A two-step automatic injection device

Abstract

A two-step automatic injection device is composed of a housing (10), a protective sleeve (11), a prefilled injection assembly (9), and a drive feedback device. The prefilled injection assembly (9) is loaded into the housing (10) and is covered on the needle (9.201) of the prefilled injection assembly (9) through the protective sleeve (11). When in use, the protective sleeve (11) directly contacts the injection part and presses to trigger the drive feedback device to achieve the injection function. The operation is fast and convenient, and the needle tip is hidden during the entire process. The drive feedback device of the piston (9.1) in the drive syringe (9.2) combines a release mechanism with a firing mechanism and a feedback mechanism. The release mechanism is triggered by pressing the protective sleeve (11), thereby achieving the release of the firing mechanism. At the moment of release, the firing mechanism and the feedback mechanism generate a sound signal and / or a tactile signal in the form of collision, etc., prompting the patient to start the injection. When the firing mechanism ends its movement, the firing mechanism and the feedback mechanism again generate a sound signal and / or a tactile signal in the form of collision, etc., prompting the user to end the injection.

Description

[0001] This application is a divisional application based on patent application number 202080081234.7 (PCT / CN2020 / 089782) filed on May 12, 2020, and entitled “A Two-step Automatic Injection Device” (date of entry into the Chinese national phase: June 10, 2022). Technical Field

[0002] The present invention relates to the technical field of injection device design, and in particular to a two-step automatic injection device. Background Art

[0003] With the development of science and technology and social progress, people have higher expectations for the use of injection devices. They hope that the operation steps of injection devices are simple; multi-dimensional feedback (such as auditory, visual, and tactile) during the injection process is provided to facilitate patient control of the entire injection process and reduce anxiety; the needle tip must be exposed before and after injection to avoid causing fear to the user; and features such as anti-accidental touch and / or anti-secondary use are also required. At the same time, higher requirements are being placed on product miniaturization, portability, ease of use, and cost-effectiveness. How to achieve these functions and meet market demands is currently attracting the attention of more and more engineers and technicians.

[0004] Existing syringes have the following disadvantages:

[0005] 1. Currently, in most cases, this type of product uses electric motors to power the motion mechanism, which consumes energy, has high operating costs, and is prone to environmental pollution. In addition, connecting with various transmission mechanisms will cause the overall size of the product to be too large, and there are certain requirements for the installation space and operating space of the place of use. It cannot be used in extreme situations such as small spaces.

[0006] 2. Currently, products using multi-dimensional feedback designs rely on electronic components for auditory and visual feedback, which requires a power supply. This can prevent the product from functioning properly in environments with strong electromagnetic interference. Furthermore, power supplies such as batteries are susceptible to environmental influences and aging. This makes it difficult to ensure the stability and reliability of the entire device when used in complex environments, and it is not suitable for long-term storage. Furthermore, to monitor the mechanism's motion status in real time, sensors and other components are required for feedback signals. This requires signal transmission, which is susceptible to interference from strong electromagnetic environments, rendering the product's feedback function ineffective.

[0007] 3. Currently, most of these automatic injection products on the market are inconvenient to operate, often requiring more than two steps, and requiring unlocking steps. The operation process is cumbersome and patient compliance is poor.

[0008] 4. The product needs to have a mechanism designed to prevent secondary triggering and use. Currently, most products use stop pins and other stop components that are inserted after use. In some cases, users may miss or lose the stop components. This design approach often violates human factors engineering design and is not in line with the development of the times.

[0009] 5. In order to achieve the automatic injection function, most existing products use structural designs such as snap-on designs, which use the elastic deformation of parts to complete release, locking and other actions. This design requires the snap-on structures and other structures to be in an unreleased state, often in a compressed and deformed state, which is not conducive to transportation and long-term storage, and is greatly affected by the environment. Such structures are prone to plastic deformation and lose their due elasticity during use, making it impossible to snap into the proper position, causing product failure.

[0010] 6. Existing products use mechanical impact to generate sound feedback. The impact and the thrust required for injection are powered by the injection spring, which can easily cause jamming and uneven force distribution, resulting in changes in injection time and injection volume, thereby reducing efficacy. Summary of the Invention

[0011] In response to the problems in the background technology, the present invention provides a two-step automatic injection device, comprising a housing, a protective sleeve disposed within the housing, a pre-filled injection assembly, and a drive feedback device, wherein one end of the housing is a proximal end and the other opposite end is a distal end;

[0012] The prefilled injection assembly includes a syringe, one end of which is provided with a needle, the other end of which is provided with a piston, and the syringe is filled with liquid medicine; the syringe is installed in the housing at one end close to the proximal end, and the needle at least partially extends out of the housing;

[0013] The drive feedback device includes a launching mechanism, a releasing mechanism, and a feedback mechanism. The launching mechanism is connected to the piston. The releasing mechanism is used to release the launching mechanism, and after the launching mechanism is released, it pushes the piston to move. The feedback mechanism is used to generate an audible signal and / or a tactile signal at the beginning and end of the movement of the launching mechanism, indicating the beginning and end of the movement of the launching mechanism.

[0014] The protective sleeve is arranged at the proximal end of the housing, one end of which extends into the housing to contact the release mechanism and is movable relative to the housing, and the other end of which extends out of the housing; the protective sleeve cover is arranged on the needle, and the end of the protective sleeve is provided with a channel for the needle to extend out;

[0015] The protective sleeve is pressed onto the injection part, and the protective sleeve moves from the proximal end to the distal end relative to the shell. When the protective sleeve moves, the needle extends from the channel and penetrates into the injection part. At the same time, the protective sleeve pushes the release mechanism to trigger the firing mechanism. The firing mechanism pushes the piston to move toward the side of the needle, and the piston pushes the liquid medicine to be injected from the needle into the injection part.

[0016] Preferably, a guide and limiting assembly is provided between the end of the protective sleeve extending into the shell and the inner wall of the shell.

[0017] Preferably, the guide limit assembly includes a slide groove arranged on the protective sleeve and a limit boss arranged on the inner wall of the shell. The limit boss is placed in the slide groove. When the protective sleeve moves relative to the shell, the limit boss moves along the slide groove. The limit boss moves until the slide groove moves to achieve limitation.

[0018] Preferably, a syringe protective cap is further included, wherein the syringe protective cap is arranged at the proximal end of the shell, the end of the protective sleeve is located in the syringe protective cap, and the syringe protective cap is detachably connected to the proximal end of the shell.

[0019] Preferably, the prefilled injection assembly further comprises a needle protection cap, which is disposed on the needle and is detachably connected to the syringe.

[0020] Preferably, the syringe protection cap is connected to the needle protection cap, and when the syringe protection cap is removed from the housing, the needle protection cap is driven to be removed from the syringe.

[0021] Preferably, the syringe protection cap and the needle protection cap are detachably connected via a snap assembly.

[0022] Preferably, the buckle assembly includes a hook structure arranged on the inner side of the syringe protection cap and a bayonet structure arranged on the outer side of the needle protection cap, and the hook structure is buckled in the bayonet structure to achieve connection.

[0023] Preferably, an inner hole boss is provided on the inner wall of the shell, the syringe and the drive feedback device are arranged on both sides of the inner hole boss, and the distal end of the syringe rests on the inner hole boss.

[0024] Preferably, the launching mechanism includes a guide tube, a push rod coaxially arranged in the guide tube, a first energy storage element for axial energy storage provided between the push rod and the guide tube; a first position limiting structure provided between the push rod and the guide tube; an end of the push rod toward the proximal end extends out of the guide tube and is coaxially connected to the piston;

[0025] The release mechanism includes a release sleeve coaxially sleeved on the outside of the guide tube, and a second limiting structure is provided on the release sleeve; one end of the protective sleeve extends into the outer shell and contacts the release sleeve; when the launching mechanism is not released, the second limiting structure cooperates with the first limiting structure to position the push rod in the guide tube; when the axial movement of the protective sleeve drives the axial movement of the release sleeve, the first limiting structure is separated from the second limiting structure, and under the action of the first energy storage element, the push rod is pushed to move axially from the distal end to the proximal end, and the launching mechanism is released.

[0026] Preferably, the feedback mechanism includes a feedback ring coaxially sleeved on the outside of the push rod, and a second energy storage element for storing energy in the circumferential direction is provided between the feedback ring and the push rod; a first convex portion is provided on the outer wall of the feedback ring, and a first guide groove for sliding of the first convex portion is provided on the inner wall of the guide tube along its axial direction; a start feedback portion and an end feedback portion are provided in the first guide groove; when the push rod starts and ends movement, the first convex portion passes through the start feedback portion and the end feedback portion respectively, and the second energy storage element drives the first convex portion to hit the side wall of the first guide groove, generating a sound signal and / or a tactile signal, indicating the start and end of the system movement.

[0027] Preferably, the first limiting structure includes a second protrusion provided on the outer wall of the push rod and a second guide groove provided on the inner wall of the guide tube, and the second protrusion is located in the second guide groove.

