Compact fluid delivery system

Abstract

A system for fluid delivery includes a propulsion unit configured to be positioned against a plunger in a chamber of a barrel to eject fluid from the barrel. The propulsion unit has a motor shaft coaxially aligned with the barrel. A motor shaft gear is attached to the motor shaft, and a plurality of wheel extensions are disposed about the motor shaft, each wheel extension having a second gear, one or more wheels, and a wheel gear attached to the one or more wheels such that rotation of the motor shaft in a first direction deploys the wheel extensions until the wheels of the plurality of wheel extensions are in contact with an inner wall of the barrel, rotation of the motor shaft then rotates the wheel along the inner wall to propel the propulsion unit and drive the plunger forward.

Description

Technical Field

[0001] The present invention relates generally to the field of devices for fluid delivery, particularly via wearable systems for delivering medications. Background Art

[0002] Wearable fluid delivery devices are becoming increasingly popular due to the convenience they provide to patients who require regular injections of medications and / or supplements. Such devices can be attached to the patient's body to release fluid (or similar injectable materials) over a period of time. Delivery can be intravenous (IV), intramuscular (IM), or subcutaneous (SQ). Similar constructed fluid delivery devices also have additional applications, such as for wet lab research, industrial applications, and any other application requiring precise, small-scale fluid delivery.

[0003] The inventor of the present invention, Ben David, has described a fluid delivery device in international patent publication WO2021 / 099992A2. The fluid delivery device includes a mechanism having a central longitudinal axis and configured to move forward in the axial direction. The mechanism includes a housing and one or more swing members pivotally connected to the housing, the swing member being configured to swing between an initial position and a terminal position relative to the housing.

[0004] More compact fluid transfer devices can improve convenience and usability across a range of applications. Summary of the invention

[0005] Embodiments of the present invention provide a system and method for fluid delivery, and in particular for the delivery of a drug, such as insulin or a nutritional supplement to a patient, such as by injection from a wearable device. The system may include a propulsion unit for driving a plunger in a chamber of a barrel to eject fluid from the barrel. The propulsion unit may include a bidirectional motor having a motor shaft capable of rotating in a first direction and a second direction, and the propulsion unit may be configured to be positioned in the chamber of the barrel, wherein the motor shaft is coaxially aligned with the barrel. The propulsion unit may also have a motor shaft gear attached to the motor shaft and a plurality of wheel extensions arranged around the motor shaft, such that rotation of the motor shaft in a first direction deploys the wheel extension until the wheels of the plurality of wheel extensions contact the inner wall of the barrel, and such that when the wheels contact the inner wall of the barrel, the rotation of the motor shaft in the first direction causes the wheels to rotate to propel the propulsion unit, thereby driving the plunger forward.

[0006] Each wheel extension may include a second gear, one or more wheels and a wheel gear mounted to the wheel axle of the one or more wheels. The second gear of each wheel extension may mesh with the motor shaft gear and the wheel gear. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] In order to better understand the various embodiments of the present invention and to show how to implement the present invention, reference will now be made to the accompanying drawings by way of example. The structural details of the present invention are shown to provide a basic understanding of the present invention, and the description combined with the accompanying drawings makes it clear to those skilled in the art how to implement several forms of the present invention in practice.

[0008] In the attached picture:

[0009] Figure 1 , Figure 2A and Figure 2B is a schematic diagram of a system for fluid delivery according to some embodiments of the present invention;

[0010] Figure 3 is a schematic diagram of a drive portion of a system according to some embodiments of the present invention;

[0011] Figure 4 is a schematic diagram of a fluid cartridge of a system according to some embodiments of the present invention;

[0012] Figure 5 is a schematic diagram of a delivery portion of a system according to some embodiments of the present invention;

[0013] Fig. 6A , Figure 6B and Figure 7 shows peripheral devices of a system according to some embodiments of the present invention;

[0014] Figures 8 to 12 is a schematic diagram of a propulsion unit having a screw shaft assembly of a system according to some embodiments of the present invention;

[0015] Figures 13 to 19 is a schematic diagram of a propulsion unit having an alternative shaft assembly according to some embodiments of the present invention;

[0016] Figure 20 to Figure 22 is a schematic diagram of elements of a base of a system including a retraction strap according to some embodiments of the present invention;

[0017] Figures 23 to 26B is a schematic diagram of a coupling mechanism of a system according to some embodiments of the present invention;

[0018] FIG. 27A to FIG. 29B is a schematic diagram of a bonding mechanism of a system according to some embodiments of the present invention;

[0019] Fig.30 is a schematic diagram of a mechanism for activation of a hypodermic needle of an indicator system according to some embodiments of the present invention;

[0020] FIG. 31A to FIG. 31C is a schematic diagram of a mechanism for sensing activation and skin contact of a system according to some embodiments of the present invention;

[0021] FIG. 32A to FIG. 32E is a schematic diagram of a drive plate structure according to some embodiments of the present invention; and

[0022] Fig.33A , Fig.33B , Fig.34A and Fig.34B is a schematic diagram of a mechanism for sealing a drive portion and a delivery portion according to some embodiments of the present invention. DETAILED DESCRIPTION

[0023] It should be understood that the invention and its applications are not limited to the systems and methods described below or the arrangements of components set forth or illustrated in the drawings, but are amenable to implementations that may be practiced or carried out in various ways.

[0024] Figure 1 1 is a schematic diagram of a system 100 for fluid delivery according to some embodiments of the present invention. The system 100 includes three main parts or components: a drive portion 110, a barrel 120, and a delivery portion 130. In typical use, the barrel 120 is assembled into the drive portion 110 (also referred to as the "reusable portion" herein), and the drive portion 110 is then mounted on the delivery portion 130 (also referred to as the "disposable portion" herein). The fluid in the fluid barrel 120 is dispensed through the delivery portion 130, and the barrel is then refilled or replaced by separating the drive portion and the delivery portion.

[0025] Figure 2A and Figure 2B It is a schematic diagram of the corresponding top side 210 and bottom side 220 of the system 100 when the system is assembled, that is, the drive part and the delivery part are engaged together. The typical application of the system 100 is as a wearable device for automatic drug injection, such as an insulin pump. The top side 210 can include a needle trigger port 212, through which a hypodermic needle (and / or cannula) 230 (referred to as needle / cannula 230 in this article) can be added, and the needle / cannula 230 is shown as an injection opening 232 at the bottom side 220 of the system. For insulin pump applications, the system 100 can be attached to the patient's skin, and the patient can wear the system to apply multiple injections over time. For such applications, the delivery part 130 and the barrel 120 are usually discarded after each use to ensure sterility. The bottom side 220 includes an adhesive for bonding to the patient's skin, as further described below. Typically, the adhesive side and the needle trigger port 212 are elements of the delivery part 130 of the system.

