluid container to reduce the number of components required for the connector and drug delivery device, or to provide easier and more efficient operation of the connector and drug delivery device. The connector, sterile fluid passage assembly, and infusion pump disclosed herein are not limited to medical applications and may also include any applications, including industrial applications where sterile or uncontaminated fluid delivery is desired. When the fluid is a drug, this embodiment provides a device that is safe, easy to use, and aesthetically and ergonomically appealing to self-administering patients. The embodiments described herein incorporate features that simplify the operation, handling, and lockout of the device, even for untrained users. One or more components of this embodiment may be modular in that they may be pre-assembled, for example, as separate components during manufacturing and configured to fit into a predetermined position within the housing of the drug delivery device.

[0172] Figures 53A and 53B show the initial configuration of an embodiment of a sterile fluid passage connector 23030 integrated with a fluid vessel 23050 having a fluid chamber 23021 and a plunger seal 23060. In some embodiments, the fluid passage connector 23030 and the fluid vessel 23050 may be partially or entirely replaced by a fluid passage connector 30 and a fluid vessel 50 illustrated in Figure 1B of this application. The fluid passage connector 23030 may be permanently or detachably installed, connected, or attached to the fluid vessel 23050 at the end opposite the plunger seal 23060. As shown in the embodiments of Figures 53A and 53B, the fluid vessel 23050 has a variable fluid chamber 23021 within a barrel 23058, defined by the positions of a perforable seal 23056 and a plunger seal 23060. The seals described herein may be made of several materials, but are typically made of one or more elastomers or rubbers. The fluid chamber 23021 may contain fluid for delivery through an integrated sterile fluid passage connector 23030. In the embodiments of Figures 53A and 53B, the fluid passage connector 23030 includes a sterile fluid conduit 23035, a piercing member 23033, a connector hub 23031, and a piercing seal 23056. The fluid passage connector 23030 includes a piercing member guide 37 engaged with the connector hub 23031, which allows the piercing seal 23056 to interface with the piercing member 23033 of the connector hub 23031 during operation. A permeable, semipermeable, or porous membrane, such as filter 23039, may be used to allow air to circulate from within the fluid passage connector 23030 during device operation, for example, through a port or vent 23031B in the connector hub 23031. Filter 23039 may be mounted, installed, bonded, overmolded, co-formed, pre-formed, or connected to seal a sterile cavity 23032 between the external connector hub 23031 and the perforable seal 23056.The terms “seal” or “enclosed” are used herein to define a confined area that is at least semipermeable or porous, which is sterilized, evacuated by vacuum, and permeable, but is not permeable by microorganisms, contaminants, or other undesirable environmental factors. For example, a filter 23039 may be at least partially overmolded within a connector hub 23031 to isolate a sterilized cavity 23032 from the outside environment. In some embodiments, the filter is a membrane, such as a semipermeable membrane, that allows air to pass through a permeable seal 23056, a fluid passage connector 23030, and the pump device during startup. The filter 23039 may be sterilized by methods well known to those skilled in the art, and thus the filter can maintain a sterilized barrier that prevents exposure of the permeable member 23033 to microorganisms, contaminants, or other undesirable environmental factors.

[0173] As shown in Figure 53B, the perforating member 23033 is held within an integrated sterile fluid passage connector 23030 in or near the seal barrier 23056C of the perforable seal 23056. The perforating member 23033 may be an embodiment of the fluid conduit 23035, or it may be a component separate from the fluid conduit 23035, as will be readily apparent to those skilled in the art. Additionally, the fluid passage connector 23030 may optionally include one or more gaskets, O-rings, or other sealing members compressed into a seal between the barrel 23058 (particularly in the lip 23058A), the connector hub 23031, and the housing 23052. In at least one embodiment, the sealing embodiment 23056A of the perforable seal 23056 may be configured as a seal between the barrel lip 23058A, the connector hub 23031, and the housing 23052. The housing 23052 may be a separate component, such as a crimp cap, or it may be a connector hub 23031 that can be mounted on the barrel 23058. The housing or cap may also have threads configured to complement the threads in the fluid vessel, or other temporary means may be used to connect the fluid vessel to the sterile fluid passage connector. As shown in Figures 53A and 53B, the sterile fluid passage connector 23030 may be mounted (i.e., integrated with) the fluid vessel 23050, which is then sterilized by some known method, and subsequently mounted permanently or detachably on an assembly platform or housing of a fluid pump, such as the drug delivery device 10 shown in Figures 1A-1C. The assembly platform may be a separate component from the housing, or it may be an integrated component of the housing, such as a pre-formed mounting configuration on the inner surface of the housing. In this configuration, the sterility of the fluid passage is maintained, the passage for fluid flow is not connected until desired by the user, and user-initiated operation triggers the connection of the fluid chamber and the fluid passage connector. The fluid passage connector may optionally further include one or more separate flow limiters, or one or more of the perforating member 23033 and the fluid conduit 23035 may additionally function as flow limiters.

[0174] The integrated fluid connection of this embodiment is further illustrated with reference to a drive mechanism, as shown in Figures 54A and 54B. This embodiment includes a fluid conduit 23035 engaged with a perforating member 23033 at an engaging portion 23038, a connector hub 23031 including a vent 23031B, a filter 23039 housed in contact with the connector hub 23031, and a perforated seal 23056A whose sealing portion 23056 abuts against the connector hub 23031 and the end of the barrel 23058, all of which are housed in a cap 23052. The barrel 23058 includes a variable fluid chamber 23021, which houses a plunger seal 23060 slidably positioned therein and in contact with a drive mechanism (e.g., drive mechanism 100 illustrated in Figure 1B), including a deflection member 23099. Figure 54A is an exploded side view of the components of an integrated sterile fluid passage connector and fluid container according to at least one embodiment. Figure 54B shows a cross-sectional exploded view of the same embodiment. The sterile fluid passage connector 23030 can be at least partially integrated into the fluid container 23050 at the end opposite to the plunger seal 23060. To clarify the orientation of these components, an exemplary drive mechanism 23090 is shown in these figures. The components of a novel sterile fluid passage connector 23030 can be pre-assembled (see, for example, Figure 56A) and then permanently or detachably attached, installed, connected, or mated with a fluid container such as the fluid container 23050.

