EA040370B1 - AUTOMATIC MEDICAL SYRINGE - Google Patents

Description

Cross-reference to related application(s)

This patent application claims priority over U.S. Provisional Application No. 62/502278, filed May 5, 2017, pursuant to 35 U.S.C. § 119, the entire contents of which are incorporated herein by reference.

Technical field

This description of the invention relates to an automatic medical syringe and associated uses.

Introduction

In various existing automatic medical syringes, after activation by the user, the needle is withdrawn and the solution is injected through the needle to the user. After completion of the injection of the solution, the needle must be withdrawn for the convenience of the user, protection of the needle and a positive perception of the product. However, many automatic medical syringes use separate springs or motors for the injection and needle removal steps. In addition, such injection devices typically require separate actions on the part of the user to insert and withdraw the needle.

The essence of the invention

In one aspect, the present description of the invention relates to an injection device. The injection device comprises a carrier element, a needle, a drive element connected to the needle, wherein the drive element moves relative to the carrier element between the retracted state and the withdrawn state, a shuttle configured to move the drive mechanism between the retracted state and the withdrawn state, and a stopper made with the ability to move from the first state to the second state, while the stopper is configured to hold the drive element in the withdrawn state, and the movement of the stopper from the first state to the second state allows the shuttle to move the drive element from the withdrawn state to the retracted state.

The shuttle moves from the first position to the second position and from the second position to the third position, while when the shuttle is in the first position, the drive element is in the retracted state, when the shuttle is in the second position, the drive element is in the withdrawn state when the shuttle is in the third position, the drive element is in the retracted state. The first position and the third position are different. The shuttle moves in one direction along the axis when moving from the first position to the second position and from the second position to the third position. The shuttle is designed to move in only one direction. The injection device also includes a withdrawal gear connected to the carrier element and a retracting gear connected to the carrier element, wherein the drive element is connected to the withdrawal gear and the retraction gear, the shuttle comprises a gear rack configured to engage with gear to withdraw and gear to retract, while direct engagement of the rack with the gear to withdraw moves the drive element from the retracted state to the withdrawn state, and direct engagement of the rack with the gear to retract moves the drive element from the withdrawn state to the retracted state. The rack is in direct contact at any time only with the pull-out gear and the pull-in gear. The rack is configured to drive the withdrawal gear in the first direction to move the drive element from the retracted state to the withdrawn state, and to drive the retraction gear in the first direction to move the drive element from the withdrawn state to the retracted state. The drive element comprises a first toothed rack and a second toothed rack, wherein the first toothed rack is configured to engage with the pull-out gear, and the second gear rack is configured to engage with the pull-in gear. The first gear rack and the second gear rack are located on opposite sides of the drive element. The shuttle is movable along the first axis, the drive element is movable along the second axis, and the first axis and the second axis are perpendicular to each other. Prior to activation, the drive element is blocked and prevented from moving out of the retracted state by means of an obstacle. The injection device also includes a housing containing a carrier element, while the obstacle is built into the housing. Movement of the carrier relative to the body moves the actuator out of contact with the obstruction, allowing the actuator to move from the retracted state to the retracted state. The injection device also contains an elastic element connected to the shuttle, wherein, after the drive element is removed from contact with the obstacle, the elastic element is configured to expand from the first compressed state to the second compressed state to move the shuttle from the first position to the second position. After the stopper is moved from the first state to the second state, the elastic element is configured to expand from the second compressed state to the rest state to move the shuttle from the second position to the third position.

In another aspect, the present description of the invention relates to an injection device that contains a carrier element containing a stopper, while the stopper has a first end fixed to the remainder of the carrier element, and a free second end, a first gear connected to a non

- 1 040370 by an existing element, a needle, a drive element connected to the carrier element, while the specified first gear, the needle, as well as the drive element move relative to the carrier element between the retracted state and the withdrawn state, the shuttle contains a gear rack configured to be driven into rotation of the first gear, wherein the rotation of the first gear moves the drive element from the retracted state to the withdrawn state, while the free second end of the stopper is configured to at least temporarily prevent movement of the shuttle while the drive element is in the withdrawn state.

The injection device additionally comprises a second gear connected to the carrier element, while bending the stopper around the fixed first end forces the shuttle to move relative to the stopper and drive the second gear, while rotation of the second gear moves the drive element from the withdrawn state to the retracted state.

In another aspect, the present description of the invention relates to an injection device that includes a needle movable between a retracted state and an withdrawn state, an ampoule configured to be hydraulically connected to the needle, a piston configured to move within the ampoule, a motor configured to move the piston , and a controller connected to the motor, wherein the controller is configured to receive information indicating that the injection device is in contact with the user and send a signal to the motor to control movement of the piston in the first direction to bring the needle and ampoule into a hydraulic position. connection after receiving such information and moving the needle from the retracted state to the retracted state without any intervention from the user, and after receiving such information, as well as after sending a signal to control the movement of the motor in the first direction, automatically and sending a signal to the motor to control movement of the piston in the second direction to move the needle from the retracted state to the retracted state.

The injection device further comprises a housing containing an ampoule, a piston, a motor, a controller and a needle in a retracted state, while the needle comes out of the housing in the withdrawn state. The injection device may include a cap or guard that holds the distal portion of the needle in a retracted state. The injection device may include an audio module, a visual module, and a tactile module, each of which is connected to a controller and configured to provide feedback to the user of the injection device. The injection device may include a cap sealing the opening of the ampoule, the cap contains an element of rubber material that is permeable to the sterilizing agent, while the needle contains a proximal part configured to be connected to the ampoule, and the proximal part of the needle is located inside the element formed by the rubber material before the needle and ampoule are in the hydraulic connection position. The injection device may include a lever connected to the controller and moved by the needle, with the needle in the retracted state, the lever forms an open loop that indicates to the controller that the needle is in the retracted state, and when the needle is in the retracted state, the lever forms part of a closed loop that indicates to the controller that the needle is in the withdrawn state.

Brief description of graphic materials

The accompanying drawings, included in this description and constituting a part of it, illustrate various examples and, together with the description, serve to explain the principles of the examples set forth and embodiments of the present invention.

Aspects of the present specification may be practiced in conjunction with the embodiments of the present invention illustrated in the accompanying drawings. These drawings illustrate various aspects of the present description of the invention, and where necessary, the reference numbers illustrated as structures, components, materials and/or elements in different figures, have the same designation. It should be understood that various combinations of structures, components and/or elements, other than those expressly illustrated, are contemplated and fall within the scope of the present specification.

In addition, there are many embodiments of the present invention described and illustrated in this document. The present description of the invention is in no way limited to any individual aspect, the corresponding embodiment of the present invention, as well as any combination and/or combination of such aspects and/or embodiments of the present invention. In addition, each of the aspects of the present specification and/or respective embodiments of the present invention may be implemented alone or in combination with one or more other aspects of the present specification and/or respective embodiments of the present invention. For brevity, certain combinations and combinations are not described and/or illustrated separately in this document. In particular, the embodiment of the present invention or embodiment described herein as an example should not be understood as being preferred or advantageous, for example, over other embodiments.

- 2 040370 implementation of the present invention or its embodiment; rather, it is assumed or evidence that the embodiment(s) of the present invention is(are) an example of the embodiment(s) of the present invention.

Fig. 1 is a perspective view of an automatic medical syringe according to an exemplary description of the present invention.

Fig. 2 is a bottom view of the automatic medical syringe illustrated in FIG. 1.

Fig. 3 is a side view of the automatic medical syringe illustrated in FIG. 1 showing an activation switch protruding beyond the tissue facing surface.

Fig. 4 is an exploded view of the automatic medical syringe illustrated in FIG. 1.

Fig. 4A is a schematic representation of the control system of the automatic medical syringe illustrated in FIG. 1.

Fig. 4B is an exploded view of an automatic medical syringe according to the present specification.

Fig. 4C is a perspective view of a portion of a package and an electronic board in accordance with an aspect of the present specification.

Fig. 5 is an exploded view of the needle mechanism.

Fig. 6 is a perspective view of the needle mechanism illustrated in FIG. 5 in the first position.

Fig. 7-11 are side views of the needle mechanism illustrated in FIG. 5.

Fig. 12 is a side cross section of a portion of the automatic medical syringe illustrated in FIG. 1.

Fig. 13 and 14 illustrate a side cross-section of the piercing mechanism.

Fig. 14A is a cross-sectional view of a cap used in an alternative piercing mechanism.

Fig. 15 is a side view of the needle insertion switch.

Fig. 16 is a flowchart of an example of a method in accordance with the present specification.

Fig. 17-23 represent a needle mechanism in accordance with other examples of the present description of the invention.

Fig. 24 is a cross-sectional view of the automatic medical syringe illustrated in FIG. 1, and the needle guard.

Fig. 25 is an enlarged part illustrated in FIG. 24.

Recall that there are many embodiments of the present invention described and illustrated in this document. The present description of the invention is in no way limited to any individual aspect, the corresponding embodiment of the present invention, as well as any combination and/or combination of such aspects and/or embodiments of the present invention. Each of the aspects of the present specification and/or respective embodiments of the present invention may be implemented alone or in combination with one or more other aspects of the present specification and/or respective embodiments of the present invention. For brevity, many of these combinations and combinations are not described separately in this document.