[0028] Preferably, the second limiting structure includes a third protrusion provided on the release sleeve, the guide tube is provided with a third guide groove penetrating the side wall of the guide tube along its axial direction, and the third protrusion is located in the third guide groove;

[0029] The second guide groove is arranged adjacent to the third guide groove, and one side of the second guide groove is circumferentially connected to the third guide groove; a fourth guide groove is further provided on the inner side wall of the guide tube and is axially connected to the third guide groove;

[0030] When the launching mechanism is not released, one side of the third protrusion abuts against one side of the second protrusion in the second guide groove, thereby limiting the circumferential position of the second protrusion; the second guide groove and the proximal end of the second protrusion are in matching inclined planes, and abut against each other to limit the axial position of the second protrusion;

[0031] When the release sleeve moves from the proximal end to the distal end, the third protrusion moves and separates from the second protrusion. Under the action of the first energy storage element, the second protrusion slides into the third guide groove and the fourth guide groove in sequence, and the second protrusion moves along the fourth guide groove.

[0032] Preferably, the push rod is provided with two symmetrically arranged second protrusions, and the guide tube is correspondingly provided with two second guide grooves;

[0033] The release sleeve is provided with two symmetrically arranged third protrusions, and the guide tube is provided with two third guide grooves and two fourth guide grooves at corresponding positions.

[0034] Preferably, the first energy storage element is a spring structure, which is coaxially arranged with the push rod;

[0035] An end cap is provided at the distal end of the guide tube, one end of the first energy storage element is connected to the push rod, and the other end is connected to the end cap; initially, the first energy storage element is in an energy storage state.

[0036] Preferably, one side of the first guide groove is in a three-stage stepped shape, and adjacent step transitions constitute the starting feedback portion and the ending feedback portion respectively.

[0037] Preferably, the first guide groove comprises a distal groove section, a middle groove section and a proximal groove section connected in sequence, the groove width of the distal groove section is smaller than the groove width of the middle groove section, and the groove width of the middle groove section is smaller than the groove width of the proximal groove section;

[0038] When the launching mechanism is not released, the first protrusion abuts against the side wall of the distal slot segment under the action of the second energy storage element; the release sleeve is pushed, triggering the axial movement of the push rod, and the first protrusion falls from the distal slot segment into the middle slot segment; when falling into the middle slot segment, the second energy storage element drives the feedback ring to rotate, causing the first protrusion to hit the side wall of the middle slot segment and generate an audible signal and / or a tactile signal, indicating that the launching mechanism has been released and the push rod has started to move;

[0039] The release sleeve continues to move from the distal end to the proximal end, and the first protrusion moves along the middle groove section; when the push rod movement stroke is completed, the first protrusion falls from the middle groove section into the proximal groove section; when falling into the proximal groove section, the second energy storage element drives the feedback ring to rotate, so that the first protrusion hits the side wall of the proximal groove section and generates a sound signal and / or a tactile signal, indicating that the push rod movement is completed.

[0040] Preferably, the feedback ring is provided with two symmetrically arranged first protrusions, and the guide tube is correspondingly provided with two first guide grooves.

[0041] Preferably, the second energy storage structure is a torsion spring structure and is coaxially sleeved on the push rod, one end of the torsion spring structure is connected to the feedback loop, and the other end is connected to the push rod; when not injected, the second energy storage structure is in an energy storage state.

[0042] Preferably, a self-locking component is further included for locking the release sleeve and the push rod after the push rod finishes moving.

[0043] Preferably, the self-locking component includes:

[0044] a third energy storage element disposed between the release sleeve and the guide tube, wherein the third energy storage element stores energy when the release sleeve moves from the proximal end to the distal end;

[0045] a first locking member provided on the proximal end of the release sleeve; and a second locking member provided on the push rod;

[0046] After the movement of the push rod is completed, the force applied to the protective sleeve is cancelled, the force applied to the release sleeve disappears, and the release sleeve is pushed from the distal end to the proximal end under the action of the third energy storage element, so that the first locking member and the second locking member are buckled together to achieve self-locking; at the same time, the release sleeve pushes the protective sleeve to move from the distal end to the proximal end, and the needle is retracted into the protective sleeve.

[0047] Preferably, the first locking member is a fourth protrusion provided on the inner side wall of the proximal end of the release sleeve, and one side of the fourth protrusion is inclined, so that the end of the fourth protrusion close to the proximal end is narrower than the end close to the distal end;

[0048] The first protrusion constitutes a second locking member;

[0049] A fifth guide groove is provided on the outer wall of the proximal end of the guide tube, and the fourth protrusion is located in the fifth guide groove; the end portion of the proximal end of the first guide groove is radially connected to the end portion of the proximal end of the fifth guide groove;

[0050] After the movement of the push rod is completed, the first protrusion moves to the end of the proximal end of the first guide groove and is partially located in the fifth guide groove; the release sleeve moves from the distal end to the proximal end, and when passing through the fourth protrusion, it pushes the first protrusion to move circumferentially and separate from the side wall of the first guide groove, and at the same time the first energy storage element stores energy; the fourth protrusion passes over the first protrusion and hooks on the end of the protrusion, and at the same time, the first protrusion hits the side wall of the first guide groove again under the action of the first energy storage element, and generates a sound signal and / or a tactile signal, indicating that the self-locking of the push rod is completed.

[0051] Preferably, the third energy storage element is a spring structure, and the third energy storage element is coaxially sleeved on the outside of the release sleeve; and one end of the third energy storage element is connected to the release sleeve, and the other end is connected to the push rod.

[0052] Preferably, an observation window for observing the advancement process of the piston is provided on the housing at a position corresponding to the syringe.

[0053] Due to the adoption of the above technical solution, the present invention has the following advantages and positive effects compared with the prior art:

[0054] 1. The two-step automatic injection device provided by the present invention consists of a housing, a protective sleeve, a prefilled injection assembly, and a drive feedback device. The prefilled injection assembly is loaded into the housing and covered by the protective sleeve over the needle tip of the prefilled injection assembly. During use, the protective sleeve directly contacts the injection portion and presses to trigger the drive feedback device to achieve the injection function. The operation is fast and convenient, and the needle tip is hidden throughout the process, reducing the user's anxiety and panic.

[0055] Moreover, the driving feedback device for driving the piston in the syringe effectively combines the release mechanism with the firing mechanism and the feedback mechanism through design. The release mechanism is triggered by pressing the protective sleeve, thereby realizing the release of the firing mechanism. At the moment of release, the firing mechanism and the feedback mechanism produce a sound signal and / or a tactile signal through collision or other forms, prompting the patient to start the injection; when the firing mechanism finishes moving, the firing mechanism and the feedback mechanism again produce a sound signal and / or a tactile signal through collision or other forms, prompting the user to end the injection, thereby facilitating the user to control the entire injection process and further reducing the risk of misoperation and anxiety and fear.

[0056] 2. The two-step automatic injection device provided by the present invention is entirely composed of a mechanical structure, which is easy to assemble. After the product is assembled, all components (except the energy storage mechanism) are in a natural state without stress deformation. The use conditions and service life are not restricted, and the product is stable and reliable. In addition, the entire system adopts a nested assembly method, and a single component can have multiple functions. The entire system has a compact structure and few parts, which can achieve miniaturization and micro-manufacturing, greatly reducing production costs.

[0057] In addition, the entire system only needs to push the protective sleeve to realize multiple functions such as one-step release, automatic feedback, anti-retraction self-locking, etc. The operation steps are simple, reducing the risk of user misoperation and omission.

[0058] 3. The two-step automatic injection device provided by the present invention, under the action of the second energy storage element, generates sound and / or vibration by the first protrusion striking the sidewall of the stepped first guide groove on the guide tube, thereby notifying the user of the current motion state of the entire system. This motion state feedback method facilitates the operator to monitor the motion state of the product and is applicable to a wide range of people and environments.

[0059] 4. In the two-step automatic injection device provided by the present invention, the release process of the entire drive feedback device adopts circumferential track change, from the initial position (second guide groove) to the motion track (fourth guide groove). The entire process does not achieve the release function through structural elastic deformation as in traditional designs, and the system reliability is high.