[0175] Several drive mechanisms may be used to push the fluid out of the fluid container for delivery. In one such embodiment, the drive mechanism 23090 may be substantially the same as that described in WO2013 / 023033467 (PCT / US2012 / 023052303241). During operation, components of the drive mechanism may be used to drive axial translation of the plunger seal of the fluid container distally (i.e., toward the housing 23052 in Figure 53). Optionally, the drive mechanism may include one or more compliance features that allow for additional axial translation of the plunger seal to ensure, for example, that substantially the entire drug dose has been delivered to the user and that the feedback contact mechanism has been connected or interconnected. Furthermore, the drive mechanism may include one or more safety mechanisms, such as a premature activation prevention mechanism, to improve the safety and usefulness of the mechanism and device.

[0176] In certain embodiments, the drive mechanism 23090 uses one or more compression springs 23099 as biasing members, as shown in Figure 54B. When the fluid pump is activated by the user, the power and control system is activated to directly or indirectly release the compression spring(s) from their biased state. Once released, the compression spring(s) exert pressure on and act upon the plunger seal 23060, thereby pushing the fluid out of the variable fluid chamber 23021 of the drug container 23050, as further described with reference to Figures 55A-55C.

[0177] Figures 55A to 55C illustrate the features of embodiments before use, during penetration of the perforated seal, and upon completion of fluid delivery. More specifically, in the configuration shown in Figure 55A, the perforated member 23033 is maintained within the sterile cavity 23032, with its first end (proximal end) adjacent to or in contact with the perforated seal 23056 of the fluid passage connector 23030. The sterility of the cavity 23032 and the perforated member 23033 is maintained, for example, by a filter 23039 positioned between the sterile cavity 23032 and the outside environment. In at least one embodiment, as shown in Figure 55, the filter 23039 is connected to, engaged with, or part of the connector hub 23031, sealing the sterile cavity 23032 from the outside environment. The sterile cavity 23032 can be vented through a vent or port 23031B in the hub connector 23031. Thus, the fluid passage connector 23030 is mounted on and integrated with the fluid container 23050, for example, by the housing (cap) 23052 engaging with the lip 23058A of the barrel 23058, in at least one embodiment. The piercing member can be a variety of cannulas or conduits, such as a rigid needle, and can be made of a variety of materials, such as steel. In at least one embodiment, the piercing member 23033 is a rigid steel needle. The piercing seal 23056 may have a sealing configuration 23056A that allows the piercing seal 23056 to be mounted directly on the barrel 23058, connector hub 23031, and cap 23052, or to be held in place between them. The connector hub 23031 includes an internal seal mount 23034 that further stabilizes the position of the perforated membrane 23056 in a more fixed manner. At least a portion of the perforated seal 23056, such as the seal barrier 23056C, can be translated on the connector hub 23031 as described herein, to contact the perforating member 23033 and rupture, thereby activating the fluid passage connector to the sterile fluid conduit 23035. Advantageously, such an arrangement allows the perforated seal 23056 to be translated toward the cap 23052 but not toward the plunger seal 23060.This is a desirable feature, as it allows the fluid chamber 23021 of the fluid container 23050 to be evacuated by vacuum or the like before being filled with fluid, without impairing the function of the sterilization fluid passage connector 23030.

[0178] In the initial position, the proximal end of the piercing member 23033 may reside adjacent to or in contact with the seal barrier 23056C of the pierceable seal 23056, for example, to minimize the distance that needs to be moved parallel to allow the seal barrier 23056C to be pierced and to open the fluid container 23050 to the fluid passage connector 23030. In certain embodiments, the proximal end of the piercing member 23033 may reside at least partially within the seal barrier 23056C of the pierceable seal 23056, but still not fully through it until the user activates the device.

[0179] As shown in Figure 55B, once the pump device is activated and the drive mechanism presses the plunger seal 23060, the plunger seal 23060 exerts force on the fluid chamber 23021, and air pressure and / or hydraulic pressure accumulate due to the compression of the fluid within the chamber 23021. When air pressure and / or hydraulic pressure accumulate within the fluid chamber 23021, this force is transferred to the perforated seal 23056, causing deformation of the barrier seal 23056C. This transformation may include shifting, reversing, translating, bending, deforming, snapping, or any other functionally equivalent change, such as a portion of the perforated seal 23056, including the seal barrier 23056C, colliding with a substantially fixed position on the perforating member 23033, causing the perforating member 23033 to penetrate the perforated seal 23056 in the seal barrier 23056C as shown in Figure 55B, thereby opening or connecting a fluid passage between the variable fluid chamber 23021, the perforating member 23033, and the fluid conduit 23035.

[0180] Therefore, the integrated sterile fluid passage connector 23030 is connected (i.e., the fluid passage is opened) by the air pressure and / or fluid pressure in the fluid chamber 23021 generated by the operation of the drive mechanism. Once the integrated sterile fluid passage connector 23030 is connected or opened, the fluid is allowed to flow from the drug container 23050 through the integrated sterile fluid passage connector 23030 and the sterile fluid conduit 23035. In embodiments where the fluid pump is a portable drug infusion pump, the fluid drug then flows into the user's body through the insertion mechanism for drug delivery. In at least one embodiment, several flow limiters may be optionally used to modify the flow of fluid in the fluid passage connector. In at least one embodiment, the fluid flows only through the manifold and the cannula or needle of the insertion mechanism, thereby maintaining the sterility of the fluid passage before and during fluid delivery.