In particular, for simplicity and clarity of illustration, certain aspects of the figures depict the basic structures and/or mechanisms of construction of various embodiments of the present invention. Description and details of well-known features and technologies may be omitted to avoid confusion in understanding other features. Elements in the figures are not necessarily drawn to scale; the dimensions of some parts may be increased in relation to other elements for a better understanding of the exemplary embodiments of the present invention. For example, those skilled in the art will appreciate that the cross sections are not drawn to scale and should not be construed as showing a proportional relationship between the various components. Cross-sections are provided to assist in illustrating the various components of the depicted assemblies and to show their relative position relative to each other.

Detailed Description of the Invention

Reference materials will now be set forth in more detail with respect to the examples of the present invention, which are illustrated in the accompanying drawings. Wherever possible, the same reference numerals will be used throughout the drawings to refer to the same or like parts. In the following description, relative terms, such as about, mostly, about, etc., are used to indicate the possible variations of the components of ±10% of the specified numerical values.

- 3 040370

As described above, existing automatic medical syringes often require multiple user interactions for self-administration of medications, including, for example, a separate user interaction to withdraw the needle and then return the needle to its original state after drug administration. These additional steps can complicate self-administration of medications, lead to user error, and cause user discomfort. Accordingly, the present disclosure relates to various embodiments of an injection device (eg, an automatic medical syringe) that facilitates self-administration of medications or other therapeutic agents by a user. Mainly, in accordance with certain embodiments of the present invention, the automatic medical syringe does not require any additional action on the part of the user to remove the needle when the needle is injected subcutaneously to the user. Thus, the automatic medical syringe according to the present specification helps to prevent device misuse or user error.

General description of the system.

An example of such an automatic medical syringe 2 is illustrated in FIG. 1-4. Automatic medical syringe 2 may include a body 3 having a surface in contact with the tissue 4 (for example, from below), through which the needle can be withdrawn and retracted through the hole 6 (Fig. 2). An activation switch 1409 (FIG. 2) may be located on the tissue contacting surface 4 and may be configured to activate the automatic medical syringe 2 or otherwise put the automatic medical syringe 2 on standby. The touch sensor 1410 (FIG. 2) may also be located on the tissue contact surface 4 and may be configured to assist the auto-medicine syringe 2 controller to determine if the auto-medicine syringe 2 is located on the user's tissue (indicating that the auto-medicine syringe is capable of releasing or otherwise retracting the needle) or that the activation switch 1409 has not been actuated correctly (indicating the need to stop the operation of the automatic medical syringe 2). The activation switch 1409 and the touch sensor 1410 will be described in more detail below with reference to FIG. 4A. The connection port 13 may also be located on the tissue contact surface 4 to allow programming of the automatic medical syringe 2. The body 3 may include a transparent window 50 as a viewing window for viewing one or more screens or LED indicators 52 (with reference to Fig. 4B) located inside the housing 3, and may also contain a plurality of holes 51, made with the ability to transmit sound signals generated inside the housing 3 (for example, speakers). The LED indicators 52 may be combined into a ring structure or any other suitable structure. The auto-medical syringe 2 may be of any suitable size for proper portability and self-installation by the user. In one example, the automatic medical syringe 2 may be about 2.98 inches (7.57 cm) long, about 2.07 inches (5.26 cm) wide, and about 1.07 inches (2.72 cm) high. However, other suitable values may also be used, including, for example, a length in the range of about 0.5 inches (1.27 cm) to about 5.0 inches (12.7 cm), a width in the range of about 0. 5 inches (1.27 cm) to 3.0 inches (7.62 cm) and height from about 0.5 inches (1.27 cm) to 2.0 inches (5.08 cm).

Automated syringe 2 may be oriented along a longitudinal axis 40 (for example, the X-axis), a transverse axis 42 (for example, the Y-axis), which is actually perpendicular to the longitudinal axis 40, and a vertical axis 44 (for example, the Z-axis), which is actually perpendicular to both the longitudinal axis 40 and the transverse axis 42.

The adhesive pad 12 can be connected to the tissue contact surface 4 to facilitate fixing the automatic medical syringe 2 to the user's body (eg, skin). The adhesive pad 12 may be made of fabric or other suitable material and may contain an adhesive material. The adhesive material may be a water-based or solvent-based material, or be, for example, a hot melt adhesive. Suitable adhesives may also include acrylic, dextrin and urethane based adhesives, as well as natural and synthetic elastic polymers. In some examples, the adhesive materials applied to patch 12 can be activated upon contact with the wearer's skin. In still other examples, patch 12 may comprise a nonwoven polyester backing and an acrylic or silicone adhesive. The patch 12 may be attached to the body 3, for example, by means of a double-sided adhesive or by other mechanisms such as ultrasonic welding. The pad 12 may have a length greater than the width of the automatic medical syringe 2.

Needle mechanism.

With reference to FIG. 5-11, the needle mechanism 20 includes a carrier 202 which is movable (eg sliding) within the body 3 between a first position (FIG. 6) and a second position (FIG. 7). The needle mechanism 20 may also include a fluid conduit 300 that is mounted on the carrier 202 and that can be withdrawn when administered subcutaneously in a beneficial manner.

- 4 040370 and be retracted by the drive element 320. The shuttle 340 (for example, the shuttle drive) can be configured to move the drive element 320 through the output gear 360 and the retract gear 362. The shuttle 340 can be attached to an elastic element (for example, spring 370). A cover 380 (FIG. 5) may be attached to the carrier 202 to protect various components of the needle mechanism 20.

With reference to FIG. 5, fluid conduit 300 may extend from first end 302 to second end 304. First end 302 may include a needle 306 that is capable of being inserted subcutaneously by a user. Needle 306 may include a sharp and/or beveled tip and may extend substantially along or parallel to axis 44. Second end 304 may include needle 308, which is essentially the same as needle 306, but may be positioned within an automatic medical syringe 2 to penetrate ampoule 1302 (illustrated in Fig. 13 and described in more detail below) to allow subcutaneous administration of drugs to the user. Fluid conduit 300 may include an intermediate section 310 having one portion extending along or parallel to axis 40 and a second portion extending along or parallel to axis 40. The first and second portions of intermediate section 310 may be connected to a helix 312 providing bending of fluid conduit 300, and movement of the needle 306 along axis 44 when inserted subcutaneously to the user and when withdrawn from the user's skin. While coil 312 is illustrated, any other shape may be considered, such as a serpentine, arcuate, or other shapes, to provide flexibility to fluid conduit 300. Coil 312 or a similar structure may act as a lever in retracting and/or retracting needle 306. Coil 312 may also drive fluid conduit 300. to the deployed position illustrated in FIG. 5. Once the needle 308 penetrates and establishes a hydraulic connection with the ampoule 1302 (see, for example, Fig. 14), the drugs move from the ampoule 1302 through the needle 308, the intermediate section 310 and the needle 306 (passing through the skin of the user) and are injected subcutaneously to the user. In some examples, liquid conduit 300 may contain only metal or a metal alloy. In other examples, liquid conduit 300 may contain any other suitable material such as polymers and the like. Needle 308 and intermediate portion 310 may form a 22 or 23 gauge thin wall needle, whereby needle 306 may be a 27 gauge needle. Depending on the situation, other needle sizes can also be used, ranging for example from 6 to 34 gauge. The liquid conduit 300 can reduce the amount of material that comes into contact with medicines, reduce the number of joints and assemblies, and require less sterilization than conventional devices.

The carrier 202 may be made of plastic (e.g., injection molded plastic), metal, metal alloy, or the like, and may also include a flange 204 with a hole 206 and pins 210 and 212. The carrier 202 may also include a hole 216 through which a needle or other fluid conduit may be discharged. Hole 216 may be a groove cut into the bottom surface of carrier 202, or in an alternative embodiment of the present invention, the entire perimeter of aperture 216 may be formed by the material of carrier 202. Carrier 202 also includes a path for actuator 218. The path for actuator 218 may be a groove in carrier 202 that extends along or parallel to axis 44. The path of driver 218 may be configured to carry a protrusion of driver 320, such as protrusion 330, described in more detail below. The carrier 202 may also include a shuttle path 220 along which the shuttle 340 may move, as described in more detail below.

The carrier 202 may also include a stopper 240 that is configured to engage with the shuttle 340. The stopper 240 may be a lever having a fixed end 241 (FIG. 8) and a free end 242 (FIG. 8). The stopper 240 may include an angled portion 243 (FIGS. 9 and 12) that, when contacted or pressed by the pad 1500 (described with reference to FIG. 12), causes the stopper 240 to deflect relative to the fixed end 241. In the first position, the free end 242 may block or the other to prevent the movement of the shuttle 340, and in the second position may allow the shuttle 340 to move. The relationship between stopper 240 and shuttle 340 will be described in more detail later in the appendix.

The drive member 320 includes two racks 322 and 324 (illustrated in FIG. 8) parallel to each other and located on opposite sides of the drive member 320. The racks 322 and 324 may include teeth and may be configured to engage with and rotate pull-out gears 360 and pull-in gears 362, respectively. The drive member 320 may include a lumen 326 (or a groove, notch, or other suitable structure) (FIG. 5) that is configured to carry a needle 306 of the fluid conduit 300. The drive member 320 may also include a protrusion 330 (FIGS. 6 and 7 ) configured to slide within the path of the driver 218 of the carrier 202. The protrusion 330 may have an angled configuration that may engage an obstacle 600, as described in more detail below.

Continuing with reference to FIG. 5, the shuttle 340 may include a rack 342 made with

- 5 040370 the possibility of engagement with gear mechanisms 360 and 362. Shuttle 340 may also include a bottom surface 344 and a cut 346 that runs along the entire length of the shuttle 340 in the same direction as the rack 342. The groove 348 (Fig. 9) may extend along the length of cutout 346. Slot 348 may extend through the middle of cutout 346 and may extend along all or substantially all of cutout 346.