[0026] It should be understood that for some alternative applications, such as applications that provide fluid delivery without injection, the delivery portion 130 can be reused, i.e., not necessarily intended to be discarded after a single use. For such alternative applications, the cartridge may alternatively be refillable. Examples of such applications include electronic cigarettes and adhesive applicators. Hereinafter, in view of non-limiting medical applications (i.e., "single-use" applications) that require the delivery portion to be discarded, the delivery portion 130 is also referred to as a disposable portion, and the drive portion 110 is referred to as a reusable portion.

[0027] Figure 3 300 is a schematic diagram of a drive portion 110 having a cover 300. The figure presents the cover 300 in a translucent form so that the internal components are visible. These components may include a propulsion unit 302 having a motor 304 and a wheel 306. Hereinafter, the propulsion unit is also referred to as a "propulsion device". In addition, the drive portion generally has a base 308 on which components are mounted, which may include a flexible cable 310, i.e., a belt such as a flat flexible cable (FFC) or a flexible printed circuit (FPC). The flexible cable 310 is also referred to herein as a retracting belt because one of its functions may be to retract the propulsion unit. The base 308 may also include a printed circuit board (PCB) 312 and an encoder 314. The PCB 312 generally includes a controller (not shown) or a similar processor, which includes a memory storing instructions further described below. The PCB 312 may also include a communication device or a driver for external communication (e.g., communication with an external controller), the external controller being, for example, a mobile device, which may be configured to send instructions to the controller and provide status notifications related to the operation of the system to the user.

[0028] The cover 300 of the drive portion includes a cartridge port 320 in which the plunger end of the cartridge 120 is placed (as further described below). Additional components of the drive portion may include a power source (i.e., battery 322), battery charger contacts 324, and a buzzer and / or display 340, which may be used to communicate messages to the user, such as errors or notifications that the cartridge is empty. (If the battery is intended to be discarded after a single use, it may also be located in the disposable delivery portion of the system, or it may be located in any part for non-single-use applications).

[0029] Figure 4 is a schematic diagram of a fluid cartridge 120 of a system 100 for fluid delivery. The cartridge includes a cartridge plunger 400, which is a flexible plug located in a chamber 410 of the cartridge and fits against an inner wall 412 of the cartridge.

[0030] When the plunger 400 is pushed forward, it is propelled forward in the chamber 410 along the central axis of the barrel, and the fluid 420 is ejected from the barrel through the barrel delivery end 430. As shown, the barrel fluid delivery end 430 is located at the end of the barrel opposite the plunger end 440. The syringe in the delivery portion of the system can be configured to pierce the seal 432 of the delivery end 430 to access the fluid.

[0031] Figure 5 is a schematic diagram of a delivery portion 130 of a system 100 for fluid delivery. As described above, the two elements of the delivery portion may be the needle trigger port 212 and the adhesive bottom side 220. An additional component that may be provided with the delivery portion is a barrel delivery end port 510 that receives the barrel delivery end 430. When the barrel is inserted into the port 510, the seal of the barrel delivery end is typically pierced by a syringe 520, which is typically connected to a tube 522 of the delivery portion. The barrel needle and connected tube may be described below with reference to FIGS. 6 to 7. Figure 7 The needle injector is depicted connected to the needle and / or cannula 230. The delivery portion 130 may also include a coupling connector 540, which is also described in more detail below.

[0032] Fig. 6A and Figure 6B Peripheral devices of the system 100 for fluid delivery are shown. Fig. 6A A charger 610 is shown for recharging the system's battery. The system 100 is inserted into the charger 610 so that the cartridge charger contacts 324 described above are in contact with the charger's contacts. Alternatively or additionally, the system 100 may include an inductive charging coil for charging by inductive charging.

[0033] As described above, the system can communicate with an external device, such as a mobile device with an appropriately constructed application that transmits instructions to the system, such as an injection dose. The mobile device application can also provide an error message to the user, for example, notifying the user of the low battery state of the system, an event that the system needs to be recharged (or the battery is replaced). The mobile device application can also interact with the system to send instructions for advancing the propulsion unit to start the needle before attaching to the user's skin. For example, before the user attaches the system to his skin, the mobile device application can request the user to approve the ejection of additional fluid drops from the needle. Upon receiving user approval (e.g., by the user clicking "ok" on the screen of the application), the mobile device can send instructions to the system to advance the propulsion unit forward by a small amount (e.g., 0.5mm) so as to eject additional fluid drops from the needle. The user can then be asked to confirm the ejection of the fluid droplets, that is, the successful activation of the needle. After confirming the activation, the user can then receive a notification that the system can be attached to the skin.

[0034] Figure 6B A needle injector 620 is shown including a needle injector cap 622 that may be configured to fit over a delivery portion to inject a needle for intramuscular or subcutaneous fluid delivery.

[0035] Figure 7 is a schematic diagram of a needle injector 620 showing a spring mechanism 700 through which the needle / cannula 230 may be injected, as described above.

[0036] Figure 8 1 is a schematic diagram of a propulsion unit 302 of a system 100 for fluid delivery. A bidirectional motor 304 of the propulsion unit drives a wheel 306 of the propulsion unit, which propels the propulsion unit forward in a chamber 440 of a cartridge 120. The motor 304 has an axis 800 around which an axis assembly 802 is mounted. The motor is configured to fit inside the cartridge, with the motor axis coaxially aligned with the cartridge (as described above with reference to FIG. 1 ). Figure 3 to Figure 4 Wheel 306 is mounted on a shaft assembly 802 which includes several gears described further below and is mounted around the motor. Figure 8 The shaft assembly 802 shown is configured for helical propulsion of the propulsion unit and is therefore also referred to herein as a helical configuration of the shaft assembly, or more simply as a "helical" shaft assembly 802. Figures 8 to 12 As shown in Fig. 9 As shown, in the helical configuration, the wheel 306 is mounted on a shaft that is inclined at an angle α greater than 0 degrees but less than 90 degrees relative to the motor shaft. Figures 13 to 19 An alternative configuration of a shaft assembly, referred to herein as direct shaft assembly 1300 , is described.

[0037] Both the spiral and direct configurations of the shaft assembly include a drive plate 810. When the propulsion unit is first positioned in the chamber of the barrel, i.e., when the drive portion and the delivery portion are engaged together, the drive plate 810 contacts the barrel plunger and can be configured to push the barrel plunger slightly forward. The initial push of the plunger overcomes static friction that has previously accumulated between the plunger and the barrel wall (i.e., after manufacturing a pre-filled barrel). The subsequent static friction is lower, thereby reducing the force that the propulsion unit must apply when driving the plunger by self-propulsion. The initial push applied to the plunger by engaging the drive portion and the delivery portion can be configured to eject a small amount of fluid from the barrel, thereby activating the ejection needle (described further below). Figure 9 to Figure 1 1, the drive plate of the shaft assembly has been removed to show additional components of the shaft assembly.