[0060] 5. The two-step automatic injection device provided by the present invention can achieve self-locking of the device after use through the provision of a self-locking component, thereby preventing secondary use or injury to personnel and environmental pollution when discarded; it can also prevent unnecessary human disassembly, which is conducive to the effective protection of internal parts. BRIEF DESCRIPTION OF THE DRAWINGS

[0061] The above and other features and advantages of the present invention will be more clearly understood through the following detailed description in conjunction with the accompanying drawings, in which:

[0062] Figure 1 A front view of the two-step automatic injection device provided by the present invention when not in use;

[0063] Figure 2 XX cross-sectional view of the two-step automatic injection device provided by the present invention when not in use;

[0064] Figure 3 A top view of the two-step automatic injection device provided by the present invention when not in use;

[0065] Figure 4 A YY cross-sectional view of the two-step automatic injection device provided by the present invention when not in use;

[0066] Figure 5 A disassembled schematic diagram of the two-step automatic injection device provided by the present invention;

[0067] Figure 6 A schematic diagram of the two-step automatic injection device provided by the present invention when the syringe protective cap is opened;

[0068] Figure 7 A diagram showing the use status of the two-step automatic injection device provided by the present invention;

[0069] Figure 8 A front view of the two-step automatic injection device provided by the present invention when in use;

[0070] Figure 9 Schematic diagram of the structure of the drive feedback device in the present invention;

[0071] Figure 10 Schematic diagram of the structure of the push rod in the present invention;

[0072] Figure 11 It is a front view of the push rod of the present invention;

[0073] Figure 12 is a side view of the push rod of the present invention;

[0074] Figure 13 AA sectional view of the push rod of the present invention;

[0075] Figure 14 Schematic diagram of the structure of the guide tube in the present invention;

[0076] Figure 15 For the front view of the guide tube in the present invention Figure 1 ;

[0077] Figure 16 For the front view of the guide tube in the present invention Figure 2 ;

[0078] Figure 17 is a side view of the guide tube of the present invention;

[0079] Figure 18 BB is a cross-sectional view of the guide tube of the present invention;

[0080] Figure 19 It is a CC cross-sectional view of the guide tube of the present invention;

[0081] Figure 20 DD is a cross-sectional view of the guide tube of the present invention;

[0082] Figure 21 It is a structural schematic diagram of the release sleeve in the present invention;

[0083] Figure 22 It is a front view of the release sleeve of the present invention;

[0084] Figure 23 EE is a cross-sectional view of the release sleeve of the present invention;

[0085] Figure 24 Schematic diagram of the structure of the feedback loop in the present invention;

[0086] Figure 25 It is a front view of the feedback loop in the present invention;

[0087] Figure 26 Schematic diagram of the structure of the end cover in the present invention;

[0088] Figure 27 4 is a radial cross-sectional view (from the proximal end to the distal end) of the driving feedback device of the present invention when no injection is performed;

[0089] Figure 28 This is a schematic diagram of the second limiting structure in the driving feedback device limiting the first limiting structure when no injection is performed in the present invention;

[0090] Figure 29 is an axial cross-sectional view of the present invention when the push rod is released;

[0091] Figure 30 A radial cross-sectional view (from the proximal end to the distal end of the system) of the present invention when the push rod is released; Figure 31 is an axial cross-sectional view of the present invention when the push rod is launched;

[0092] Figure 32 A radial cross-sectional view of the present invention when the push rod is fired (from the proximal end to the distal end of the system); Figure 33 is an axial cross-sectional view of the present invention during the push rod movement process;

[0093] Figure 34 A radial cross-sectional view of the present invention during push rod movement (from the proximal end to the distal end of the system); Figure 35 The axial cross-section of the present invention at the end of the push rod movement Figure 1 ;

[0094] Figure 36 A schematic diagram of the release sleeve resetting process in the present invention;

[0095] Figure 37 A radial cross-sectional view (from the proximal end to the distal end of the system) of the release sleeve resetting process of the present invention;

[0096] Figure 38 A schematic diagram of the release sleeve achieving self-locking in the present invention;

[0097] Figure 39 This is a schematic structural diagram of the guide tube in the modified solution of the present invention;

[0098] Figure 40 A view of a guide tube in a variation of the present invention;

[0099] Figure 41 FF sectional view of the guide tube in the alternative solution of the present invention;

[0100] Figure 42 Schematic diagram of the release sleeve achieving self-locking in the modification of the present invention Figure 1 ;

[0101] Figure 43 Schematic diagram of the release sleeve achieving self-locking in the modification of the present invention Figure 2 . DETAILED DESCRIPTION

[0102] The present invention will be described in more detail below with reference to the accompanying drawings illustrating embodiments of the present invention. However, the present invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and so that those skilled in the art will fully understand the scope of the present invention. In these drawings, the sizes and relative sizes of layers and regions may be exaggerated for clarity.

[0103] It should be noted that all directional indications in the embodiments of the present invention (such as up, down, left, right, front, back, etc.) are only used to explain the relative position relationship, movement status, etc. between the various components under a certain specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indication will also change accordingly.

[0104] The present invention provides a two-step automatic injection device suitable for outpatient treatment, patient self-injection and other occasions.

[0105] This two-step automatic injection device consists of a housing, a protective sleeve, a pre-filled injection assembly, and a drive feedback device. The pre-filled injection assembly is loaded into the housing and covered by the protective sleeve over the needle of the pre-filled injection assembly. During use, the protective sleeve directly contacts the injection part and presses to trigger the drive feedback device to achieve the injection function. The operation is fast and convenient, and the needle tip is hidden throughout the process, reducing the user's anxiety and panic.

[0106] Moreover, the driving feedback device for driving the piston in the syringe effectively combines the release mechanism with the firing mechanism and the feedback mechanism through design. The release mechanism is triggered by pressing the protective sleeve, thereby realizing the release of the firing mechanism. At the moment of release, the firing mechanism and the feedback mechanism generate a sound signal and / or a tactile signal through collision or the like, prompting the patient to start the injection; at the end of the movement of the firing mechanism, the firing mechanism and the feedback mechanism again generate a sound signal and / or a tactile signal through collision or the like, prompting the user that the injection is finished, thereby making it easier for the user to control the entire injection process and further reducing the risk of misoperation and anxiety and fear.

[0107] The following is a further description of specific embodiments:

[0108] Example 1

[0109] Reference Figure 1-38 The present invention provides a two-step automatic injection device comprising a housing 10, a protective sleeve 11 disposed within the housing 10, a pre-filled injection assembly 9, and a drive feedback device; wherein one end of the housing 10 is defined as a proximal end, and the other end thereof is defined as a distal end, i.e. Figure 1 As shown in , the left end is positioned as the proximal end and the right end is defined as the distal end.

[0110] In this embodiment, the housing 10 is a cylindrical structure with two ends open. Figure 5 Of course, in other embodiments, the housing 10 may also be a square tube structure, etc., which is not limited here and can be adjusted according to specific needs.

[0111] In this embodiment, combined with Figure 1-5 The prefilled injection assembly includes a syringe 9.2, with a needle 9.201 at one end and a piston 9.1 at the other end. Syringe 9.2 is pre-filled with a liquid medication 9.4 to be injected. Syringe 9.2 is coaxially mounted within the proximal end of housing 10, ensuring that needle 9.201 at least partially extends beyond the proximal end of housing 10. A drive feedback device is mounted within the distal end of housing 10 to drive piston 9.1.

[0112] In this embodiment, the protective sleeve 11 is disposed on the proximal end of the housing 10. One end of the protective sleeve 11 extends into the housing 10 and contacts the drive feedback device and is movable relative to the housing 10. The other end extends out of the housing 110. The protective sleeve 11 covers the needle 9.201 and is provided with a channel for the needle to extend. Figure 7 As shown in the figure, the protective sleeve 11 is pressed against the injection part, and the protective sleeve 11 moves from the proximal end to the distal end relative to the housing 10. When the protective sleeve 11 moves, the needle 9.201 extends from the channel and penetrates into the injection part of the person being injected. At the same time, the protective sleeve 11 triggers the drive feedback device, which drives the piston 9.1 to move toward the needle. The piston 9.1 pushes the liquid medicine from the needle 9.201 into the injection part.

[0113] Furthermore, a guide and limiting assembly is provided between the end of the protective sleeve 11 extending into the housing 10 and the inner wall of the housing 10. Specifically, Figure 5 As shown in the figure, one end of the protective sleeve 11 extending into the shell 10 has two cantilevers 1101, which are located between the shell 10 and the syringe, and extend to the drive feedback device to contact it; the guide limit assembly includes a slide groove 1102 arranged on the protective sleeve 11 and a limit boss 1004 arranged on the inner wall of the shell 10; of course, when the protective sleeve 11 extends into the shell 10, it encounters an obstruction from the limit boss 1004, and the cantilever 1101 retracts inward. When it passes over the limit boss 1004, the limit boss 1004 is embedded in the slide groove 1102; when the protective sleeve 11 is pushed, it can move relative to the shell 10, and the limit boss 1004 moves along the slide groove 1102, thereby ensuring the connection relationship between the protective sleeve 11 and the shell 10 while limiting the displacement of the protective sleeve 11.

[0114] Of course, in other embodiments, the specific structural form of the guide and limit assembly can also be adjusted according to specific needs, which is not limited here.

[0115] In this embodiment, an inner hole boss 1005 is provided on the inner wall of the shell 10, and the syringe 9.2 and the drive feedback device are arranged on both sides of the inner hole boss 1005. A flange edge is provided on the distal end of the syringe, and the syringe rests on the inner hole boss 1005 through the flange edge.