Shuttle 340 can move along the entire groove 220 from a first start position (FIG. 8) to a second intermediate position (FIGS. 9 and 10) and from a second position to a third final position (illustrated between the second and third configurations in FIG. 11). By moving the shuttle 340 along the groove 220, the rack 342 can first engage with the withdrawal gear 360 and then with the retraction gear 362. For a certain time, the rack 342 is maximally engaged with either the withdrawal gear 360 or the retraction gear 362 in any given point in time. In some instances, for example, when the rack 342 is positioned longitudinally between the withdrawal gear 360 and the retraction gear 362, the rack 342 does not engage with either the withdrawal gear 360 or the retraction gear 362. The shuttle 340 may be configured with the ability to move along one axis (for example, axis 40) and only in one direction along one axis. The force required to move shuttle 340 along groove 220 can be provided by decompressing spring 370. Spring 370 can be compressed from rest and decompressing spring 370 is able to move shuttle 340 along groove 220 through a series of positions/states mentioned above. Different positions of the shuttle 340, different features of the automatic medical syringe 2 can directly or indirectly block the movement of the shuttle 340.

The first shuttle position 340 illustrated in FIG. 8 may correspond to an unused, retracted, and/or new state of the automatic medical syringe 2. In the first position, the actuator 320 may be in a retracted state. The shuttle 340 is held in the first position by positioning an obstacle 600 in the path of the drive member 320 (FIG. 6). The obstruction 600, which may be a protrusion of the housing 3 or other suitable blocking device, may prevent movement of the drive member 320 by engaging and/or holding the protrusion 330. Thus, since the drive member 320, the output gear 360 and the rack 342 are connected with each other, blocking the drive member 320 also prevents the shuttle 340 from moving. The shuttle 340 can move from the first position to the second position by moving the obstacle 600 relative to the carrier 202 (or vice versa). In one example, carrier 202 has been moved (eg, to the left in FIG. 6) while obstruction 600 remains in place.

When the path of drive member 320 is clear of obstruction 600 (FIG. 7), spring 370 can expand and move shuttle 340 along groove 220. This linear movement of shuttle 340 can rotate drive gear 360 counterclockwise (or clockwise in other examples) through the rack 342, and rotation of the withdrawal gear 360 may move the drive member 320 down along the axis 44 through the rack 322 of the drive member 320. Such downward movement of the drive member 320 causes the needle 306 to penetrate the wearer's skin. In some examples, the drive element 320 may be configured to move relative to the carrier element 202 along the axis 44.

The shuttle 340 can be moved by expanding the spring 370 until its bottom surface 344 contacts the free end 242 of the stopper 240 so that the shuttle 340 is held in the second position illustrated in FIG. 9 and 10. At this point, the free end 242 may prevent further expansion of the spring 370 and further movement of the shuttle 340 along the groove 220. At this second position, the fluid conduit 300 may be withdrawn subcutaneously to the user and the fluid from the ampoule 1302 may be administered to the user via the needle 306. Additionally, while the hook 340 is in the second position, the rack 342 may engage with the withdrawal gear 360 to hold the needle 306 in the withdrawn state. The shuttle 340 can move from the second position to the third position by bending the stopper 240 relative to its free end 242. Further details of this bending are described below with reference to FIG. 12-14. Bending of stopper 240 allows spring 370 to continue expanding, advancing shuttle 340 further along groove 220. In some instances, stopper 240 may be held and/or within recess 346 of shuttle 340, and ramp 243 may slide within slot 348 as shuttle 340 is moved from its second position. to the third position.

The movement of the hook 340 from the second position to the third position may correspond to the retraction of the needle 306 from under the user's skin into the housing 3. In particular, the rack 342 may engage and rotate with the retraction gear 362 in the same direction (for example, counterclockwise rotation of the withdrawal gear 360. Rotation of the retract gear 362 may cause the drive member 320 to retract through the rack 324. The shuttle 340 may reach a third position in which the drive member 320 is fully retracted when its bottom surface 344 engages with the wall of the bearing element 202,

- 6 040370 when the free end 242 of the stopper 240 reaches the end of the notch 346 and/or when the spring 370 reaches rest.

In some embodiments of the present invention, when the actuating member 320 moves from the retracted state back to the retracted state, it may prevent exiting the retracted state. As a result, the needle 306 will be blocked from repeated subcutaneous injection to the user. In this configuration, the automatic medical syringe 2 is a disposable product (for example, discarded after an injection). In other embodiments of the present invention, the automatic medical syringe 2 can be returned to its original state and reused. In addition, the withdrawal gear 360 and the retract gear 362 may in some embodiments simply be rotating gears located within the auto-medical syringe 2.

Piercing system and sterile connection.

In FIG. 13 and 14 illustrate the features of the 1300 puncture system of the Automated Medical Syringe 2. For more information on examples of puncture systems, see US Published Application No. 2016/0262984 A1 by Arnott et al., published September 15, 2016. , the entire content of which is incorporated herein by reference. The piercing system 1300 includes a primary container, chamber, syringe, cartridge, or ampoule 1302 with a first end 1304 and a second end 1306. The ampoule 1302 may also include a cavity 1308 open at one end 1304 and extending toward the second end 1306. The second end 1306 may include a neck 1310 with a cap 1312 that surrounds the neck 1310 to close the second end 1306. The septum 1314 is located between the ampoule 1302 and the cap 1312, further closing the second end 1306 and allowing the introduction of a needle 308 (for example, a non-removable needle) into the ampoule 1302. The cavity 1308 can be closed from the side of the first end 1304 by means of the piston 1316.

Ampoule 1302 in some embodiments may have a capacity of 5 ml, however, other suitable capacities may also be used (for example, from 1 to 50 ml, or from 2 to 10 ml, or from 3 to 6 ml, or from 2 to 5 ml, or other suitable range) depending on the medicinal product being administered. In other embodiments, vial 1302 may have a capacity greater than or equal to 1 ml, or greater than or equal to 2 ml, or greater than or equal to 3 ml, or greater than or equal to 4 ml, or greater than or equal to 5 ml. Ampoule 1302 may contain and store a medicament for subcutaneous injection to a user and may ensure sterility of the medicament. Ampoule 1302 may have a neck diameter of 13 mm, a length of 45 mm, and an internal diameter of 19.05 mm. These values are very approximate and other suitable sizes may be used if necessary. In some embodiments, the ampoule 1302 may be made using conventional materials and may be shorter than existing devices, allowing the automatic medical syringe 2 to remain inexpensive and small in size. Ampoule 1302 can be a shortened 10 ml ISO cartridge.

The baffle 1314 may comprise uncoated bromobutyl rubber material or any suitable material. The plunger 1316 may comprise a fluoropolymer coated bromobutyl rubber material and may also include a tapered nose to reduce dead space within the ampoule 1302. The plunger 1316 may comprise, among other materials, one or more rubber materials such as, for example, halobutyl (e.g. , bromobutyl, chlorobutyl, fluorobutyl) and/or nitriles.

The piercing system 1300 may also include a top 1354 located at the second end 1306. The top 1354 may include a base 1355 located above the septum 1314 and ampoule opening 1302. The top 1354 may include a chamber 1356 extending from the base 1355 in the opposite direction from the piston 1316. The chamber 1356 defines the cavity 1357 and includes an opening 1358 connected to the cavity 1357. In some embodiments of the present invention, the top 1354 may be built into the baffle 1314 (for example, be integrated or be a single structure). In alternative embodiments of the present invention, the tip 1354 may be originally installed or mounted on the liquid conduit 300 and not installed directly on/together with the ampoule 1302 and/or integrated with the baffle 1314.

A portion of the fluid conduit 300, such as a needle 308, tube, or the like, in a pre-activated state, may pass through the opening 1358 of the chamber 1356 into the cavity 1357, but not through the base 1355. The opening 1358 may be preformed or formed by passing the needle 308 through chamber 1356. The opening 1358 of the chamber 1356 may form a sterile sliding seal around the needle 308 so that pathogens or other pathogens cannot enter the cavity 1357. The needle 308 may move relative to the tip 1354 without compromising the sterility of the seal therebetween. The cavity 1357 may be sterile or decontaminated such that the interior of the cavity 1357 and the needle 308 are sterile. In another embodiment of the present invention, cavity 1357 may be sterilized after insertion of needle 308 through opening 1358 and into cavity 1357. In alternative embodiments, the present

- 7 040370 of the first invention, instead of the top 1354, the cavity 1357 may form a twisted flexible (eg, rubber) element or a soft insert capable of moving the ampoule 1302 relative to the needle 308 (or vice versa). The flexible member may also seal or form a cavity 1354 around the needle 308 after sterilization.

In an alternative embodiment of the present invention illustrated in FIG. 14A, the tip 1354a may be used with the piercing system 1300 in place of the tip 1354. The tip 1354a may include a stopper 1356a and a base 1355a positioned over the opening of the ampoule 1302. The stopper 1356a may extend from the base 1355a in a direction away from the piston 1316. In the pre-activated state, the needle 308 may be located within the plug 1356a. The plug 1356a may be a tight plug devoid of any holes, cavities or openings and may be made from the first rubber material. The first rubber material may be impervious to a sterilizing gas such as ethylene oxide or hydrogen peroxide vapor. The first rubber material may contain, among other things, one or more of the following materials: isoprene, a rubber compound based on ethylene propylene diene monomer (EPDM) (M-class) and styrene butadiene. The permeability of the first rubber material to the sterilizing gas allows the needle 308 located inside the stopper 1356a to be sterile prior to use. Plug 1356a may follow the contours of needle 308 such that needle 308 passes through plug 1356a. The impermeability of the base 1355a to the sterilizing gas prevents contamination and/or damage to the medicinal product contained within the ampoule 1302. The base 1355a may contain, among other materials, impermeable rubber materials such as, for example, halobutyl (e.g., bromobutyl, chlorobutyl, fluorobutyl) and /or nitriles.