[0038] Fig.10800. As described above, the propulsion unit includes a motor 304 having a motor shaft 800. The shaft assembly 802 (similar to the alternative shaft assembly 1300 described below) is centered around the motor shaft 800. The motor gear 1002 of the shaft assembly 802 is attached to the motor shaft 800 and rotates with the motor shaft. The motor gear 1002 then meshes with the second gear 1006 of the corresponding wheel extension 1004. As shown, the shaft assembly includes a plurality of wheel extensions 1004, which are generally positioned around the motor shaft in a symmetrical manner, i.e., with similar spacing between each wheel extension (e.g., within a range of + / - 10%).

[0039] Each second gear 1006 rotates around a second gear axle 1008. The second gear axle 1008 is inclined relative to an axis parallel to the motor shaft (i.e., as shown in FIG. Fig. 9 Typically, a gripping gear 1010 is also mounted on the second gear axle 1008, or is otherwise configured to rotate with the second gear, and meshes with a fixed gear 1012. The fixed gear 1012 is positioned at the base of the motor shaft and mounted to the motor so that the motor shaft passes through the fixed gear.

[0040] The traction of the gripping gear 1010 on the fixed gear prevents the gear motor 304 from rotating against the direction of rotation of the wheel extension. That is, the motor does not rotate relative to the barrel.

[0041] Each wheel extension 1004 includes at least one and typically two wheels 306. (More wheels can provide greater traction.) Each wheel or wheel pair has a common wheel gear 1020. As shown, each wheel gear 1020 meshes with a corresponding second gear 1006 of its common wheel extension, and each second gear also meshes with the motor gear 1002. Gears 1002, 1006, 1012 and 1020 (i.e., motor gears, second gears, fixed gears and wheel gears) can have different sizes so that different rotation ratios can be achieved, which means that the wheels do not have to rotate at the same rate as the motor shaft. Typically, the motor gear is the smallest, so that the wheels rotate slower than the motor gears. Note that all gears of the helical shaft assembly are shown as spur gears, but they can have helically tilted grooves to facilitate the tilting of the wheels described above. It should be understood that the structure of the gears shown is exemplary, and the gear arrangement can include additional gears or alternative types of gears (e.g., helical) for transmitting torque from the motor shaft to the wheel gears.

[0042] Fig.10Also shown in FIG. 1040 is a wheel extension plate. Such a plate may include the following elements, which may be included in the helical wheel extension 802 in the same manner as they are included in the following description: Fig.16 The same approach is shown in the direct wheel extension 1300. These elements may include a connecting plate 1630 that connects the axle of the wheel to the second gear axle. Additional elements of the extension plate 1040 may include a ratchet gear 1640 and a pawl spring 1642, as well as a torsion spring (1520) or similar device, which are further described below.

[0043] Fig.11A and Fig. 11B FIG. 8 is a top view of the propulsion unit 302 showing the gears of the screw shaft assembly 802 above the motor 304. The wheel extension is Fig.11A is shown expanded (to contact the barrel wall) and in Fig. 11B 1100 of the screw shaft assembly is also shown. As described above, the wheel shaft is tilted relative to the axis parallel to the motor shaft so that when the wheel rotates, as described below with reference to Fig.12 As shown, the shaft assembly advances into the barrel chamber in a spiral manner. Fig.11A As shown, when the wheels are unfolded to contact the inner wall of the cylinder, they are generally still slightly folded at an angle θ relative to a line extending directly from the motor shaft to the second gear. 1 In this position, the maximum radius of the shaft assembly including the wheel extension is denoted as R1. Fig. 11B In FIG. 1 , the wheel extensions are folded, thereby releasing their grip from the inner wall of the barrel; the wheel extensions are shown at an angle θ 2 Folded, and the radius is shown as R2, which is smaller than R1.

[0044] Fig.12 is a view of the barrel 120 and the helical movement of the helical shaft assembly 802 as the propulsion unit 302 advances forward in the barrel.

[0045] Fig.13 is a view of an alternative shaft assembly described above and referred to herein as direct shaft assembly 1300. The wheels 306 of the direct shaft assembly and their wheel gears 1200 are mounted on an axis that is orthogonal to the motor axis, unlike the angled positioning of the axis of the wheels of the screw shaft assembly 802. The gears of the direct shaft assembly 1300 are held in position by a direct shaft assembly frame 1310, which also holds the position of the drive plate 810 (also as is the case with the screw shaft assembly 802).

[0046] Fig.141 is a view of a direct shaft assembly 1300, wherein the shaft assembly frame 1310 is shown as transparent so as to show the gear structure of the direct shaft assembly including the direct motor shaft gear 1400. Unlike the motor gear 1002 of the screw shaft assembly 802, the direct motor shaft gear 1400 is configured to mesh with a second gear at a 90 degree angle. The direct motor shaft gear 1400 is typically a worm gear as shown, or any other type of gear that transmits rotation at 90 degrees, such as a bevel gear. Therefore, the wheel axles 1410 of the direct shaft assembly 1300 are orthogonal to the motor shaft. (Each wheel axle 1410 is also parallel to a plane tangential to the contact point of the wheel and the barrel).

[0047] Fig.15 1 is another view of the direct shaft assembly 1300 showing additional elements. Similar to the screw shaft assembly 802, the direct shaft assembly 1300 is positioned around the motor shaft 800 of the propulsion unit. Similar to the screw shaft assembly 802, the direct shaft assembly 1300 also has a plurality of wheel extensions, shown as wheel extensions 1510. Typically, each wheel extension has a torsion spring 1520 that applies pressure to "open" the wheel extension to a configuration where the wheel is away from the motor shaft. The torsion spring is attached to the shaft assembly frame 1310 by a torsion spring bracket 1522. Also shown is a shaft assembly bottom bearing 1530 and a shaft assembly top bearing 1532. It should be noted that similar to the direct shaft assembly 1300, the screw shaft assembly 802 described above has its own torsion spring 1520 that similarly applies pressure to "open" each wheel extension to a configuration where the wheel contacts the inner wall of the cylinder. In the open ("unfolded") position, the torsion spring maintains pressure on the wheel extension to ensure the required level of friction for the wheel to grip the cylinder wall, thereby propelling the propulsion unit forward as the wheel rotates.