[0116] During assembly of the entire two-step automatic injection device, the syringe 9.2 is inserted through the proximal opening of the housing 10, with the flange edge of the syringe end resting on the inner hole boss 1005. The protective sleeve 11 is installed on the proximal end of the housing 10, so that the syringe 9.2 is restrained between the protective sleeve 11 and the inner hole boss 1005. The drive feedback device is inserted through the distal opening of the housing 10, and an end cap 1 is then installed on the distal end of the housing 10, so that the drive feedback device is restrained between the end cap 1 and the inner hole boss 1005. Assembly is complete.

[0117] In this embodiment, the two-step injection device further includes a syringe protective cap 12, which is disposed at the proximal end of the housing 10. The end of the protective sleeve 11 extending from the housing 10 is located within the syringe protective cap 12, and the syringe protective cap 12 is detachably connected to the proximal end of the housing 10. In this embodiment, the provision of the syringe protective cap 12 protects the protective sleeve 11, preventing accidental contact with the protective sleeve 11 when not in use, which could result in injection.

[0118] Among them, a lip 1003 is provided on the outer wall of the proximal end of the shell 10, and an annular protrusion 1201 is provided on the inner wall of the connecting end of the syringe protective cap 12. The syringe protective cap 12 is put on the proximal end of the shell 10, and the annular protrusion 1201 is stuck in the lip 1003 to realize a detachable connection. When injection is required, the syringe protective cap 12 can be directly pulled off; of course, in other embodiments, the detachable connection method between the syringe protective cap 12 and the shell 10 is not limited to the above description, for example, the detachable connection can also be achieved by threaded connection or other methods.

[0119] In this embodiment, the prefilled injection assembly further includes a needle protection cap 9.3, which is mounted on the needle and detachably connected to the syringe 9.2. Specifically, the needle protection cap 9.3 is directly attached to the syringe 9.2 through an interference fit. In this embodiment, the provision of the needle protection cap 9.3 further protects the syringe, preventing accidental contact when not in use.

[0120] Furthermore, the needle protection cap 9.3 is connected to the syringe protection cap 12. When it is needed for injection, the syringe protection cap 12 is removed from the housing 10, and the needle protection cap 9.3 is also removed from the syringe 9.2. Specifically, an extension arm is provided on the inner wall of the syringe protection cap 12. After the syringe protection cap 12 is connected to the housing 10, the extension arm extends from the channel at the end of the protective sleeve 11 for the needle to extend into the protective sleeve 11 and is detachably connected to the needle protection cap 9.3 via a snap assembly. The snap assembly includes a hook structure 1202 provided on the extension arm and a bayonet structure 9.301 provided on the outside of the needle protection cap 9.3. The hook structure 1202 is snapped into the bayonet structure 9.301 to achieve connection. Of course, in other embodiments, the connection method between the needle protection cap 9.3 and the syringe protection cap 12 is not limited to the above description and can be adjusted according to specific circumstances, which is not limited here.

[0121] In this embodiment, if Figure 8 In the figure, an observation window 1002 is provided on the housing 10 corresponding to the syringe 9.2 for observing the forward movement of the piston, wherein the syringe 9.2 is made of a transparent material, and the observation window 1002 can be an opening or a transparent part, which is not limited here; in this embodiment, the setting of the observation window 1002 allows the user to observe the entire injection process and achieve the effect of visual feedback.

[0122] In this embodiment, combined with Figure 4 and Figure 9-26 The driving feedback device includes a launching mechanism, a releasing mechanism and a feedback mechanism.

[0123] Among them, the launching mechanism includes a guide tube 2 and a push rod 8 coaxially arranged in the guide tube 2, a first energy storage element 7 for axial energy storage is provided between the push rod 8 and the guide tube 2, and the proximal end of the push rod 8 abuts against the piston 9.1; when the launching mechanism is not released, the push rod 8 is positioned in the guide tube 2 by the first limiting structure; the releasing mechanism includes a release sleeve 4 coaxially sleeved on the outside of the guide tube 2, and a second limiting structure is provided on the release sleeve 4, and the cantilever 1101 of the protective sleeve 11 extending into the shell 10 abuts against the proximal end of the release sleeve 4; when the launching mechanism is not released, the second limiting structure cooperates with the first limiting structure to realize the positioning of the push rod 8; when injection is required, the protective sleeve 11 is pushed axially, and the protective sleeve 11 further pushes the release sleeve 4 axially, the first limiting structure and the second limiting structure are separated, the second limiting structure fails, and under the action of the first energy storage element 7, the push rod 8 is pushed to move axially, thereby triggering the unlocking of the launching mechanism, and the push rod starts to push the piston 9.1 to move;

[0124] The feedback mechanism includes a feedback ring 6 coaxially sleeved on the outside of the push rod 8, and a second energy storage element 5 for storing energy in the circumferential direction is provided between the feedback ring 6 and the push rod 8. The feedback ring 6, the second energy storage element 5 and the push rod constitute an integral mechanism and can move together; a first convex portion 601 is provided on the outer wall of the feedback ring 6, and a first guide groove for sliding of the first convex portion 601 is provided on the inner wall of the guide tube 2 along its axial direction; a start feedback portion and an end feedback portion are provided in the first guide groove; when the push rod 8 starts and ends movement, the first convex portion 601 passes through the start feedback portion and the end feedback portion respectively, and the second energy storage element 5 drives the first convex portion 601 to hit the side wall of the first guide groove, generating a sound signal and / or a tactile signal, indicating the start and end of the system movement.

[0125] In this embodiment, the first energy storage element 7 is a spring structure, coaxially arranged with the push rod 8. Specifically, an end cap 1 is provided on the distal end of the guide tube 2, which is mounted to the distal end of the guide tube 2 via a snap-fit ​​connection. A deep mounting hole 802 is coaxially provided on the end of the push rod 8 facing the end cap 1. One end of the first energy storage element 7 extends into the mounting hole 802 and rests on the bottom of the hole, while the other end rests on the end cap 1. When not injecting, that is, when the push rod is not moving, the first energy storage element 7 is in an energy storage state.

[0126] Of course, in other embodiments, the first energy storage element can also be implemented by an elastic structure or a material with memory function, such as an air cushion structure; the specific installation method of the first energy storage element can also be adjusted according to the specific situation, and there is no restriction here, as long as the first energy storage element can store energy axially relative to the push rod 8 and the guide tube 2.

[0127] In this embodiment, the first limiting structure includes a second protrusion 801 arranged on the outer wall of the distal end of the push rod 8 and a second guide groove 202 arranged on the inner wall of the distal end of the guide tube 2, and the second protrusion 801 is located in the second guide groove 202; the end of the second protrusion 801 facing the proximal end is designed as a first inclined surface, and the end of the second protrusion 801 close to the proximal end is designed as a second inclined surface, and the first inclined surface is tightly pressed against the second inclined surface under the action of the first energy storage element.

[0128] The second limiting structure includes a third protrusion 401 provided at the distal end of the release sleeve 4. Specifically, the distal end of the release sleeve 4 is provided with a distal cantilever extending in the axial direction, and the third protrusion 401 is provided on the side of the distal cantilever end facing the guide tube 2. Figure 21-23As shown in ; a third guide groove 201 is provided along the axial direction of the distal end of the guide tube 2, which passes through the side wall of the guide tube 2, and the third protrusion 401 is located in the third guide groove 201; the second guide groove 202 is circumferentially adjacent to the third guide groove 201, and one side of the second guide groove 202 is circumferentially connected with the third guide groove 201; a fourth guide groove is further provided on the inner side wall of the guide tube 2, which is axially connected with the third guide groove 201, and the fourth guide groove extends from the distal end to the proximal end.

[0129] When not injected, Figure 4 、 Figures 27-28 As shown in , one side of the third protrusion 401 abuts against one side of the second protrusion 801 in the second guide groove 202, thereby limiting the circumferential position of the second protrusion 801; the second guide groove 202 and the second protrusion 801 toward the proximal end are tightly pressed by the inclined surface to achieve axial limitation; at this time, Figure 28 As shown in FIG, the first energy storage element 7 exerts an axial thrust F on the second protrusion 801. Due to the contact between the inclined surfaces, the thrust F can be decomposed into a force component F1 parallel to the inclined surface and a force component F2 perpendicular to the inclined surface.

[0130] When injection is required, the housing 10 is held by hand and the protective sleeve 11 is pressed against the target injection part. The protective sleeve 11 moves from the proximal end to the distal end, thereby pushing the release sleeve 4 to move axially from the proximal end to the distal end, and driving the third protrusion 401 to move distally along the third guide groove 201 and pass over the second protrusion 801. The circumferential limit of the second protrusion 801 fails. Figures 29-30 At this time, under the action of F1, the second protrusion 801 performs a spiral motion from the distal end to the proximal end (rotating while moving toward the proximal end). The second protrusion 801 first slides into the third guide groove 201, and then enters the fourth guide groove under the action of the F force. Figures 31-32 During the subsequent movement of the push rod 8, the second protrusion 801 moves along the fourth guide groove, as shown in Figures 33-34 As shown in .