The piston 1316 may be coupled to a movement mechanism 1366 which is configured to move the piston 1316 and the ampoule 1302 towards the second end 1306. Movement of the piston 1316 towards the second end 1306 causes the piston 1316 to act on the contents contained in the ampoule 1302 (e.g., medicines). , medicaments), which ultimately results in impact on the second end 1306 of the ampoule 1302, causing the ampoule 1302 to move along the longitudinal axis 40. The movement mechanism 1366 may comprise a 12 mm motor with a five-speed reduction gear (360:1). The movement mechanism 1366 may have spring contacts that provide an electrical connection to the associated printed circuit board (eg, the first electronic board 1402). The engine may be configured to generate a torque of about 136 mNm at 36 rpm. These motor performance parameters are very approximate and any other suitable motor may also be used.

The travel mechanism 1366 may include a screw drive mechanism coupled to a piston 1316 that extends axially with respect to rotation about a longitudinal axis 40. Such a telescoping screw drive may have an output force of 100 N, a stroke of 20 mm, and a trapezoidal thread with 7/45 angles. ° in steps of 0.75 mm. Materials for the screw drive mechanism may contain acetal and polybutylene terephtharate. The screw drive mechanism may extend within the piston 1316 to reduce the dead space behind the piston 1316. Although the piston 1316 illustrated in FIG. 13 and 14 is made with longitudinal projections having certain intervals, in some examples the projections may be absent. In another exemplary embodiment of the present invention (not illustrated), the movement mechanism 1366 may include a surface or element with which the user interacts manually to move the piston 1316. For example, the piercing system 1300 may include a cartridge or plunger secured to the back of the piston 1316. In another exemplary embodiment of the present invention (not illustrated), the movement mechanism 1366 may comprise a pneumatic or hydraulic actuator that is activated or actuated by a user to move the piston 1316. The actuator may be in the form of an expandable diaphragm, an expandable collar, an expandable diaphragm, or, e.g. a sliding seal or a piston. Direct pneumatic or hydraulic pressure provides the force needed to move piston 1316.

The piercing system 1300 also includes a shoulder 1390 connected or secured at the second end 1306. The shoulder 1390 may include a plurality of separately located on the circumference of the tongues 1392 that engage and surround the neck 1310. The shoulder 1390 may be fixed or otherwise connected to the second end 1306. The collar 1390 may include a wall 1390a extending at least partially around the neck 1310, a second end opening 1306, a cap 1312, a baffle 1314, and/or a top 1354. The wall 1390a of the collar 1390 may be located radially or outward from the neck 1310 and extend longitudinally past necks 1310, lids 1312 and baffles 1314.

In the pre-activated state of the piercing system 1300 illustrated in FIG. 13, the edge 1393 of the bead 1390 may engage a corresponding radial or lateral inwardly extending cam, latch, or actuating portion 1394 of the drive member holder 1395. The holder 1395 may be movable with respect to the collar 1390. The collar 1390 and

- 8 040370 holder 1395 can be configured so that in the pre-activated state or location illustrated in FIG. 13, at least a portion of the cam or actuating portion 1394 of the holder 1395 is positioned directly behind the retained portion 1399 of the drive member 1398 movable within the holder 1395. The wall 1391 of the drive member 1398 may extend into and through the front cover portion 1396 of the holder 1395 and into the interior of the holder 1395. and the retained portion 1399 of the actuator 1398 may extend radially outward from the wall 1391. In some embodiments of the present invention, the wall 1391 of the actuator 1398 may be substantially cylindrical and the retained portion 1399 of the actuator 1398 may be a flange extending around the edge of the wall 1391.

In the pre-activated state of the piercing system 1300, a resiliently deformed clamping or resilient element 1397 may be positioned between the cap portion 1396 of the holder 1395 and the retained portion 1399 of the drive element 1398. direction of the ampoule 1302. The pressing element 1397 can be any element that effectively applies a force in a pre-activated state and then releases such a force when activated, as described in more detail below with reference to FIG. 14. In some embodiments of the present invention, the clamping element 1397 may be a conical or flat spring.

The needle 308 of the fluid conduit 300 may be fixed or secured to the drive member 1398 such that the fluid conduit 300 moves with the drive member 1398. In the pre-activated state of the piercing system 1300, the needle 308 may be positioned within the sterile cavity 1357 but not pass through the base 1355 tops 1354, septum 1314 and/or cavity 1308 of ampoule 1302.

To move the piercing system 1300 from the pre-activated state in FIG. 13, the movement mechanism 1366 can be activated to move the piston 1316 towards the second end 1306 and move the ampoule 1302 along the longitudinal axis 40 towards the drive member 1398. pressure against the liquid contained in the ampoule 1302, which is then applied to the ampoule 1302 itself. This pressure also causes the shoulder 1393 to be pushed back and deflects the activating portion 1394 radially outward. Without the activating part 1394 blocking its path, the retained part 1399 and the needle 308 move in the direction of the ampoule 1302 by expanding the clamping element 1397. The driving element 1398 can be connected to the flange 204 of the carrier element 202, and thus direction of the ampoule 1302 also moves the carrier 202 in the same direction. This movement corresponds to the movement of the carrier 202 relative to the body 3 in FIG. 6 and 7, which allows the protrusion 330 to release the obstruction 600 for the insertion of the needle 306.

The movement of the needle 308 towards the second end 1306 of the ampoule 1302 also causes the needle 308 to pass through the base 1355 of the top 1354, the septum 1314 and the cavity 1308 into a state of fluid connection with the contents of the ampoule 1302. Once the needle 308 is in fluid connection with the ampoule 1302, further movement piston 1316 toward second end 1306 causes fluid to pass through needle 308 and the remainder of fluid conduit 300. In some embodiments of the present invention, piercing system 1300 may be configured such that, upon activation, less of needle 308 passes into cavity 1308 than that portion that is already located inside the sterile cavity 1357. This can help prevent contamination of the contents of the ampoule 1302 from the non-sterile part of the needle 308.

Clamping member 1397 may be configured to expand such that fluid conduit 300 punctures top 1354 and/or septum 1314 at high speed, such as at least about 10 mm/s or at least about 40 mm/s. The relatively rapid piercing of the top 1354 and/or the septum 1314 by the pressure member 1397 helps prevent leakage of the contents of the cavity 1308, which may be pressurized by the piston 1316.

After the medication has been administered to the user through the needle 306, the needle 306 may be automatically withdrawn from the user's skin. With reference to FIG. 12-14, the movement mechanism 1366 may be operated in reverse such that the rotation of the lead screw is opposite to the direction of the insertion step. This counterclockwise rotation causes the piston 1316 to move back toward the first end 1304 and also causes the ampoule 1302 to move back along the axis 40 (compared to the fluid delivery and needle insertion step 306). Movement of ampoule 1302 in the opposite direction may cause platform 1500 in FIG. 12 (which is attached to the wall 1391) push the pad 243 of the stopper 240. This may cause the stopper 240 to deviate around its fixed end 241 in the direction of arrow 240a and allow the hook 340 to move from the second position to its third position to retract the needle 306,

- 9 040370 as described above. In this case, retraction and insertion of the needle subcutaneously into the patient is performed using a spring inside the device.

It should also be appreciated that the fluid conduit 300 may be exclusively the fluid conduit of the automatic medical syringe 2, configured to be hydraulically coupled to the ampoule 1302. Thus, the medicament from the ampoule 1302 can only be withdrawn through the fluid conduit 300 and administered to the user only during normal operation. of the automatic medical syringe 2. Additionally, the needle 306 may be only the needle of the automatic medical syringe 2, configured to be injected subcutaneously to the user. In this case, a separate metal or plastic element can be used to deliver fluid from the ampoule 1302 to the patient.

Sterile needle cap.

With reference to FIG. 24 and 25, the automedical syringe 2 may include a needle cap or needle cap 2400 configured to maintain the sterility of the needle 306. The needle cap 2400 may extend from the first end 2402 towards the second end 2404. The flange 2406 may be positioned at the first end 2402. , and the tubular extension 2408 may extend from the flange 2406 toward the second end 2404. The needle cap 2400 may include an opening 2410 through the flange 2406 that may be in fluid communication with a lumen 2412 passing through the extension 2408. Seal 2414 may be located at the second end 2404 within lumen 2412. Seal 2414 may define an opening 2416 that is in fluid communication with the remainder of lumen 2412. Seal 2414 may include a constricted portion 2414a, an intermediate portion 2414b, and an internal seal portion 2414c. Intermediate portion 2414b may be located between neck portion 2414a and inner sealing portion 2414c, and of all three components, neck portion 2414a may be positioned closer to second end 2404. have a larger inner diameter than the inner sealing zone 2414c. The needle cap 2400 may also include a membrane 2418 covering the opening 2410 on the flange 2406. The membrane 2418 may be made of a gas permeable material that is impervious to liquid, such as a high density polyethylene fiber membrane. In one example, membrane 2418 may be a Tyvek® brand material. Membrane 2418 can sterilize seal 2414 such that seal 2414 does not contaminate needle 306 when needle cap 2400 is released from body 3.