[0181] In addition or alternatively, the plunger seal 23060 or the perforated seal 23056 may have some compressibility to allow a push by compliance of the drug fluid from the drug container 23050. Furthermore, the drive mechanism, plunger seal 23060, connector hub 23031, perforated seal 23056, or a combination thereof may include one or more sensors or status indicators, such as interconnects and contacts, to measure and communicate the status of the drug delivery drive before, during, and after operation of the device for delivering fluid.

[0182] Figure 55C shows the components of the fluid container 23050 and the sterilized fluid passage connector 23030 after substantially all of the fluid has been pushed out of the fluid container 23050. Specifically, the plunger seal 23060 is located at the most distal position within the barrel 23058. In the embodiment shown in Figure 55C, the connector hub side (e.g., distal end) of the plunger seal 23060 is configured with an optional projection and cavity configuration 23069, which minimizes the remaining volume within the now folded fluid chamber 23021. Alternatively, the plunger seal may be a flat-face plunger seal (e.g., the plunger seal 23160 in Figures 57A and 58) or may have any number of other configurations that will be readily understood by those skilled in the art. In the embodiment shown in Figure 55, the plunger seal 23060 further includes an interconnection / contact portion 23061, and the connector hub 23031 further includes an interconnection / contact portion 62. Upon completion of delivery, the interconnection / contact portion 61 of the plunger seal 23060 and the interconnection / contact portion 62 of the connector hub 23031 interconnect and transmit a signal that can be perceived by the user. Numerous sensors and signal transmission means may be incorporated or adapted for use in this embodiment, as described herein.

[0183] Due to the novel design of the fluid passage connectors in this embodiment and the at least partial integration mechanism within their fluid containers, the sterility of the fluid passages is maintained throughout the transport, storage, and operation of the device, simplifying operation by the user of the device, and connecting the fluid passages only when desired by the user. The sterility of the fluid passage connectors is initially maintained by making connections between the connector hub 23031, the perforated seal 23056, and the perforated member guide 23037 within the sterilization cavity 23032. In at least one embodiment, the sterility of the cavity 23032 is maintained by a filter 23039 that abuts against, engages with, or is part of the connector hub 23031. The filter 23039 may be, for example, a semipermeable membrane that allows air to pass through the vent 23031B of the connector hub 23031 during the activation and translation of the perforated seal 23056. The filter 23039 may be sterilized by a typical sterilization method readily understood by those skilled in the art, thereby maintaining a sterile barrier to prevent exposure of the penetrating member 23033 to microorganisms, contaminants, or other undesirable environmental factors. For example, when the insertion mechanism is substantially simultaneously operated, the fluid passage between the variable fluid chamber 23021 and the insertion mechanism is completed, allowing drug delivery into the user's body. The fluid passage connector 23030 is not fluidly connected or in communication with the fluid chamber 23021 until the fluid pump and drive mechanism are operated, thus preventing the flow of fluid from the fluid container 23050 until desired by the user. This provides the user with an important safety feature and maintains the container integrity of the fluid container and the sterility of the fluid passage.

[0184] The drive mechanism for translating the plunger seal 23060 may house one or more drive biasing members (for example, as shown in Figure 54B). The components of the drive mechanism function to push the fluid out of the variable fluid chamber 23021 through the perforated seal 23056 and through the perforating member 23033 or sterile fluid conduit 23035 for delivery through the fluid passage connector 23030. Further with respect to the drive mechanism, several drive mechanisms may be used to push the fluid out of the drug container for delivery into the user's body. In one such embodiment, the drive mechanism 23090 may be substantially similar to that described in WO2013 / 023033467 (PCT / US2012 / 023052303241), and these documents are thus incorporated herein by reference in their entirety. When in operation, the components of the drive mechanism are used to drive the distal axial translation of the plunger seal of the drug container. Optionally, the drive mechanism may include one or more compliance features that allow for additional axial translation of the plunger seal, for example, to ensure that substantially the entire fluid dose is delivered to the user and that the feedback contact mechanism is connected. Furthermore, the drive mechanism may include one or more safety mechanisms, such as a premature operation prevention mechanism, to improve the safety and usefulness of the mechanism and device.

[0185] At least one embodiment enables a modular fluid passage connector. Figures 56A and 56B detail an embodiment of a modular fluid passage connector that includes a connector hub 23031 that abuts a filter 23039 and a perforated seal 23056A in a sealing member 23056A. The connector hub 23031, filter 23039 and perforated seal 23056 are housed in a cap 23052 as shown in Figure 56A. The connector hub 23031 further includes a header 23031C that forms a joint between the fluid conduit 23035 and the perforated member 23033. As shown in Figures 56A and 56B, the fluid conduit 23035 may be connected directly to the perforated member 23033. Alternatively, as shown in Figure 57A, the fluid conduit 223035 may be connected via a conduit port 223038. Nevertheless, the modular fluid passage connector can be adapted for use with several alternative barrel and drive configurations and can be used in a variety of portable infusion devices. The components of the novel sterile fluid passage connector 23030 may be pre-assembled to have the appearance illustrated in Figure 56A, and then be attached, installed, connected, or mated to a fluid container such as the fluid container 23050. Alternatively, the components of the sterile fluid passage connector 23030 may be assembled directly to the drug container 23050. As will be readily apparent to those skilled in the art, one or more of the components described herein can be engaged in permanent or temporary connections as desired for a particular use, using several glues or adhesives, or other connection methods such as snap fastening, interlocking, screw fastening, fusion bonding, welding, ultrasonic welding, laser welding, and mechanical fastening. For example, glue can be used between the distal end of the barrel 23058, the sealing member 23056A, or the connector hub 23031A. In addition or alternatively, the components of the sterile fluid passage connector 23030 may be mounted on the barrel 23058 and held in place by the crimped cap 23052 relative to the distal aspect of the barrel 23058, for example, relative to the flanged aspect or lip of the barrel 23058A.