[0131] In this embodiment, the release process of the entire drive feedback device adopts circumferential track changes, from the initial position (second guide groove) to the motion track (fourth guide groove). The entire process does not achieve the release function through structural elastic deformation in traditional designs, and the system reliability is high.

[0132] Furthermore, in this embodiment, preferably, the push rod 8 is provided with two symmetrically arranged second protrusions 801, and the guide tube 2 is provided with two corresponding second guide grooves 202; the release sleeve 4 is provided with two symmetrically arranged third protrusions 401, and the guide tube 2 is provided with two corresponding third guide grooves 201 and two fourth guide grooves. The present invention is provided with two symmetrically arranged first limiting structures and two symmetrically arranged second limiting structures, which is conducive to ensuring the stability of the limiting. Of course, in other embodiments, the number and arrangement of the first limiting structures and the second limiting structures can be adjusted according to specific circumstances. For example, there can be only three circumferentially evenly distributed first limiting structures and three circumferentially evenly distributed second limiting structures, and this is not limited here.

[0133] In this embodiment, one side of the first guide groove is in a three-stage stepped shape, and adjacent step transitions constitute a starting feedback portion and the end feedback portion respectively.

[0134] Specifically, such as Figure 18 As shown in , the first guide groove is divided into a distal groove section 203, an intermediate groove section 205, and a proximal groove section 207. The distal groove section 203, the intermediate groove section 205, and the proximal groove section 207 are sequentially connected from the distal end to the proximal end to form a complete first guide groove. The groove width of the distal groove section 203 is smaller than the groove width of the intermediate groove section 205, and the groove width of the intermediate groove section 205 is smaller than the groove width of the proximal groove section 207. The transition step 204 between the distal groove section 203 and the intermediate groove section 205 constitutes the starting feedback portion, and the transition step 206 between the intermediate groove section 205 and the proximal groove section 207 constitutes the ending feedback portion. The other side of the first guide groove can be straight, stepped, or other irregular shapes, which are not limited here.

[0135] When not injected, the second energy storage element 5 is in an energy storage state, with torque stored thereon. The first protrusion 601 is pressed against the side wall of the distal groove section 203 under the action of the torque of the second energy storage element 5 and is in a stationary state.

[0136] When the protective sleeve 11 pushes the release sleeve 4 to release the push rod 8, the push rod 8 drives the feedback ring 6 to move axially from the distal end to the proximal end. At the moment the push rod 8 is released, the first protrusion 601 passes over the transition step 204 from the distal groove section 203 and falls into the middle groove section 205. When falling into the middle groove section 205, since the groove width of the middle groove section 205 is greater than the groove width of the distal groove section 203, the feedback ring 6 is driven to rotate counterclockwise around the axis of the push rod 8 under the action of the torque force of the second energy storage element 5. Figures 31-32As shown in ; during this process, due to the large energy of the second energy storage element 5, the first protrusion 601 hits the side wall of the middle slot section 205, making a "click" sound, thereby prompting the user through a sound signal that the system is released and starts to move; of course, in other embodiments, when the first protrusion 601 hits the side wall of the middle slot section 205, a "click" sound and a vibration feeling are generated at the same time, thereby indicating that the system starts to move through a sound signal and a tactile signal, or, when the first protrusion 601 hits the side wall of the middle slot section 205, only a vibration feeling is generated, and the user indicates that the system starts to move through a tactile signal.

[0137] After the push rod is released, the release sleeve 4 continues to move from the distal end to the proximal end, and the first protrusion 601 moves along the middle groove section 205; preferably, the length of the middle groove section 205 is the movement stroke of the push rod 8 after being released.

[0138] When the push rod 8 completes its movement stroke, i.e., when the injection is completed, the first protrusion 601 passes over the transition step 206 from the middle groove section 205 and falls into the proximal groove section 207. When falling into the proximal groove section 207, since the groove width of the proximal groove section 207 is greater than the groove width of the middle groove section 205, the feedback ring 6 is driven by the torque force of the second energy storage element 5 to continue to rotate counterclockwise around the axis of the push rod 8. Figures 33-34 During this process, due to the large energy of the second energy storage element 5, the first protrusion 601 hits the side wall of the proximal groove section 207, making a "click" sound, thereby prompting the user through a sound signal that the system movement is over. Figure 35 As shown in ; of course, in other embodiments, when the first protrusion 601 hits the side wall of the proximal slot segment 207, a "click" impact sound and a vibration feeling are generated at the same time, thereby indicating the end of the system movement through sound signals and tactile signals. Alternatively, when the first protrusion 601 hits the side wall of the proximal slot segment 207, only a vibration feeling is generated, and the user indicates the end of the system movement through a tactile signal.

[0139] The drive feedback device provided by the present invention, under the action of the second energy storage element, generates sound and / or vibration by the first protrusion 601 hitting the side wall of the stepped first guide groove on the guide tube, thereby prompting the user of the current motion state of the entire system; this motion state feedback method facilitates the operator to control the motion state of the product, is suitable for a wide range of people, and can be used in various environments.

[0140] In this embodiment, the second energy storage element 5 is preferably a torsion spring structure, which is coaxially sleeved on the push rod 8. One end of the torsion spring structure is connected to the feedback ring 6, and the other end is connected to the push rod 8. Specifically, in this embodiment, the other end of the torsion spring structure is connected to the second protrusion 801. Of course, in other embodiments, the second energy storage element 5 can also be replaced by other elastic elements or materials with memory functions, which is not limited here.

[0141] In this embodiment, the feedback ring 6 preferably has two symmetrically arranged first protrusions 601, and the guide tube 2 has two corresponding first guide grooves. This arrangement helps ensure feedback stability and reliability. Of course, in other embodiments, more than two first protrusions 601 and first guide grooves may be provided, and this is not a limitation here.

[0142] In this embodiment, the drive feedback device further includes a self-locking component for releasing the locking of the sleeve 4 and the push rod 8 after the push rod 8 finishes moving.

[0143] When the syringe has a usage limit (single use) or the internal structure of the product needs to be protected after use, the syringe needs to be designed with relevant mechanisms to prevent the product from being triggered and used again. This embodiment solves the above problem by setting a self-locking component.

[0144] Specifically, the self-locking component includes a third energy storage element 3 arranged between the release sleeve 4 and the guide tube 2, a first locking piece arranged on the proximal end of the release sleeve 4, and a second locking piece arranged on the push rod 8; when the release sleeve 4 moves from the proximal end to the distal end, the third energy storage element 3 stores energy; after the push rod movement is completed (after the injection is completed), that is, when the first protrusion 601 hits the side wall of the proximal groove section 207, the user releases the injection device after obtaining the sound signal and / or tactile signal prompting the end of the system movement, and the force on the protective sleeve 11 disappears, that is, the external force applied to the release sleeve 4 is cancelled. Since energy was previously stored in the process of pushing the release sleeve 4 from the proximal end to the distal end, when the external force is cancelled, the third energy storage element 3 releases energy to push the release sleeve 4 from the distal end to the proximal end, and makes the first locking piece and the second locking piece engage together to achieve self-locking, thereby driving the feedback device to self-lock. During this process, the release sleeve 4 will also push the protective sleeve 11 from the distal end to the proximal end, so that the needle 9.201 is retracted into the protective sleeve 11, making the needle hidden. The self-locking of the drive feedback device can also prevent the protective sleeve 11 from retreating and prevent the needle from extending again.

[0145] Furthermore, in this embodiment, the first locking member is a fourth protrusion 402 provided on the inner side wall of the proximal end of the release sleeve 4. One side of the fourth protrusion 402 is inclined to form a wedge-shaped surface 403, so that the end of the fourth protrusion 402 near the proximal end is narrower than the end near the distal end. Figure 21 As shown in ; the first protrusion 601 constitutes the second locking member.