The flange 2406 and extension 2408 may be made of plastic or other material, while the seal 2414 is made of a rubber material. In another embodiment of the present invention, flange 2406 and extension 2408 may also be made of rubber. The rubber material may be substantially the same as that of the plug 1356a described above. For example, the rubber material forming flange 2406, extension 2408, and seal 2414 may be permeable to a sterilant or sterilant gas such as ethylene oxide or hydrogen peroxide vapor. The rubber material may contain, among other things, one or more of the following materials: isoprene, a rubber compound based on ethylene propylene diene monomer (EPDM) (M-class), styrene butadiene and thermoplastic elastomer (thermoplastic elastomers - TPE) . In one embodiment of the present invention, when the flange 2406 is made of a sterilant-permeable rubber material, the flange 2406 may not have an opening 2410 and instead be a solid plug of the material.

The needle cap 2400 can be connected to the auto-medical syringe 2 to ensure that the needle 306 is sterile, for example, during delivery of the auto-medicine syringe 2 prior to use. With this connection, the needle 306 may pass through the inner seal portion 2414c of the seal 2414 such that the seal 2414 forms a seal around the needle 306. Thus, the inner seal portion 2414c may initially be a closed and pierceable membrane. Alternatively, the inner sealing portion 2414c may be a constricted portion having a smaller internal diameter than the constricted portion 2414a, and the needle 306 may move through this smaller constricted portion. The pierced portion (inner sealing portion 2414c) of the seal 2414 may be thin enough not to substantially blunt the needle 306. The constricted portion 2414a may engage and form a seal around a portion of the intermediate section 310 of the conduit 300. The intermediate section 310 may have a larger outer diameter than the outer diameter of the needle 306. Additionally, a space or gap 2414d may be formed between the inner diameter of the intermediate portion 2414b and the outer diameter of the intermediate section 310.

Automated syringe 2 can be sterilized by exposure to a sterilizing gas (e.g., ethylene oxide) after the needle shield 2400 is placed on the automedical syringe 2. Both lumen 2412 and gap 2414d and the surfaces forming lumen 2412 and gap 2414d, as well as the components they contain (for example, the withdrawn part of the 306 needle that passes through the tissues of the patient/user) can be sterilized under the influence of

- 10 040370 releasing gas. The user may be instructed to manually remove the needle cap 2400, for example, by pulling the needle shield 2400 out of the housing 3. In another embodiment of the present invention, the needle shield 2400 may be incorporated into the packaging of the automatic medical syringe 2 such that when the auto-medical syringe 2 is removed from the package; the needle cap 2400 is removed from the auto-medicine syringe 2. For example, the flange 2406 may be attached to the package (not illustrated) with an adhesive material. Then, when the user removes the auto-medical syringe 2 from the package, the protective cap for the needle 2400 disengages from the body 3 so that the needle 306 can be freely withdrawn to the normal operating position of the auto-medicine syringe 2. In some cases, the retracted portion of the seal 2414, located closer to the second end 2404 than the neck 2414a (and/or the neck 2414a itself) may be contaminated after sterilization. Thus, it is important that such contaminated surfaces do not come into contact with the needle 306 during removal of the protective cap 2400 from the automatic medical syringe 2. that part of the needle 306 that is inserted into the tissues of the patient/user, by maintaining the centering of the extension 2408 of the protective cap 2400.

In an alternative embodiment of the present invention, the seal 2414 may be directly installed on the drive member 320. In this embodiment of the present invention, the seal 2414 may be pressed tightly against the plastic or other part of the extension 2408 and may remain inside the automatic medical syringe 2 when the protective cap for the needle 2400 is removed.

Electronics.

Fig. 4A is a control system 1400 for an automatic medical syringe 2. The control system 1400 may include components located on a first electronic board 1402 and a second electronic board 1404, and may also include a power supply 1406. The first electronic board 1402 may include a controller 1408, an activation switch 1409 , a touch sensor 1410, a needle insertion switch 1412, and an emitter 1414. The second electronic board 1404 may include a detector 1416, an audio module 1418, a visual module 1420, and a tactile module 1422. One or more components of the first electronic board 1402 and the second electronic board 1404 may be functionally connected to the controller 1408 and receive power through the power supply 1406. The controller 1408 may also be operatively associated with the movement mechanism 1366 and may be configured to control the operation of the movement mechanism 1366 to initiate and control the insertion and withdrawal of the needle, as described higher. The movement mechanism 1366 may be connected to the first electronic board 1404 through one or more spring contacts at the final assembly stage when the ampoule 1302 is inserted into the housing 3.

Most of the assembly steps of the automatic medical syringe 2 are carried out, for example, on an assembly line in a production environment. The two halves of the device (or parts) can then be shipped to be filled with medication or to a final assembly plant. Of course, the two separate parts 1490 and 1492 need not be the same size, as illustrated in FIG. 4B. When a medicine vial, such as ampoule 1302, is filled with a medicine or other medication, ampoule 1302 can be assembled with the remainder of the automatic medical syringe 2. For example, the two halves of the device (parts 1490 and 1492) can be assembled with the ampoule they contain. 1302 filled with a medical preparation. In one example, part 1490 and movement 1366 may be locked in place behind ampoule 1302. Part 1490 may be part of housing 3, including a base or module configured to contain movement 1366 and associated electronics. Portion 1492 may be part of the body 3 containing substantially all of the other components described herein, including, for example, the needle mechanism, sterile connection, and piercing mechanism described herein. In this example, the electrical connection of the movement motor 1366 can be made at the moment the movement mechanism 1366 snaps behind the ampoule 1302 (for example, during the assembly step in which parts 1490 and 1492, as well as the ampoule 1302 are assembled to obtain a complete and working automatic medical syringe 2 ). To provide such an electrical connection, the movement actuator 1366 may include one or more spring contacts 1494 (with reference to FIG. 4C) that will contact pads 1495 (also with reference to FIG. 4C) on the first electronic board 1402 after assembly. Thus, the connection of the movement mechanism 1366 to the first electronic board 1402 (including the controller 1408) can be made without loose wires or similar structures.

Such an assembly process can be easier than simple devices (eg automatic medical syringes) with a rather more complex final assembly process. As a result, the planned assembly process described in this document can result in reduced labor costs.

- 11 040370

The controller 1408 may be configured to receive information from the system and system components described above and process such information in accordance with various algorithms to generate signals that control movement mechanism 1366. The processor may receive information from the system and system components, process such information in according to various algorithms and generate information signals that can be sent to the audio module 1418, the visual module 1420, the tactile module 1422, or other indicators, for example, the second electronic board 1404 to inform the user about the status of the system, the status of the components, the status of operations, or any other useful information controlled by the system. The processor may be a digital integrated circuit, an analog processor, or any other logic or control system that contains control algorithms.

As described above with respect to FIG. 2 and 3, the activation switch 1409 may be a plunger-type mechanical switch that protrudes from the tissue contact surface 4 of the automatic medical syringe 2. The activation switch 1409 may comprise an electrical circuit that is open until the activation switch 1409 is depressed. For example, when the auto-medicine syringe 2 is attached to the user's skin, the switch 1409 may be depressed, completing an electrical circuit and indicating to the controller 1408 that the auto-medicine syringe 2 needs to be activated. To conserve electrical energy, the components of the automatic medical syringe 2 may be in a standby state or in a sleep mode as long as the switch 1409 is in an activated state. In yet another example, the automatic medical syringe 2 may not receive power at all until the switch 1409 is activated, and deactivation of the switch 1409 may completely cut off power to the automatic medical syringe 2. Although a plunger-type mechanical switch is described, any other a suitable mechanism for activating the automatic medical syringe 2, including but not limited to a user-pressed button, voice signals, wireless signals from another electronic device.

The touch sensor 1410 may be configured to assist the controller 1408 in determining whether the auto-medical syringe 2 is correctly positioned on the user's skin. In one example, touch sensor 1410 may be a capacitive signal electrode or other device capable of distinguishing skin contact from contact with other materials, such as wood, plastic, metal, or other materials. When the skin is in close proximity to the capacitive signal electrode, a signal indicative of such contact is sent to the controller 1408. Thus, the touch sensor 1410 can serve to verify that the automatic medical syringe 2 is correctly placed on the user's skin, even if the switch 1409 is pressed. The touch sensor 1410 may include a capacitive signal electrode connected to the first electronics board 1402 as well as to the interior of the housing 3. The housing 3 and the adhesive pad 12 may serve as a patch (insulator) that acts as a dielectric between the user's skin and the capacitive signal electrode. Contact of the body parts 3 and/or the adhesive pad 12 next to the capacitive signal electrode can lead to an increase in the capacitance of the electrode, for example, from 1 to 10 pF, indicating the placement of an automatic medical syringe 2 on the skin surface.

The needle insertion switch 1412 may be configured to send a signal to the controller 1408 that the needle 306 has been inserted subcutaneously to the user. For example, with reference to FIG. 15, the needle insertion switch 1412 may include a curved arm 1510 comprising a first contact 1512. The needle insertion switch 1412 may also include a second contact 1514. The first contact 1512 may overlap the electrical contact of the second contact 1514 when the needle 306 is inserted subcutaneously to the user. When the needle 306 is withdrawn, the actuator 320 may move downward along the axis 44 and deflect the curved arm 1510 and the first contact 1512 towards the second contact 1514. When the first contact 1512 and the second contact 1514 are connected together, a signal is sent to the controller 1408 indicating that the needle 306 was successfully administered subcutaneously to the user. The separation of the first contact 1512 from the second contact 1514 may indicate that the needle 306 has been removed from the user's skin.