[0048] Fig.161 is another view of the direct shaft assembly 1300, showing additional elements of the wheel extension 1510. These elements include a second gear 1006 that meshes with both the direct motor shaft gear 1400 and the wheel gear 1020, such that rotation of the motor shaft gear 1400 rotates the second gear 1620, which then rotates the wheel gear 1020. The second gear 1620 can be the same as the second gear 1006 of the screw shaft assembly described above (and similarly, multiple second gears can be included on the second wheel shaft 1630, for example, when different gear ratios are desired). In addition, it should be understood that, similar to the wheel extension 1510, the wheel extension 1004 of the screw shaft assembly typically includes a ratchet gear 1640 attached to the shaft of the wheel and wheel gear, and a pawl spring 1642 attached to the shaft of the second gear. A connecting plate 1644 also typically connects the two shafts. In typical operation, regardless of the type of shaft assembly, when the wheel extension is "closed", the advancement unit is inserted into the barrel at the plunger end so that the wheel does not contact the inner wall of the barrel. The motor then rotates the motor gear, which in turn rotates the second gear. Due to the torsion spring, the rotation of the second gear first lifts the wheel extension, unfolding the wheel extension until the wheel contacts the inner wall of the barrel. The wheel begins to rotate only after the wheel contacts the inner wall of the barrel, making it impossible for the torsion spring to open the wheel extension further (but continuing to apply pressure as described above).

[0049] When the propulsion unit is retracted from the barrel, the reverse rotation of the motor gear causes a similar reverse rotation of the second gear. However, as the second gear rotates, the ratchet gear interlocks with the pawl spring, thereby preventing the wheel gear from rotating. Instead, the wheel extension folds, thereby separating the wheel from the barrel wall.

[0050] Fig.17 An initial rotation R1 of the motor shaft is shown, which causes a rotation S1 of the second gear. Due to the torsion spring, the second gear first lifts the wheel as shown by arrow E1. The wheel starts rotating (in the direction of W1) only after the wheel extension reaches the open position, where the wheel is in contact with the inner wall of the cylinder. The rotation of the wheel (W1) advances the propulsion unit into the cylinder in the direction X1.

[0051] When Fig.18 When the motor shaft rotates in the opposite direction as shown in R2, the second gear rotates in the opposite direction S2. This initially causes a slight rotation of the wheel (W2) until the ratchet and pawl are locked. Further rotation of the wheel is impossible and further rotation of the second gear causes the wheel extension to close, thereby separating the wheel from the inner wall of the cylinder. The elements of the wheel extension are Fig.19 The side view is shown in more detail, Fig.19 The contact points 1900 of the ratchet and pawl are shown, thereby preventing the wheel from rotating backwards. Figures 17 to 19An example of a direct shaft assembly is shown, but a screw shaft assembly may include the same elements, resulting in the same operating steps, namely, first opening the wheel extension (due to the torsion spring), then rotating the wheel, and then reverse rotation of the motor gear, thereby closing the wheel extension (due to locking of the ratchet and pawl springs).

[0052] Figure 20 to Figure 22 3 is a schematic diagram of the retraction mechanism of the system 100. Shown is the base 308 of the drive portion on which the above-mentioned elements are located, including the propulsion unit 302, the propulsion unit motor 304, the flexible cable 310, the PCB 312 and the battery charging contacts 324. Also shown is the propulsion unit container 2000, which holds the propulsion unit before it is advanced into the cartridge. The propulsion unit container 2000 is positioned so that when the cartridge is inserted into the drive portion, the wheel extension of the propulsion unit is positioned in the chamber behind the plunger of the cartridge.

[0053] The flexible cable 310 is also referred to herein as a "retraction strap 310" because one of its functions is to retract the propulsion unit into the container 2000. The flexible cable 310 is typically attached to the propulsion unit at the rear of the propulsion unit at a flexible cable to motor connection point 2010. As the propulsion unit is advanced into the barrel, the flexible cable is pulled into the barrel along with the propulsion unit.

[0054] In some embodiments, when the flexible cable is pulled into the barrel, the retraction wheel 2020 rotates in a first direction using the flexible cable. The retraction wheel 2020 can be spring-operated or motor-operated to provide a retraction mechanism for subsequently rotating in the opposite direction, thereby pulling the flexible cable and retracting the propulsion unit from the barrel. The operation of the retraction wheel and the motor of the propulsion unit is usually controlled by the controller 2030. When the propulsion unit is to be retracted, the controller first operates the motor 304 of the propulsion unit to close the wheel extension, thereby separating the wheel from the inner wall of the barrel. The retraction wheel 2020 then pulls the flexible cable, and the flexible cable pulls the propulsion unit back into the container 2000. Alternatively, the retraction wheel can have its own motor, and the motor can receive a signal from the controller to rewind so as to retract the propulsion unit.

[0055] As described above, the controller may also be programmed to receive instructions from an external device, such as a smart phone, via a communication device 2040, which may also be embedded in the controller. The external device may be configured to send such instructions, which may include, for example, instructions regarding the amount of fluid to be ejected at a predetermined time and / or instructions to retract the propulsion unit. Upon receiving an input indicating the amount of fluid to be ejected, the controller may trigger a signal to the motor to advance the propulsion unit a distance calibrated to eject the indicated amount of fluid (i.e., converting volume units to distance units).

[0056] The retraction wheel 2020 may also include an encoder 314 to measure the distance the propulsion unit moves, such as by measuring the degree of rotation of the retraction wheel. The distance to be measured may be measured both when the propulsion unit moves forward and when the propulsion unit is retracted.

[0057] The flexible cable 310 may also include a control line (e.g., two lines with a DC voltage difference, such as +5V and 0V) connected to a power source and / or controller to power the motor, thereby controlling the forward or reverse movement of the motor. The connection of the control line from the flexible cable to the motor is shown by a flexible connector 2050, which has multiple pins to allow bidirectional control of the motor.

[0058] Details of the flexible cable 310 and the retracting wheel 2020 can be found at Fig.21 2020 and the propulsion unit 2020. The flexible cable 310 may have a hole 2110 into which the pin 2112 of the retracting wheel is inserted. As the flexible cable advances into the barrel, the flexible cable pulls the pin of the retracting wheel, thereby rotating the retracting wheel in a forward direction. Subsequently, as described above, the retracting wheel can be triggered to rotate in the opposite direction, so that the pin pulls the flexible cable, which then pulls and retracts the propulsion unit. Arrow T1 in the figure shows the tension generated in the flexible cable, which is tightened between the pin of the retracting wheel 2020 and the flexible cable connection point 2010.

[0059] The retraction wheel may also include an encoding gear 2120 having an encoding to measure the degree of rotation that can be read by the encoder 314. The retraction wheel may also include a spring mechanism 2122 for providing a force for subsequent retraction of the propulsion unit. The flexible cable 310 is typically attached to the drive portion base at a base connector 2130, which provides a signal to the control line of the flexible cable as described above. The flexible cable is initially folded at the bend 2132 so that the total length of the flexible cable is sufficient to pull the flexible cable into the barrel until the entire extent of the chamber of the barrel (when fluid is ejected).