[0146] A fifth guide groove 208 is provided on the outer wall of the proximal end of the guide tube 2, and the fourth protrusion 402 is located in the fifth guide groove 208; further, the end portion of the proximal end of the first guide groove is radially connected to the end portion of the proximal end of the fifth guide groove 208, that is, the proximal groove section 207 is partially connected to the fifth guide groove 208, and the first protrusion 601 falls into the proximal groove section 207 and is partially located in the fifth guide groove 208, as shown in FIG. Figure 36 As shown in;

[0147] After the user receives the sound signal and / or tactile signal prompting the end of the system movement, he releases the injection device, and the force on the protective sleeve 11 disappears, that is, the external force applied to the release sleeve 4 is cancelled, and the release sleeve 4 moves from the distal end to the proximal end, driving the fourth protrusion 402 to move from the distal end to the proximal end along the fifth guide groove 208. At this time, the first protrusion 601 is partially located in the second guide groove 208, and a gap is formed between the side surface of the first protrusion 601 and the side wall of the fifth guide groove 208; when the fourth protrusion 402 moves toward the first protrusion 601 and passes through the above-mentioned gap, the wedge surface 403 contacts the first protrusion 601 and pushes the first protrusion 601 to rotate axially counterclockwise, as shown in FIG. Figure 37 As shown in , during this process, the first protrusion 601 drives the feedback loop to rotate counterclockwise, and causes the second energy storage element 5 to store energy; the fourth protrusion 402 continues to move toward the proximal end as the release sleeve 4 moves. When the fourth protrusion 402 passes over the first protrusion 601, the distal hook of the fourth protrusion 402 is locked on the proximal end of the first protrusion 601, thereby achieving the locking between the release sleeve 4 and the push rod 8, and then simultaneously achieving the locking of the entire injection device; in this process, at the same time, the first protrusion 601 is rotated clockwise under the action of the second energy storage element 5 and strikes the side wall of the proximal groove section 207, emitting a third "click" sound, thereby prompting the user through a sound signal that the self-locking of the entire injection device is completed, as shown in FIG. Figure 38 As shown in ; of course, in other embodiments, when the first protrusion 601 hits the side wall of the proximal slot section 207, a "click" impact sound and a vibration feeling are generated at the same time, thereby indicating that the system is self-locking through sound signals and tactile signals. Alternatively, when the first protrusion 601 hits the side wall of the proximal slot section 207, only a vibration feeling is generated, and the user indicates that the system is self-locking through a tactile signal.

[0148] The self-locking assembly provided in this embodiment directly utilizes the feedback ring on the feedback mechanism to cooperate with the fourth protrusion 402 on the release sleeve to achieve locking. It is cleverly designed, simple in structure, and has multiple uses, which greatly simplifies the system structure. At the same time, it also uses sound signals and / or tactile signals to indicate that the device is self-locking, making it easier for the operator to control the movement status of the product. It is suitable for a wide range of people and can be used in various environments.

[0149] The working principle of the two-step automatic injection device provided by the present invention is further described below, specifically:

[0150] When the injection device is not in use, the third protrusion 401 in the internal drive feedback device radially abuts against the second protrusion 801, thereby positioning the push rod in the guide tube, and the entire drive feedback device is in a relatively static state;

[0151] When an injection is required, the syringe protective cap 12 is pulled off, and the needle protective cap 9.3 is also pulled off. The housing 10 is held by hand, and the protective sleeve 11 is pressed down against the injection site. At this time, the protective sleeve 11 is pushed to move from the proximal end to the distal end, and then the release sleeve 4 is pushed to move from the proximal end to the distal end. The release sleeve 4 drives the third protrusion 401 to separate from the second protrusion 801, and the second protrusion 801 is radially released. Under the action of the first energy storage element, the whole composed of the second protrusion 801, the push rod 8, and the feedback ring 6 performs a spiral movement (i.e., displacement occurs in both axial and circumferential directions), so that the second protrusion 801 is transferred from the second guide groove to the fourth guide groove to achieve axial release, and the push rod 8 is released. At the same time, the axial movement of the feedback ring 6 drives the protrusion to fall from the distal groove section 203 into the middle groove section 205, and under the action of the second storage element, it knocks on the side wall of the middle groove section 205, making a first "click" impact sound, prompting the user that the push rod starts to move, that is, the injection starts.

[0152] After the push rod is released, under the action of the first energy storage element 7, the push rod moves from the distal end to the proximal end; during this process, the first protrusion 601 moves along the middle groove section 205 of the first guide groove, and the second protrusion 801 moves along the fourth guide groove, thereby guiding the axial movement of the push rod.

[0153] When the push rod completes its movement, i.e., the injection is completed, the first protrusion 601 just falls from the middle groove section 207 into the proximal groove section 207 and, under the action of the second accumulator, strikes the side wall of the proximal groove section 207, emitting a second "click" sound, which notifies the user that the push rod movement has ended, i.e., the injection is completed.

[0154] After the user hears the second "click" sound, they release the syringe device. Under the action of the third energy storage element 3, the release sleeve 4 moves from the distal end to the proximal end, driving the fourth protrusion 402 along the fifth guide groove 208 and pushing the first protrusion 601 to rotate so that it passes over the first protrusion 601 and hooks with it to achieve locking. During this process, the first protrusion 601 is pushed and rotated again and reset. The first protrusion 601 hits the side wall of the proximal groove section 207 again, emitting a third "click" sound, notifying the user that the device has been self-locked. During this process, the release sleeve 4 also pushes the protective sleeve 11 from the distal end to the proximal end, causing the needle 9, 201 to retract into the protective sleeve 11, concealing the needle.

[0155] The two-step automatic injection device provided by the present invention has the following advantages:

[0156] 1. The entire injection device is composed entirely of mechanical structures, which makes assembly easy. After the product is assembled, all components (except the energy storage mechanism) are in a natural state without stress deformation. There are no restrictions on usage conditions and service life, and the product is stable and reliable. In addition, the present invention can be divided into subsystems (such as the drive feedback device as a subsystem, the filling injection device as a subsystem, and the housing, protective sleeve, and syringe protective cap as a subsystem) and provided to pharmaceutical companies for final assembly. This method ensures that the pre-filled injection device (containing the drug solution) is assembled in subsequent steps, reducing the probability of the entire product being scrapped due to unqualified remaining components, which is of great help to manufacturers in reducing costs.

[0157] 2. In addition to visual feedback, the present invention can also provide auditory and tactile feedback, making it easier for the operator to control the injection status of the product. It is suitable for a wide range of people and can be used in a variety of environments;

[0158] 3. The product is easy to use and has simple operating steps. Through two-step operation, it can realize multiple functions such as automatic injection, feedback, anti-retraction and self-locking, reducing the risk of user misoperation;

[0159] 4. The power source for generating the feedback signal of the present invention is different from the injection power source, which reduces the phenomenon of jamming caused by uneven power distribution during the injection process. The feedback signal is more obvious, especially when the injection is completed, the feedback signal does not decay due to the decay of the injection force, so the operator can better identify the feedback signal.

[0160] 5. The entire injection device adopts nested assembly, and the core components can have multiple functions. The entire product structure is compact, with fewer parts, and can be miniaturized and micro-miniaturized, greatly reducing production costs;

[0161] 6. The needle tip of the injection device is not exposed before and after use, which reduces the patient's fear. After use, the release mechanism can be self-locked to prevent secondary use or injury to personnel and environmental pollution when discarded; it can also prevent unnecessary human disassembly and is conducive to effective protection of internal parts.

[0162] Example 2

[0163] This embodiment is an adjustment based on the embodiment 1. Compared with the embodiment 1, this embodiment adjusts the self-locking component.

[0164] Reference Figures 39-43 Specifically, in the present embodiment, the first locking member in the self-locking assembly adopts an elastic soft tongue 404, one end of the elastic soft tongue 404 is connected to the release sleeve 4, and the other end is extended toward the proximal end and the interior of the release sleeve 4, and the end of the other end of the elastic soft tongue 404 is provided with a hook; and a through groove is provided on the guide tube 2 for the elastic soft tongue 404 to extend into the guide tube 2, and the other end of the elastic soft tongue 404 extends toward the proximal end while passing through the through hole into the guide tube, and the through groove is connected with the proximal groove section 207; the second locking member directly adopts the first convex portion 601, and the first convex portion 601 and the hook are both provided with matching inclined surfaces.

[0165] After the push rod is moved, the first protrusion 601 is located in the proximal groove section 207; the release sleeve 4 is loosened, and the release sleeve 4 moves from the distal end to the proximal end under the action of the third energy storage element 3. When the hook portion of the elastic soft tongue 404 passes through the first protrusion 601, the inclined surface of the hook portion of the elastic soft tongue 404 interacts along the inclined surface of the first protrusion 601 and pushes the elastic soft tongue 404 to open outward, so that the hook portion of the elastic soft tongue 404 can smoothly pass over the first protrusion 601. Figure 41 After the hook portion of the elastic soft tongue 404 passes over the first convex portion 601, the elastic soft tongue 404 is reset under the action of its own elastic force and makes the hook portion hooked on the first convex portion 601 to achieve locking, thereby achieving self-locking of the system, as shown in FIG. Figure 42 As shown in .

[0166] Those skilled in the art will appreciate that the present invention may be implemented in many other specific forms without departing from its spirit or scope. Although embodiments of the present invention have been described, it should be understood that the present invention is not limited to these embodiments, and those skilled in the art may make changes and modifications within the spirit and scope of the present invention as defined by the appended claims.