The emitter 1414 and detector 1416 may operate as an optical interrupt sensor or photointerrupter to allow the controller 1408 to determine the state of the automatic medical syringe 2. The emitter 1414 may be an LED or other light emitter, and the detector 1416 may be, for example, a phototransistor made capable of receiving light emitted by emitter 1414. In one example, emitter 1414 may emit infrared light, and yet any suitable wavelengths of light may also be used. The use of infrared light helps to reduce interference from external light sources. Emitter 1414 and detector 1416 may be positioned opposite each other within housing 3 to allow light beams 1430 to pass from emitter 1414 through ampoule 1302 to detector 1416. Ampoule 1302 and any liquid contained therein may be at least partially transparent to beams 1430, and thus beams 1430 can pass through ampoule 1302 and its contents. Since the piston 1316 moves towards the second end 1306 during the administration of the medical drug (with reference to Fig. 13 and 14),

- 12 040370 piston 1316 and in particular piston stop 1316 can interrupt beams 1430. contained inside ampoule 1302 was expelled). In some examples, the trajectory of the reflection beams 1430 may be taken into account when positioning the emitter 1414 and detector 1416 relative to each other. For example, beams 1430 may be reflected as they pass through ampoule 1302 and any liquid contained therein, and emitter 1414 and detector 1416 may be offset relative to each other, respectively. Additionally, emitter 1414 and detector 1416 may be offset from the center of housing 3 such that piston stop 1316 can block beams 1430. In at least some instances, optical interruption of a sensor or similar mechanism avoids false alarms in the event of actuator failures. In other words, the optical switch helps the controller 1408 more accurately determine that an injection has failed than other mechanisms.

The audio module 1418 may include a speaker or the like to provide audible feedback to the user. The openings in the housing 3 may allow audio to be transmitted from the audio module 1418 to the user. The audio module 1418 may generate a tone or other sound at the beginning and end of the injection, and/or inform about any other steps during the injection. The visual module 1420 may include one or more LEDs or the like to provide visual feedback to the user. The visual module 1420 may include various colored LEDs to provide various messages to the user. For example, a plurality of green LEDs arranged in a ring may be used to show the progress of an injection over time, with a red LED used to display error information to the user. Any other suitable colors, combinations and/or number of LEDs may be used in various examples. For example, a combination of red, blue and purple LEDs can be used. In one arrangement, sixteen LEDs may be mounted in a circle with a diameter of 26.5 mm, or a diameter of about 10.0 mm to about 40.0 mm. The LEDs can be activated sequentially in a circle to indicate the progress of the injection (for example, in the form of a ring progress indicator similar to a clock; see, for example, LEDs 52 in Fig. 4C). Controller 1408 may also be configured to receive feedback from various sensors and change the rate at which the LEDs are activated based on feedback from various sensors. For example, progress ring LEDs may be activated during three or more phases of operation, including, for example, injection cycle control activation phases, an injection phase, and a draw phase. Those skilled in the art will appreciate that the automatic medical syringe 2 may have more or less than the three operating phases described above. There is a specific time to complete each phase, but there may also be some variation in the actual time obtained by experience during the execution of any of the above working phases of the automatic medical syringe 2. An algorithm can be used to prevent premature activation of the LEDs, for example, when a certain phase ends earlier, than expected, or to stop the progress ring when a particular phase is longer than expected. At any given point, the algorithm may divide the remaining time to complete drug administration by the number of non-activated progress ring LEDs to determine the rate at which the remaining progress ring LEDs should be activated.

For example, before the activation phase of the injection cycle control, the LEDs may be activated at a rate equal to the remaining time for the process of complete administration of the medicinal product (for example, the remaining time to complete all phases: the activation phase of the injection cycle control, the injection phase and the draw phase) divided by the total the number of inactive LEDs on the progress ring. In other words, the remaining time for the entire drug administration process can be divided by a number that is the total number of LEDs on the progress ring minus any number of LEDs already activated. Thus, if, for example, one LED has already been activated, then the remaining time of the entire drug administration process can be divided by the total number of LEDs on the progress ring minus one.

After completion of the activation phase of the injection cycle control, the LEDs can be activated at a rate equal to the total time to complete the remaining phases (eg injection phase and draw phase) divided by the total number of inactive LEDs on the progress ring. After the completion of the injection phase, the LEDs may be activated at a rate equal to the remaining time for the completion of the pull phase divided by the number of LEDs not activated.

The visual module 1420 may also include a display screen, touch screen, or other suitable device to provide one-way or two-way communication with the user.

- 13 040370 vatel. The visual module 1420 may be visible to the user from outside the housing 3 through a window in the housing 3. The tactile module 1422 may include, for example, a tactile motor configured to generate vibrations that can be felt by the user. Vibrations indicate the start and end of an injection and/or may provide additional information to the user.

The controller 1408 may be connected to a wireless communication module and an antenna. The wireless communication module may be configured to transmit data from, for example, the controller 1408 to a mobile device, computer, cell phone, or the like. The wireless communication module may be configured to transmit information via, among other things, one or more wireless methods such as Bluetooth, Bluetooth low energy (BLE), infrared transmission, cellular networks, and wireless networks. The antenna may be any suitable device capable of assisting the wireless communication module in transmitting data and/or amplifying it. Thus, the controller 1408 may be configured to transmit user and/or automedical syringe 2 diagnostic information, injection performance related information, and/or information related to the automedical syringe 2 error state to the user's device or to the cloud. Signals indicating needle insertion and/or early device withdrawal may also be transmitted via the wireless communication module. The controller 1408 may also receive activation and/or delay commands via the wireless communication module.

Fig. 16 is an example of a method 2000 in accordance with the present specification. The method 2000 begins at step 2002 where the user may place the automatic medical syringe 2 on their body such that the tissue contact surface 4 is in contact with the skin surface. The automatic medical syringe 2 may be placed in any suitable location, such as the thigh, abdomen, upper arm, forearm, upper arm, leg, buttock, or any other suitable location. The automatic medical syringe 2 may be attached to the skin by means of an adhesive patch 12. Attaching the automatic medical syringe 2 in step 2002 activates a switch 1409 that protrudes outward from the tissue contact surface 4 to depress and turn on the electronic circuitry. Turning on the electronics causes a signal to be sent to the controller 1408 to transition from the power save mode, sleep mode, to the on mode. Alternatively, any other suitable mechanism may include or otherwise activate the automatic medical syringe 2 before or after step 2002.

Once the auto-medicine syringe 2 is activated in step 2002, the method 2000 proceeds to step 2004 where the controller 1408 determines if the tissue contact surface 4 is located on the skin surface. At step 2004, the controller 1408 may receive measurements from the touch sensor 1410 indicating whether the automatic medical syringe 2 is on the skin or other surface. If the controller 1408 determines that the touch sensor 1410 is in contact with the skin, such as when the capacitance value received from the touch sensor 1410 is within a predetermined range, the method 2000 may proceed to step 2008. If the controller 1408 determines that the touch sensor is not in contact with the skin, for example, if the capacitance measurement obtained from the touch sensor 1410 indicates that the auto-medicine syringe 2 is in contact with a non-skin surface, such as wood or metal, the method 2000 may proceed to step 2006. At step 2006 automatic medical syringe 2 may not be installed correctly. In the event of an error, an LED (eg, a red LED) may be activated to indicate to the user that an error has occurred, or a message may be displayed on the screen. In some examples, the automatic medical syringe 2 may need to be manually reset before completing an injection. In other examples, the auto-medicine syringe 2 may return to step 2004 with the controller 1408 continuously attempting to determine if the touch sensor 1410 is in contact with the skin. The method 2000 may also require that the touch sensor 1410 be in contact with the skin during the entire injection procedure. Thus, if at any point in the injection procedure the controller 1408 determines that the touch sensor 1410 is no longer in contact with the skin, then the controller 1408 may stop the injection (e.g., by stopping further movement of the movement mechanism 1366), may generate an error signal or message, and may draw in needle 306 if it has been withdrawn.

At step 2008, the controller 1408 may send a signal to activate the movement mechanism 1366. Once activated, the movement mechanism 1366 may move towards the second end 1306 of the ampoule 1302 (with reference to Fig. 13 and 14), which causes the ampoule 1302 itself to move in the same direction . This causes the needle 308 to move in the opposite direction to access the ampoule 1302 as described above. Movement of driver 1398 and needle 308 causes carrier 202 to move in the same direction, which describes a sequence of events that ultimately results in needle 306 being inserted subcutaneously to the user via the mechanism described in FIG. 5-11. The movement mechanism 1366 continues to move towards the second end 1306 until the required amount of medical drug contained inside

- 14 040370 ampoules 1302 will not be administered to the user.