[0060] Fig. 22 is a perspective schematic diagram of the base 308 of the drive portion of the system, wherein the base is relative to Fig.21 The view of is rotated to better show the motor connector 2050. As shown, the connector can have four contacts for activating a motor (typically a stepper motor) in two directions.

[0061] Fig.23308 of the drive portion of the system, aligned to connect with the delivery portion 130 of the system. As described above, the delivery portion may also have an adhesive bottom by which the system can be attached to the patient. The peel-away adhesive cover 2310 can cover the top adhesive patch that combines the drive portion and the delivery portion and is also positioned on the delivery portion (the top adhesive patch is hidden by the adhesive cover in the figure). The delivery portion may also include a coupling connector 540 that interlocks with the drive portion (see above). Figure 5 mentioned).

[0062] like Fig.24 As shown, the coupling connector 540 of the delivery portion 130 generally includes two elements: a coupling plate 2410 and a set of one or more axial snaps 2420 (or similar interlocking connectors).

[0063] like Fig.25 As shown, the base 308 has one or more coupling sensors 2510 (eg, spring pins) and snap stops 2520 that are configured to interconnect with corresponding axial snaps 2420 .

[0064] Fig.26A 308 is a top view of a coupling connector 540 interlocked with complementary elements of the base 308 of the drive portion. As shown, the coupling plate 2410 is in contact with the coupling sensor 2510. The coupling sensor 2510 is typically connected to a controller, which determines whether there is continuity between the coupling sensors. Continuity provides an indication to the controller that the coupling plate is in place and the drive portion and the conveying portion are therefore interlocked.

[0065] The drive part and the delivery part can be configured to be separated from each other in order to insert a new pre-filled barrel. The user can first insert the new barrel into the delivery part, which pierces the seal (i.e., "septum") of the barrel so that the fluid can flow through the tube of the delivery part to the hypodermic needle. Next, the user attaches the drive part to the barrel and pushes the drive part and the delivery part together (so that, for example, the coupling connector and the axial snap can be interconnected). The process of connecting the two parts can also press the propulsion unit against the barrel plunger, activating the fluid tube and the hypodermic needle.

[0066] The controller is typically programmed to recognize the connection by sensing electrical continuity indicated by the coupling sensor, and trigger the motor accordingly to deploy the wheel extension and drive the propulsion unit forward to contact the plunger.

[0067] The controller is typically further programmed to recognize that the drive portion is disconnected from the conveying portion by sensing a lack of electrical continuity indicated by one or more coupling sensors 2510, and to trigger the motor accordingly to fold the wheel extension, which triggers the retraction wheel to retract the propulsion unit (typically by releasing the spring-loaded torque of the retraction wheel). As described above, the coupling sensor can include one or more electrical contacts in one part (the conveying portion or the drive portion) and one or more conductive elements in the other part, the electrical contacts and conductive elements being configured to measure contact between the drive portion and the conveying portion. Alternatively or additionally, the coupling sensor can include a Hall sensor in one part aligned with a magnet in the other part, or a near field communication (NFC) sensor in one part aligned with an Ntag in the other part. Any of these or other known coupling sensors can be used to detect separation between the drive portion and the conveying portion and trigger retraction of the propulsion unit.

[0068] Fig.26A Also shown is a full locking mechanism 2610 that provides locking through the interconnection of the catch 2420 and the stop 2520 to help maintain the connection between the drive portion and the delivery portion. Fig.26B The same interconnection is shown in perspective.The interconnection is usually designed to release the two parts when the drive part is lifted from the conveyor part or the conveyor part is bent under the drive part.

[0069] Fig.27A and Fig.27B is a schematic diagram of the adhesive mechanism of the system 100. As described above, the transport portion 130 typically has an adhesive bottom side 220 for attaching the system to the user's body after the drive portion and the transport portion are connected. In addition, the transport portion may have a top side adhesive patch 2700, which ensures a secure connection between the drive portion and the transport portion.

[0070] As shown, the peel cover 2310 initially covers the top side adhesive patch 2700 . Fig.27B is a side view of the conveying portion, showing that the peel cover can be folded over the top side, where it covers the top adhesive patch 2700 and also extends to cover the adhesive patch on the underside of the conveying portion. When the peel cover is in place above the top adhesive patch, the drive portion can be attached to the conveying portion via the above-mentioned coupling connector. (To prevent the user from sliding the two parts together, the peel cover should not be removed before connecting the drive portion, as this will expose the top adhesive patch.) After the parts are connected, the user can pull the peel cover in the direction of arrow A1, thereby exposing the top adhesive patch 2700, so that the two parts stick together. Fig.28A and Fig.28BAn exposed view of the top adhesive patch is shown in . When the top adhesive patch 2700 is exposed, the two parts are usually already joined so that the top adhesive patch is hidden and not visible.

[0071] In such Fig.28A and Fig.28B After the drive part and the conveying part are attached to each other and the peeling cover is pulled out from between the two parts, the user can pull the peeling cover away from the lower adhesive patch by pulling the peeling cover in the direction of the arrow shown in A2. Fig.29A and Fig.29B The adhesive underside 220 is shown exposed so that the system can be attached to the patient's body. Typically, when the system is subsequently pulled away from the patient's skin, the delivery portion bends under the drive portion so that the adhesive patch bonding the two portions releases the portions from each other.

[0072] Fig.30 is a schematic diagram of a mechanism for displaying activation of a needle / cannula 230 of the system 100. The lower side 220 of the delivery portion 130 includes an opening 232 for injecting the needle / cannula 230. Prior to injection, the system is configured to advance the propulsion unit against the plunger to "prime" the system, ejecting a small amount of fluid 420, such as a fluid droplet, to ensure that no air is retained in the tube or needle / cannula prior to injection. To provide a display of activation to the user, the lower side 220 of the delivery portion may include a litmus patch 3002, such as a small litmus paper patch. The litmus patch may also be configured to be attached to the peel-off adhesive cover 2310. The litmus patch absorbs the fluid droplet ejected by activation and "reacts", such as by changing color or otherwise displaying fluid absorption, thereby indicating a correct activation. The controller may be configured to receive a user input confirming the activation in order to continue the operation (e.g., injection and fluid ejection).