[0186] In at least one embodiment, as shown in Figures 57A to 57C, a penetrating member guide 230237 may be used to guide the penetrating seal 23056 and slidably engage with the connector hub 230231. In addition or alternatively, the penetrating member guide 230237 may be used to ensure that the penetrating member 230233 remains substantially centered on the axis so that the penetrating seal 23056 penetrates a desired portion of the seal barrier 23056C. The embodiment in Figure 57A shows a fluid container that includes a barrel 23058, forming a variable fluid chamber 23021 between the plunger seal 230260 and the penetrating seal 56. As shown in Figure 57A, the plunger seal 230260 is a flat plunger seal, but various plunger seal shapes can be adapted for use with the fluid connection and infusion pump of this embodiment. The embodiment in Figure 57A further includes a filter 23039 which abuts against the connector hub 230231 and is used to maintain the sterility of the sterilization chamber 23032 between the connector hub 230231 and the perforated seal 23056. The connector hub 230231 also includes a seal mount 230234 which abuts against the perforated seal 23056, and a flange 230231A which abuts against the sealing member 23056A of the seal 23056, which in turn abuts against the distal lip 23058A of the barrel 23058. The contact surfaces of the connector hub 230231A, the sealing member 23056A, and the barrel lip 23058A are positioned and fixed within the periphery of the cap 23052. The connector hub 230231 also houses a perforated member 230233 which connects to a fluid conduit 230235. The connector hub 230231 also has a vacuum port 230231B, which is a filtration channel leading to the sterilization chamber 23032. The connector hub 230231 is also configured with a conduit port 230231D, which provides an outlet from the sterilization fluid connector 230230 to an infusion device (e.g., an injection means), via a sterilization fluid conduit 23035 (not shown), etc.The conduit port 230231D and vacuum port 230231B may include membranes or seals, such as unidirectional seals, that allow fluid flow from the chamber 23032 through their respective ports but do not allow fluid flow into the chamber 23032 through these ports. Additionally or alternatively, the conduit port 230231D and vacuum port 230231B may be plugged at a particular assembly or operation point. For example, the sterile cavity 23032 may be evacuated using the vacuum port 230231B at any point during manufacturing, assembly, or before operation of the device, and then the vacuum port 230231B can be plugged after the evacuation is complete.

[0187] Furthermore, with respect to the piercing member guide 230237, this component can be slidably attached to the connector hub 230231. This slidable attachment may be facilitated by several means known in the art, such as the engagement between the connector tip 230237D and leg 230237A of the piercing member guide 230237 and the complementary cavity 230236 in the connector hub 230231. These components can be seen more clearly in Figures 57A and 144B. Figure 57B shows the orientation of the piercing member 230233 within the piercing member guide 230237, emerging from the header 230237C, and Figure 57C shows the orientation of the piercing member 23033 and the piercing member guide 230237 within the connector hub 230231. Such arrangement configurations allow the perforated seal 23056 and the perforated member guide 230237 to move together toward the housing 23052 over at least a portion of the translation of the seal barrier 23056C. Additionally, the perforated seal 23056 may be detachably attached to the perforated member guide 230237 by some means known in the art, such as a detachable snap-fit ​​engagement, or it may be configured to allow contact between components for guiding the translation of the seal barrier 23056C over the perforated member 230233. When a perforated member guide such as the perforated member guide 230237 in Figure 57A is used, the perforated member guide may move together with the perforated seal 23056 over at least a portion of their translation to ensure that the seal barrier 23056C contacts the perforated member 230233 and is thereby perforated. Once the fluid passage is opened or connected, the distal parallel movement of the plunger seal 230160 by the drive mechanism causes the fluid in the drug chamber 23021 to be pushed through to the sterile fluid connector. In some embodiments, the needle insertion mechanism described herein may be connected at the other end of the fluid conduit 23035 to facilitate the transfer of fluid to the user, allowing the needle to be inserted into the user's body.

[0188] The embodiment shown in Figure 57A also includes a plunger seal 260 which may be used as part of a status indicator mechanism together with the penetration member guide 237. More specifically, in this embodiment, the plunger seal 260 includes interconnection / contact portion 261 and corresponding interconnection / contact portion 262 located on the penetration member guide 237. When the plunger seal 260 and the penetration member guide 237 reach proximal position at the end of delivery (for example, as shown in Figure 57C), the interconnection / contact portion 261 and the interconnection / contact portion 262 interconnect and transmit a signal perceptible to the user.

[0189] Novel embodiments presented herein provide an integrated sterile fluid passage connector and fluid container, as well as a fluid pump utilizing such a connector, configured to maintain the sterility of the fluid passage before, during, and after device operation, thereby enabling active safety control of the device. Integrating the fluid passage connector into a portion of the fluid container helps to ensure the integrity of the container and the sterility of the fluid passage. Additionally, by integrating the sterile fluid passage connector into a portion of the fluid container, the connection for fluid transfer can be controlled by the user (i.e., user-operated) and activated by the function of the drive mechanism. Thus, user-operated processes and the internal operation of the fluid pump can be greatly simplified by the novel integrated sterile fluid passage connector of this embodiment.