Claims

1. A two-step automatic injection device, characterized in that: It includes a housing, a protective sleeve, a pre-filled injection assembly, and a drive feedback device arranged in the housing, wherein one end of the housing is a proximal end and the other end opposite thereto is a distal end; The prefilled injection assembly comprises a syringe, one end of which is provided with a needle, the other end of which is provided with a piston, and the syringe is filled with liquid medicine; the syringe is installed in the housing at one end close to the proximal end; The drive feedback device includes a launching mechanism, a releasing mechanism, and a feedback mechanism. The launching mechanism is used to push the liquid medicine in the prefilled injection assembly; the releasing mechanism is used to realize the release of the launching mechanism; and the feedback mechanism is used to generate an audible signal and / or a tactile signal at the start and end of the movement of the launching mechanism. The launching mechanism includes a guide tube and a push rod; The feedback mechanism includes a feedback ring sleeved on the outside of the push rod, and a second energy storage element is provided between the feedback ring and the push rod; a first convex portion is provided on the outer wall of the feedback ring, and a first guide groove for sliding of the first convex portion is provided on the inner wall of the guide tube along its axial direction; a start feedback portion and an end feedback portion are provided in the first guide groove; when the push rod starts and ends movement, the first convex portion passes through the start feedback portion and the end feedback portion respectively, and the second energy storage element drives the first convex portion to hit the side wall of the first guide groove, generating a sound signal and / or a tactile signal to prompt the user to start and end the movement.

2. The two-step automatic injection device according to claim 1, characterized in that: The protective sleeve is pressed onto the injection part, and the protective sleeve moves from the proximal end to the distal end relative to the shell. When the protective sleeve moves, the needle extends from the channel and penetrates into the injection part. At the same time, the protective sleeve pushes the release mechanism to trigger the firing mechanism. The firing mechanism pushes the piston to move toward the side of the needle, and the piston pushes the liquid medicine from the needle into the injection part.

3. The two-step automatic injection device according to claim 1, characterized in that: A guide and limiting component is provided between the end of the protective sleeve extending into the shell and the inner wall of the shell.

4. The two-step automatic injection device according to claim 3, characterized in that: The guide and limiting assembly includes a slide groove arranged on the protective sleeve and a limiting boss arranged on the inner wall of the shell. The limiting boss is placed in the slide groove. When the protective sleeve moves relative to the shell, the limiting boss moves along the slide groove. The limiting boss moves until the slide groove moves to achieve limitation.

5. The two-step automatic injection device according to claim 1, characterized in that: It also includes a syringe protection cap, which is arranged at the proximal end of the shell. The end of the protection sleeve is located in the syringe protection cap, and the syringe protection cap is detachably connected to the proximal end of the shell.

6. The two-step automatic injection device according to claim 5, characterized in that: The prefilled injection assembly further comprises a needle protection cap, which is disposed on the needle and is detachably connected to the syringe.

7. The two-step automatic injection device according to claim 6, characterized in that: The syringe protection cap is connected to the needle protection cap, and when the syringe protection cap is removed from the shell, the needle protection cap is driven to be removed from the syringe.

8. The two-step automatic injection device according to claim 1, characterized in that: An inner hole boss is provided on the inner wall of the shell, the syringe and the drive feedback device are arranged on both sides of the inner hole boss, and one end of the syringe facing the distal end abuts against the inner hole boss.

9. The two-step automatic injection device according to claim 1, characterized in that: A first limiting structure is provided between the push rod and the guide tube. The first limiting structure includes a second protrusion provided on the outer wall of the push rod and a second guide groove provided on the inner wall of the guide tube. The second protrusion is located in the second guide groove.

10. The two-step automatic injection device according to claim 9, characterized in that: The release mechanism includes a release sleeve coaxially sleeved on the outside of the guide tube, the release sleeve being provided with a second limiting structure; the second limiting structure including a third protrusion provided on the release sleeve; the guide tube being provided with a third guide groove extending through a side wall of the guide tube along its axial direction, the third protrusion being located within the third guide groove; the second guide groove being provided adjacent to the third guide groove, and one side of the second guide groove being circumferentially connected to the third guide groove; and a fourth guide groove being further provided on the inner side wall of the guide tube being axially connected to the third guide groove; When the launching mechanism is not released, one side of the third protrusion abuts against one side of the second protrusion in the second guide groove, thereby limiting the circumferential position of the second protrusion; the second guide groove and the proximal end of the second protrusion are in matching inclined planes, and abut against each other to limit the axial position of the second protrusion; When the release sleeve moves from the proximal end to the distal end, the third protrusion moves and separates from the second protrusion. Under the action of the first energy storage element, the second protrusion slides into the third guide groove and the fourth guide groove in sequence, and the second protrusion moves along the fourth guide groove.

11. The two-step automatic injection device according to claim 10, characterized in that: The push rod is provided with two symmetrically arranged second protrusions, and the guide tube is correspondingly provided with two second guide grooves; the release sleeve is provided with two symmetrically arranged third protrusions, and the guide tube is correspondingly provided with two third guide grooves and two fourth guide grooves.

12. The two-step automatic injection device according to claim 1, wherein: A first energy storage element for axial energy storage is provided between the push rod and the guide tube. The first energy storage element is a spring structure and is coaxially arranged with the push rod. An end cap is provided at the distal end of the guide tube. One end of the first energy storage element is connected to the push rod, and the other end is connected to the end cap. Initially, the first energy storage element is in an energy storage state.

13. The two-step automatic injection device according to claim 1, wherein: One side of the first guide groove is in a three-stage stepped shape, and adjacent step transitions constitute the starting feedback portion and the ending feedback portion respectively.

14. The two-step automatic injection device according to claim 10, wherein: The first guide groove comprises a distal groove section, a middle groove section and a proximal groove section connected in sequence, the groove width of the distal groove section is smaller than the groove width of the middle groove section, and the groove width of the middle groove section is smaller than the groove width of the proximal groove section; When the launching mechanism is not released, the first protrusion abuts against the side wall of the distal slot segment under the action of the second energy storage element; Pushing the release sleeve triggers the axial movement of the push rod, causing the first protrusion to slide from the distal groove section into the middle groove section. When the first protrusion slides into the middle groove section, the second energy storage element drives the feedback ring to rotate, causing the first protrusion to strike the side wall of the middle groove section and generate an audible signal and / or a tactile signal, indicating that the firing mechanism has been released and the push rod has begun to move. The release sleeve continues to move from the distal end to the proximal end, and the first protrusion moves along the middle groove section; when the push rod movement stroke is completed, the first protrusion falls from the middle groove section into the proximal groove section; when falling into the proximal groove section, the second energy storage element drives the feedback ring to rotate, so that the first protrusion hits the side wall of the proximal groove section and generates a sound signal and / or a tactile signal, indicating that the push rod movement is completed.

15. The two-step automatic injection device according to claim 1, characterized in that: The feedback ring is provided with two symmetrically arranged first protrusions, and the guide tube is correspondingly provided with two first guide grooves.

16. The two-step automatic injection device according to claim 1, wherein: The second energy storage element is a torsion spring structure and is coaxially sleeved on the push rod. One end of the torsion spring structure is connected to the feedback loop, and the other end is connected to the push rod. When no injection is performed, the second energy storage element is in an energy storage state.

17. The two-step automatic injection device according to claim 10, wherein: The push rod is capable of acting on the prefilled injection assembly; one end of the protective sleeve extends into the housing and contacts the release sleeve; when the firing mechanism is not released, the second limiting structure cooperates with the first limiting structure to position the push rod; when the protective sleeve moves axially and drives the release sleeve to move axially, the first limiting structure separates from the second limiting structure, and under the action of the first energy storage element, the push rod is pushed axially from the distal end to the proximal end, and the firing mechanism is released; The first locking member is a fourth protrusion provided on the inner side wall of the proximal end of the release sleeve, and one side of the fourth protrusion is inclined, so that the end of the fourth protrusion close to the proximal end is narrower than the end close to the distal end; The first protrusion constitutes a second locking member; A fifth guide groove is provided on the outer wall of the proximal end of the guide tube, and the fourth protrusion is located in the fifth guide groove; the end portion of the proximal end of the first guide groove is radially connected to the end portion of the proximal end of the fifth guide groove; After the movement of the push rod is completed, the first protrusion moves to the end of the proximal end of the first guide groove and is partially located in the fifth guide groove; the release sleeve moves from the distal end to the proximal end, and when passing through the fourth protrusion, it pushes the first protrusion to move circumferentially and separate from the side wall of the first guide groove, and at the same time the first energy storage element stores energy; after the fourth protrusion passes over the first protrusion, it hooks on the end of the first protrusion, and at the same time, the first protrusion hits the side wall of the first guide groove again under the action of the first energy storage element, and generates a sound signal and / or a tactile signal, indicating that the self-locking of the push rod is completed.

18. The two-step automatic injection device according to claim 10, wherein: The third energy storage element is a spring structure, and the third energy storage element is coaxially sleeved on the outside of the release sleeve; and one end of the third energy storage element is connected to the release sleeve, and the other end is connected to the push rod.