[0073] FIG. 31A to FIG. 31C is a schematic diagram of the mechanism used to sense skin contact in the system. Fig.31A As shown, the drive portion may include a proximity sensor 3100. The sensor is configured to measure the proximity and / or contact between the system and the patient's skin. Fig.31B When the drive section and conveyor section are shown engaged, the proximity sensor is located above the window 3102 on the underside of the conveyor section. Fig.31CA system is shown with the peel-away adhesive cover 2310 removed. As described above, the sensor is typically connected to a controller, providing a signal to the controller indicating skin contact (i.e., "proximity"). The controller can be configured to wait for such a signal before proceeding with subsequent steps (e.g., injection of a needle / cannula, ejection of a fluid, etc.), verifying system attachment, and then providing a detachment signal for detachment of the system from the skin. The controller can be configured to respond to such a detachment trigger signal by retracting the propulsion unit to its initial position in the propulsion unit container (e.g., by triggering retraction of the flexible cable as described above). As described above, such retraction ensures that the propulsion unit is not in the transport portion when the drive portion is detached.

[0074] FIG. 32A to FIG. 32E is a schematic diagram of the mechanism of the drive plate structure of the propulsion unit. Fig.32A As shown, the plunger of the barrel 120 can have a variety of structures, such as plunger 400A and plunger 400B. In most structures, the plunger face has a protrusion 3202 that can absorb some of the pressure of the propulsion unit plate 810, thereby reducing the consistency of operation. In order to overcome this problem of the plunger protrusion, a groove cutout can be provided in the plate, Fig.32B is shown as a complete cutout 3210 and in Fig.32D and Fig.32E It is shown as a partial cutout 3214. Fig.32C As shown, the edges of the panel having the complete cutout 3210 may be supported by edge supports 3212 .

[0075] Fig.33A , Fig.33B , Fig.34A and Fig.34B 1 is a schematic diagram of a mechanism for forming a seal between the drive portion 110 and the delivery portion 130 when the two portions are joined to close the cylinder 120. FIG. 33A to FIG. 33B As shown, the drive section barrel port 320 may include a rigid circular sleeve 3302 (such as ceramic or metal), and the delivery section barrel end port 510 may include a flexible circular seal 3304. When the barrel is inserted into each section, the sleeve and seal surround the barrel. FIG. 34A to FIG. 34B As shown, the interconnection of the drive portion and the delivery portion partially inserts the sleeve between the barrel and the seal when the two portions are locked together, thereby preventing fluids and gases from entering the drive portion.

[0076] Example

[0077] Example 1, i.e., the first exemplary embodiment of the present invention described herein, is a system comprising:

[0078] 1) a propulsion unit (302) for driving a plunger (400) in a chamber (410) of a barrel (120) to eject a fluid (420) from a delivery end (430) of the barrel;

[0079] 2) a drive section (110) comprising a drive section barrel port (320) configured to receive a plunger end (440) of the barrel and a propulsion unit container (2000) configured to hold the propulsion unit and from which the propulsion unit enters the chamber of the barrel; and

[0080] 3) A delivery portion (130) comprising a barrel delivery end port (510) configured to receive the delivery end of the barrel and release the fluid from the barrel when the advancement unit drives the plunger forward.

[0081] Example 2 includes the features of Example 1, and the propulsion unit further includes:

[0082] 1) a motor (304) having a motor shaft (800) coaxially aligned with the barrel;

[0083] 2) a motor shaft gear (1002, 1400) attached to the motor shaft; and

[0084] 3) A plurality of wheel extensions (304, 1510) arranged around the motor shaft, each wheel extension comprising a second gear (1006, 1620), one or more wheels (306), and a wheel gear (1020) mounted to the wheel axle (1100, 1410) of the one or more wheels. Rotation of the motor shaft in a first direction deploys the wheel extensions until the wheels of the plurality of wheel extensions contact the inner wall (412) of the barrel. When the wheels contact the inner wall of the barrel, rotation of the motor shaft in the first direction causes the wheels in contact with the inner wall to rotate to propel the propulsion unit forward.

[0085] In Example 3, Example 2 includes the following additional feature: the second gear of each wheel extension is configured to mesh with the motor shaft gear and a corresponding wheel gear of the wheel of the wheel extension.

[0086] In Example 4, Example 2 or 3 includes the following additional feature: the plurality of wheel extensions are positioned in a substantially symmetrical arrangement about the motor shaft.

[0087] In Example 5, any one of Examples 2-4 includes the following additional features: the motor can be controlled to rotate in a reverse direction opposite to the first direction, wherein each wheel extension also includes a ratchet gear (1640) and a pawl spring (1642) that are locked during the reverse rotation of the wheel, and wherein after the ratchet gear and the pawl spring are locked, rotation of the motor shaft in the reverse direction folds the wheel extension.

[0088] In Example 6, any one of Examples 2-5 includes the following additional feature: when the motor rotates in the first direction, a spring (1520) applies a torque to deploy the wheel extension away from the motor shaft. In Example 7, the spring is a torsion spring connected to the wheel extension to apply the torque to deploy the wheel extension.

[0089] In Example 8, any one of Examples 2-7 includes the following additional feature: the second gear (1620) rotates on a wheel axle (1630) orthogonal to the main axis so that rotation of the wheels when in contact with the inner wall of the barrel advances each wheel in a direction parallel to the motor shaft. In Example 9, the motor shaft gear is a worm gear (1400).

[0090] In Example 10, any one of the above Examples 2-7 includes the following additional features: the propulsion unit has a fixed gear (1012) mounted to the motor, and the motor shaft extends through the fixed gear (1012). Each wheel extension also has a gripping gear (1010) configured to rotate with the corresponding second gear of the wheel extension and mesh with the fixed gear (1012). The wheel gears of the wheel extension are mounted on a wheel axle (1100) that is tilted less than 90 degrees relative to the motor shaft, and rotation of the wheel when in contact with the inner wall of the barrel advances the wheel extension in a spiral motion in the chamber of the barrel.

[0091] In Example 11, any of the above examples includes the following additional feature: the controller (2030) is configured to receive an input indicating a fluid quantity and, in response, trigger a signal to the motor to advance the propulsion unit a distance calibrated to eject the indicated fluid quantity.

[0092] In example 12, any of the above examples includes the following additional feature: a flexible cable (310) connects the propulsion unit to a retraction mechanism (2020) in the drive portion. The retraction mechanism is configured to be triggered to pull the flexible cable, thereby pulling the propulsion unit into the drive portion for reuse.

[0093] In Example 13, the features of Example 12 further include the retraction mechanism comprising a spring-loaded wheel (2020).

[0094] In Example 14, the features of any one of Examples 12 to 13 further include an encoder (314), wherein the retraction mechanism has a code readable by the encoder, and wherein the encoder measures the distance moved by the propulsion unit and the corresponding amount of fluid ejected based on the displacement of the flexible cable.

[0095] In Example 15, the features of any one of Examples 12 to 14 further include a coupling sensor (324) configured to measure contact between the drive portion and the conveying portion and trigger retraction of the propulsion unit when the drive portion is separated from the conveying portion.