[0190] In another embodiment, the fluid container includes at least two variable internal compartments, each including a separate perforated seal at the interface between the compartments, which can be broken by a perforating member of a sterile fluid passage connector to create sterile fluid communication between the sterile fluid passage and that compartment of the container of sterile fluid. As shown in Figure 58, the container 23050 may utilize one or more seals in addition to the plunger seal 230160 and the perforated seal 230156. This may be applicable, for example, when it is desired that multiple fluid substances be delivered by the container and infusion pump device. Figure 58 shows one such embodiment in which two additional seals, 230163 and 230165, are used to create compartments or chambers 230121A, 230121B and 230121C in which one or more fluid substances can be contained for delivery. In the embodiment shown in Figure 58, the perforated seal 230156 comprises a seal barrier 230156C and a base 230156A, the base 230156A which abuts the barrel lip 23058A distally and the connector hub 230131A which abuts proximal, with these abutments held within the housing 23052. The connector hub 230151 further includes a vacuum port 230131B having a channel leading to a sterilization chamber 23032. The connector hub 230131 also comprises a conduit port 230131D which provides an outlet from the sterilization fluid connector 230130 to an infusion device (e.g., an injection mechanism). The conduit port 230131D and the vacuum port 230131B each allow fluid flow from the chamber 23032 through their respective ports, but do not allow fluid flow into the chamber 23032 through those ports, and may include membranes, filters, or seals such as unidirectional seals. Additionally or alternatively, the conduit port 230131D and the vacuum port 230131B may be plugged at a particular assembly or operation point. For example, the sterile cavity 32 may be evacuated using the vacuum port 230131B at any point during manufacturing, assembly, or before operation of the device, and then the vacuum port 230131B can be plugged after the evacuation is complete.

[0191] When the fluid pump is operated, the pressure at the plunger seal 230160 interface 230168 causes distal parallel movement of the plunger seal 230160 toward the housing 23052. The air pressure in the drug chambers 230121A, 230121B, and 230121C and / or the fluid pressure in the fluid(s) contained therein transfers its force to the chamber seals 230163, 230165, and the perforated seal 230156, causing their distal parallel movement so that the seal barrier 230156C moves toward the housing 23052 and is perforated by the perforating member 230133. This causes the sterile fluid passage connector to be formed or opened as described herein. As the plunger seal 160 moves further, the fluid contained in the variable drug chamber 230121A is dispensed through the conduit 230135. As the fluid and seals move further in parallel, the seal 230165 may then be penetrated by the penetrating member 230133, thereby allowing the fluid substance in the variable fluid chamber 230121B to be dispensed from the fluid passage connector. If further compartments or chambers are desired, more seals and chambers (e.g., seal 230163 and variable chamber 230121C) may be configured and then engaged in the same manner until the plunger seal 230160 is fully moved in parallel toward the housing 23052. This configuration may offer advantages over a single-compartment fluid container. For example, a diluent may be stored in the variable fluid chamber 230121A and a therapeutic agent in the variable fluid chamber 230121B, thereby purging the sterile fluid passage with the diluent before delivery of the therapeutic agent to the patient. If combination agents are desired for delivery, multiple therapeutic agents may be stored and delivered using the configuration provided by this embodiment. Any number of seals and drug chambers may be used in such a configuration, provided that the penetrating member 230133, the drive mechanism, and the other components of this embodiment are appropriately configured for such delivery.

[0192] The novel integrated sterile fluid passage connector of this disclosure may further incorporate status indicators into the fluid delivery mechanism. Such status indicator features may be incorporated into the drive mechanism 23090 as described in WO2013 / 033467. In addition or alternatively, status indicator features may be incorporated into components of the sterile fluid passage connector. In one embodiment, one or more interconnects are included in or near the plunger seal. At the end of fluid delivery, feedback to the user may be provided by opening, closing, or generating a signal to the power and control system using a penetrating member to contact the interconnect, or by using the penetrating member as a contact to the interconnect. In another embodiment, either the interconnect or contact is included in or near the plunger seal, while the other is included distal to or within a penetrating seal, e.g., in or on a seal mount or guide piece. At the end of fluid delivery, the interconnect and the corresponding contact are close enough to allow a signal to be transmitted to the power and control system to provide feedback to the user.

[0193] In another embodiment, the surface of the connector hub sealed within the sterilization chamber 23032 may incorporate a contact or interconnection for a status indicator mechanism, or it may be used as a contact or interconnection itself. For example, a delivery completion signal may be provided using a plate / bend arm or spring-type switch mechanism housed within the sterilization compartment 23032, which engages with the surface of the connector hub and is connected through the hub to an appropriate electronic circuit. In this configuration, when unpressurized (before device activation), the switch remains in the open position, and no contact / interconnection or signal is transmitted. When the device is activated, i.e., when the drive engages with the plunger seal in the drug container, pneumatic and / or hydraulic pressure moves the pierceable seal parallel to the piercing member, thus breaking the pierceable seal and allowing the fluid to flow through the sterilization fluid connector. The pneumatic and / or hydraulic pressure further presses the diaphragm of the pierceable seal against the switch mechanism until it interconnects with its complementary contact, thereby closing the circuit and allowing a signal to be sent to the user indicating that drug delivery has begun. Upon completion of delivery, the air and / or fluid pressure within the sterilization chamber is released, the switch is opened again, the circuit is shut off, and a delivery completion signal is provided to the user.