The method 2000 proceeds to step 2010 where the controller 1408 may determine if the injection has been completed. The determination may be based on the interruption of beams 1430 by piston 1316 (as described with reference to FIGS. 4A, 13 and 14). In other words, when beams 1430 are interrupted (not received by detector 1416), controller 1408 may determine that an injection has been made. Once the controller 1408 determines that the injection has been completed, the controller 1408 may send a signal to the movement mechanism 1366 to reverse the rotation of the lead screw, which may cause the pad 1500 to press against the pad 243 of the stopper 240, allowing the needle 306 to be retracted as described above with reference to FIG. 11. In one example, controller 1408 may set a delay after learning that beams 1430 are being interrupted. This delay can range from 0.1 to 60 seconds. An additional end-of-procedure detection mechanism may be used instead of or in combination with the interrupt sensor described above. For example, the current in the motor of the movement mechanism 1366 can be used to determine if an injection has been made. In other words, when the piston 1316 reaches the second end 1306 of the ampoule 1302, the current in the motor will increase (for example, due to the fact that the piston 1316 touches the end of the ampoule 1302), indicating that substantially all of the contents of the ampoule 1302 have been withdrawn. One combination, given as an example, contains the use of beams 1430, when the interruption of the beams 1430 indicates that, for example, 90 to 98% of the injection procedure is completed. The current in the drive motor 1366 is then used to determine whether the remaining 2 to 10% of the injection procedure has been completed. In another example, instead of using an optical switch, the controller 1408 may use a delay from when the movement mechanism 1366 is initialized to determine when to change the direction of the movement mechanism 1366. In one example, such a delay may range from 1 to 120 seconds, although also any other time intervals may be considered. In any case, the delay from initialization may be long enough to allow the ampoule 1302 to be completely empty.

In some examples, the injection procedure time delays, measured from the initial initialization of the activation switch 1409 to the retraction of the needle 306 from the user after administration of the medication, may range from about 20 seconds to about 90 seconds, or from about 25 seconds to about 60 seconds, from about 30 s to about 45 s, or less than or equal to about 120 s, or less than or equal to about 90 s, less than or equal to about 60 s, less than or equal to about 45 s, less than or equal to about 30 s.

Method 2000 may also include additional steps. For example, the method 2000 may include determining if the medical product inside the ampoule 1302 is too cold to be administered to the user, if the power supply 1406 has sufficient electrical power to perform the injection, if the needle 306 is withdrawn and/or retracted prematurely, if the current is in the motor movement mechanism 1366 in the required range and whether the injection procedure has exceeded the maximum allowable time to complete the procedure. When the controller 1408 detects any of the above errors, it may communicate such errors to the user and may abort the continuation of the injection by, for example, stopping or reversing the movement mechanism 1366 and retracting the needle 306 from under the user's skin.

Alternative embodiments of the invention

Other embodiments of the needle mechanism are illustrated in FIG. 17-19. The needle mechanism 2400 may include a base 2402 and a hook 2420. The base 2402 may have an extension 2404 extending from the top surface of the base 2402. The base 2402 may also include a channel 2406 extending along the longitudinal axis of the base 2402 (parallel to axis 40) and having a cutout at the top. surface of the base 2402. The channel 2406 may pass through the first wall 2407 and the second wall 2408 of the base 2402, and also pass through the extension element 2404. The extension element 2404 may include, for example, a groove 2410 extending from the top of the extension element 2404 through a portion of the base 2402 direction of the bottom surface of base 2402. Slot 2410 may be substantially perpendicular to channel 2406 and extend parallel to axis 44. Base 2402 may further include a pin 2412 and a second pin 2414.

The shuttle 2420 may include an end member 2422 connected to the first wall 2426 on the first sidewall and the second wall 2428 on the second sidewall. The first wall 2426 and the second wall 2428 may be substantially parallel to each other. First and second walls 2426, 2428 may be separated from each other by a width of base 2402 to allow base 2402 to move relative to shuttle 2420. Hole 2424 may pass through end member 2422, which may be configured to accommodate first end of shaft 2456 .

The wall 2426 may include a first slot 2430, a second slot 2432, and a drive element member opening 2434 with an enlarged portion 2434a (whereby the protrusion 2454 may be in a first, non-pulled-out state). The first slot 2430 may be located proximate and longitudinally spaced from the axis of the second slot 2432. The first slot 2430 engages the pin 2412, and the second slot 2432 engages the pin 2414. The slots 2430, 2432 may include a first curved portion or slope for injection.

- 15 040370 tsii, passing from the bottom towards the top of the shuttle 2420, the top located near the hole 2434, and the second curved part or inclination for retraction, passing from the top to a position near the bottom of the shuttle 2420. The first curved part may have , for example, a convex shape, and the second curved portion may be, for example, a concave shape when viewed from the top side of the needle mechanism 2400. The injection slope may, for example, have an angle and curvature less than the angle and curvature of the retraction slope. The gentle slope for injection can provide a mechanical advantage while the elements are at rest to overcome the static friction force. The first curved portion allows the needle (eg, needle 306 described above) to be inserted subcutaneously to the user to control medication, and the second curved portion allows the needle 306 to be withdrawn from the user's skin. The second wall 2428 may include two slots and a hole similar to slots 2430 and 2432 and holes 2434. The slots and holes of the second wall 2428 may be installed similarly or identically to those installed on the wall 2426.

The needle mechanism 2400 may also include an elastic element or spring (not illustrated) that is connected to a shaft 2456. The shaft 2456 may be located in the hole 2424 of the shuttle 2420. The shaft 2456 may be connected to the protrusions 2454. The protrusions 2454 may slide through the slot 2410 of the extension element 2404 and may be connected to a 306 needle.

To move out of the retracted state illustrated in FIG. 17 to the withdrawn state illustrated in FIG. 18, the spring expands, causing the shuttle 2420 to move longitudinally relative to the shaft 2456 along the longitudinal axis 40. Due to the curvature of the slots 2430 and 2432, the longitudinal force applied to the shuttle 2420 also moves the shuttle 2420 down. Such downward movement also causes the protrusion 2454 to move down through the slot 2410, retracting the needle 306. When the needle mechanism 2400 is in the retracted state, the pins 2412 and 2414 are positioned at the apex or junction between the injection slope and the retraction slope of the slots 2430 and 2432. Additionally, the protrusion 2454 is located near the middle or center of the hole 2434. The protrusion 2454 is also located near the middle of the slot 2410 between the top surface of the extension member 2404 and the bottom surface of the slot 2410. The shaft 2456 may extend out of the hole 2424 beyond the end of the shuttle 2420.

Once the drug has been administered, the injection needle 470 can be removed, allowing the spring to decompress further. The additional expansion of the spring causes the shuttle 2420 to further move longitudinally towards the shaft 2456 along the longitudinal axis 40. Due to the curvature of the slots 2430 and 2432, the additional longitudinal force applied to the shuttle 2420 also moves the shuttle 2420 upward. This upward movement also causes the protrusion 2454 to move upward through the slot 2410, retracting the needle 306. The protrusion 2454 may be located in the bore of the drive member 2434 at an end proximate the bottom surface 2422. Additionally, the protrusions 2454 are positioned near the top of the slot 2410. The shaft 2456 may extend even farther outward through holes 2424 beyond the end of the shuttle 2420.

Another embodiment of the needle assembly is illustrated in FIG. 20. The needle assembly 3300 includes a carrier 3302, a driver 3320, a shuttle 3340, a gear 3360, and a spring (elastic member) 3370. The driver 3320 may be connected to a fluid conduit (e.g., fluid conduit 300 described above) and may be configured to insert a needle located at the end of this liquid conduit into the user. The drive member 3320 may be similar to the drive member 320, except that the drive member 320 may comprise only one toothed rack 3222, configured to be driven by a gear mechanism 3360. The shuttle 3340 may be similar to the shuttle 340, except that it may comprise a first rack 3342 and a second rack 3344. The first rack 3342 and the second rack 3344 may be spaced longitudinally but substantially parallel to each other and may engage the gear mechanism 3360 at different times. In some examples, the first gear rack 3342 and the second gear rack 3344 may only be configured to engage the gear mechanism 3360 at different times.

The second gear rack 3344 may cause the gear mechanism 3360 to rotate in a first direction (for example, counterclockwise) when the shuttle 3340 is moved in a direction 3380 along the longitudinal axis 40, while the first gear rack 3342 may cause the gear mechanism 3360 to move in a second direction opposite the first direction (eg, clockwise) as the shuttle 3340 moves in the direction 3380. Rotation of the gear mechanism 3360 in the first direction may move the drive member 3320 down through the rack 3222 and cause the needle to be inserted into the user, and rotation of the gear mechanism 3360 in the second direction may move the drive member 3320 upward to withdraw the needle from the user. Depressing the spring 3370, which may be connected to both the carrier 3302 and the inner surface of the shuttle 3340, may move the shuttle 3340 towards 3380 to initiate withdrawal and subsequent retraction of the needle. It is further contemplated that a stopper similar to stopper 240 can be used to stop longitudinal movement of shuttle 3340 when drive member 3320 (and associated needle) is in the retracted state. Then the stopper is removed from the trajectory of people

- 16 040370 nock 3340 to retract the drive element 3320 and the associated needle.

Another embodiment of the needle assembly is illustrated in FIG. 21. The needle assembly 4000 includes a carrier 4202 and a drive member (illustrated by projection 330 only). The needle assembly 4000 may also include the following components, which are not illustrated, but which may be substantially the same as those described above under the same names, such as a hook, draw and retract gears, and a spring. The driver of the needle assembly 4000 may be connected to a fluid conduit (eg, fluid conduit 300) and may be configured to insert the needle at the end of that fluid conduit into a user. In the retracted state (illustrated in FIG. 21), the drive member lugs 330 may be blocked by an obstruction 4600. The carrier 4202 may be caused to move in the direction 4002 to allow the lugs 330 to move down the platform 4602, moving the drive member and associated needle from the retracted state. to the withdrawn state. Carrier 4202 can be made to move in direction 4002 by, for example, movement mechanism 1366 and ampoule 1302 in a similar manner as described above with respect to carrier 202.