[0096] In Example 16, the features of Example 15 further include: the coupling sensor is configured to trigger folding of the wheel extension of the propulsion unit before triggering retraction of the propulsion unit.

[0097] In Example 17, the features of any of Examples 15-16 further include a controller configured to receive a first signal from the coupling sensor indicating separation of the drive system and the conveying system, and to correspondingly issue a second signal triggering retraction of the propulsion unit.

[0098] In Example 18, the features of any one of Examples 15 to 17 also include: the coupling sensor has one or more electrical contacts in the driving part and one or more complementary conductive elements in the conveying part, or has a Hall sensor in the driving part and a magnet in the conveying part, or has an NFC sensor in the driving part and an Ntag on the conveying part, so as to detect the separation of the driving part from the conveying part and trigger the retraction of the propulsion unit.

[0099] In Example 19, the features of any of Examples 12-18 further include: the flexible cable is further configured to provide power from a power source (322) to the motor.

[0100] In Example 20, the features of any of Examples 1-19 further include a locking mechanism (2610) configured to lock the drive portion and the delivery portion together and release the lock when the delivery portion bends under the drive portion.

[0101] In Example 21, the features of Example 20 further include: the locking mechanism has an axial stop positioned in the drive portion, the axial stop interlocking with an axial catch in the delivery portion.

[0102] In Example 22, the features of any of Examples 1-21 further include an adhesive patch (2700) for attaching the drive portion to the transport portion. The adhesive patch is covered by a folded adhesive cover (2310) to prevent the drive portion and the transport portion from adhering together before the drive portion is aligned on top of the transport portion, and when the drive portion is aligned with the transport portion, the folded adhesive cover can be removed by pulling to expose the adhesive patch.

[0103] In Example 23, the features of Example 22 further include the adhesive patch as a first adhesive patch and a second adhesive patch (220), the second adhesive patch (220) being provided for attaching the delivery portion to the patient's skin. The folded adhesive cover also covers the second adhesive patch, and the folded adhesive cover can be removed from the second adhesive patch before or after the second adhesive patch is removed from the first adhesive patch.

[0104] In Example 24, the features of any one of Examples 1-23 also include: the barrel is made of glass, wherein the propulsion unit has a wheel for propelling the propulsion unit into the chamber of the barrel, and wherein the wheel is made of a material with a coefficient of friction (COF) with glass > 0.05.

[0105] In Example 25, the features of Example 24 further include a wheel material of any one of: a machinable glass ceramic; a tetragonal zirconia polycrystalline, ZrO 2 -Y 2 O 3 ; Zirconia (ZrO 2 ); Alumina (Al 2 O 3 ); silicon carbide (SiC); stainless steel; nickel (Ni); glass reinforced plastic; or glass.

[0106] In Example 26, features of any of Examples 1-25 further include: the fluid is a therapeutic drug, and the delivery portion has a tube (520) connecting the fluid delivery end to a needle / cannula (230) for injection into a patient.

[0107] In Example 27, features of any of Examples 1-26 also include: the underside of the delivery portion has an opening (232) for the needle / cannula (230) and a litmus patch (3002) covering the opening and configured to respond (e.g., visibly) to the release of the fluid during activation of the system.

[0108] In Example 28, the features of any of Examples 1-27 also include a proximity sensor (3100) configured to measure proximity and / or contact between the system and the patient's skin and trigger an alarm and / or retract the propulsion unit to an initial position in the propulsion unit container when the system is separated from the patient's skin.

[0109] In Example 29, the features of Example 28 further include a controller configured to receive a first signal from the proximity sensor indicating that the system is attached to the patient's skin, and to responsively emit a second signal indicating effective attachment.

[0110] In Example 30, features of any of Examples 1-29 further include: the propulsion unit having a drive plate (810) that contacts the plunger when the propulsion unit drives the plunger and has one or more cutouts (3210, 3214) positioned to avoid the plunger protrusion.

[0111] In Example 31, the features of any of Examples 1-30 further include: the drive portion barrel port has a rigid sleeve surrounding the barrel, and the barrel delivery end port includes a flexible seal surrounding the barrel. The interconnection of the drive portion and the delivery portion inserts the sleeve and the barrel into the seal, thereby preventing fluids and gases from entering the drive portion.

[0112] It should be understood that the scope of the present invention includes variations and modifications that will occur to those skilled in the art upon reading the foregoing description and that are not disclosed in the prior art. Although the present invention has been described in detail, changes and modifications that do not depart from the teachings of the present invention will be apparent to those skilled in the art. Such changes and modifications are considered to be within the scope of the present invention and the appended claims.

[0113] It is obvious that the various methods and algorithms described about the controller can be implemented by appropriately programmed general-purpose computers and other types of computing devices. In addition, various media can be used to store and transmit programs implementing such methods and algorithms in various ways. In some embodiments, hard-wired circuits or custom hardware can be used to replace software instructions or combinations thereof for implementing the processes of various embodiments. Therefore, the embodiments are not limited to any specific combination of hardware and software. Transmission media include coaxial cables, copper wires and optical fibers, including wires containing buses connected to the processor. Transmission media can include or transmit sound waves, light waves and electromagnetic emissions, such as those generated during radio frequency (RF) and infrared (IR) data communications. Instructions that can be transferred from the memory to the processor can be executed by wireless transmission media, and / or can be formatted according to various formats, standards or protocols (such as Bluetooth, TDMA, CDMA, 3G).

[0114] The following is a list of components cited in the above description of the present invention:

[0115]

[0116]

[0117]

[0118]

[0119]

Claims

1. A system (100) for fluid delivery, comprising: a propulsion unit (302) for driving a plunger (400) in a chamber (410) of a barrel (120) to eject a fluid (420) from a delivery end (430) of the barrel; a drive section (110) comprising a drive section cartridge port (320) configured to receive the plunger end (440) of the cartridge and a propulsion unit container (2000) configured to hold the propulsion unit and from which the propulsion unit enters the cartridge chamber; and A delivery portion (130) includes a barrel delivery end port (510) configured to receive the delivery end of the barrel and release the fluid from the barrel when the advancement unit drives the plunger forward.

2. The system according to claim 1, wherein: The propulsion unit further comprises: a motor (304) having a motor shaft (800) coaxially aligned with the barrel; a motor shaft gear (1002, 1400) attached to the motor shaft; and a plurality of wheel extensions (304, 1510) arranged around the motor shaft, each wheel extension comprising a second gear (1006, 1620), one or more wheels (306), and a wheel gear (1020) mounted to the wheel axle (1100, 1410) of the one or more wheels; wherein rotation of the motor shaft in a first direction causes the wheel extensions to unfold until the wheels of the plurality of wheel extensions contact the inner wall (412) of the barrel; Wherein, when the wheel contacts the inner wall of the cylinder, the rotation of the motor shaft in the first direction causes the wheel in contact with the inner wall to rotate to propel the propulsion unit forward.