[0194] A configuration in which the surface of the connector hub sealed within the sterile chamber of the sterile fluid passage connector incorporates a contact or interconnection for a status indicator mechanism, or can be used as a contact or interconnection itself, can be facilitated by a perforated seal configuration. For example, as shown in Figures 59A to 59E, the fluid chamber 23058 includes a plunger seal 230160 configured to engage with a drive mechanism that forces the plunger seal 230160 toward the sterile fluid connector 230130. In the initial position (i.e., before the drive is engaged), the perforated seal 230356 maintains the space within the sterile chamber 23032 defined by the perforated seal 230356 and the connector hub 230131, in particular, partially maintained by the seal mount 230134 as shown in Figure 59A. The connector hub 230131 further includes a perforating member 23033 vacuum port or vent 131B, and the sterility of the chamber 23032 is maintained by a filter 23039. The connector hub base 230131A, the sealing member 230356A of the perforating member 230356, and the barrel lip 23058A are all fixed within a housing 23052, which may be a cap such as a crimp cap. The connector hub 230131 also includes an outlet port 230131D that provides an outlet passage from the sterilized fluid passage connector of the fluid conduit 23035. Once the pump is activated and the plunger seal 230160 is forced toward the penetrating member 23033, the pneumatic and / or hydraulic pressure in the variable fluid chamber 23021 forces the seal barrier 230356C of the penetrating seal 230356 toward the penetrating member 23033, which then penetrates the seal barrier 230356C, opening the sterilization fluid passage. The continuous pneumatic and / or hydraulic pressure in the variable chamber 23021 forces at least a portion of the penetrating seal 230356 toward at least a portion of the connector hub 230131 in the sterilization chamber 23032, as shown in Figure 59B. This continuous pneumatic and / or hydraulic pressure maintains contact between the seal 230356 and the connector hub 230131, as shown in Figures 59C and 59D, as long as the drive unit is operated and the fluid remains in the variable chamber 23021.When the fluid is pumped out of the variable fluid chamber 23021 to the point where the chamber essentially no longer exists, the pneumatic and / or hydraulic pressure on the seal 230356 is released, and the seal 230356 returns to an unpressurized state within the chamber 23032, as shown in Figure 59E, where there is no longer any contact between the seal 230356 and the hub 230131.

[0195] This aspect of the embodiment is advantageous for several devices and configurations useful in providing a sterile fluid passage connector having at least one sensor configured to indicate the status of fluid transfer from the sterile fluid container to the connector. An example of such a sensor is a “switch” mechanism contained within the sterile chamber in the sterile fluid connector. For example, in the embodiment shown in Figures 60A to 60H, the fluid container 230350 includes a barrel 230358 housing the fluid chamber 230321 and plunger seal 230360, configured to engage with a drive mechanism that forces the fluid in the variable fluid chamber 230321 toward the sterile fluid connector 230330, and a perforated seal 230356 maintains the sterile chamber 230332 within the space defined by the perforated seal 230356 and the connector hub 230331, as shown in Figures 60A and 60B, where the fluid passage is “closed”. The connector 230330 further includes a connector hub 230331 (which further includes a vacuum port 230331B), a fluid conduit 230335 that provides an outlet passage from the sterilized fluid passage connector 230330 and engages with a penetrating member 333, the sterilization of the chamber 230332 being maintained by a filter 230339, and an outlet port 230331D. The connector hub base 230331A, the penetrating seal 230356 sealing member 230356A, and the barrel lip 230358A are fixed within the housing 230352. The connector hub 230331 further houses within the sterilization chamber 230332 a punching ring 230391 fitted onto the seal mount 230334 of the connector hub 230331, a contact portion 230392, a spring 230393, and an interconnect 230362 that communicates with the flexible power strip 230394 (bent portion). As shown in Figures 60A and 60B, in the initial state before the drive unit is activated, the spring 230393 remains in an uncompressed state, the contact portion 230392 is held in a fixed position between the spring 230393 and the punching ring 230391, and between the contact interconnect 230362 and the contact portion 230392.The contact portion 230392 is further stabilized within the sterilization chamber 230332 by the position of the penetrating member 230333, which passes through the contact portion 230392 through the passage 230392C.

[0196] As shown in Figures 60C and 60D, once the drive mechanism is activated and the plunger seal 230360 is forced toward the penetrating member 230333 as indicated by the arrow, the pneumatic and / or hydraulic pressure in the variable fluid chamber 230321 forces the seal barrier 230356C of the penetrating seal 230356 toward the penetrating member 230333, thereby penetrating the seal barrier 230356C and opening the sterilization fluid passage so that the fluid can pass through the sterilization fluid conduit 230335. The pneumatic and / or hydraulic variable chamber 230321 also forces at least a portion of the barrier seal 230356C toward at least a portion of the contact portion 230392, thereby compressing the spring 230393 until the contact portion 230392 comes into contact with the interconnection portion 230362 in the sterilization chamber 230332 and forms an interconnection. The signal can then be transmitted through the contact portion 230392, the interconnect portion 230362, and the bend portion 230394. Continuous pneumatic and / or hydraulic pressure (see arrows) compresses the spring 230393, as shown in Figures 60E–60F, as long as the drive unit is activated and the fluid remains in the variable chamber 230321, maintaining contact between the contact seal 230356, the contact portion 230392, and the interconnect portion 230362, thereby maintaining the interconnection. As shown in Figures 60G and 60H (the latter being a different cross-sectional view of the sterilization fluid passage connector showing the location of the interconnect 230362 within the connector hub 230331), when the fluid is pumped out of the variable fluid chamber 230321 to the point where the chamber essentially no longer exists, and the flow through the sterilization fluid connector 230330 stops, the pneumatic and / or hydraulic pressure on the seal 230356 is released, the spring 230393 returns to its uncompressed state, pushing the contact 230362 back toward the punching ring 230391 and breaking the interconnect between the contact 230392 and the interconnect 230362. Once this interconnect is broken, signals are no longer transmitted through the bend 230394.