19. A two-step automatic injection device, characterized in that: It includes a housing, a protective sleeve, a pre-filled injection assembly, a drive feedback device, and a self-locking assembly arranged in the housing, wherein one end of the housing is a proximal end and the other end opposite thereto is a distal end; The prefilled injection assembly comprises a syringe, one end of which is provided with a needle, the other end of which is provided with a piston, and the syringe is filled with liquid medicine; the syringe is installed in the housing at one end close to the proximal end; The driving feedback device includes a launching mechanism, a releasing mechanism and a feedback mechanism. The launching mechanism is used to push the liquid medicine in the pre-filled injection assembly; the releasing mechanism is used to realize the release of the launching mechanism. The launching mechanism includes a guide tube and a push rod, the releasing mechanism includes a releasing sleeve sleeved outside the guide tube, and the self-locking assembly includes: a third energy storage element arranged between the releasing sleeve and the guide tube, and when the releasing sleeve moves from the proximal end to the distal end, the third energy storage element stores energy; a first locking piece arranged on the proximal end of the releasing sleeve; a second locking piece arranged on a feedback ring sleeved outside the pushing rod, and the second locking piece is a first protrusion arranged on the outer wall of the feedback ring; after the pushing rod ends its movement, the force applied to the protective sleeve is canceled, and the force applied to the releasing sleeve disappears. Under the action of the third energy storage element, the releasing sleeve is pushed to move from the distal end to the proximal end, and the first locking piece and the second locking piece are fastened together to achieve self-locking.

20. The two-step automatic injection device according to claim 19, wherein: The protective sleeve is pressed onto the injection part, and the protective sleeve moves from the proximal end to the distal end relative to the shell. When the protective sleeve moves, the needle extends from the channel and penetrates into the injection part. At the same time, the protective sleeve pushes the release mechanism to trigger the firing mechanism. The firing mechanism pushes the piston to move toward the side of the needle, and the piston pushes the liquid medicine from the needle into the injection part.

21. The two-step automatic injection device according to claim 19, wherein: A guide and limiting assembly is provided between one end of the protective sleeve extending into the shell and the inner wall of the shell.

22. The two-step automatic injection device according to claim 21, characterized in that The guide and limiting assembly includes a slide groove arranged on the protective sleeve and a limiting boss arranged on the inner wall of the shell. The limiting boss is placed in the slide groove. When the protective sleeve moves relative to the shell, the limiting boss moves along the slide groove. The limiting boss moves until the slide groove moves to achieve limitation.

23. The two-step automatic injection device according to claim 19, wherein: It also includes a syringe protection cap, which is arranged at the proximal end of the shell. The end of the protection sleeve is located in the syringe protection cap, and the syringe protection cap is detachably connected to the proximal end of the shell.

24. The two-step automatic injection device according to claim 23, wherein: The prefilled injection assembly further comprises a needle protection cap, which is disposed on the needle and is detachably connected to the syringe.

25. The two-step automatic injection device according to claim 24, characterized in that: The syringe protection cap is connected to the needle protection cap, and when the syringe protection cap is removed from the shell, the needle protection cap is driven to be removed from the syringe.

26. The two-step automatic injection device according to claim 19, wherein: An inner hole boss is provided on the inner wall of the shell, the syringe and the drive feedback device are arranged on both sides of the inner hole boss, and one end of the syringe facing the distal end abuts against the inner hole boss.

27. The two-step automatic injection device according to claim 19, wherein: A first limiting structure is provided between the push rod and the guide tube. The first limiting structure includes a second protrusion provided on the outer wall of the push rod and a second guide groove provided on the inner wall of the guide tube. The second protrusion is located in the second guide groove.

28. The two-step automatic injection device according to claim 27, wherein: A first energy storage element is provided between the push rod and the guide tube; a second limiting structure is provided on the release sleeve, the second limiting structure including a third protrusion provided on the release sleeve; a third guide groove is provided along the axial direction of the guide tube and passes through the side wall of the guide tube, and the third protrusion is located in the third guide groove; the second guide groove is provided adjacent to the third guide groove, and one side of the second guide groove is circumferentially connected to the third guide groove; a fourth guide groove is further provided on the inner side wall of the guide tube and is axially connected to the third guide groove; When the launching mechanism is not released, one side of the third protrusion abuts against one side of the second protrusion in the second guide groove, thereby limiting the circumferential position of the second protrusion; the second guide groove and the proximal end of the second protrusion are in matching inclined planes, and abut against each other to limit the axial position of the second protrusion; When the release sleeve moves from the proximal end to the distal end, the third protrusion moves and separates from the second protrusion. Under the action of the first energy storage element, the second protrusion slides into the third guide groove and the fourth guide groove in sequence, and the second protrusion moves along the fourth guide groove.

29. The two-step automatic injection device according to claim 28, wherein: The push rod is provided with two symmetrically arranged second protrusions, and the guide tube is correspondingly provided with two second guide grooves; the release sleeve is provided with two symmetrically arranged third protrusions, and the guide tube is correspondingly provided with two third guide grooves and two fourth guide grooves.

30. The two-step automatic injection device according to claim 28, wherein: The first energy storage element is a spring structure and is coaxially arranged with the push rod; An end cap is provided at the distal end of the guide tube. One end of the first energy storage element is connected to the push rod, and the other end is connected to the end cap. Initially, the first energy storage element is in an energy storage state.

31. The two-step automatic injection device according to claim 28, wherein: The feedback mechanism includes the feedback ring sleeved on the outside of the push rod, the first convex portion is provided on the outer wall of the feedback ring, and the first guide groove for sliding of the first convex portion is provided on the inner wall of the guide tube along its axial direction. One side of the first guide groove is in a three-stage stepped shape, and adjacent step transitions respectively constitute a starting feedback portion and an ending feedback portion.

32. The two-step automatic injection device according to claim 31, wherein: A second energy storage element is provided between the feedback loop and the push rod, the first guide groove includes a distal groove section, an intermediate groove section and a proximal groove section connected in sequence, the groove width of the distal groove section is smaller than the groove width of the intermediate groove section, and the groove width of the intermediate groove section is smaller than the groove width of the proximal groove section; When the launching mechanism is not released, the first protrusion abuts against the side wall of the distal slot segment under the action of the second energy storage element; Pushing the release sleeve triggers the axial movement of the push rod, causing the first protrusion to slide from the distal groove section into the middle groove section. When the first protrusion slides into the middle groove section, the second energy storage element drives the feedback ring to rotate, causing the first protrusion to strike the side wall of the middle groove section and generate an audible signal and / or a tactile signal, indicating that the firing mechanism has been released and the push rod has begun to move. The release sleeve continues to move from the distal end to the proximal end, and the first protrusion moves along the middle groove section; when the push rod movement stroke is completed, the first protrusion falls from the middle groove section into the proximal groove section; when falling into the proximal groove section, the second energy storage element drives the feedback ring to rotate, so that the first protrusion hits the side wall of the proximal groove section and generates a sound signal and / or a tactile signal, indicating that the push rod movement is completed.

33. The two-step automatic injection device according to claim 31, wherein: The feedback ring is provided with two symmetrically arranged first protrusions, and the guide tube is correspondingly provided with two first guide grooves.

34. The two-step automatic injection device according to claim 32, wherein: The second energy storage element is a torsion spring structure and is coaxially sleeved on the push rod. One end of the torsion spring structure is connected to the feedback loop, and the other end is connected to the push rod. When no injection is performed, the second energy storage element is in an energy storage state.

35. The two-step automatic injection device according to claim 31, wherein: The push rod is capable of acting on the prefilled injection assembly; one end of the protective sleeve extends into the housing and contacts the release sleeve; when the firing mechanism is not released, the second limiting structure cooperates with the first limiting structure to position the push rod; when the protective sleeve moves axially and drives the release sleeve to move axially, the first limiting structure separates from the second limiting structure, and under the action of the first energy storage element, the push rod is pushed axially from the distal end to the proximal end, and the firing mechanism is released; The first locking member is a fourth protrusion provided on the inner side wall of the proximal end of the release sleeve, and one side of the fourth protrusion is inclined, so that the end of the fourth protrusion close to the proximal end is narrower than the end close to the distal end; The first protrusion constitutes a second locking member; A fifth guide groove is provided on the outer wall of the proximal end of the guide tube, and the fourth protrusion is located in the fifth guide groove; the end portion of the proximal end of the first guide groove is radially connected to the end portion of the proximal end of the fifth guide groove; After the push rod movement is completed, the first protrusion moves to the end of the proximal end of the first guide groove and is partially located in the fifth guide groove; the release sleeve moves from the distal end to the proximal end, and when passing through the fourth protrusion, it pushes the first protrusion to move circumferentially and separate from the side wall of the first guide groove, and at the same time the first energy storage element stores energy; after the fourth protrusion passes over the first protrusion, it hooks on the end of the first protrusion, and at the same time, the first protrusion hits the side wall of the first guide groove again under the action of the first energy storage element, and generates a sound signal and / or a tactile signal, indicating that the self-locking of the push rod is completed.

36. The two-step automatic injection device according to claim 19, wherein: The third energy storage element is a spring structure, and the third energy storage element is coaxially sleeved on the outside of the release sleeve; and one end of the third energy storage element is connected to the release sleeve, and the other end is connected to the push rod.

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