The needle assembly 4000 may include a stop 4240 that is separated from the carrier 4202. The stop 4240 may be moved in the direction 4004 by means of a spring 4241. The end of the stop 4240 may include a protrusion 4242 that can hold the actuating element in an extended state by blocking the retraction path of the protrusions 330. Thus Thus, when the drive member is withdrawn, the projections 330 may be positioned below the projection 4242 of the stopper 4240, preventing the drive member from being retracted while the stopper 4240 is moving. through one or more mechanical links (not illustrated) apply force to stop 4240 in direction 4002 to compress spring 4241. Movement of stop 4240 in direction 4002 can release protrusions 330 to move back into a retracted state.

Another embodiment of the needle assembly is illustrated in FIG. 22 and 23. The needle assembly 5300 includes a carrier 5302. In this embodiment of the present invention, the stopper 5240 may be configured to directly stop the rotation of the withdraw and/or retract gear 5360 instead of directly stopping the entire hook or driver of the needle assembly. In this embodiment of the present invention, the gear mechanism 5360 may be connected to the switch 5362 via a shaft 5361. The gear mechanism 5360 may rotate about the axis 5364 to provide the withdrawal and/or retraction of the corresponding drive element and/or needle. Switch 5362 may have a length that extends substantially perpendicular to axis 5364 and may also rotate about axis 5364.

The stopper 5240 may include an opening 5380 through which the switch 5362 may be dropped. Hole 5380 may include a circular portion 5382 and a tapered portion 5384. The circular portion 5382 may have a diameter greater than the length of the switch 5362 to allow free rotation of the switch 5362 (and gear 5360) while the switch 5362 is located within the circular portion 5382. The stopper 5240 may move relative to the carrier 5302 by any suitable mechanism. When the stopper 5240 and carrier 5302 are displaced relative to each other, the switch 5362 may be displaced within the neck 5384, which may be sized to limit the rotation of the switch 5362 (and gear 5360). For example, when the switch 5362 is generally rectangular as illustrated, the neck 5384 may also be rectangular.

In particular, as used herein, the term single implementation or implementation means that certain features, structure, or characteristics described in relation to a given implementation may be included, used, and/or built into one, some, or all implementations of this inventions. The use or appearance of a phrase in one implementation or another implementation in a specification does not imply references to the same implementations, or to separate or alternative implementations that are not mutually exclusive, or other implementations, nor is it limited to a single implementation. The same applies to the terms embodiment and example. The present description of the invention is in no way limited to any individual aspect, as well as the corresponding embodiment of the present invention, as well as any combination and/or combination of such aspects and/or embodiments of the present invention. In addition, each of the aspects of the present specification and/or respective embodiments of the present invention may be implemented alone or in combination with one or more other aspects of the present specification and/or respective embodiments of the present invention. For brevity, certain combinations and combinations are not described and/or illustrated separately in this document.

In addition, as mentioned above, an embodiment of the present invention or an embodiment thereof,

- 17 040370 described in this document as an example, should not be understood as preferable or advantageous, for example, in comparison with other embodiments of the present invention or its embodiment; rather, it is assumed or evidence that an embodiment of the present invention or embodiments of the present invention are examples of embodiment(s) of the present invention.

Claims (17)

CLAIM 1. An injection device containing a carrier element (202, 3302); needle (306); a drive element (320, 3320) connected to the needle (306), wherein the drive element (320, 3320) is movable relative to the carrier element (202) between a retracted state and an extended state; one or two gear mechanisms (360, 362, 3360) connected to the drive element; a shuttle (340, 3340) configured to move the drive member (320) between a retracted state and an extended state, the shuttle (340, 3340) comprising one or two gear racks (342, 3342, 3344) configured to engage with one or two gear mechanisms (360, 362, 3360); moreover, the carrier element (202, 3302) is connected to one or more of the needle (306), drive element (320, 3320), one or two gears (360, 362, 3360) and/or shuttle (340, 3340); elastic element (370, 3370) connected to the shuttle (340, 3340); and a stopper (240) configured to move from the first state to the second state, while the stopper (240) is configured to stop the longitudinal movement of the shuttle (340, 3340) in the first state and to hold the drive element in the extended state, and when when the stopper (240) is moved from the first state to the second state, the shuttle (340, 3340) is configured to move the drive element (320, 3320) by elastic deformation of the elastic element (370, 3370), wherein the direct engagement of one or two toothed racks (342, 3342, 3344) and one or two gears (360, 362, 3320) moves the drive element (320, 3320) from the retracted state to the extended state, while the direct engagement of one or two toothed racks (342, 3342, 3344) and one or two gear mechanisms (360, 362, 3360) also moves the drive member (320) to retract the needle (306). 2. The injection device according to claim 1, in which the shuttle (340, 3340) is movable from the first position to the second position and from the second position to the third position, while when the shuttle (340, 3340) is in the first position , the drive element (320, 3320) is in the retracted state; when the shuttle (340, 3340) is in the second position, the drive element (320, 3320) is in the extended state; and when the shuttle (340, 3340) is in the third position, the needle (306) is retracted, with the first position, second position, and third position corresponding to different actual positions of the shuttle (340, 3340) in the injection device. 3. The injection device of claim 2, wherein the shuttle (340, 3340) is movable in one direction along an axis to move from a first position to a second position and from a second position to a third position. 4. An injection device according to claim 3, wherein the shuttle (340, 3340) is movable in only one direction. 5. The injection device of claim 1, wherein the one or two gears (360, 362, 3360) comprise an extension gear (360) coupled to the carrier (202) and a retract gear (362) coupled to bearing element (202), while the drive element (302) is connected to the gear (360) for extension and the gear (362) for retraction, and one or two toothed racks (342, 3342, 3344) contain a toothed rack (342) made with the ability to engage with the gear (360) for extension and the gear (362) for retraction. 6. The injection device according to claim 5, wherein the rack (342) is in direct contact with only one of the advance gear (360) and the retract gear (362) at any time. 7. The injection device according to claim 5, in which the rack (342) is configured to rotate the gear (360) to extend in the first direction to move - 18 040370 drive element (320, 3320) from the retracted state to the extended state; and driving the retraction gear (362) in the first direction to move the drive member (320, 3320) to retract the needle (306). 8. The injection device according to claim 5, in which the drive element (320) contains the first gear rack (322) and the second gear rack (324), while the first gear rack (322) is configured to engage with the gear (360 ) for extension, and the second gear rack (324) is configured to engage with the gear (362) for retraction. 9. The injection device according to claim 8, wherein the first gear rack (322) and the second gear rack (324) are located on opposite sides of the drive element (320). 10. The injection device according to claim 1, in which the shuttle (340, 3340) is movable along the first axis, and the drive element (320, 3320) is movable along the second axis, while the first axis and the second axis are perpendicular each other. 11. The injection device according to claim 1, further comprising an obstacle (600) that stops the trajectory of the drive element (320, 3320), and before activation, the drive element (320, 3320) is in contact with the obstacle (600) and is unable to move out of the retracted state due to the obstruction (600). 12. The injection device according to claim 11, further comprising a housing containing a carrier element (202, 3302), wherein the obstacle (600) is integral with the housing. 13. The injection device according to claim 12, wherein the movement of the carrier (202, 3302) relative to the obstacle (600) removes the drive element (320, 3320) from contact with the obstacle (600), allowing the drive element (320, 3320) to move from the first retracted state to the extended state. 14. The injection device according to claim 13, in which the shuttle (340, 3340) is movable from the first position to the second position and from the second position to the third position, and when the shuttle (340, 3340) is in the first position, the drive element (320, 3320) is in the retracted state; when the shuttle (340, 3340) is in the second position, the drive element (320, 3320) is in the extended state; when the shuttle (340, 3340) is in the third position, the needle (306) is retracted, with the first position, the second position and the third position corresponding to the actual positions of the shuttle (340, 3340) in the injection device, moreover, after the drive element ( 320, 3320) is removed from contact with the obstacle (600), the elastic element (370, 3370) is configured to expand from the first compressed state to the second compressed state to move the shuttle (340, 3340) from the first position to the second position. 15. The injection device according to claim 14, in which after the stopper (240) has moved from the first state to the second state, the elastic element (370, 3370) is configured to expand from the second compressed state to a rest state to move the shuttle (340, 3340) from the second position to the third position. 16. The injection device according to claim 1, in which the carrier element (202) contains a stopper (240), while the stopper (240) has a first end (241) attached to the remainder of the carrier element (202), and a second free end (242), and one or two gear mechanisms (360, 362, 3360) contain the first gear (360) connected to the bearing element (202, 3302); the drive element (320) is connected to the carrier element (202), the first gear (360) and the needle (306), and one or two toothed racks (342, 3342, 3344) contain a toothed rack (342) made with the possibility of bringing into rotation of the first gear (360), while the rotation of the first gear (360) moves the drive element (320, 3320) from the retracted state to the extended state, while the second free end (242) of the stopper (240) is configured to at least temporarily prevent movement shuttle (340, 3340) while the drive element (320, 3320) is in the extended state. 17. The injection device according to claim 16, in which one or two gear mechanisms (360, 362, 3360) contain a second gear (362) connected to the carrier element (202), while bending the stopper (240) around the fixed first end (241), while the free second end (242) is in contact with the shuttle (340, 3340), forces the shuttle (340, 3340) to move relative to the stopper (240) and to rotate the second gear (362), wherein the rotation of the second gear (362) moves the drive member (320, 3320) from the extended state to retract the needle (306).