[0197] Other switch mechanisms can be designed to transmit signals indicating the status of fluid transfer from the sterile fluid container to the connector, using the position of the membrane in pressurized and unpressurized states. For example, as shown in Figures 61A to 61G, the connector hub 230331 can house switch components including a plate / bent arm contact 395. Figures 61B, 61D, and 61E show the sterile fluid passage connector in its pre-use position, with the perforated seal 230356 untouched and intact. In this position, the contact 230395 is not touching (or sufficiently close to) the interconnect 230362, and no signals can be transmitted. Figures 61C, 61F, and 61G show the sterile fluid passage connector in an activated and pressurized position, where air and / or hydraulic pressure from the fluid chamber deforms the barrier seal 230356C against the piercing member 230333, piercing the pierceable seal 230356 and opening the fluid passage. In this position, the barrier seal 230356C is further pressed against the contact portion 230395, thereby bringing the contact portion 230395 into contact with (or sufficiently close to) the interconnection portion 230362, resulting in the interconnection forming a signal that can be transmitted via the bend portion 230394. Figures 148D and 10F are perspective views (barrel and housing not shown) illustrating the positions of the pierceable seal 230356, connector hub 230331, and piercing member 230333 in their pre-use and pressurized positions, respectively. Figures 61E and 61G are perspective views, without the barrel, housing, and perforated seal shown, illustrating the positions of the contact portion 230395 and the interconnect portion 230362 in their pre-use (unconnected) and pressurized (connected) positions, respectively.

[0198] Figures 62A to 62D further illustrate embodiments in which, as shown in Figures 62B and 62D, pneumatic and / or hydraulic pressure forces the seal barrier 230356C onto the connector 230395 (the force then transmitted to the contact 230395 in contact with the interconnect 230362, which then allows the flow of signals through the bend 230394), and otherwise the plate / arm contact 230395 does not form an interconnect with the interconnect 362. Additionally, as shown in embodiments of Figures 62A to 62D, the connector hub 230331 further includes an internal post 230334A, which is a structure that restricts the position of the contact 230395 and membrane 230356 to avoid an overcenter position that may obstruct the fluid passage through the sterilization fluid passage connector.

[0199] Figures 63A to 63D further illustrate embodiments of a sterile fluid connector capable of transmitting signals indicating the status of fluid transfer from a sterile fluid container to the connector. Figure 63B illustrates the position of components of the sterile fluid connector 230330 in an unpressurized state, Figure 63C illustrates the pressurized state, and Figure 63D illustrates the completed delivery state. The interconnectors(s) 230362 and contactors(s) 230395 are located within the sterile chamber 230332 between the connector hub 230331 and the perforated seal 230356, so that after the perforated seal 230356 is punctured, the continuous pressure within the drug chamber 230321 causes interconnections between one or more interconnectors(s) 230362 and one or more contactors(s) 230395, which then transmit a signal to the user, which is terminated once the pressure inside the drug chamber 321 drops and the interconnections are lost, i.e., at the end of delivery. Several known interconnectors and contactors may be used with this embodiment, which will be readily apparent to those skilled in the art. For example, various sensors, namely Hall effect sensors; giant magnetoresistance (GMR) or magnetic field sensors; optical sensors; capacitive or capacitance change sensors; ultrasonic sensors; and linear travel, LVDT, linear resistance, or radiometric linear resistance sensors; and combinations thereof, can be used for such purposes, and these sensors can be harmonized to transmit signals between components to determine their positions. Figures 64A to 64C illustrate another embodiment of a sterile fluid connector that can transmit signals indicating the status of fluid transfer from a sterile fluid container to the connector.

[0200] Another switch mechanism is shown in Figures 65A and 65B, which show cross-sectional and isometric cross-sectional views of the sterilization fluid passage connector (barrel not shown). In this embodiment, the sterilization chamber 230332 is partially determined by the position of the perforated seal 230356, seal mount 230334 and hub connector 230331. The connector hub also houses the perforated member 230333 and interconnect 230362 within the sterilization chamber 230332. The switch mechanism includes the interconnect 230362, a first compression spring 230393, a contact 230392, and a second compression spring 230396. In this embodiment, shown in an unactivated and unpressurized state, both compression springs 230393 and 396 are compressed so that the contact 230392 forms an interconnect with the interconnect 230362. Before and during the release of pneumatic and / or hydraulic pressure on the seal barrier 230356, the compression springs 230393 and 230396 are decompressed and their interconnections are broken.

[0201] Another embodiment of the switch mechanism is shown in Figures 66A and 66B. In this embodiment, the perforated seal 230456 comprises a conductive material or coating. The connector hub 230431 includes a rib 434A that ensures the conductivity between the conductive perforated seal 230456 and the contact portion 230462 is broken when the system pressure drops at the end of fluid delivery. More specifically, in a pressurized system where the conductive perforated membrane 230456 is ruptured by the perforating member 230433 by pneumatic and / or hydraulic pressure, as shown in Figure 66B, the conductive perforated membrane 230456 must be further deformed proximal to the rib 230434 to contact the interconnect portion 230462. Once the air pressure and / or hydraulic pressure ceases, i.e., when fluid delivery ends, the conductive, permeable membrane 230456 is spontaneously released from its interconnection with the ribs 230434.

[0202] Another embodiment of the switch mechanism is shown in Figure 67. In this embodiment, the connector hub 230531 includes a conductive elastomer 230597 held in a sterilization chamber 230532 between the connector hub 230531 and the perforable membrane 230556. In this embodiment, at least a portion of the conductive elastomer 230597 is attached to or engaged with the seal mount 230534 and is configured with a centrally located opening that allows the barrier seal 230556C to be forced into contact with the perforating member 230533 when the pump is operated and when pneumatic and / or hydraulic pressure is generated on the perforable membrane 230556. The conductive elastomer 230597 is inherently "springy" and can deform (i.e., stretch) in response to a distal force from the perforated seal 230556, thereby being able to deform to contact the interconnect 230362 under pressure from the perforated seal 230356. The elastic nature of the conductive elastomer 230597 allows it to return to its pre-deformed state in an unpressurized environment where the interconnect is not present. Thus, once the air and / or hydraulic pressure ceases, i.e., at the end of delivery, the conductive elastomer film 230597 is passively released from contact with the interconnect 230562, and the signal is interrupted.