3. The system of claim 2, wherein the second gear of each wheel extension meshes with the motor shaft gear and a corresponding wheel gear of the wheel extension.

4. The system of claim 2, wherein the plurality of wheel extensions are positioned in a generally symmetrical configuration about the motor shaft.

5. A system according to claim 2, wherein the motor can be controlled to rotate in a reverse direction opposite to the first direction, wherein each wheel extension further includes a ratchet gear (1640) and a pawl spring (1642) that are locked during reverse rotation of the wheel, and wherein after the ratchet gear and the pawl spring are locked, rotation of the motor shaft in the reverse direction causes the wheel extension to fold.

6. The system of claim 2, further comprising a spring (1520) that applies a torque to deploy the wheel extension away from the motor shaft when the motor rotates in the first direction.

7. The system of claim 6, wherein the spring is a torsion spring connected to the wheel extension to apply the torque to deploy the wheel extension.

8. A system according to claim 2, wherein the second gear (1620) rotates on a wheel axle (1630) orthogonal to the main axis so that rotation of the wheels when in contact with the inner wall of the cylinder causes each wheel to advance in a direction parallel to the motor shaft.

9. The system of claim 8, wherein the motor shaft gear is a worm gear (1400).

10. The system according to claim 2, wherein: The propulsion unit also includes a fixed gear (1012) mounted to the motor and through which the motor shaft extends, and wherein each wheel extension has a gripping gear (1010) configured to rotate together with a corresponding second gear of the wheel extension and to mesh with the fixed gear (1012), wherein the wheel gear of the wheel extension is mounted on a wheel axle (1100) that is inclined less than 90 degrees relative to the motor shaft, and wherein rotation of the wheel when in contact with the inner wall of the barrel causes the wheel extension in the barrel chamber to advance in a spiral motion.

11. The system of claim 2, further comprising a controller (2030) configured to receive an input indicating a fluid quantity and, in response, trigger a signal to the motor to advance the propulsion unit a distance calibrated to eject the indicated fluid quantity.

12. The system according to claim 1 further includes a flexible cable (310) connecting the propulsion unit to a retraction mechanism (2020) in the drive portion, and wherein the retraction mechanism is configured to be triggered to pull the flexible cable, thereby pulling the propulsion unit into the drive portion for reuse.

13. The system of claim 12, wherein the retraction mechanism comprises a spring-loaded wheel (2020).

14. The system of claim 12, further comprising an encoder (314), wherein the retraction mechanism has a code readable by the encoder, and wherein the encoder measures the displacement of the propulsion unit and the corresponding amount of fluid ejected based on the displacement of the flexible cable.

15. The system of claim 12, further comprising a coupling sensor (324) configured to measure contact between the drive portion and the conveying portion and trigger retraction of the propulsion unit when the drive portion is decoupled from the conveying portion.

16. The system of claim 15, wherein: The coupling sensor is further configured to trigger folding of the wheel extension of the propulsion unit before triggering retraction of the propulsion unit.

17. The system of claim 15, wherein the system further comprises a controller configured to receive a first signal from the coupling sensor indicating separation of the drive system and the conveying system and, in response, to issue a second signal triggering retraction of the propulsion unit.

18. The system of claim 15, wherein the coupling sensor comprises one or more electrical contacts in the drive part and one or more complementary conductive elements in the conveying part, or a Hall sensor in the drive part and a magnet in the conveying part, or an NFC sensor in the drive part and an Ntag on the conveying part, so as to detect separation of the drive part from the conveying part and trigger retraction of the propulsion unit.

19. The system of claim 12, wherein the flexible cable is further configured to provide power from a power source (322) to the motor.

20. The system of claim 1, further comprising a locking mechanism (2610) configured to lock the drive portion and the transport portion together and release the lock when the transport portion is bent under the drive portion.

21. The system of claim 20, wherein the locking mechanism comprises an axial stop positioned in the drive portion that interlocks with an axial catch in the delivery portion.

22. The system according to claim 1 further includes an adhesive patch (2700) for attaching the drive portion to the conveying portion, wherein the adhesive patch is covered by a folded adhesive cover (2310) to prevent the drive portion and the conveying portion from adhering together before the drive portion is aligned on top of the conveying portion, and wherein when the drive portion is aligned with the conveying portion, the folded adhesive cover can be removed by pulling to expose the adhesive patch.

23. A system according to claim 22, wherein the adhesive patch is a first adhesive patch and the system further comprises a second adhesive patch (220) for attaching the delivery portion to the patient's skin, wherein the folded adhesive cover also covers the second adhesive patch, and wherein the folded adhesive cover can be removed from the second adhesive patch before or after being removed from the first adhesive patch.

24. The system of claim 1, wherein the cartridge is made of glass, wherein the propulsion unit has a wheel for propelling the propulsion unit into the cartridge chamber, and wherein the wheel is made of a material having a coefficient of friction (COF) with glass > 0.

05.

25. The system of claim 24, wherein the material of the wheel is any of: Machinable glass ceramics; Tetragonal zirconia polycrystal, ZrO2-Y2O3; Zirconium oxide (ZrO2); Alumina (Al2O3); Silicon carbide (SiC); Stainless steel; Nickel (Ni); Glass reinforced plastic; or Glass.

26. The system of claim 1, wherein the fluid is a therapeutic drug, and wherein the delivery portion comprises a tube (520) connecting the fluid delivery end to a needle / cannula (230) for injection into a patient.

27. The system of claim 1, wherein: The underside of the delivery portion includes an opening (232) for a needle / cannula (230) and also includes a litmus patch (3002) covering the opening and configured to respond to the release of the fluid during activation of the system.

28. The system according to claim 1 further includes a proximity sensor (3100) which is constructed to measure the proximity and / or contact between the system and the patient's skin, and trigger an alarm and / or retract the propulsion unit to an initial position in the propulsion unit container when the system is separated from the patient's skin.

29. The system of claim 28, wherein the system further comprises a controller configured to receive a first signal from the proximity sensor indicating that the system is attached to the patient's skin, and to responsively emit a second signal indicating effective attachment.

30. The system of claim 1, wherein the propulsion unit further comprises a drive plate (810) that contacts the plunger when the propulsion unit drives the plunger and has one or more cutouts (3210, 3214) positioned to avoid a plunger protrusion.

31. A system according to claim 1, wherein the drive portion barrel port includes a rigid sleeve surrounding the barrel, wherein the barrel delivery end port includes a flexible seal surrounding the barrel, and wherein the interconnection of the drive portion and the delivery portion causes the sleeve and the barrel to be inserted into the seal, thereby preventing fluids and gases from entering the drive portion.

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