[0203] In another embodiment shown in Figure 68, the sterilization fluid passage connector includes a sensor mechanism comprising a dome switch 230666, the dome of which is made from or includes a conductive material, thereby allowing the dome switch 230666 to act as a contact that generates a signal when it moves to contact or come sufficiently close to the interconnect 230662 to complete the circuit. The dome switch 230666 is configured with at least one external portion 230666A that resists deformation and engages with or applies pressure to the inner wall of the connector hub seal mount 230634. Alternatively, the external deformation-resistant portion of the dome switch can be a radial ring or any structure that stabilizes the position of the dome within the sterilization fluid passage connector. The conductive portion of the dome switch may include a shape memory alloy that "remembers" its dome shape but deforms to a flatter shape under pressure and then returns to the dome shape once the pressure is released. In the embodiment shown in Figure 68, the dome switch 230666 further includes an opening 230666C through which the perforating member 230633 can pass when the dome switch 230666 is pressed toward the interconnection 230662. More specifically, when the pump device is activated and pneumatic and / or hydraulic pressure accumulates against a perforated membrane (not shown), the perforated membrane is forced toward the perforating member 230633, rupturing and opening a fluid passage. The dome switch 230666 is similarly deformed by the pneumatic and / or hydraulic pressure, or by the pressure exerted toward the distal portion of the deformed part of the perforated seal, and the dome switch 666 flattens toward the interconnection 230662, allowing the signal to be transmitted. Once the pneumatic and / or hydraulic pressure stops, i.e., at the end of transmission, the dome switch returns to its pre-deformed dome shape, and the interconnection ends. As shown in Figure 68, the dome switch 230666 is configured to be positioned beneath a perforable seal (not shown) within the sterile cavity of the fluid passage connector.The dome switch, however, can be configured to "rest" on top of the perforated seal and, under pressure, will be pressed to be sufficiently close to the interconnect 230662 to generate a signal. Alternatively, the dome switch can be fabricated from a uniformly deformable / resistant shape-memory material, in which the conductive portion of the dome switch is formed on the outer portion or periphery of the dome and is placed "upside down" (as a bowl shape) in the sterilization chamber of the fluid passage connector. In this configuration, the pne...

Claims

1. A wearable drug delivery device, Housing and A container at least partially located within the housing, A plunger movably disposed within the container, An insertion mechanism, at least partially disposed within the housing, wherein the insertion mechanism is A delivery member that is movable between a first position and a second position, wherein in the first position, the insertion portion of the delivery member is located inside the housing, and in the second position, the insertion portion of the delivery member is located outside the housing for insertion into a patient, Rotatable member and A rotational bias member configured to rotate the rotatable member, wherein at least a portion of the rotational bias member surrounds at least a portion of the rotatable member, An insertion mechanism comprising: a hub in contact with the rotatable member, configured to facilitate connection between the delivery member and the container such that a fluid passage passes through at least a portion of the hub during operation of the attachable drug delivery device; A drive mechanism, at least partially located within the housing, wherein the drive mechanism is A biasing member configured to move the plunger within the container when released, A gear operably connected to the plunger, A lever operably connected to the gear, A drive mechanism comprising: an electric actuator configured to vibrate the lever to rotate the gear by a certain increment; A wearable drug delivery device equipped with the following features.

2. The wearable drug delivery device according to claim 1, wherein the gear comprises a plurality of teeth, and the lever is configured to selectively engage with the teeth when vibrating.

3. The drug delivery device according to claim 1, wherein the delivery member comprises a needle.

4. The attachable drug delivery device according to claim 1, wherein the rotatable member is operably connected to the hub such that the initial rotation of the rotatable member moves the delivery member axially from a first position to a second position.

5. The attachable drug delivery device according to claim 1, wherein the rotatable member comprises a cylindrical portion, and at least a portion of the delivery member is positioned within the cylindrical portion when the delivery member is in a first position.

6. The rotatable member comprises a first guide surface, The attachable drug delivery device according to claim 1, wherein the hub comprises an outwardly extending follower configured to slidably engage with the first guide surface during rotation of the rotatable member.

7. The attachable drug delivery device according to claim 6, wherein at least a portion of the first guide surface extends in the axial and circumferential directions.

8. The attachable drug delivery device according to claim 1, wherein the rotatable member is rotatable about a rotation axis, and the rotation axis is parallel to the vertical axis of the delivery member.

9. A wearable drug delivery device according to claim 1, comprising a first contact member having a first position and a second position, wherein in the first position the first contact member engages with the rotatable member so that the rotation biasing member prevents the rotation of the rotatable member, and in the second position the first contact member engages with and disengages from the rotatable member so that the rotation biasing member allows the rotation of the rotatable member.

10. The attachable drug delivery device according to claim 9, wherein the rotatable member includes a cylindrical portion and a second contact member extending outward from the cylindrical portion, the second contact member engaging with the first contact member when the first contact member is in the first position.

11. The attachable drug delivery device according to claim 1, further comprising an adhesive applied to the outer surface of the housing for attaching the housing to the patient's skin.

12. The container comprises a drug placed inside the container, The attachable drug delivery device according to claim 1, wherein the drug comprises at least one of the following: a proprotein convertase subtilisin / kexin type 9 (PCSK9) specific antibody, granulocyte colony-stimulating factor (G-CSF), sclerostin antibody, or calcitonin gene-related peptide (CGRP) antibody.

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